MDedge Rheumatology

In a national study of older Danes who had previously had a fracture and were taking bisphosphonates, the risk of having a serious though rare atypical femoral fracture (AFF) was greater after 3-5 years of bisphosphonate use.

The risk quickly dropped after patients stopped taking a bisphosphonate, which suggests that bisphosphonate “holidays” may be useful for some patients, the researchers said. These findings support previous work.

But the study also found that 34% of the AFFs occurred in patients who had not been taking a bisphosphonate. That rate is higher than the 6%-22% that has been reported by others.

Doug Bauer, MD, from the University of California, San Francisco, presented the new study findings during the virtual American Society of Bone and Mineral Research 2020 annual meeting.

“We found no clear risk factor that accounts for this increased risk [for AFFs] among those not exposed to bisphosphonates,” he said, “but we believe this was a real finding, as our study protocol ensured that the study radiologists were completely blinded to treatments received.”

Suzanne N. Morin, MD, who was not involved in this research, pointed out that the reported AFF risks related to bisphosphonate dose and cessation are in keeping with findings of other studies, including a recent large study by Dennis M. Black, MD, and colleagues that was published in the New England Journal of Medicine.

That study found that Asians are at higher risk for AFFs than White persons. Others have reported that specific femur geometry or physique and use of glucocorticoids increase AFF risk, Dr. Morin, from the Research Institute of the McGill University Health Center, Montreal, said in an interview.

The current study suggests that rheumatoid arthritis may be a risk factor, she added.

The fact that the rate of AFFs among patients who had not been exposed to bisphosphonates was higher than previously reported “may be due to differences in the method they used to ascertain the fractures or in medication use,” she speculated.

The clinical implications of research to date are that “the risk of AFF should not dissuade patients and providers from short-term use of bisphosphonates [3-5 years],” Dr. Bauer said. He noted that most patients should not take a bisphosphonate for longer than this unless they have a very high fracture risk.

Similarly, Dr. Morin said that clinicians “should consider initiating bisphosphonate in those at high risk for fractures and reevaluate their use after 3-6 years, depending on individual’s risk profile.”

AFF is serious but rare complication of bisphosphonate use

“Since first reported over 10 years ago, it has become clear that AFFs are a rare but serious complication of bisphosphonate therapy,” Dr. Bauer explained. However, there is still uncertainty about the magnitude of this risk, including the absolute risk for AFFs among adults who take bisphosphonates and those who do not.

To study this, the researchers analyzed data from national health care and pharmacy records and a radiology image database in Denmark. They identified almost 5,000 adults who were aged 50 years or older and who experienced a subtrochanteric and femoral shaft fracture during the period from 2010 to 2015. Two expert radiologists who were blinded to the patients’ clinical history or treatment identified AFF on the basis of ASBMR 2014 criteria.

The researchers compared three patient groups: 189 patients with AFF, 2,397 patients with typical subtrochanteric and femoral shaft fractures (no AFF), and35,946 adults aged older than 50 years (control persons).

Compared with patients with typical fractures, patients with AFF were younger (aged 71 vs. 77), more likely to be women (79% vs. 69%), and more likely to have RA (12% vs. 2.5%).

Compared with patients in the other two groups, those with AFF were more likely to use corticosteroids, proton pump inhibitors, statins, and hormone replacement therapy.

They were also more likely to use bisphosphonates (58%) than patients with typical subtrochanteric and femoral shaft fractures (19%) or control patients (10%).

The bisphosphonates used in Denmark at the time were mostly alendronate (85%) and rarely ibandronate (6%), intravenous zoledronic acid (5%), etidronate (3%), or risedronate (1%).
 

One-third of patients with AFFs had no bisphosphonate exposure

In this national cohort of adults aged older than 50 years, the absolute rates of AFF per 10,000 person-years were as follows: 0.07 in nonusers of bisphosphonates, 1.84 in those with 3-5 years of bisphosphonate use, and 4.63 in those with >7 years of bisphosphonate use. As a comparison, the rate of classic hip fracture was 43.8 per 10,000 person-years.

Compared with no bisphosphonate use, the relative risk for AFF was close to 40 times higher with more than 7 years of use, after adjusting for multiple confounders. The risk for AFF was also significantly higher among patients with RA or hypertension and for those who used proton pump inhibitors.

“Note that age, gender, and previous fracture were not associated with the risk of AFF” after controlling for multiple confounders, Dr. Bauer stressed.

The relative risk for AFF fell significantly after it had been withheld from use for more than 1 year.

Among the 189 patients with confirmed AFF, 64 patients (34%) had never taken a bisphosphonate.

Preliminary analysis showed that, among patients with AFF, those who had not been exposed to bisphosphonates were younger, more likely to be male, and less likely to have had a previous fracture, RA, or to have used corticosteroids, proton pump inhibitors, statins, or hormone-replacement therapy.

The study was funded by the National Institute of Arthritis and Musculoskeletal and Skin Diseases. Dr. Bauer and Dr. Morin disclosed no relevant financial relationships.

A version of this article originally appeared on Medscape.com.

In a national study of older Danes who had previously had a fracture and were taking bisphosphonates, the risk of having a serious though rare atypical femoral fracture (AFF) was greater after 3-5 years of bisphosphonate use.

The risk quickly dropped after patients stopped taking a bisphosphonate, which suggests that bisphosphonate “holidays” may be useful for some patients, the researchers said. These findings support previous work.

But the study also found that 34% of the AFFs occurred in patients who had not been taking a bisphosphonate. That rate is higher than the 6%-22% that has been reported by others.

Doug Bauer, MD, from the University of California, San Francisco, presented the new study findings during the virtual American Society of Bone and Mineral Research 2020 annual meeting.

“We found no clear risk factor that accounts for this increased risk [for AFFs] among those not exposed to bisphosphonates,” he said, “but we believe this was a real finding, as our study protocol ensured that the study radiologists were completely blinded to treatments received.”

Suzanne N. Morin, MD, who was not involved in this research, pointed out that the reported AFF risks related to bisphosphonate dose and cessation are in keeping with findings of other studies, including a recent large study by Dennis M. Black, MD, and colleagues that was published in the New England Journal of Medicine.

That study found that Asians are at higher risk for AFFs than White persons. Others have reported that specific femur geometry or physique and use of glucocorticoids increase AFF risk, Dr. Morin, from the Research Institute of the McGill University Health Center, Montreal, said in an interview.

The current study suggests that rheumatoid arthritis may be a risk factor, she added.

The fact that the rate of AFFs among patients who had not been exposed to bisphosphonates was higher than previously reported “may be due to differences in the method they used to ascertain the fractures or in medication use,” she speculated.

The clinical implications of research to date are that “the risk of AFF should not dissuade patients and providers from short-term use of bisphosphonates [3-5 years],” Dr. Bauer said. He noted that most patients should not take a bisphosphonate for longer than this unless they have a very high fracture risk.

Similarly, Dr. Morin said that clinicians “should consider initiating bisphosphonate in those at high risk for fractures and reevaluate their use after 3-6 years, depending on individual’s risk profile.”

AFF is serious but rare complication of bisphosphonate use

“Since first reported over 10 years ago, it has become clear that AFFs are a rare but serious complication of bisphosphonate therapy,” Dr. Bauer explained. However, there is still uncertainty about the magnitude of this risk, including the absolute risk for AFFs among adults who take bisphosphonates and those who do not.

To study this, the researchers analyzed data from national health care and pharmacy records and a radiology image database in Denmark. They identified almost 5,000 adults who were aged 50 years or older and who experienced a subtrochanteric and femoral shaft fracture during the period from 2010 to 2015. Two expert radiologists who were blinded to the patients’ clinical history or treatment identified AFF on the basis of ASBMR 2014 criteria.

The researchers compared three patient groups: 189 patients with AFF, 2,397 patients with typical subtrochanteric and femoral shaft fractures (no AFF), and35,946 adults aged older than 50 years (control persons).

Compared with patients with typical fractures, patients with AFF were younger (aged 71 vs. 77), more likely to be women (79% vs. 69%), and more likely to have RA (12% vs. 2.5%).

Compared with patients in the other two groups, those with AFF were more likely to use corticosteroids, proton pump inhibitors, statins, and hormone replacement therapy.

They were also more likely to use bisphosphonates (58%) than patients with typical subtrochanteric and femoral shaft fractures (19%) or control patients (10%).

The bisphosphonates used in Denmark at the time were mostly alendronate (85%) and rarely ibandronate (6%), intravenous zoledronic acid (5%), etidronate (3%), or risedronate (1%).
 

One-third of patients with AFFs had no bisphosphonate exposure

In this national cohort of adults aged older than 50 years, the absolute rates of AFF per 10,000 person-years were as follows: 0.07 in nonusers of bisphosphonates, 1.84 in those with 3-5 years of bisphosphonate use, and 4.63 in those with >7 years of bisphosphonate use. As a comparison, the rate of classic hip fracture was 43.8 per 10,000 person-years.

Compared with no bisphosphonate use, the relative risk for AFF was close to 40 times higher with more than 7 years of use, after adjusting for multiple confounders. The risk for AFF was also significantly higher among patients with RA or hypertension and for those who used proton pump inhibitors.

“Note that age, gender, and previous fracture were not associated with the risk of AFF” after controlling for multiple confounders, Dr. Bauer stressed.

The relative risk for AFF fell significantly after it had been withheld from use for more than 1 year.

Among the 189 patients with confirmed AFF, 64 patients (34%) had never taken a bisphosphonate.

Preliminary analysis showed that, among patients with AFF, those who had not been exposed to bisphosphonates were younger, more likely to be male, and less likely to have had a previous fracture, RA, or to have used corticosteroids, proton pump inhibitors, statins, or hormone-replacement therapy.

The study was funded by the National Institute of Arthritis and Musculoskeletal and Skin Diseases. Dr. Bauer and Dr. Morin disclosed no relevant financial relationships.

A version of this article originally appeared on Medscape.com.

In a national study of older Danes who had previously had a fracture and were taking bisphosphonates, the risk of having a serious though rare atypical femoral fracture (AFF) was greater after 3-5 years of bisphosphonate use.

The risk quickly dropped after patients stopped taking a bisphosphonate, which suggests that bisphosphonate “holidays” may be useful for some patients, the researchers said. These findings support previous work.

But the study also found that 34% of the AFFs occurred in patients who had not been taking a bisphosphonate. That rate is higher than the 6%-22% that has been reported by others.

Doug Bauer, MD, from the University of California, San Francisco, presented the new study findings during the virtual American Society of Bone and Mineral Research 2020 annual meeting.

“We found no clear risk factor that accounts for this increased risk [for AFFs] among those not exposed to bisphosphonates,” he said, “but we believe this was a real finding, as our study protocol ensured that the study radiologists were completely blinded to treatments received.”

Suzanne N. Morin, MD, who was not involved in this research, pointed out that the reported AFF risks related to bisphosphonate dose and cessation are in keeping with findings of other studies, including a recent large study by Dennis M. Black, MD, and colleagues that was published in the New England Journal of Medicine.

That study found that Asians are at higher risk for AFFs than White persons. Others have reported that specific femur geometry or physique and use of glucocorticoids increase AFF risk, Dr. Morin, from the Research Institute of the McGill University Health Center, Montreal, said in an interview.

The current study suggests that rheumatoid arthritis may be a risk factor, she added.

The fact that the rate of AFFs among patients who had not been exposed to bisphosphonates was higher than previously reported “may be due to differences in the method they used to ascertain the fractures or in medication use,” she speculated.

The clinical implications of research to date are that “the risk of AFF should not dissuade patients and providers from short-term use of bisphosphonates [3-5 years],” Dr. Bauer said. He noted that most patients should not take a bisphosphonate for longer than this unless they have a very high fracture risk.

Similarly, Dr. Morin said that clinicians “should consider initiating bisphosphonate in those at high risk for fractures and reevaluate their use after 3-6 years, depending on individual’s risk profile.”

AFF is serious but rare complication of bisphosphonate use

“Since first reported over 10 years ago, it has become clear that AFFs are a rare but serious complication of bisphosphonate therapy,” Dr. Bauer explained. However, there is still uncertainty about the magnitude of this risk, including the absolute risk for AFFs among adults who take bisphosphonates and those who do not.

To study this, the researchers analyzed data from national health care and pharmacy records and a radiology image database in Denmark. They identified almost 5,000 adults who were aged 50 years or older and who experienced a subtrochanteric and femoral shaft fracture during the period from 2010 to 2015. Two expert radiologists who were blinded to the patients’ clinical history or treatment identified AFF on the basis of ASBMR 2014 criteria.

The researchers compared three patient groups: 189 patients with AFF, 2,397 patients with typical subtrochanteric and femoral shaft fractures (no AFF), and35,946 adults aged older than 50 years (control persons).

Compared with patients with typical fractures, patients with AFF were younger (aged 71 vs. 77), more likely to be women (79% vs. 69%), and more likely to have RA (12% vs. 2.5%).

Compared with patients in the other two groups, those with AFF were more likely to use corticosteroids, proton pump inhibitors, statins, and hormone replacement therapy.

They were also more likely to use bisphosphonates (58%) than patients with typical subtrochanteric and femoral shaft fractures (19%) or control patients (10%).

The bisphosphonates used in Denmark at the time were mostly alendronate (85%) and rarely ibandronate (6%), intravenous zoledronic acid (5%), etidronate (3%), or risedronate (1%).
 

One-third of patients with AFFs had no bisphosphonate exposure

In this national cohort of adults aged older than 50 years, the absolute rates of AFF per 10,000 person-years were as follows: 0.07 in nonusers of bisphosphonates, 1.84 in those with 3-5 years of bisphosphonate use, and 4.63 in those with >7 years of bisphosphonate use. As a comparison, the rate of classic hip fracture was 43.8 per 10,000 person-years.

Compared with no bisphosphonate use, the relative risk for AFF was close to 40 times higher with more than 7 years of use, after adjusting for multiple confounders. The risk for AFF was also significantly higher among patients with RA or hypertension and for those who used proton pump inhibitors.

“Note that age, gender, and previous fracture were not associated with the risk of AFF” after controlling for multiple confounders, Dr. Bauer stressed.

The relative risk for AFF fell significantly after it had been withheld from use for more than 1 year.

Among the 189 patients with confirmed AFF, 64 patients (34%) had never taken a bisphosphonate.

Preliminary analysis showed that, among patients with AFF, those who had not been exposed to bisphosphonates were younger, more likely to be male, and less likely to have had a previous fracture, RA, or to have used corticosteroids, proton pump inhibitors, statins, or hormone-replacement therapy.

The study was funded by the National Institute of Arthritis and Musculoskeletal and Skin Diseases. Dr. Bauer and Dr. Morin disclosed no relevant financial relationships.

A version of this article originally appeared on Medscape.com.

The Centers for Disease Control and Prevention (CDC) today abruptly deleted information from its website that it had updated Friday on how COVID-19 is spread.

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 Centers for Disease Control and Prevention (CDC) today abruptly deleted information from its website that it had updated Friday on how COVID-19 is spread.

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 Centers for Disease Control and Prevention (CDC) today abruptly deleted information from its website that it had updated Friday on how COVID-19 is spread.

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.

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.”

Supreme Court of the United States

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. But in the longer term, her absence from the bench could accelerate a trend underway to get cases to the Supreme Court toward invalidating the ACA and rolling back reproductive freedoms for women.

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.”

Supreme Court of the United States

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. But in the longer term, her absence from the bench could accelerate a trend underway to get cases to the Supreme Court toward invalidating the ACA and rolling back reproductive freedoms for women.

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.”

Supreme Court of the United States

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. But in the longer term, her absence from the bench could accelerate a trend underway to get cases to the Supreme Court toward invalidating the ACA and rolling back reproductive freedoms for women.

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.

Rheumatologists are seeing the number of telehealth visits skyrocket in their practices as the COVID-19 pandemic rages on and patients seek out alternatives to in-person visits. Telemedicine makes it easier for patients to connect with physicians, but not all patients have access to a computer or device. It also limits what a physician can do. Rheumatologists often rely on physical exams to make diagnoses and treatment decisions – an obstacle if you’re looking at patients through a computer screen.

FatCamera/E+

Presenters at the 2020 Coalition of State Rheumatology Organizations’ state advocacy conference discussed the benefits and challenges of this mode of care in early September. Within weeks, the U.S. health system eliminated almost half of all medical care as the pandemic ramped up and things went virtual, said Larry Van Horn, PhD, MPH, a speaker at the CSRO conference. Still, “we are in uncharted territory with respect to how telehealth is being used. ... It’s being deployed everywhere, but it’s too early to tell how it’s affecting patient outcomes,” said Dr. Van Horn, founder and director of the Center of Health Care Market Innovation at Vanderbilt University, Nashville, Tenn.

Patients seem to like using telemedicine, observed New Jersey state Sen. Herb Conaway, MD, another presenter. “I think it’s here to stay, and it’s likely to expand going forward. But physicians and others are going to want to make sure it’s used appropriately.”

Some payers feel that telemedicine should be billed differently than brick and mortar visits, Dr. Conaway said. “Physicians feel differently about that, and so we’ll see how this goes, moving forward.”

Lately, there have been discussions of liability concerns associated with telemedicine, said CSRO President Madelaine A. Feldman, MD, who practices in New Orleans. “There are some things you can miss with virtual visits. Certain new patient visits may need to be done in person.”
 

The landscape of telehealth in rheumatology

Telehealth has directly affected the way rheumatologists do business. In a national survey of more than 1,100 adult patients, the American College of Rheumatology found that 66% are choosing telehealth for rheumatology visits, mainly to avoid exposure to the SARS-CoV-2 virus. This contrasts with a 52% decline in the percentage of patients who are currently seeing a rheumatologist since 2019. “The pandemic has altered almost every aspect of our rheumatology practices,” said ACR President Ellen Gravallese, MD in a statement. “It has impacted our patients’ lives significantly and required us to create new ways of delivering care through improved telehealth and other adaptations.”

While many rheumatologists have resumed in-person visits, “others, like myself, are doing a hybrid,” Dr. Feldman said.

At the height of the pandemic in New York City, Elana J. Bernstein, MD’s practice relied entirely on telehealth visits. “We weren’t seeing any patients in the office for a couple of months. Now that things have reopened here, we’ve resumed face-to-face visits,” keeping some telehealth visits for patients who are still uncomfortable with in-person visits or who live far away, Dr. Bernstein, director of the scleroderma program at Columbia University, New York, said in an interview. She estimates that telehealth represents about 20%-30% of her practice right now.
 

Advantages, drawbacks of telehealth

For patients in underserved or geographically distant areas, telehealth means access to care, Kanika Monga, MD, of the University of Texas Health Science Center, Houston, said in an interview. During the COVID-19 public health crisis, “it has allowed the most vulnerable patient populations to continue receiving care at the click of a button.”

Virtual visits also improve patient care by improving follow-up and compliance, Dr. Monga continued. “For example, in our patient population, mobility can be a major issue because of the underlying disease. Telemedicine improves care for patients who struggle to make it to appointments.” It’s also more convenient for patients in her county that depend on arranged and/or public transportation and have to request a portion of their day off work for a doctor’s appointment.

But the virtual visit has its drawbacks. Different available platforms and their usability create challenges, Dr. Monga said. “Although some patients are tech-savvy, some are not. This is a challenge, especially when using platforms that have many steps involved.” Telemedicine also highlights general health inequities that already exist in some populations. Patients who are older, live in rural areas, are less educated, or are from a lower socioeconomic household might not have the technology or Internet connection available to enable telemedicine visits.

Telemedicine also complicates the physical examination, which is a central part of the diagnostic process, Dr. Bernstein said. Some components of the physical exam lend themselves to a video visit, such as evaluating for facial rashes or examining a patient’s digital ulcers. “But if you suspect the patient has rheumatoid arthritis, for example, you can’t examine the joints for swelling.” When seeing scleroderma patients over telemedicine, “I can’t perform the modified Rodnan skin score to assess for skin thickening, or auscultate the lungs for crackles. It’s also hard to assess a patient’s response to therapy over telemedicine,” Dr. Feldman added.

Some rheumatologists have sought out multiple pathways on telemedicine to provide more options for patients.

Christine Peoples, MD, clinical assistant professor of medicine at the University of Pittsburgh Medical Center, uses several telehealth options to reach patients that live in the largely rural area she serves. For her, telemedicine isn’t a novel concept. “I’ve been providing care through telemedicine for 6 years,” she said in an interview. Prior to COVID-19, her patients had gone to teleconsult centers for a telemedicine visit. With the onset of the COVID-19 pandemic, she expanded telehealth services to include more home video visits through the practice’s online medical record.

For care that can’t take place online, Dr. Peoples said she works with colleagues in orthopedics, which have far greater numbers than rheumatologists in Pennsylvania, to provide injections to patients. All of the teleconference centers are at local hospitals or outpatient community centers. Patients can go there to get an injection from another doctor, she said. Additionally, all of her practice’s locations at UPMC hospitals have infusion centers.
 

Adopting a ‘computer-side’ manner

Any practice offering telemedicine should be training their staff, as virtual meetings require certain skills, Dr. Peoples stressed. “You have to have experience as a rheumatologist, but you also have to have experience in telemedicine. Then it’s about merging those two skills.” Physicians need to be familiar with the technology and equipment. “I have a Bluetooth stethoscope that hears the heart and the lungs” of a patient during a virtual visit, she said.

Most importantly, physicians need to adopt a “computer-side” manner. “Make sure you have good eye contact on the screen, that you’re maintaining a good, professional relationship with the patient.” Training nurses to assist doctors during a telehealth visit is also key.

Dr. Peoples said UPMC has been training its fellows in telemedicine to adopt these skills.
 

Efforts to pay doctors for telehealth

As rheumatologists navigate the growing market for telehealth, questions remain about the long term payment outlook for these services.

For now, there appears to be reimbursement parity for telehealth visits, Dr. Feldman said. COVID-19’s public health emergency put into place certain flexibilities for telehealth. But some concerns remain about the commercial insurance sector. Whether private payers will continue paying the same amount as they do for in-person visits once the pandemic is over is unknown, Dr. Feldman added. “Insurance companies have had a boom in profits and should not be able to use ‘losses’ from COVID as an excuse for stopping pay parity for telehealth visits.”

David Allen, spokesperson for America’s Health Insurance Plans, said some plans are voluntarily offering telehealth payment parity during the public health emergency. “However, as a policy, AHIP does not support mandating that clinicians be paid the same amount for telehealth and in-person care,” Mr. Allen said, adding that AHIP hasn’t tallied how many insurance companies offer payment parity. “Too many variances exist between plans to make any kind of declarative statement on this.”

For her telemedicine visits at teleconsult centers, Dr. Peoples said compensation is comparable with traditional in-person visits. “Compensation is different for video visits where the patient is at home. However, these video visits are still reimbursed by most insurance plans.”

Federal payers and many states have taken actions on parity. Telehealth is seeing major legislative action at the state level, Kelly Hughes, a program director for the National Conference of State Legislatures, said during the CSRO meeting. All 50 states, the District of Columbia, and Puerto Rico have made revisions to telehealth policies during the COVID-19 pandemic to maintain access to health care services and to minimize potential exposure. Most of these are temporary modifications to address the pandemic, but some states are either adopting permanent changes or mulling over permanent changes to telehealth, Ms. Hughes said.

Modifications vary widely by state, but the top three trends include allowing reimbursement for phone calls (not requiring video), expanding the types of providers authorized to provide telehealth services, and allowing a relationship between a patient and provider to begin with a telehealth visit.

The Commonwealth Fund reports that at least 13 states have enacted payment parity laws in response to COVID-19. Another four had parity laws in place prior to the pandemic. “Many states have taken direct action via Medicaid policy; all but two issued specific guidance on the expansion or reimbursement of Medicaid-based telehealth services,” according to the Commonwealth Fund.

In Texas, where Dr. Monga practices. Gov. Greg Abbott (R) has temporarily waived regulations to lift certain telehealth restrictions. The Texas Department of Insurance under an emergency rule is directing state-regulated health plans to cover telemedicine visits at the same rate as in-person visits during the COVID-19 emergency declaration. “This has helped expand our telehealth options in Texas,” Dr. Monga said.

Medicare has also boosted coverage of telehealth services. “I appreciate that the Centers for Medicare & Medicaid Services has acknowledged the value of telehealth services by reimbursing for audio-only visits at the same rate as audiovisual and in-person evaluations during the public health emergency,” Dr. Monga said.

CMS has also proposed to expand telehealth access in its CY 2021 Physician Fee Schedule Proposed Rule. Additionally, the Department of Health & Human Services Office of Rights will not be penalizing physicians for HIPAA noncompliance for conducting visits through technologies such as FaceTime or Skype during COVID-19, she added.

While telehealth can’t replace all in-person visits in rheumatology, “it can certainly provide us with support during certain circumstances, as we have learned during the current health emergency,” Dr. Monga said. “I hope that even after this crisis has passed that parity for telehealth will be maintained and we can make permanent some of the current updates.”

Rheumatologists are seeing the number of telehealth visits skyrocket in their practices as the COVID-19 pandemic rages on and patients seek out alternatives to in-person visits. Telemedicine makes it easier for patients to connect with physicians, but not all patients have access to a computer or device. It also limits what a physician can do. Rheumatologists often rely on physical exams to make diagnoses and treatment decisions – an obstacle if you’re looking at patients through a computer screen.

FatCamera/E+

Presenters at the 2020 Coalition of State Rheumatology Organizations’ state advocacy conference discussed the benefits and challenges of this mode of care in early September. Within weeks, the U.S. health system eliminated almost half of all medical care as the pandemic ramped up and things went virtual, said Larry Van Horn, PhD, MPH, a speaker at the CSRO conference. Still, “we are in uncharted territory with respect to how telehealth is being used. ... It’s being deployed everywhere, but it’s too early to tell how it’s affecting patient outcomes,” said Dr. Van Horn, founder and director of the Center of Health Care Market Innovation at Vanderbilt University, Nashville, Tenn.

Patients seem to like using telemedicine, observed New Jersey state Sen. Herb Conaway, MD, another presenter. “I think it’s here to stay, and it’s likely to expand going forward. But physicians and others are going to want to make sure it’s used appropriately.”

Some payers feel that telemedicine should be billed differently than brick and mortar visits, Dr. Conaway said. “Physicians feel differently about that, and so we’ll see how this goes, moving forward.”

Lately, there have been discussions of liability concerns associated with telemedicine, said CSRO President Madelaine A. Feldman, MD, who practices in New Orleans. “There are some things you can miss with virtual visits. Certain new patient visits may need to be done in person.”
 

The landscape of telehealth in rheumatology

Telehealth has directly affected the way rheumatologists do business. In a national survey of more than 1,100 adult patients, the American College of Rheumatology found that 66% are choosing telehealth for rheumatology visits, mainly to avoid exposure to the SARS-CoV-2 virus. This contrasts with a 52% decline in the percentage of patients who are currently seeing a rheumatologist since 2019. “The pandemic has altered almost every aspect of our rheumatology practices,” said ACR President Ellen Gravallese, MD in a statement. “It has impacted our patients’ lives significantly and required us to create new ways of delivering care through improved telehealth and other adaptations.”

While many rheumatologists have resumed in-person visits, “others, like myself, are doing a hybrid,” Dr. Feldman said.

At the height of the pandemic in New York City, Elana J. Bernstein, MD’s practice relied entirely on telehealth visits. “We weren’t seeing any patients in the office for a couple of months. Now that things have reopened here, we’ve resumed face-to-face visits,” keeping some telehealth visits for patients who are still uncomfortable with in-person visits or who live far away, Dr. Bernstein, director of the scleroderma program at Columbia University, New York, said in an interview. She estimates that telehealth represents about 20%-30% of her practice right now.
 

Advantages, drawbacks of telehealth

For patients in underserved or geographically distant areas, telehealth means access to care, Kanika Monga, MD, of the University of Texas Health Science Center, Houston, said in an interview. During the COVID-19 public health crisis, “it has allowed the most vulnerable patient populations to continue receiving care at the click of a button.”

Virtual visits also improve patient care by improving follow-up and compliance, Dr. Monga continued. “For example, in our patient population, mobility can be a major issue because of the underlying disease. Telemedicine improves care for patients who struggle to make it to appointments.” It’s also more convenient for patients in her county that depend on arranged and/or public transportation and have to request a portion of their day off work for a doctor’s appointment.

But the virtual visit has its drawbacks. Different available platforms and their usability create challenges, Dr. Monga said. “Although some patients are tech-savvy, some are not. This is a challenge, especially when using platforms that have many steps involved.” Telemedicine also highlights general health inequities that already exist in some populations. Patients who are older, live in rural areas, are less educated, or are from a lower socioeconomic household might not have the technology or Internet connection available to enable telemedicine visits.

Telemedicine also complicates the physical examination, which is a central part of the diagnostic process, Dr. Bernstein said. Some components of the physical exam lend themselves to a video visit, such as evaluating for facial rashes or examining a patient’s digital ulcers. “But if you suspect the patient has rheumatoid arthritis, for example, you can’t examine the joints for swelling.” When seeing scleroderma patients over telemedicine, “I can’t perform the modified Rodnan skin score to assess for skin thickening, or auscultate the lungs for crackles. It’s also hard to assess a patient’s response to therapy over telemedicine,” Dr. Feldman added.

Some rheumatologists have sought out multiple pathways on telemedicine to provide more options for patients.

Christine Peoples, MD, clinical assistant professor of medicine at the University of Pittsburgh Medical Center, uses several telehealth options to reach patients that live in the largely rural area she serves. For her, telemedicine isn’t a novel concept. “I’ve been providing care through telemedicine for 6 years,” she said in an interview. Prior to COVID-19, her patients had gone to teleconsult centers for a telemedicine visit. With the onset of the COVID-19 pandemic, she expanded telehealth services to include more home video visits through the practice’s online medical record.

For care that can’t take place online, Dr. Peoples said she works with colleagues in orthopedics, which have far greater numbers than rheumatologists in Pennsylvania, to provide injections to patients. All of the teleconference centers are at local hospitals or outpatient community centers. Patients can go there to get an injection from another doctor, she said. Additionally, all of her practice’s locations at UPMC hospitals have infusion centers.
 

Adopting a ‘computer-side’ manner

Any practice offering telemedicine should be training their staff, as virtual meetings require certain skills, Dr. Peoples stressed. “You have to have experience as a rheumatologist, but you also have to have experience in telemedicine. Then it’s about merging those two skills.” Physicians need to be familiar with the technology and equipment. “I have a Bluetooth stethoscope that hears the heart and the lungs” of a patient during a virtual visit, she said.

Most importantly, physicians need to adopt a “computer-side” manner. “Make sure you have good eye contact on the screen, that you’re maintaining a good, professional relationship with the patient.” Training nurses to assist doctors during a telehealth visit is also key.

Dr. Peoples said UPMC has been training its fellows in telemedicine to adopt these skills.
 

Efforts to pay doctors for telehealth

As rheumatologists navigate the growing market for telehealth, questions remain about the long term payment outlook for these services.

For now, there appears to be reimbursement parity for telehealth visits, Dr. Feldman said. COVID-19’s public health emergency put into place certain flexibilities for telehealth. But some concerns remain about the commercial insurance sector. Whether private payers will continue paying the same amount as they do for in-person visits once the pandemic is over is unknown, Dr. Feldman added. “Insurance companies have had a boom in profits and should not be able to use ‘losses’ from COVID as an excuse for stopping pay parity for telehealth visits.”

David Allen, spokesperson for America’s Health Insurance Plans, said some plans are voluntarily offering telehealth payment parity during the public health emergency. “However, as a policy, AHIP does not support mandating that clinicians be paid the same amount for telehealth and in-person care,” Mr. Allen said, adding that AHIP hasn’t tallied how many insurance companies offer payment parity. “Too many variances exist between plans to make any kind of declarative statement on this.”

For her telemedicine visits at teleconsult centers, Dr. Peoples said compensation is comparable with traditional in-person visits. “Compensation is different for video visits where the patient is at home. However, these video visits are still reimbursed by most insurance plans.”

Federal payers and many states have taken actions on parity. Telehealth is seeing major legislative action at the state level, Kelly Hughes, a program director for the National Conference of State Legislatures, said during the CSRO meeting. All 50 states, the District of Columbia, and Puerto Rico have made revisions to telehealth policies during the COVID-19 pandemic to maintain access to health care services and to minimize potential exposure. Most of these are temporary modifications to address the pandemic, but some states are either adopting permanent changes or mulling over permanent changes to telehealth, Ms. Hughes said.

Modifications vary widely by state, but the top three trends include allowing reimbursement for phone calls (not requiring video), expanding the types of providers authorized to provide telehealth services, and allowing a relationship between a patient and provider to begin with a telehealth visit.

The Commonwealth Fund reports that at least 13 states have enacted payment parity laws in response to COVID-19. Another four had parity laws in place prior to the pandemic. “Many states have taken direct action via Medicaid policy; all but two issued specific guidance on the expansion or reimbursement of Medicaid-based telehealth services,” according to the Commonwealth Fund.

In Texas, where Dr. Monga practices. Gov. Greg Abbott (R) has temporarily waived regulations to lift certain telehealth restrictions. The Texas Department of Insurance under an emergency rule is directing state-regulated health plans to cover telemedicine visits at the same rate as in-person visits during the COVID-19 emergency declaration. “This has helped expand our telehealth options in Texas,” Dr. Monga said.

Medicare has also boosted coverage of telehealth services. “I appreciate that the Centers for Medicare & Medicaid Services has acknowledged the value of telehealth services by reimbursing for audio-only visits at the same rate as audiovisual and in-person evaluations during the public health emergency,” Dr. Monga said.

CMS has also proposed to expand telehealth access in its CY 2021 Physician Fee Schedule Proposed Rule. Additionally, the Department of Health & Human Services Office of Rights will not be penalizing physicians for HIPAA noncompliance for conducting visits through technologies such as FaceTime or Skype during COVID-19, she added.

While telehealth can’t replace all in-person visits in rheumatology, “it can certainly provide us with support during certain circumstances, as we have learned during the current health emergency,” Dr. Monga said. “I hope that even after this crisis has passed that parity for telehealth will be maintained and we can make permanent some of the current updates.”

Rheumatologists are seeing the number of telehealth visits skyrocket in their practices as the COVID-19 pandemic rages on and patients seek out alternatives to in-person visits. Telemedicine makes it easier for patients to connect with physicians, but not all patients have access to a computer or device. It also limits what a physician can do. Rheumatologists often rely on physical exams to make diagnoses and treatment decisions – an obstacle if you’re looking at patients through a computer screen.

FatCamera/E+

Presenters at the 2020 Coalition of State Rheumatology Organizations’ state advocacy conference discussed the benefits and challenges of this mode of care in early September. Within weeks, the U.S. health system eliminated almost half of all medical care as the pandemic ramped up and things went virtual, said Larry Van Horn, PhD, MPH, a speaker at the CSRO conference. Still, “we are in uncharted territory with respect to how telehealth is being used. ... It’s being deployed everywhere, but it’s too early to tell how it’s affecting patient outcomes,” said Dr. Van Horn, founder and director of the Center of Health Care Market Innovation at Vanderbilt University, Nashville, Tenn.

Patients seem to like using telemedicine, observed New Jersey state Sen. Herb Conaway, MD, another presenter. “I think it’s here to stay, and it’s likely to expand going forward. But physicians and others are going to want to make sure it’s used appropriately.”

Some payers feel that telemedicine should be billed differently than brick and mortar visits, Dr. Conaway said. “Physicians feel differently about that, and so we’ll see how this goes, moving forward.”

Lately, there have been discussions of liability concerns associated with telemedicine, said CSRO President Madelaine A. Feldman, MD, who practices in New Orleans. “There are some things you can miss with virtual visits. Certain new patient visits may need to be done in person.”
 

The landscape of telehealth in rheumatology

Telehealth has directly affected the way rheumatologists do business. In a national survey of more than 1,100 adult patients, the American College of Rheumatology found that 66% are choosing telehealth for rheumatology visits, mainly to avoid exposure to the SARS-CoV-2 virus. This contrasts with a 52% decline in the percentage of patients who are currently seeing a rheumatologist since 2019. “The pandemic has altered almost every aspect of our rheumatology practices,” said ACR President Ellen Gravallese, MD in a statement. “It has impacted our patients’ lives significantly and required us to create new ways of delivering care through improved telehealth and other adaptations.”

While many rheumatologists have resumed in-person visits, “others, like myself, are doing a hybrid,” Dr. Feldman said.

At the height of the pandemic in New York City, Elana J. Bernstein, MD’s practice relied entirely on telehealth visits. “We weren’t seeing any patients in the office for a couple of months. Now that things have reopened here, we’ve resumed face-to-face visits,” keeping some telehealth visits for patients who are still uncomfortable with in-person visits or who live far away, Dr. Bernstein, director of the scleroderma program at Columbia University, New York, said in an interview. She estimates that telehealth represents about 20%-30% of her practice right now.
 

Advantages, drawbacks of telehealth

For patients in underserved or geographically distant areas, telehealth means access to care, Kanika Monga, MD, of the University of Texas Health Science Center, Houston, said in an interview. During the COVID-19 public health crisis, “it has allowed the most vulnerable patient populations to continue receiving care at the click of a button.”

Virtual visits also improve patient care by improving follow-up and compliance, Dr. Monga continued. “For example, in our patient population, mobility can be a major issue because of the underlying disease. Telemedicine improves care for patients who struggle to make it to appointments.” It’s also more convenient for patients in her county that depend on arranged and/or public transportation and have to request a portion of their day off work for a doctor’s appointment.

But the virtual visit has its drawbacks. Different available platforms and their usability create challenges, Dr. Monga said. “Although some patients are tech-savvy, some are not. This is a challenge, especially when using platforms that have many steps involved.” Telemedicine also highlights general health inequities that already exist in some populations. Patients who are older, live in rural areas, are less educated, or are from a lower socioeconomic household might not have the technology or Internet connection available to enable telemedicine visits.

Telemedicine also complicates the physical examination, which is a central part of the diagnostic process, Dr. Bernstein said. Some components of the physical exam lend themselves to a video visit, such as evaluating for facial rashes or examining a patient’s digital ulcers. “But if you suspect the patient has rheumatoid arthritis, for example, you can’t examine the joints for swelling.” When seeing scleroderma patients over telemedicine, “I can’t perform the modified Rodnan skin score to assess for skin thickening, or auscultate the lungs for crackles. It’s also hard to assess a patient’s response to therapy over telemedicine,” Dr. Feldman added.

Some rheumatologists have sought out multiple pathways on telemedicine to provide more options for patients.

Christine Peoples, MD, clinical assistant professor of medicine at the University of Pittsburgh Medical Center, uses several telehealth options to reach patients that live in the largely rural area she serves. For her, telemedicine isn’t a novel concept. “I’ve been providing care through telemedicine for 6 years,” she said in an interview. Prior to COVID-19, her patients had gone to teleconsult centers for a telemedicine visit. With the onset of the COVID-19 pandemic, she expanded telehealth services to include more home video visits through the practice’s online medical record.

For care that can’t take place online, Dr. Peoples said she works with colleagues in orthopedics, which have far greater numbers than rheumatologists in Pennsylvania, to provide injections to patients. All of the teleconference centers are at local hospitals or outpatient community centers. Patients can go there to get an injection from another doctor, she said. Additionally, all of her practice’s locations at UPMC hospitals have infusion centers.
 

Adopting a ‘computer-side’ manner

Any practice offering telemedicine should be training their staff, as virtual meetings require certain skills, Dr. Peoples stressed. “You have to have experience as a rheumatologist, but you also have to have experience in telemedicine. Then it’s about merging those two skills.” Physicians need to be familiar with the technology and equipment. “I have a Bluetooth stethoscope that hears the heart and the lungs” of a patient during a virtual visit, she said.

Most importantly, physicians need to adopt a “computer-side” manner. “Make sure you have good eye contact on the screen, that you’re maintaining a good, professional relationship with the patient.” Training nurses to assist doctors during a telehealth visit is also key.

Dr. Peoples said UPMC has been training its fellows in telemedicine to adopt these skills.
 

Efforts to pay doctors for telehealth

As rheumatologists navigate the growing market for telehealth, questions remain about the long term payment outlook for these services.

For now, there appears to be reimbursement parity for telehealth visits, Dr. Feldman said. COVID-19’s public health emergency put into place certain flexibilities for telehealth. But some concerns remain about the commercial insurance sector. Whether private payers will continue paying the same amount as they do for in-person visits once the pandemic is over is unknown, Dr. Feldman added. “Insurance companies have had a boom in profits and should not be able to use ‘losses’ from COVID as an excuse for stopping pay parity for telehealth visits.”

David Allen, spokesperson for America’s Health Insurance Plans, said some plans are voluntarily offering telehealth payment parity during the public health emergency. “However, as a policy, AHIP does not support mandating that clinicians be paid the same amount for telehealth and in-person care,” Mr. Allen said, adding that AHIP hasn’t tallied how many insurance companies offer payment parity. “Too many variances exist between plans to make any kind of declarative statement on this.”

For her telemedicine visits at teleconsult centers, Dr. Peoples said compensation is comparable with traditional in-person visits. “Compensation is different for video visits where the patient is at home. However, these video visits are still reimbursed by most insurance plans.”

Federal payers and many states have taken actions on parity. Telehealth is seeing major legislative action at the state level, Kelly Hughes, a program director for the National Conference of State Legislatures, said during the CSRO meeting. All 50 states, the District of Columbia, and Puerto Rico have made revisions to telehealth policies during the COVID-19 pandemic to maintain access to health care services and to minimize potential exposure. Most of these are temporary modifications to address the pandemic, but some states are either adopting permanent changes or mulling over permanent changes to telehealth, Ms. Hughes said.

Modifications vary widely by state, but the top three trends include allowing reimbursement for phone calls (not requiring video), expanding the types of providers authorized to provide telehealth services, and allowing a relationship between a patient and provider to begin with a telehealth visit.

The Commonwealth Fund reports that at least 13 states have enacted payment parity laws in response to COVID-19. Another four had parity laws in place prior to the pandemic. “Many states have taken direct action via Medicaid policy; all but two issued specific guidance on the expansion or reimbursement of Medicaid-based telehealth services,” according to the Commonwealth Fund.

In Texas, where Dr. Monga practices. Gov. Greg Abbott (R) has temporarily waived regulations to lift certain telehealth restrictions. The Texas Department of Insurance under an emergency rule is directing state-regulated health plans to cover telemedicine visits at the same rate as in-person visits during the COVID-19 emergency declaration. “This has helped expand our telehealth options in Texas,” Dr. Monga said.

Medicare has also boosted coverage of telehealth services. “I appreciate that the Centers for Medicare & Medicaid Services has acknowledged the value of telehealth services by reimbursing for audio-only visits at the same rate as audiovisual and in-person evaluations during the public health emergency,” Dr. Monga said.

CMS has also proposed to expand telehealth access in its CY 2021 Physician Fee Schedule Proposed Rule. Additionally, the Department of Health & Human Services Office of Rights will not be penalizing physicians for HIPAA noncompliance for conducting visits through technologies such as FaceTime or Skype during COVID-19, she added.

While telehealth can’t replace all in-person visits in rheumatology, “it can certainly provide us with support during certain circumstances, as we have learned during the current health emergency,” Dr. Monga said. “I hope that even after this crisis has passed that parity for telehealth will be maintained and we can make permanent some of the current updates.”

The American College of Physicians and the American Academy of Family Physicians recently authored a guideline regarding the treatment of acute, non–low back, musculoskeletal injuries in adults in the outpatient setting. While their recommendations mirror what most clinicians currently do in their medical practices, they don’t address the multiple components of pain that include sensory, emotional, cognitive, and behavioral processes in addition to the physical discomfort.

According to the authors, musculoskeletal injuries result in more than 65 million medical visits a year with an annual estimated cost of $176.1 billion in 2010.

In summary, the guideline, which was published in the Annals of Internal Medicine, is based on a review of the best available evidence. The research reviewed by the guideline authors showed favorable results with topical NSAIDs, oral NSAIDs, oral acetaminophen, acupressure, and transcutaneous electrical nerve stimulation in reducing pain and/or improving function. The guideline authors “recommend that clinicians treat patients with acute pain from non–low back, musculoskeletal injuries with topical [NSAIDs] with or without gel as first-line therapy to reduce or relieve symptoms, including pain; improve physical function; and improve the patient’s treatment satisfaction (Grade: strong recommendation; moderate-certainty evidence).” Additionally, the guideline recommends against treating acute pain from non–low back, musculoskeletal injuries with opioids, including tramadol (Grade: conditional recommendation; low-certainty evidence).

The guideline also mentions improving function in relation to decreasing pain, which can be multifactorial.

Treating pain requires a multipronged approach. Many patients require more than one therapy to treat their pain, such as NSAIDs plus physical therapy. The ACP and AAFP did not make any recommendations for combination therapies in this guideline.

When physical therapy is needed

Nonopioid pain medications can do a great job of reducing a patient’s physical discomfort, which the evidence for these guideline demonstrates. However, much of the dysfunction caused by musculoskeletal injuries will not improve by reducing the pain alone. Physical therapy, exercise, and mobilization did not show a significant benefit in reducing symptoms in the systematic review and meta-analysis of randomized trials that appeared alongside the guideline. The type of pain, however, was not evaluated in relation to the effectiveness of these treatments. A fractured bone, for example, may heal just fine with casting and pain management, without the need for additional therapies. However, the muscles surrounding that bone can atrophy and become weak from not being used. Physical therapy may be needed to restrengthen those muscles. Therefore, a multifaceted approach is often needed, even for uncomplicated conditions.

Mental pain often comes with physical pain, and this is an aspect of care that is often neglected. It can be quite devastating for patients to not be able to do the things they were previously able to do. While this is easily recognized in professional athletes when they can no longer play, it is not so readily apparent with a mother who is just trying to take care of her kids. As doctors, especially those of us in family medicine, we should be addressing more than just physical pain.

Patients can also do activities that exacerbate their pain. As doctors, we need to be asking questions that help us determine whether a patient’s pain is caused by a particular action. Maybe that increase in shoulder pain is due to nothing more than lifting something heavy rather than a failure in a prescribed medication. Pain diaries are helpful, and clinicians don’t use them often enough.
 

How pain affects mental health

Acute injuries can also lead to disability. Many patients become quite distressed about being unable to work. They often need Famiy & Medical Leave Act forms filled out, and this task usually falls to the primary care doctor. In addition to assessing the pain, we need to be evaluating, at each visit, a patient’s level of functioning and their ability to do their job.

Every patient responds to pain differently, and it is important to evaluate patients’ mindsets regarding theirs. A patient may be in severe pain and may try to ignore it for a variety of reasons. A patient may “catastrophize” their pain, believing only the worst outcome will happen to them. Helping patients set appropriate expectations and having a positive mindset can help.

Overall, the new recommendations are a great tool as a guideline, but they are not complete enough to be the only ones used in managing acute, non–low back, musculoskeletal pain in adults.

They are very important for clinicians who may be prescribing opioid medications for patients with this type of pain. Amid an opioid crisis, it is the responsibility of every doctor to prescribe these medications appropriately. The evidence clearly shows they provide little benefit and place patients at risk of addiction.

We should all be following these recommendations as the baseline of care for acute pain. However, we need to delve deeper and manage all the components involved. We would be ignoring very real suffering in our patients if we limited our focus to only the physical discomfort.
 

Dr. Girgis practices family medicine in South River, N.J., and is a clinical assistant professor of family medicine at Rutgers RWJ Medical School.

SOURCE: Ann Intern Med. 2020 Aug 18. doi: 10.7326/M19-3602.

The American College of Physicians and the American Academy of Family Physicians recently authored a guideline regarding the treatment of acute, non–low back, musculoskeletal injuries in adults in the outpatient setting. While their recommendations mirror what most clinicians currently do in their medical practices, they don’t address the multiple components of pain that include sensory, emotional, cognitive, and behavioral processes in addition to the physical discomfort.

According to the authors, musculoskeletal injuries result in more than 65 million medical visits a year with an annual estimated cost of $176.1 billion in 2010.

In summary, the guideline, which was published in the Annals of Internal Medicine, is based on a review of the best available evidence. The research reviewed by the guideline authors showed favorable results with topical NSAIDs, oral NSAIDs, oral acetaminophen, acupressure, and transcutaneous electrical nerve stimulation in reducing pain and/or improving function. The guideline authors “recommend that clinicians treat patients with acute pain from non–low back, musculoskeletal injuries with topical [NSAIDs] with or without gel as first-line therapy to reduce or relieve symptoms, including pain; improve physical function; and improve the patient’s treatment satisfaction (Grade: strong recommendation; moderate-certainty evidence).” Additionally, the guideline recommends against treating acute pain from non–low back, musculoskeletal injuries with opioids, including tramadol (Grade: conditional recommendation; low-certainty evidence).

The guideline also mentions improving function in relation to decreasing pain, which can be multifactorial.

Treating pain requires a multipronged approach. Many patients require more than one therapy to treat their pain, such as NSAIDs plus physical therapy. The ACP and AAFP did not make any recommendations for combination therapies in this guideline.

When physical therapy is needed

Nonopioid pain medications can do a great job of reducing a patient’s physical discomfort, which the evidence for these guideline demonstrates. However, much of the dysfunction caused by musculoskeletal injuries will not improve by reducing the pain alone. Physical therapy, exercise, and mobilization did not show a significant benefit in reducing symptoms in the systematic review and meta-analysis of randomized trials that appeared alongside the guideline. The type of pain, however, was not evaluated in relation to the effectiveness of these treatments. A fractured bone, for example, may heal just fine with casting and pain management, without the need for additional therapies. However, the muscles surrounding that bone can atrophy and become weak from not being used. Physical therapy may be needed to restrengthen those muscles. Therefore, a multifaceted approach is often needed, even for uncomplicated conditions.

Mental pain often comes with physical pain, and this is an aspect of care that is often neglected. It can be quite devastating for patients to not be able to do the things they were previously able to do. While this is easily recognized in professional athletes when they can no longer play, it is not so readily apparent with a mother who is just trying to take care of her kids. As doctors, especially those of us in family medicine, we should be addressing more than just physical pain.

Patients can also do activities that exacerbate their pain. As doctors, we need to be asking questions that help us determine whether a patient’s pain is caused by a particular action. Maybe that increase in shoulder pain is due to nothing more than lifting something heavy rather than a failure in a prescribed medication. Pain diaries are helpful, and clinicians don’t use them often enough.
 

How pain affects mental health

Acute injuries can also lead to disability. Many patients become quite distressed about being unable to work. They often need Famiy & Medical Leave Act forms filled out, and this task usually falls to the primary care doctor. In addition to assessing the pain, we need to be evaluating, at each visit, a patient’s level of functioning and their ability to do their job.

Every patient responds to pain differently, and it is important to evaluate patients’ mindsets regarding theirs. A patient may be in severe pain and may try to ignore it for a variety of reasons. A patient may “catastrophize” their pain, believing only the worst outcome will happen to them. Helping patients set appropriate expectations and having a positive mindset can help.

Overall, the new recommendations are a great tool as a guideline, but they are not complete enough to be the only ones used in managing acute, non–low back, musculoskeletal pain in adults.

They are very important for clinicians who may be prescribing opioid medications for patients with this type of pain. Amid an opioid crisis, it is the responsibility of every doctor to prescribe these medications appropriately. The evidence clearly shows they provide little benefit and place patients at risk of addiction.

We should all be following these recommendations as the baseline of care for acute pain. However, we need to delve deeper and manage all the components involved. We would be ignoring very real suffering in our patients if we limited our focus to only the physical discomfort.
 

Dr. Girgis practices family medicine in South River, N.J., and is a clinical assistant professor of family medicine at Rutgers RWJ Medical School.

SOURCE: Ann Intern Med. 2020 Aug 18. doi: 10.7326/M19-3602.

The American College of Physicians and the American Academy of Family Physicians recently authored a guideline regarding the treatment of acute, non–low back, musculoskeletal injuries in adults in the outpatient setting. While their recommendations mirror what most clinicians currently do in their medical practices, they don’t address the multiple components of pain that include sensory, emotional, cognitive, and behavioral processes in addition to the physical discomfort.

According to the authors, musculoskeletal injuries result in more than 65 million medical visits a year with an annual estimated cost of $176.1 billion in 2010.

In summary, the guideline, which was published in the Annals of Internal Medicine, is based on a review of the best available evidence. The research reviewed by the guideline authors showed favorable results with topical NSAIDs, oral NSAIDs, oral acetaminophen, acupressure, and transcutaneous electrical nerve stimulation in reducing pain and/or improving function. The guideline authors “recommend that clinicians treat patients with acute pain from non–low back, musculoskeletal injuries with topical [NSAIDs] with or without gel as first-line therapy to reduce or relieve symptoms, including pain; improve physical function; and improve the patient’s treatment satisfaction (Grade: strong recommendation; moderate-certainty evidence).” Additionally, the guideline recommends against treating acute pain from non–low back, musculoskeletal injuries with opioids, including tramadol (Grade: conditional recommendation; low-certainty evidence).

The guideline also mentions improving function in relation to decreasing pain, which can be multifactorial.

Treating pain requires a multipronged approach. Many patients require more than one therapy to treat their pain, such as NSAIDs plus physical therapy. The ACP and AAFP did not make any recommendations for combination therapies in this guideline.

When physical therapy is needed

Nonopioid pain medications can do a great job of reducing a patient’s physical discomfort, which the evidence for these guideline demonstrates. However, much of the dysfunction caused by musculoskeletal injuries will not improve by reducing the pain alone. Physical therapy, exercise, and mobilization did not show a significant benefit in reducing symptoms in the systematic review and meta-analysis of randomized trials that appeared alongside the guideline. The type of pain, however, was not evaluated in relation to the effectiveness of these treatments. A fractured bone, for example, may heal just fine with casting and pain management, without the need for additional therapies. However, the muscles surrounding that bone can atrophy and become weak from not being used. Physical therapy may be needed to restrengthen those muscles. Therefore, a multifaceted approach is often needed, even for uncomplicated conditions.

Mental pain often comes with physical pain, and this is an aspect of care that is often neglected. It can be quite devastating for patients to not be able to do the things they were previously able to do. While this is easily recognized in professional athletes when they can no longer play, it is not so readily apparent with a mother who is just trying to take care of her kids. As doctors, especially those of us in family medicine, we should be addressing more than just physical pain.

Patients can also do activities that exacerbate their pain. As doctors, we need to be asking questions that help us determine whether a patient’s pain is caused by a particular action. Maybe that increase in shoulder pain is due to nothing more than lifting something heavy rather than a failure in a prescribed medication. Pain diaries are helpful, and clinicians don’t use them often enough.
 

How pain affects mental health

Acute injuries can also lead to disability. Many patients become quite distressed about being unable to work. They often need Famiy & Medical Leave Act forms filled out, and this task usually falls to the primary care doctor. In addition to assessing the pain, we need to be evaluating, at each visit, a patient’s level of functioning and their ability to do their job.

Every patient responds to pain differently, and it is important to evaluate patients’ mindsets regarding theirs. A patient may be in severe pain and may try to ignore it for a variety of reasons. A patient may “catastrophize” their pain, believing only the worst outcome will happen to them. Helping patients set appropriate expectations and having a positive mindset can help.

Overall, the new recommendations are a great tool as a guideline, but they are not complete enough to be the only ones used in managing acute, non–low back, musculoskeletal pain in adults.

They are very important for clinicians who may be prescribing opioid medications for patients with this type of pain. Amid an opioid crisis, it is the responsibility of every doctor to prescribe these medications appropriately. The evidence clearly shows they provide little benefit and place patients at risk of addiction.

We should all be following these recommendations as the baseline of care for acute pain. However, we need to delve deeper and manage all the components involved. We would be ignoring very real suffering in our patients if we limited our focus to only the physical discomfort.
 

Dr. Girgis practices family medicine in South River, N.J., and is a clinical assistant professor of family medicine at Rutgers RWJ Medical School.

SOURCE: Ann Intern Med. 2020 Aug 18. doi: 10.7326/M19-3602.

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.

Low-dose aspirin may be considered for the primary prevention of cardiovascular disease (CVD) in patients with autoimmune systemic rheumatic diseases who are at particularly high risk because of their individual cardiovascular risk profile, according to authors of a new review article in the journal Rheumatology who acknowledge the controversial nature of the issue, because while significant cardiovascular benefit from aspirin for secondary prevention is well established, it has not been for primary prevention.

Secondary prevention with daily, low-dose aspirin is part of aggressive, comprehensive risk modification in patients who have experienced an MI or stroke or are considered at high risk for CVD. But when it comes to primary prevention of the onset of disease, the authors, led by Serena Fasano, MD, PhD, of the rheumatology unit at the University of Campania, Naples, Italy, acknowledged the contradictory positions of international guidelines and uncertainty over balancing benefit versus harm – including risk of mortality in the context of excess bleeding. They called for “robust data” from high-quality randomized, controlled trials for subgroups of patients with specific rheumatologic diseases in order to better answer the question of aspirin for primary prevention.

“This review is devoted to reporting the present knowledge on the effectiveness of low-dose [aspirin] in primary CV prevention in a number of autoimmune systemic rheumatic diseases, not a systematic review or meta-analysis,” the authors stated. “We are not claiming to have covered more than a selection of the literature for each disease. Available data are not high-quality data and do not provide firm conclusions.”

The authors focused primarily on accelerated, rather than spontaneous, atherosclerosis or buildup of plaque in artery walls, implicated in ischemic heart diseases such as MI and ischemic cerebrovascular diseases such as stroke. They looked at its association with autoimmune rheumatic diseases, primarily systemic lupus erythematosus (SLE) and RA, but also including antiphospholipid syndrome, systemic sclerosis, mixed connective tissue disease, dermatomyositis/polymyositis, primary Sjögren’s syndrome, and systemic vasculitis.

They shared results from a review of 167 patients with SLE consecutively admitted to their tertiary medical center who had not previously experienced a cardiovascular event and who were prescribed low-dose (100 mg) aspirin on their first visit and followed for 8 years. The cardiovascular event-free rate was higher in the aspirin group and no excess bleeding was noted, although this may be attributable to a younger patient population and routine use of proton pump inhibitors. Subsequently, hydroxychloroquine was added to the aspirin treatment and was associated with further reduction in cardiovascular events.

The research group also conducted a retrospective analysis of 746 patients with RA consecutively admitted to four tertiary medical centers who hadn’t experienced a cardiovascular event previously. Incidence of cardiovascular events was significantly lower in aspirin-treated patients.
 

Individualized aspirin prescribing with cardiologist comanagement

There may be a modest benefit of using low-dose aspirin on a long-term basis, but that benefit needs to be offset by the risk of bleeds, said M. Elaine Husni, MD, MPH, vice chair of rheumatology and director of the Arthritis and Musculoskeletal Center at the Cleveland Clinic. It’s important to remind clinicians of cardiovascular risk, she said. “But the message for rheumatologists is it needs to be prescribed on an individual basis, rather than based on diagnosis of a rheumatic condition – at least until we have better evidence.”

Dr. Husni recommended keeping an open mind regarding individual approaches – for example, low-dose aspirin plus statins. A composite approach to prevention likely is called for, including attention to lifestyle issues such as smoking cessation, exercise, and weight loss. “That kind of complexity in decision-making highlights the need for comanagement with a cardiologist,” she said. “I’m a big believer in comanagement. At my multidisciplinary medical center, I am able to pick up the phone and talk to a cardiologist with whom our group has a relationship.” If physicians don’t have that kind of relationship with a cardiology group, she suggested reaching out to establish one.

The review paper could give some guidance to rheumatologists for use on an individual case, Michael Nurmohamed, MD, PhD, of the Amsterdam Rheumatology and Immunology Center in the Netherlands commented in an interview. “However, firm recommendations cannot be given as proper investigations are still lacking, as acknowledged by the authors. In addition, the review paper itself has some methodological constraints. Although this is a narrative review, the search strategy should have been specified, and a quality assessment of the individual studies is lacking.”

There is no doubt that the CVD burden in RA and other rheumatologic conditions is substantially increased in comparison to the general population, Dr. Nurmohamed said. That has been assessed by several well-designed, prospective, controlled studies. Other relatively frequent inflammatory arthropathies, including ankylosing spondylitis and psoriatic arthritis, also pose cardiovascular risk.

“Aspirin cannot be recommended for primary CVD prevention in inflammatory arthropathies due to the absence of adequate studies. That’s why the EULAR [European League Against Rheumatism] guidelines did not recommend its use,” he said. Currently, a EULAR task force is developing evidence-based guidelines for primary CVD prevention in the diseases discussed by Fasano et al., where the use of aspirin will be reassessed. “As these guidelines will consider the methodological quality of the underlying studies, they will enable a more refined use of aspirin in daily clinical practice.”

Primary prevention of CVD using aspirin is not currently the standard of care in taking care of patients with rheumatologic disease in the Netherlands, Ronald F. van Vollenhoven, MD, PhD, Dr. Nurmohamed’s colleague and director of the Amsterdam Rheumatology and Immunology Center and the chair of the department of rheumatology and clinical immunology at the Amsterdam University Medical Center, said in an interview.

“One reason may be the limited data, as highlighted in the review by Dr. Fasano and colleagues. However, another consideration is the problem of polypharmacy. Rheumatic diseases usually require chronic treatment, sometimes with multiple medications. This makes it even more of a concern to add an additional medication, even a relatively innocuous one such as low-dose aspirin,” he said.

Dr. Husni, Dr. Nurmohamed, and Dr. van Vollenhoven reported having no relevant disclosures. The authors of the review article had no relevant disclosures.

SOURCE: Fasano S et al. Rheumatology. 2020 Aug 25. doi: 10.1093/rheumatology/keaa335.

Low-dose aspirin may be considered for the primary prevention of cardiovascular disease (CVD) in patients with autoimmune systemic rheumatic diseases who are at particularly high risk because of their individual cardiovascular risk profile, according to authors of a new review article in the journal Rheumatology who acknowledge the controversial nature of the issue, because while significant cardiovascular benefit from aspirin for secondary prevention is well established, it has not been for primary prevention.

Secondary prevention with daily, low-dose aspirin is part of aggressive, comprehensive risk modification in patients who have experienced an MI or stroke or are considered at high risk for CVD. But when it comes to primary prevention of the onset of disease, the authors, led by Serena Fasano, MD, PhD, of the rheumatology unit at the University of Campania, Naples, Italy, acknowledged the contradictory positions of international guidelines and uncertainty over balancing benefit versus harm – including risk of mortality in the context of excess bleeding. They called for “robust data” from high-quality randomized, controlled trials for subgroups of patients with specific rheumatologic diseases in order to better answer the question of aspirin for primary prevention.

“This review is devoted to reporting the present knowledge on the effectiveness of low-dose [aspirin] in primary CV prevention in a number of autoimmune systemic rheumatic diseases, not a systematic review or meta-analysis,” the authors stated. “We are not claiming to have covered more than a selection of the literature for each disease. Available data are not high-quality data and do not provide firm conclusions.”

The authors focused primarily on accelerated, rather than spontaneous, atherosclerosis or buildup of plaque in artery walls, implicated in ischemic heart diseases such as MI and ischemic cerebrovascular diseases such as stroke. They looked at its association with autoimmune rheumatic diseases, primarily systemic lupus erythematosus (SLE) and RA, but also including antiphospholipid syndrome, systemic sclerosis, mixed connective tissue disease, dermatomyositis/polymyositis, primary Sjögren’s syndrome, and systemic vasculitis.

They shared results from a review of 167 patients with SLE consecutively admitted to their tertiary medical center who had not previously experienced a cardiovascular event and who were prescribed low-dose (100 mg) aspirin on their first visit and followed for 8 years. The cardiovascular event-free rate was higher in the aspirin group and no excess bleeding was noted, although this may be attributable to a younger patient population and routine use of proton pump inhibitors. Subsequently, hydroxychloroquine was added to the aspirin treatment and was associated with further reduction in cardiovascular events.

The research group also conducted a retrospective analysis of 746 patients with RA consecutively admitted to four tertiary medical centers who hadn’t experienced a cardiovascular event previously. Incidence of cardiovascular events was significantly lower in aspirin-treated patients.
 

Individualized aspirin prescribing with cardiologist comanagement

There may be a modest benefit of using low-dose aspirin on a long-term basis, but that benefit needs to be offset by the risk of bleeds, said M. Elaine Husni, MD, MPH, vice chair of rheumatology and director of the Arthritis and Musculoskeletal Center at the Cleveland Clinic. It’s important to remind clinicians of cardiovascular risk, she said. “But the message for rheumatologists is it needs to be prescribed on an individual basis, rather than based on diagnosis of a rheumatic condition – at least until we have better evidence.”

Dr. Husni recommended keeping an open mind regarding individual approaches – for example, low-dose aspirin plus statins. A composite approach to prevention likely is called for, including attention to lifestyle issues such as smoking cessation, exercise, and weight loss. “That kind of complexity in decision-making highlights the need for comanagement with a cardiologist,” she said. “I’m a big believer in comanagement. At my multidisciplinary medical center, I am able to pick up the phone and talk to a cardiologist with whom our group has a relationship.” If physicians don’t have that kind of relationship with a cardiology group, she suggested reaching out to establish one.

The review paper could give some guidance to rheumatologists for use on an individual case, Michael Nurmohamed, MD, PhD, of the Amsterdam Rheumatology and Immunology Center in the Netherlands commented in an interview. “However, firm recommendations cannot be given as proper investigations are still lacking, as acknowledged by the authors. In addition, the review paper itself has some methodological constraints. Although this is a narrative review, the search strategy should have been specified, and a quality assessment of the individual studies is lacking.”

There is no doubt that the CVD burden in RA and other rheumatologic conditions is substantially increased in comparison to the general population, Dr. Nurmohamed said. That has been assessed by several well-designed, prospective, controlled studies. Other relatively frequent inflammatory arthropathies, including ankylosing spondylitis and psoriatic arthritis, also pose cardiovascular risk.

“Aspirin cannot be recommended for primary CVD prevention in inflammatory arthropathies due to the absence of adequate studies. That’s why the EULAR [European League Against Rheumatism] guidelines did not recommend its use,” he said. Currently, a EULAR task force is developing evidence-based guidelines for primary CVD prevention in the diseases discussed by Fasano et al., where the use of aspirin will be reassessed. “As these guidelines will consider the methodological quality of the underlying studies, they will enable a more refined use of aspirin in daily clinical practice.”

Primary prevention of CVD using aspirin is not currently the standard of care in taking care of patients with rheumatologic disease in the Netherlands, Ronald F. van Vollenhoven, MD, PhD, Dr. Nurmohamed’s colleague and director of the Amsterdam Rheumatology and Immunology Center and the chair of the department of rheumatology and clinical immunology at the Amsterdam University Medical Center, said in an interview.

“One reason may be the limited data, as highlighted in the review by Dr. Fasano and colleagues. However, another consideration is the problem of polypharmacy. Rheumatic diseases usually require chronic treatment, sometimes with multiple medications. This makes it even more of a concern to add an additional medication, even a relatively innocuous one such as low-dose aspirin,” he said.

Dr. Husni, Dr. Nurmohamed, and Dr. van Vollenhoven reported having no relevant disclosures. The authors of the review article had no relevant disclosures.

SOURCE: Fasano S et al. Rheumatology. 2020 Aug 25. doi: 10.1093/rheumatology/keaa335.

Low-dose aspirin may be considered for the primary prevention of cardiovascular disease (CVD) in patients with autoimmune systemic rheumatic diseases who are at particularly high risk because of their individual cardiovascular risk profile, according to authors of a new review article in the journal Rheumatology who acknowledge the controversial nature of the issue, because while significant cardiovascular benefit from aspirin for secondary prevention is well established, it has not been for primary prevention.

Secondary prevention with daily, low-dose aspirin is part of aggressive, comprehensive risk modification in patients who have experienced an MI or stroke or are considered at high risk for CVD. But when it comes to primary prevention of the onset of disease, the authors, led by Serena Fasano, MD, PhD, of the rheumatology unit at the University of Campania, Naples, Italy, acknowledged the contradictory positions of international guidelines and uncertainty over balancing benefit versus harm – including risk of mortality in the context of excess bleeding. They called for “robust data” from high-quality randomized, controlled trials for subgroups of patients with specific rheumatologic diseases in order to better answer the question of aspirin for primary prevention.

“This review is devoted to reporting the present knowledge on the effectiveness of low-dose [aspirin] in primary CV prevention in a number of autoimmune systemic rheumatic diseases, not a systematic review or meta-analysis,” the authors stated. “We are not claiming to have covered more than a selection of the literature for each disease. Available data are not high-quality data and do not provide firm conclusions.”

The authors focused primarily on accelerated, rather than spontaneous, atherosclerosis or buildup of plaque in artery walls, implicated in ischemic heart diseases such as MI and ischemic cerebrovascular diseases such as stroke. They looked at its association with autoimmune rheumatic diseases, primarily systemic lupus erythematosus (SLE) and RA, but also including antiphospholipid syndrome, systemic sclerosis, mixed connective tissue disease, dermatomyositis/polymyositis, primary Sjögren’s syndrome, and systemic vasculitis.

They shared results from a review of 167 patients with SLE consecutively admitted to their tertiary medical center who had not previously experienced a cardiovascular event and who were prescribed low-dose (100 mg) aspirin on their first visit and followed for 8 years. The cardiovascular event-free rate was higher in the aspirin group and no excess bleeding was noted, although this may be attributable to a younger patient population and routine use of proton pump inhibitors. Subsequently, hydroxychloroquine was added to the aspirin treatment and was associated with further reduction in cardiovascular events.

The research group also conducted a retrospective analysis of 746 patients with RA consecutively admitted to four tertiary medical centers who hadn’t experienced a cardiovascular event previously. Incidence of cardiovascular events was significantly lower in aspirin-treated patients.
 

Individualized aspirin prescribing with cardiologist comanagement

There may be a modest benefit of using low-dose aspirin on a long-term basis, but that benefit needs to be offset by the risk of bleeds, said M. Elaine Husni, MD, MPH, vice chair of rheumatology and director of the Arthritis and Musculoskeletal Center at the Cleveland Clinic. It’s important to remind clinicians of cardiovascular risk, she said. “But the message for rheumatologists is it needs to be prescribed on an individual basis, rather than based on diagnosis of a rheumatic condition – at least until we have better evidence.”

Dr. Husni recommended keeping an open mind regarding individual approaches – for example, low-dose aspirin plus statins. A composite approach to prevention likely is called for, including attention to lifestyle issues such as smoking cessation, exercise, and weight loss. “That kind of complexity in decision-making highlights the need for comanagement with a cardiologist,” she said. “I’m a big believer in comanagement. At my multidisciplinary medical center, I am able to pick up the phone and talk to a cardiologist with whom our group has a relationship.” If physicians don’t have that kind of relationship with a cardiology group, she suggested reaching out to establish one.

The review paper could give some guidance to rheumatologists for use on an individual case, Michael Nurmohamed, MD, PhD, of the Amsterdam Rheumatology and Immunology Center in the Netherlands commented in an interview. “However, firm recommendations cannot be given as proper investigations are still lacking, as acknowledged by the authors. In addition, the review paper itself has some methodological constraints. Although this is a narrative review, the search strategy should have been specified, and a quality assessment of the individual studies is lacking.”

There is no doubt that the CVD burden in RA and other rheumatologic conditions is substantially increased in comparison to the general population, Dr. Nurmohamed said. That has been assessed by several well-designed, prospective, controlled studies. Other relatively frequent inflammatory arthropathies, including ankylosing spondylitis and psoriatic arthritis, also pose cardiovascular risk.

“Aspirin cannot be recommended for primary CVD prevention in inflammatory arthropathies due to the absence of adequate studies. That’s why the EULAR [European League Against Rheumatism] guidelines did not recommend its use,” he said. Currently, a EULAR task force is developing evidence-based guidelines for primary CVD prevention in the diseases discussed by Fasano et al., where the use of aspirin will be reassessed. “As these guidelines will consider the methodological quality of the underlying studies, they will enable a more refined use of aspirin in daily clinical practice.”

Primary prevention of CVD using aspirin is not currently the standard of care in taking care of patients with rheumatologic disease in the Netherlands, Ronald F. van Vollenhoven, MD, PhD, Dr. Nurmohamed’s colleague and director of the Amsterdam Rheumatology and Immunology Center and the chair of the department of rheumatology and clinical immunology at the Amsterdam University Medical Center, said in an interview.

“One reason may be the limited data, as highlighted in the review by Dr. Fasano and colleagues. However, another consideration is the problem of polypharmacy. Rheumatic diseases usually require chronic treatment, sometimes with multiple medications. This makes it even more of a concern to add an additional medication, even a relatively innocuous one such as low-dose aspirin,” he said.

Dr. Husni, Dr. Nurmohamed, and Dr. van Vollenhoven reported having no relevant disclosures. The authors of the review article had no relevant disclosures.

SOURCE: Fasano S et al. Rheumatology. 2020 Aug 25. doi: 10.1093/rheumatology/keaa335.

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. Most important, the government is boosting rates for the office/outpatient evaluation and management (E/M) codes, combined with simplifying coding requirements.

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. Most important, the government is boosting rates for the office/outpatient evaluation and management (E/M) codes, combined with simplifying coding requirements.

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. Most important, the government is boosting rates for the office/outpatient evaluation and management (E/M) codes, combined with simplifying coding requirements.

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.

“A treat-to-target approach is useful in the management of osteoporosis” was the motion proposed in a debate during the recent virtual American Society of Bone and Mineral Research (ASBMR) 2020 annual meeting, and when the votes came in, Michael McClung, MD, who argued against the motion, carried the day.

Agreement with the motion dropped from 63%-46% after McClung, of the Oregon Osteoporosis Center, Portland, put his views forward in opposition to those of Celia L. Gregson, PhD, University of Bristol (England), who argued for the motion on behalf of the European Calcified Tissue Society (ECTS).

Disagreement with the statement rose from 37% predebate to 54% in the postdebate audience polls.

“The debate is part education and part entertainment,” said Dr. McClung, who represented the ASBMR. “I could just as easily have made a strong argument for the motion,” he emphasized in an interview.

On the other hand, “had I been in the audience, as a member of ASBMR relying on data and evidence to make clinical decisions, I would have voted against the motion. As appealing as the strategy sounds, we don’t yet have the hard evidence to support its use nor is there a consensus about what an appropriate target should be, he noted.

Similarly, the debate comoderator and incoming ASBMR President, Suzanne M. Jan de Beur, MD, from Johns Hopkins University, Baltimore, said that a treat-to-target strategy for osteoporosis is an attractive idea, but there is no consensus on how to apply it nor evidence that it improves clinical outcomes.
 

Treat to target to guide osteoporosis therapy is like going “backwards”

In treat to target, the target – such as bone mineral density (BMD) (the most common one) – is identified before treatment is started, Dr. McClung explained (and as stated in a review article in the New England Journal of Medicine he coauthored on the topic). 

“While treat to target has appealing concepts, using risk factors to guide therapy is almost backwards,” he said. “We can’t change bone density very much.”

Treat to target is “not quite ready for prime time,” he concluded in his rebuttal.

Invited to speculate on which of Dr. McClung’s arguments swayed the audience, Dr. Gregson conceded that with a treat-to-target strategy “there is too much focus on getting one target for the whole global population with osteoporosis.”

“This is an oversimplification of a complex disease, and it misses the main message that the target should be decided with the patient not for the patient, which means one can’t just have one rule for everyone. There has to be scope to have different targets for different people so that we can deliver individualized care.”

Also, she noted, “generally people don’t vote to change familiar systems.”
 

Arguments for treat to target

Dr. Gregson began her argument, however, by stating that treat to target “is now a feasible and useful approach in osteoporosis care.”

The main reasons for adopting this treatment strategy are as follows:

• It provides a proactive approach with a clear goal.
• It includes periodic treatment reassessment, which allows for prompt revisions to treatment.
• It can use targets to guide treatment timing and patient monitoring.
• It includes shared decision-making, the preferred method of patient care.
• It could improve treatment adherence through patient “buy-in” of the target.
• It can use targets to address the risk of rare side effects.
• It allows for sequential treatments, especially for patients at highest risk of fracture.
• It can include more patient-centered outcomes such as reduced , restored range of movement, and ability to live independently.

“Patients are not interested in their T-score. They are interested in pain,” said Dr. Gregson.

“Reduced fracture risk is a very important goal,” she emphasized. Patients “with osteoporosis and a high fracture risk have the most to gain from a treat-to-target approach.”

“Improved access to anabolic osteoporosis treatments mean achieving those goals or targets are now more achievable than ever,” she concluded.

Arguments against treat to target

“Do we truly have an appropriate, meaningful target for osteoporosis?” Dr. McClung began in his counterargument, which cast a seed of doubt in the minds of the audience.

Targets such as no fractures, fracture risk (FRAX score), bone turnover markers, and bone strength have limitations.

Moreover, “do we have treatment strategies to move patients to the chosen target?” he continued. “What is the evidence that a treat-to-target strategy provides better outcomes than our current treatment paradigm?”

After pointing out a lack of evidence that treat to target leads to better outcomes in osteoporosis, he did allow that “recent data about the relationship between treatment-related BMD values and current fracture risk are appreciated and welcomed.”

“However, a treat-to-target strategy will only be successful if the targets are individualized for each patient, those targets are attainable for most patients, and we have evidence that adopting this strategy improves clinical outcomes,” he summarized.

He then quoted his late wife Betsy Love McClung, RN, MN, who had said, “We don’t treat osteoporosis; we treat patients with osteoporosis.”

Dr. McClung wrapped up by stressing: “We should not treat T-scores or any other specific target. We should individualize our therapy based upon the patient’s risk of fracture and other clinical factors.”

As members of the ECTS and ASBMR, and “proud of our reputation of our societies as being scientifically based and driven,” Dr. McClung concluded, “recognizing that a treat-to-target strategy has appeal, we should certainly encourage more research and be attentive to those results.

“But we must hold off on the adoption of the strategy until we have evidence convincing us of its clinical value.”
 

When to use a treat-to-target strategy

However, “there are some specific situations where I use something like a treat-to-target strategy,” Dr. McClung conceded. “That is, I make decisions and recommendations to the patients about one drug rather than another because I want to maximize the improvement in their bone density.”

For example, “We have known for 15 years that denosumab results in greater increases in bone density than do bisphosphonates,” he continued.

“So I have used that information to make treatment decisions long before the term ‘treat to target’ entered the vocabulary of osteoporosis experts. I simply wanted to induce the largest possible gains in bone density – but I didn’t have a ‘target’ in mind.”

But for most patients, treatment decisions are made based on other factors, such as their fracture risk, he added. BMD is an important risk factor for fracture, but not as important as having had a recent fracture or being old and frail.

“Unfortunately, in most of today’s health systems, decisions about treatment are made on the basis of cost,” he continued. “More often than not, the health plan rules rather than optimal medical practice are the main guides to treatment decisions.”   

According to Dr. Gregson, “in some instances, treat to target would be very helpful. I don’t think it will suit everyone, but I think we should have it in our portfolio of management approaches, and we should as an osteoporosis community be trained in its use.”
 

“Attractive idea, but ...”

Invited to weigh in, Dr. Jan de Beur noted that A1c, blood pressure, and LDL cholesterol targets are used to improve clinical outcomes in patients with diabetes, hypertension, and hyperlipidemia, respectively.

However, “treat to target for the treatment of low BMD is controversial because it is an attractive idea but without consensus on what the target should be and without evidence that treat to target improves clinical outcomes,” she reiterated.

“The potential benefits of treat to target are proactive, clear goals to achieve, shared decision-making with the patient, the possibility for improved adherence, justification for sequence treatments, and balancing risk of rare side effects.”

On the other hand, “barriers to operationalizing the treat-to-target concept is that there is lack of consensus on the target to be achieved [as any specific target may minimize other important risk factors],” she noted.

There is also a “lack of evidence that demonstrates improved clinical outcomes over choosing therapy based on fracture risk, and lack of ability to achieve the target with available therapies in those with very-low bone density,” she concluded.

Dr. McClung has reported receiving consulting fees from Amgen and Myovant and speaker honoraria from Amgen. Dr. Gregson and Dr. Jan de Beur have reported no relevant financial relationships.
 

A version of this article originally appeared on Medscape.com.

“A treat-to-target approach is useful in the management of osteoporosis” was the motion proposed in a debate during the recent virtual American Society of Bone and Mineral Research (ASBMR) 2020 annual meeting, and when the votes came in, Michael McClung, MD, who argued against the motion, carried the day.

Agreement with the motion dropped from 63%-46% after McClung, of the Oregon Osteoporosis Center, Portland, put his views forward in opposition to those of Celia L. Gregson, PhD, University of Bristol (England), who argued for the motion on behalf of the European Calcified Tissue Society (ECTS).

Disagreement with the statement rose from 37% predebate to 54% in the postdebate audience polls.

“The debate is part education and part entertainment,” said Dr. McClung, who represented the ASBMR. “I could just as easily have made a strong argument for the motion,” he emphasized in an interview.

On the other hand, “had I been in the audience, as a member of ASBMR relying on data and evidence to make clinical decisions, I would have voted against the motion. As appealing as the strategy sounds, we don’t yet have the hard evidence to support its use nor is there a consensus about what an appropriate target should be, he noted.

Similarly, the debate comoderator and incoming ASBMR President, Suzanne M. Jan de Beur, MD, from Johns Hopkins University, Baltimore, said that a treat-to-target strategy for osteoporosis is an attractive idea, but there is no consensus on how to apply it nor evidence that it improves clinical outcomes.
 

Treat to target to guide osteoporosis therapy is like going “backwards”

In treat to target, the target – such as bone mineral density (BMD) (the most common one) – is identified before treatment is started, Dr. McClung explained (and as stated in a review article in the New England Journal of Medicine he coauthored on the topic). 

“While treat to target has appealing concepts, using risk factors to guide therapy is almost backwards,” he said. “We can’t change bone density very much.”

Treat to target is “not quite ready for prime time,” he concluded in his rebuttal.

Invited to speculate on which of Dr. McClung’s arguments swayed the audience, Dr. Gregson conceded that with a treat-to-target strategy “there is too much focus on getting one target for the whole global population with osteoporosis.”

“This is an oversimplification of a complex disease, and it misses the main message that the target should be decided with the patient not for the patient, which means one can’t just have one rule for everyone. There has to be scope to have different targets for different people so that we can deliver individualized care.”

Also, she noted, “generally people don’t vote to change familiar systems.”
 

Arguments for treat to target

Dr. Gregson began her argument, however, by stating that treat to target “is now a feasible and useful approach in osteoporosis care.”

The main reasons for adopting this treatment strategy are as follows:

• It provides a proactive approach with a clear goal.
• It includes periodic treatment reassessment, which allows for prompt revisions to treatment.
• It can use targets to guide treatment timing and patient monitoring.
• It includes shared decision-making, the preferred method of patient care.
• It could improve treatment adherence through patient “buy-in” of the target.
• It can use targets to address the risk of rare side effects.
• It allows for sequential treatments, especially for patients at highest risk of fracture.
• It can include more patient-centered outcomes such as reduced , restored range of movement, and ability to live independently.

“Patients are not interested in their T-score. They are interested in pain,” said Dr. Gregson.

“Reduced fracture risk is a very important goal,” she emphasized. Patients “with osteoporosis and a high fracture risk have the most to gain from a treat-to-target approach.”

“Improved access to anabolic osteoporosis treatments mean achieving those goals or targets are now more achievable than ever,” she concluded.

Arguments against treat to target

“Do we truly have an appropriate, meaningful target for osteoporosis?” Dr. McClung began in his counterargument, which cast a seed of doubt in the minds of the audience.

Targets such as no fractures, fracture risk (FRAX score), bone turnover markers, and bone strength have limitations.

Moreover, “do we have treatment strategies to move patients to the chosen target?” he continued. “What is the evidence that a treat-to-target strategy provides better outcomes than our current treatment paradigm?”

After pointing out a lack of evidence that treat to target leads to better outcomes in osteoporosis, he did allow that “recent data about the relationship between treatment-related BMD values and current fracture risk are appreciated and welcomed.”

“However, a treat-to-target strategy will only be successful if the targets are individualized for each patient, those targets are attainable for most patients, and we have evidence that adopting this strategy improves clinical outcomes,” he summarized.

He then quoted his late wife Betsy Love McClung, RN, MN, who had said, “We don’t treat osteoporosis; we treat patients with osteoporosis.”

Dr. McClung wrapped up by stressing: “We should not treat T-scores or any other specific target. We should individualize our therapy based upon the patient’s risk of fracture and other clinical factors.”

As members of the ECTS and ASBMR, and “proud of our reputation of our societies as being scientifically based and driven,” Dr. McClung concluded, “recognizing that a treat-to-target strategy has appeal, we should certainly encourage more research and be attentive to those results.

“But we must hold off on the adoption of the strategy until we have evidence convincing us of its clinical value.”
 

When to use a treat-to-target strategy

However, “there are some specific situations where I use something like a treat-to-target strategy,” Dr. McClung conceded. “That is, I make decisions and recommendations to the patients about one drug rather than another because I want to maximize the improvement in their bone density.”

For example, “We have known for 15 years that denosumab results in greater increases in bone density than do bisphosphonates,” he continued.

“So I have used that information to make treatment decisions long before the term ‘treat to target’ entered the vocabulary of osteoporosis experts. I simply wanted to induce the largest possible gains in bone density – but I didn’t have a ‘target’ in mind.”

But for most patients, treatment decisions are made based on other factors, such as their fracture risk, he added. BMD is an important risk factor for fracture, but not as important as having had a recent fracture or being old and frail.

“Unfortunately, in most of today’s health systems, decisions about treatment are made on the basis of cost,” he continued. “More often than not, the health plan rules rather than optimal medical practice are the main guides to treatment decisions.”   

According to Dr. Gregson, “in some instances, treat to target would be very helpful. I don’t think it will suit everyone, but I think we should have it in our portfolio of management approaches, and we should as an osteoporosis community be trained in its use.”
 

“Attractive idea, but ...”

Invited to weigh in, Dr. Jan de Beur noted that A1c, blood pressure, and LDL cholesterol targets are used to improve clinical outcomes in patients with diabetes, hypertension, and hyperlipidemia, respectively.

However, “treat to target for the treatment of low BMD is controversial because it is an attractive idea but without consensus on what the target should be and without evidence that treat to target improves clinical outcomes,” she reiterated.

“The potential benefits of treat to target are proactive, clear goals to achieve, shared decision-making with the patient, the possibility for improved adherence, justification for sequence treatments, and balancing risk of rare side effects.”

On the other hand, “barriers to operationalizing the treat-to-target concept is that there is lack of consensus on the target to be achieved [as any specific target may minimize other important risk factors],” she noted.

There is also a “lack of evidence that demonstrates improved clinical outcomes over choosing therapy based on fracture risk, and lack of ability to achieve the target with available therapies in those with very-low bone density,” she concluded.

Dr. McClung has reported receiving consulting fees from Amgen and Myovant and speaker honoraria from Amgen. Dr. Gregson and Dr. Jan de Beur have reported no relevant financial relationships.
 

A version of this article originally appeared on Medscape.com.

“A treat-to-target approach is useful in the management of osteoporosis” was the motion proposed in a debate during the recent virtual American Society of Bone and Mineral Research (ASBMR) 2020 annual meeting, and when the votes came in, Michael McClung, MD, who argued against the motion, carried the day.

Agreement with the motion dropped from 63%-46% after McClung, of the Oregon Osteoporosis Center, Portland, put his views forward in opposition to those of Celia L. Gregson, PhD, University of Bristol (England), who argued for the motion on behalf of the European Calcified Tissue Society (ECTS).

Disagreement with the statement rose from 37% predebate to 54% in the postdebate audience polls.

“The debate is part education and part entertainment,” said Dr. McClung, who represented the ASBMR. “I could just as easily have made a strong argument for the motion,” he emphasized in an interview.

On the other hand, “had I been in the audience, as a member of ASBMR relying on data and evidence to make clinical decisions, I would have voted against the motion. As appealing as the strategy sounds, we don’t yet have the hard evidence to support its use nor is there a consensus about what an appropriate target should be, he noted.

Similarly, the debate comoderator and incoming ASBMR President, Suzanne M. Jan de Beur, MD, from Johns Hopkins University, Baltimore, said that a treat-to-target strategy for osteoporosis is an attractive idea, but there is no consensus on how to apply it nor evidence that it improves clinical outcomes.
 

Treat to target to guide osteoporosis therapy is like going “backwards”

In treat to target, the target – such as bone mineral density (BMD) (the most common one) – is identified before treatment is started, Dr. McClung explained (and as stated in a review article in the New England Journal of Medicine he coauthored on the topic). 

“While treat to target has appealing concepts, using risk factors to guide therapy is almost backwards,” he said. “We can’t change bone density very much.”

Treat to target is “not quite ready for prime time,” he concluded in his rebuttal.

Invited to speculate on which of Dr. McClung’s arguments swayed the audience, Dr. Gregson conceded that with a treat-to-target strategy “there is too much focus on getting one target for the whole global population with osteoporosis.”

“This is an oversimplification of a complex disease, and it misses the main message that the target should be decided with the patient not for the patient, which means one can’t just have one rule for everyone. There has to be scope to have different targets for different people so that we can deliver individualized care.”

Also, she noted, “generally people don’t vote to change familiar systems.”
 

Arguments for treat to target

Dr. Gregson began her argument, however, by stating that treat to target “is now a feasible and useful approach in osteoporosis care.”

The main reasons for adopting this treatment strategy are as follows:

• It provides a proactive approach with a clear goal.
• It includes periodic treatment reassessment, which allows for prompt revisions to treatment.
• It can use targets to guide treatment timing and patient monitoring.
• It includes shared decision-making, the preferred method of patient care.
• It could improve treatment adherence through patient “buy-in” of the target.
• It can use targets to address the risk of rare side effects.
• It allows for sequential treatments, especially for patients at highest risk of fracture.
• It can include more patient-centered outcomes such as reduced , restored range of movement, and ability to live independently.

“Patients are not interested in their T-score. They are interested in pain,” said Dr. Gregson.

“Reduced fracture risk is a very important goal,” she emphasized. Patients “with osteoporosis and a high fracture risk have the most to gain from a treat-to-target approach.”

“Improved access to anabolic osteoporosis treatments mean achieving those goals or targets are now more achievable than ever,” she concluded.

Arguments against treat to target

“Do we truly have an appropriate, meaningful target for osteoporosis?” Dr. McClung began in his counterargument, which cast a seed of doubt in the minds of the audience.

Targets such as no fractures, fracture risk (FRAX score), bone turnover markers, and bone strength have limitations.

Moreover, “do we have treatment strategies to move patients to the chosen target?” he continued. “What is the evidence that a treat-to-target strategy provides better outcomes than our current treatment paradigm?”

After pointing out a lack of evidence that treat to target leads to better outcomes in osteoporosis, he did allow that “recent data about the relationship between treatment-related BMD values and current fracture risk are appreciated and welcomed.”

“However, a treat-to-target strategy will only be successful if the targets are individualized for each patient, those targets are attainable for most patients, and we have evidence that adopting this strategy improves clinical outcomes,” he summarized.

He then quoted his late wife Betsy Love McClung, RN, MN, who had said, “We don’t treat osteoporosis; we treat patients with osteoporosis.”

Dr. McClung wrapped up by stressing: “We should not treat T-scores or any other specific target. We should individualize our therapy based upon the patient’s risk of fracture and other clinical factors.”

As members of the ECTS and ASBMR, and “proud of our reputation of our societies as being scientifically based and driven,” Dr. McClung concluded, “recognizing that a treat-to-target strategy has appeal, we should certainly encourage more research and be attentive to those results.

“But we must hold off on the adoption of the strategy until we have evidence convincing us of its clinical value.”
 

When to use a treat-to-target strategy

However, “there are some specific situations where I use something like a treat-to-target strategy,” Dr. McClung conceded. “That is, I make decisions and recommendations to the patients about one drug rather than another because I want to maximize the improvement in their bone density.”

For example, “We have known for 15 years that denosumab results in greater increases in bone density than do bisphosphonates,” he continued.

“So I have used that information to make treatment decisions long before the term ‘treat to target’ entered the vocabulary of osteoporosis experts. I simply wanted to induce the largest possible gains in bone density – but I didn’t have a ‘target’ in mind.”

But for most patients, treatment decisions are made based on other factors, such as their fracture risk, he added. BMD is an important risk factor for fracture, but not as important as having had a recent fracture or being old and frail.

“Unfortunately, in most of today’s health systems, decisions about treatment are made on the basis of cost,” he continued. “More often than not, the health plan rules rather than optimal medical practice are the main guides to treatment decisions.”   

According to Dr. Gregson, “in some instances, treat to target would be very helpful. I don’t think it will suit everyone, but I think we should have it in our portfolio of management approaches, and we should as an osteoporosis community be trained in its use.”
 

“Attractive idea, but ...”

Invited to weigh in, Dr. Jan de Beur noted that A1c, blood pressure, and LDL cholesterol targets are used to improve clinical outcomes in patients with diabetes, hypertension, and hyperlipidemia, respectively.

However, “treat to target for the treatment of low BMD is controversial because it is an attractive idea but without consensus on what the target should be and without evidence that treat to target improves clinical outcomes,” she reiterated.

“The potential benefits of treat to target are proactive, clear goals to achieve, shared decision-making with the patient, the possibility for improved adherence, justification for sequence treatments, and balancing risk of rare side effects.”

On the other hand, “barriers to operationalizing the treat-to-target concept is that there is lack of consensus on the target to be achieved [as any specific target may minimize other important risk factors],” she noted.

There is also a “lack of evidence that demonstrates improved clinical outcomes over choosing therapy based on fracture risk, and lack of ability to achieve the target with available therapies in those with very-low bone density,” she concluded.

Dr. McClung has reported receiving consulting fees from Amgen and Myovant and speaker honoraria from Amgen. Dr. Gregson and Dr. Jan de Beur have reported no relevant financial relationships.
 

A version of this article originally 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.

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.