Rheumatology News

At the time of a nephritis flare in patients with systemic lupus erythematosus (SLE), elevated levels of two neutrophil extracellular trap (NET) protein complexes, elastase-DNA and HMGB1-DNA, predict declining renal function, poor response to therapy, and adverse renal outcomes, according to work presented at the annual meeting of the Canadian Rheumatology Association.

“These proteins are not only predominantly elevated in patients with proliferative lupus nephritis, but they correlate with adverse renal outcomes when patients are followed over 24 months,” reported Laura P. Whittall-Garcia, MD, a clinical fellow in rheumatology at the University of Toronto.

Lupus nephritis is common in SLE, developing in about 50% of patients, according to Dr. Whittall-Garcia. Of these, up to 20% will not respond to standard therapies, typically resulting in end-stage renal disease. Up until now, there has been no reliable method of predicting this adverse clinical course.
 

Proteins identified in NETs

The series of studies conducted by Dr. Whittall-Garcia and coinvestigators were focused on NETs, a network of strings of DNA that typically bind pathogenic microbes to prevent infection but can participate in the pathology of immune-mediated conditions. As Dr. Whittall-Garcia explained, DNA extruded from NETs has been a source of autoantigens.

Based on earlier work, they pursued the hypothesis that high mobility group box 1 (HMGB1) and elastase, which are both NET components, mediate NETosis, the immune response that protects against microbes in healthy individuals but contributes to tissue damage in patients with immune-related disorders. The first aim of this work was to confirm that elevations of elastase-DNA and HMGB1-DNA correlate with active lupus nephritis. The second aim was to determine if levels of these proteins at the time of lupus nephritis flare predicted renal outcomes at 12 and 24 months.

To pursue the first hypothesis, 49 patients with active SLE (18 of whom had active lupus nephritis) were evaluated along with 23 patients with inactive SLE and 20 healthy controls.

Highest levels seen in proliferative nephritis

Relative to healthy controls, patients with active SLE have highly significantly increased levels of both proteins (P < .0001). And relative to those with inactive SLE, the levels of active patients were higher but fell short of statistical significance. However, when the researchers compared those with active lupus nephritis with those who had active SLE but no nephritis, both proteins were significantly higher (P < .04), and the levels in patients with proliferative relative to nonproliferative lupus nephritis were higher still (P < .009).

To pursue the second aim of the study, the researchers retrospectively evaluated 109 patients with SLE. All had active lupus nephritis, a baseline estimated glomerular filtration rate (eGFR) greater than 30 mL/min prior to the flare, and at least 2 years of follow-up. They evaluated complete response at 12 and 24 months, percent decline in eGFR, and severe renal impairment (eGFR ≤ 30 mL/min) in the context of levels of elastase and HMGB1.

With elevations in either NET remnant, the odds ratio of failing to achieve a complete response at 24 months were approximately doubled for elastase-DNA (OR, 1.96; P = .01) and for HMGB1 (OR, 2.61; P = .02). For the endpoint of severe renal impairment 24 months after a lupus nephritis flare, there was also a positive association with both elastase-DNA (OR, 1.55; P = .005) and HMBG1-DNA (OR, 1.91; P = .01).

“For every 100-unit increase in elastase-DNA complexes, there is a 4.8% decrease in eGFR,” reported Dr. Whittall-Garcia, who noted this relationship was highly statistically significant (P < .0001). For HMGB1-DNA, each 100-unit increase was associated with a 5.3% decrease in eGFR (P = .0006).
 

No other biomarkers compare for prognosis

“After adjusting for multiple variables, these protein levels at the time of the flare outperformed all conventional biomarkers, including proteinuria and complement levels,” Dr. Whittall-Garcia said.

Larger validating studies are needed, but Dr. Whittall-Garcia is optimistic that measuring these NET remnant levels will prove useful for monitoring patients at the time of the lupus nephritis flare and over time for the purposes of predicting adverse outcomes and response to therapy.

Although more work is needed, Adegbenga A. Bankole, MD, associate professor of medicine at Virginia Tech University and chief of the rheumatology division at the Carilion Clinic, both in Roanoke, agreed that this is a promising research direction. He reported that NETs have been attracting interest at several research centers for their potential in helping to understand the pathogenesis of lupus nephritis.

“It is unlikely that any one test will ever be a panacea in the diagnosis or predictor of outcomes in lupus nephritis,” Dr. Bankole said in an interview, but “given the importance of NETosis in the development of this disease, studies like this will form the basis of the multistep process through which we will improve patient care.”

With further progress in this area, Dr. Bankole predicted that these studies will lead to clinical applications.

“Dr. Whittall-Garcia and her team will help in the development of diagnostic and/or predictive algorithms that may go on to help improve survival of future patients with SLE,” he said.Dr. Whittall-Garcia and Dr. Bankole report they have no relevant financial relationships.

At the time of a nephritis flare in patients with systemic lupus erythematosus (SLE), elevated levels of two neutrophil extracellular trap (NET) protein complexes, elastase-DNA and HMGB1-DNA, predict declining renal function, poor response to therapy, and adverse renal outcomes, according to work presented at the annual meeting of the Canadian Rheumatology Association.

“These proteins are not only predominantly elevated in patients with proliferative lupus nephritis, but they correlate with adverse renal outcomes when patients are followed over 24 months,” reported Laura P. Whittall-Garcia, MD, a clinical fellow in rheumatology at the University of Toronto.

Lupus nephritis is common in SLE, developing in about 50% of patients, according to Dr. Whittall-Garcia. Of these, up to 20% will not respond to standard therapies, typically resulting in end-stage renal disease. Up until now, there has been no reliable method of predicting this adverse clinical course.
 

Proteins identified in NETs

The series of studies conducted by Dr. Whittall-Garcia and coinvestigators were focused on NETs, a network of strings of DNA that typically bind pathogenic microbes to prevent infection but can participate in the pathology of immune-mediated conditions. As Dr. Whittall-Garcia explained, DNA extruded from NETs has been a source of autoantigens.

Based on earlier work, they pursued the hypothesis that high mobility group box 1 (HMGB1) and elastase, which are both NET components, mediate NETosis, the immune response that protects against microbes in healthy individuals but contributes to tissue damage in patients with immune-related disorders. The first aim of this work was to confirm that elevations of elastase-DNA and HMGB1-DNA correlate with active lupus nephritis. The second aim was to determine if levels of these proteins at the time of lupus nephritis flare predicted renal outcomes at 12 and 24 months.

To pursue the first hypothesis, 49 patients with active SLE (18 of whom had active lupus nephritis) were evaluated along with 23 patients with inactive SLE and 20 healthy controls.

Highest levels seen in proliferative nephritis

Relative to healthy controls, patients with active SLE have highly significantly increased levels of both proteins (P < .0001). And relative to those with inactive SLE, the levels of active patients were higher but fell short of statistical significance. However, when the researchers compared those with active lupus nephritis with those who had active SLE but no nephritis, both proteins were significantly higher (P < .04), and the levels in patients with proliferative relative to nonproliferative lupus nephritis were higher still (P < .009).

To pursue the second aim of the study, the researchers retrospectively evaluated 109 patients with SLE. All had active lupus nephritis, a baseline estimated glomerular filtration rate (eGFR) greater than 30 mL/min prior to the flare, and at least 2 years of follow-up. They evaluated complete response at 12 and 24 months, percent decline in eGFR, and severe renal impairment (eGFR ≤ 30 mL/min) in the context of levels of elastase and HMGB1.

With elevations in either NET remnant, the odds ratio of failing to achieve a complete response at 24 months were approximately doubled for elastase-DNA (OR, 1.96; P = .01) and for HMGB1 (OR, 2.61; P = .02). For the endpoint of severe renal impairment 24 months after a lupus nephritis flare, there was also a positive association with both elastase-DNA (OR, 1.55; P = .005) and HMBG1-DNA (OR, 1.91; P = .01).

“For every 100-unit increase in elastase-DNA complexes, there is a 4.8% decrease in eGFR,” reported Dr. Whittall-Garcia, who noted this relationship was highly statistically significant (P < .0001). For HMGB1-DNA, each 100-unit increase was associated with a 5.3% decrease in eGFR (P = .0006).
 

No other biomarkers compare for prognosis

“After adjusting for multiple variables, these protein levels at the time of the flare outperformed all conventional biomarkers, including proteinuria and complement levels,” Dr. Whittall-Garcia said.

Larger validating studies are needed, but Dr. Whittall-Garcia is optimistic that measuring these NET remnant levels will prove useful for monitoring patients at the time of the lupus nephritis flare and over time for the purposes of predicting adverse outcomes and response to therapy.

Although more work is needed, Adegbenga A. Bankole, MD, associate professor of medicine at Virginia Tech University and chief of the rheumatology division at the Carilion Clinic, both in Roanoke, agreed that this is a promising research direction. He reported that NETs have been attracting interest at several research centers for their potential in helping to understand the pathogenesis of lupus nephritis.

“It is unlikely that any one test will ever be a panacea in the diagnosis or predictor of outcomes in lupus nephritis,” Dr. Bankole said in an interview, but “given the importance of NETosis in the development of this disease, studies like this will form the basis of the multistep process through which we will improve patient care.”

With further progress in this area, Dr. Bankole predicted that these studies will lead to clinical applications.

“Dr. Whittall-Garcia and her team will help in the development of diagnostic and/or predictive algorithms that may go on to help improve survival of future patients with SLE,” he said.Dr. Whittall-Garcia and Dr. Bankole report they have no relevant financial relationships.

At the time of a nephritis flare in patients with systemic lupus erythematosus (SLE), elevated levels of two neutrophil extracellular trap (NET) protein complexes, elastase-DNA and HMGB1-DNA, predict declining renal function, poor response to therapy, and adverse renal outcomes, according to work presented at the annual meeting of the Canadian Rheumatology Association.

“These proteins are not only predominantly elevated in patients with proliferative lupus nephritis, but they correlate with adverse renal outcomes when patients are followed over 24 months,” reported Laura P. Whittall-Garcia, MD, a clinical fellow in rheumatology at the University of Toronto.

Lupus nephritis is common in SLE, developing in about 50% of patients, according to Dr. Whittall-Garcia. Of these, up to 20% will not respond to standard therapies, typically resulting in end-stage renal disease. Up until now, there has been no reliable method of predicting this adverse clinical course.
 

Proteins identified in NETs

The series of studies conducted by Dr. Whittall-Garcia and coinvestigators were focused on NETs, a network of strings of DNA that typically bind pathogenic microbes to prevent infection but can participate in the pathology of immune-mediated conditions. As Dr. Whittall-Garcia explained, DNA extruded from NETs has been a source of autoantigens.

Based on earlier work, they pursued the hypothesis that high mobility group box 1 (HMGB1) and elastase, which are both NET components, mediate NETosis, the immune response that protects against microbes in healthy individuals but contributes to tissue damage in patients with immune-related disorders. The first aim of this work was to confirm that elevations of elastase-DNA and HMGB1-DNA correlate with active lupus nephritis. The second aim was to determine if levels of these proteins at the time of lupus nephritis flare predicted renal outcomes at 12 and 24 months.

To pursue the first hypothesis, 49 patients with active SLE (18 of whom had active lupus nephritis) were evaluated along with 23 patients with inactive SLE and 20 healthy controls.

Highest levels seen in proliferative nephritis

Relative to healthy controls, patients with active SLE have highly significantly increased levels of both proteins (P < .0001). And relative to those with inactive SLE, the levels of active patients were higher but fell short of statistical significance. However, when the researchers compared those with active lupus nephritis with those who had active SLE but no nephritis, both proteins were significantly higher (P < .04), and the levels in patients with proliferative relative to nonproliferative lupus nephritis were higher still (P < .009).

To pursue the second aim of the study, the researchers retrospectively evaluated 109 patients with SLE. All had active lupus nephritis, a baseline estimated glomerular filtration rate (eGFR) greater than 30 mL/min prior to the flare, and at least 2 years of follow-up. They evaluated complete response at 12 and 24 months, percent decline in eGFR, and severe renal impairment (eGFR ≤ 30 mL/min) in the context of levels of elastase and HMGB1.

With elevations in either NET remnant, the odds ratio of failing to achieve a complete response at 24 months were approximately doubled for elastase-DNA (OR, 1.96; P = .01) and for HMGB1 (OR, 2.61; P = .02). For the endpoint of severe renal impairment 24 months after a lupus nephritis flare, there was also a positive association with both elastase-DNA (OR, 1.55; P = .005) and HMBG1-DNA (OR, 1.91; P = .01).

“For every 100-unit increase in elastase-DNA complexes, there is a 4.8% decrease in eGFR,” reported Dr. Whittall-Garcia, who noted this relationship was highly statistically significant (P < .0001). For HMGB1-DNA, each 100-unit increase was associated with a 5.3% decrease in eGFR (P = .0006).
 

No other biomarkers compare for prognosis

“After adjusting for multiple variables, these protein levels at the time of the flare outperformed all conventional biomarkers, including proteinuria and complement levels,” Dr. Whittall-Garcia said.

Larger validating studies are needed, but Dr. Whittall-Garcia is optimistic that measuring these NET remnant levels will prove useful for monitoring patients at the time of the lupus nephritis flare and over time for the purposes of predicting adverse outcomes and response to therapy.

Although more work is needed, Adegbenga A. Bankole, MD, associate professor of medicine at Virginia Tech University and chief of the rheumatology division at the Carilion Clinic, both in Roanoke, agreed that this is a promising research direction. He reported that NETs have been attracting interest at several research centers for their potential in helping to understand the pathogenesis of lupus nephritis.

“It is unlikely that any one test will ever be a panacea in the diagnosis or predictor of outcomes in lupus nephritis,” Dr. Bankole said in an interview, but “given the importance of NETosis in the development of this disease, studies like this will form the basis of the multistep process through which we will improve patient care.”

With further progress in this area, Dr. Bankole predicted that these studies will lead to clinical applications.

“Dr. Whittall-Garcia and her team will help in the development of diagnostic and/or predictive algorithms that may go on to help improve survival of future patients with SLE,” he said.Dr. Whittall-Garcia and Dr. Bankole report they have no relevant financial relationships.

Real-world, population-based data suggest that the discontinuation rates for biosimilars prescribed to treat inflammatory rheumatic diseases are similar to those for their corresponding originator biologics, according to a study of patients in British Columbia who were required to switch to biosimilars.

“The decision to mandate use of biosimilars provided an ideal context for a natural experiment,” Diane Lacaille, MD, chair in arthritis research at the University of British Columbia, Vancouver, explained in her presentation of the study at the annual meeting of the Canadian Rheumatology Association.

On the basis of the real-world data, which was collected before and after a province-wide requirement to use biosimilars in place of originator biologics, there was no major difference in discontinuation rates, an outcome that Dr. Lacaille characterized as “a surrogate for both efficacy and safety.”

In the 2019 rheumatoid arthritis treatment guidelines from the European Alliance of Associations for Rheumatology, biosimilars are advocated for addressing the high cost of biologics based on evidence of efficacy and safety comparable with originator biologics. According to one of the coauthors of those guidelines, Tom W. J. Huizinga, MD, PhD, head of rheumatology at Leiden (Netherlands) University Medical Center, there is reasonable confidence in biosimilars as an adequate substitute for originator drugs, but real-world data are welcome.

“Real-world data provide different information than controlled trials and long-term data as well, so these [Canadian findings] are useful to support the data from [randomized controlled trials],” Dr. Huizinga said in an interview. He was not involved in the Canadian study.
 

Survivorship evaluated after switch to biosimilars

In British Columbia, biosimilars were mandated province-wide for new prescriptions of infliximab and etanercept in June 2017. In 2019, the mandate was extended to patients already taking originator infliximab (Remicade) and originator etanercept (Enbrel). Since that time, the mandate for biosimilars has also been applied to adalimumab (Humira). For the comparison of infliximab and etanercept originators with their biosimilars, Dr. Lacaille and associates compared survivorship for the 3 years after the policy change, when patients were on biosimilars, with the 3 years prior to the change, when patients were on the originators. They compared survivorship with originator adalimumab with its biosimilars for prior to and after the switch.

”People were followed from anti-TNF [tumor necrosis factor] initiation until discontinuation for any reason,” reported Dr. Lacaille, who said data were censored for death and moving out of the province. In British Columbia, where there is universal health care, all dispensed medications can be tracked. The definition of anti-TNF discontinuation in this study was no prescription renewal for at least 6 months.

The follow-up was censored at March 2, 2020, to avoid the potential impact of COVID-19 on antirheumatic drug use. Discontinuation was standardized for the comparison of originator with biosimilar drugs as rates per 100 person-years. Statistical adjustments were made for potential confounders.

The researchers compared 1,312 patients on etanercept and 827 on a biosimilar of it, 230 patients on infliximab and 271 on a biosimilar of it, and 1,773 on adalimumab and 2,213 on a biosimilar of it. The indication was RA in approximately 60% of those on etanercept or a biosimilar and 50% of those on infliximab or adalimumab and their biosimilars. More than half of the remaining patients had indications for psoriatic arthritis, and the rest had ankylosing spondylitis.
 

No differences reach statistical significance

On the basis of discontinuation rates per 100 person-years, etanercept and its biosimilars performed almost identically (37.10 vs. 37.02, respectively). Although the discontinuation rate per 100 person-years was lower on infliximab than a biosimilar of it (29.97 vs. 37.96), the difference was not statistically significant (P = .076).

For adalimumab, the discontinuation rate was also lower on the originator drug than a biosimilar of it (32.92 vs. 36.36), but, again, this difference was also insignificant (P = .56).

When the discontinuation data were evaluated on the basis of a Cox model involving a propensity weight overlap, the univariate and the multivariable analyses found that the biosimilars had similar risks for discontinuation. Univariate analysis revealed hazard ratios for discontinuation of the biosimilar relative to the originator were 0.98 (P = .783) for etanercept, 1.17 (P = .242) for infliximab, and 1.08 (P = .09) for adalimumab. In the multivariable model, adjusted HRs for discontinuation were about the same for each of the biosimilars relative to the originator: 0.98 (P = .807) for etanercept, 1.19 (P = .183) for infliximab, and 1.08 (P = .089) for adalimumab.

Relative to previously published direct comparisons, this real-world analysis and its duration of follow-up address the limitations of formal trials. In a 2020 BMJ meta-analysis of published data from 45 trials comparing biosimilar with originator drugs in patients with RA who had failed methotrexate, the authors found only “minor differences in harms and benefits,” but they cautioned that the analysis was “hampered by a lack of long-term direct comparisons.”

In an interview, Dr. Huizinga noted that a systematic review of adalimumab biosimilars that he led 2 years ago showed that they perform comparably with the originator biologics. This and other published studies have consistently shown “that there is no difference between biologics and originators.”

Dr. Lacaille disclosed financial relationships with Fresenius Kabi, Janssen, Organon, Pfizer, and Viatris. Dr. Huizinga disclosed financial relationships with Abbott, Ablynx, Biotest, Bioscience, Boehringer Ingelheim, Bristol-Myers Squibb, Crescendo Bioscience, Eli Lilly, Galapagos, Janssen, Merck, Novartis, MycoMed, Roche, Sanofi-Aventis, Takeda, and Zydus.

Real-world, population-based data suggest that the discontinuation rates for biosimilars prescribed to treat inflammatory rheumatic diseases are similar to those for their corresponding originator biologics, according to a study of patients in British Columbia who were required to switch to biosimilars.

“The decision to mandate use of biosimilars provided an ideal context for a natural experiment,” Diane Lacaille, MD, chair in arthritis research at the University of British Columbia, Vancouver, explained in her presentation of the study at the annual meeting of the Canadian Rheumatology Association.

On the basis of the real-world data, which was collected before and after a province-wide requirement to use biosimilars in place of originator biologics, there was no major difference in discontinuation rates, an outcome that Dr. Lacaille characterized as “a surrogate for both efficacy and safety.”

In the 2019 rheumatoid arthritis treatment guidelines from the European Alliance of Associations for Rheumatology, biosimilars are advocated for addressing the high cost of biologics based on evidence of efficacy and safety comparable with originator biologics. According to one of the coauthors of those guidelines, Tom W. J. Huizinga, MD, PhD, head of rheumatology at Leiden (Netherlands) University Medical Center, there is reasonable confidence in biosimilars as an adequate substitute for originator drugs, but real-world data are welcome.

“Real-world data provide different information than controlled trials and long-term data as well, so these [Canadian findings] are useful to support the data from [randomized controlled trials],” Dr. Huizinga said in an interview. He was not involved in the Canadian study.
 

Survivorship evaluated after switch to biosimilars

In British Columbia, biosimilars were mandated province-wide for new prescriptions of infliximab and etanercept in June 2017. In 2019, the mandate was extended to patients already taking originator infliximab (Remicade) and originator etanercept (Enbrel). Since that time, the mandate for biosimilars has also been applied to adalimumab (Humira). For the comparison of infliximab and etanercept originators with their biosimilars, Dr. Lacaille and associates compared survivorship for the 3 years after the policy change, when patients were on biosimilars, with the 3 years prior to the change, when patients were on the originators. They compared survivorship with originator adalimumab with its biosimilars for prior to and after the switch.

”People were followed from anti-TNF [tumor necrosis factor] initiation until discontinuation for any reason,” reported Dr. Lacaille, who said data were censored for death and moving out of the province. In British Columbia, where there is universal health care, all dispensed medications can be tracked. The definition of anti-TNF discontinuation in this study was no prescription renewal for at least 6 months.

The follow-up was censored at March 2, 2020, to avoid the potential impact of COVID-19 on antirheumatic drug use. Discontinuation was standardized for the comparison of originator with biosimilar drugs as rates per 100 person-years. Statistical adjustments were made for potential confounders.

The researchers compared 1,312 patients on etanercept and 827 on a biosimilar of it, 230 patients on infliximab and 271 on a biosimilar of it, and 1,773 on adalimumab and 2,213 on a biosimilar of it. The indication was RA in approximately 60% of those on etanercept or a biosimilar and 50% of those on infliximab or adalimumab and their biosimilars. More than half of the remaining patients had indications for psoriatic arthritis, and the rest had ankylosing spondylitis.
 

No differences reach statistical significance

On the basis of discontinuation rates per 100 person-years, etanercept and its biosimilars performed almost identically (37.10 vs. 37.02, respectively). Although the discontinuation rate per 100 person-years was lower on infliximab than a biosimilar of it (29.97 vs. 37.96), the difference was not statistically significant (P = .076).

For adalimumab, the discontinuation rate was also lower on the originator drug than a biosimilar of it (32.92 vs. 36.36), but, again, this difference was also insignificant (P = .56).

When the discontinuation data were evaluated on the basis of a Cox model involving a propensity weight overlap, the univariate and the multivariable analyses found that the biosimilars had similar risks for discontinuation. Univariate analysis revealed hazard ratios for discontinuation of the biosimilar relative to the originator were 0.98 (P = .783) for etanercept, 1.17 (P = .242) for infliximab, and 1.08 (P = .09) for adalimumab. In the multivariable model, adjusted HRs for discontinuation were about the same for each of the biosimilars relative to the originator: 0.98 (P = .807) for etanercept, 1.19 (P = .183) for infliximab, and 1.08 (P = .089) for adalimumab.

Relative to previously published direct comparisons, this real-world analysis and its duration of follow-up address the limitations of formal trials. In a 2020 BMJ meta-analysis of published data from 45 trials comparing biosimilar with originator drugs in patients with RA who had failed methotrexate, the authors found only “minor differences in harms and benefits,” but they cautioned that the analysis was “hampered by a lack of long-term direct comparisons.”

In an interview, Dr. Huizinga noted that a systematic review of adalimumab biosimilars that he led 2 years ago showed that they perform comparably with the originator biologics. This and other published studies have consistently shown “that there is no difference between biologics and originators.”

Dr. Lacaille disclosed financial relationships with Fresenius Kabi, Janssen, Organon, Pfizer, and Viatris. Dr. Huizinga disclosed financial relationships with Abbott, Ablynx, Biotest, Bioscience, Boehringer Ingelheim, Bristol-Myers Squibb, Crescendo Bioscience, Eli Lilly, Galapagos, Janssen, Merck, Novartis, MycoMed, Roche, Sanofi-Aventis, Takeda, and Zydus.

Real-world, population-based data suggest that the discontinuation rates for biosimilars prescribed to treat inflammatory rheumatic diseases are similar to those for their corresponding originator biologics, according to a study of patients in British Columbia who were required to switch to biosimilars.

“The decision to mandate use of biosimilars provided an ideal context for a natural experiment,” Diane Lacaille, MD, chair in arthritis research at the University of British Columbia, Vancouver, explained in her presentation of the study at the annual meeting of the Canadian Rheumatology Association.

On the basis of the real-world data, which was collected before and after a province-wide requirement to use biosimilars in place of originator biologics, there was no major difference in discontinuation rates, an outcome that Dr. Lacaille characterized as “a surrogate for both efficacy and safety.”

In the 2019 rheumatoid arthritis treatment guidelines from the European Alliance of Associations for Rheumatology, biosimilars are advocated for addressing the high cost of biologics based on evidence of efficacy and safety comparable with originator biologics. According to one of the coauthors of those guidelines, Tom W. J. Huizinga, MD, PhD, head of rheumatology at Leiden (Netherlands) University Medical Center, there is reasonable confidence in biosimilars as an adequate substitute for originator drugs, but real-world data are welcome.

“Real-world data provide different information than controlled trials and long-term data as well, so these [Canadian findings] are useful to support the data from [randomized controlled trials],” Dr. Huizinga said in an interview. He was not involved in the Canadian study.
 

Survivorship evaluated after switch to biosimilars

In British Columbia, biosimilars were mandated province-wide for new prescriptions of infliximab and etanercept in June 2017. In 2019, the mandate was extended to patients already taking originator infliximab (Remicade) and originator etanercept (Enbrel). Since that time, the mandate for biosimilars has also been applied to adalimumab (Humira). For the comparison of infliximab and etanercept originators with their biosimilars, Dr. Lacaille and associates compared survivorship for the 3 years after the policy change, when patients were on biosimilars, with the 3 years prior to the change, when patients were on the originators. They compared survivorship with originator adalimumab with its biosimilars for prior to and after the switch.

”People were followed from anti-TNF [tumor necrosis factor] initiation until discontinuation for any reason,” reported Dr. Lacaille, who said data were censored for death and moving out of the province. In British Columbia, where there is universal health care, all dispensed medications can be tracked. The definition of anti-TNF discontinuation in this study was no prescription renewal for at least 6 months.

The follow-up was censored at March 2, 2020, to avoid the potential impact of COVID-19 on antirheumatic drug use. Discontinuation was standardized for the comparison of originator with biosimilar drugs as rates per 100 person-years. Statistical adjustments were made for potential confounders.

The researchers compared 1,312 patients on etanercept and 827 on a biosimilar of it, 230 patients on infliximab and 271 on a biosimilar of it, and 1,773 on adalimumab and 2,213 on a biosimilar of it. The indication was RA in approximately 60% of those on etanercept or a biosimilar and 50% of those on infliximab or adalimumab and their biosimilars. More than half of the remaining patients had indications for psoriatic arthritis, and the rest had ankylosing spondylitis.
 

No differences reach statistical significance

On the basis of discontinuation rates per 100 person-years, etanercept and its biosimilars performed almost identically (37.10 vs. 37.02, respectively). Although the discontinuation rate per 100 person-years was lower on infliximab than a biosimilar of it (29.97 vs. 37.96), the difference was not statistically significant (P = .076).

For adalimumab, the discontinuation rate was also lower on the originator drug than a biosimilar of it (32.92 vs. 36.36), but, again, this difference was also insignificant (P = .56).

When the discontinuation data were evaluated on the basis of a Cox model involving a propensity weight overlap, the univariate and the multivariable analyses found that the biosimilars had similar risks for discontinuation. Univariate analysis revealed hazard ratios for discontinuation of the biosimilar relative to the originator were 0.98 (P = .783) for etanercept, 1.17 (P = .242) for infliximab, and 1.08 (P = .09) for adalimumab. In the multivariable model, adjusted HRs for discontinuation were about the same for each of the biosimilars relative to the originator: 0.98 (P = .807) for etanercept, 1.19 (P = .183) for infliximab, and 1.08 (P = .089) for adalimumab.

Relative to previously published direct comparisons, this real-world analysis and its duration of follow-up address the limitations of formal trials. In a 2020 BMJ meta-analysis of published data from 45 trials comparing biosimilar with originator drugs in patients with RA who had failed methotrexate, the authors found only “minor differences in harms and benefits,” but they cautioned that the analysis was “hampered by a lack of long-term direct comparisons.”

In an interview, Dr. Huizinga noted that a systematic review of adalimumab biosimilars that he led 2 years ago showed that they perform comparably with the originator biologics. This and other published studies have consistently shown “that there is no difference between biologics and originators.”

Dr. Lacaille disclosed financial relationships with Fresenius Kabi, Janssen, Organon, Pfizer, and Viatris. Dr. Huizinga disclosed financial relationships with Abbott, Ablynx, Biotest, Bioscience, Boehringer Ingelheim, Bristol-Myers Squibb, Crescendo Bioscience, Eli Lilly, Galapagos, Janssen, Merck, Novartis, MycoMed, Roche, Sanofi-Aventis, Takeda, and Zydus.

In May 2021, a nurse at UnitedHealthcare called a colleague to share some welcome news about a problem the two had been grappling with for weeks.

United provided the health insurance plan for students at Penn State University. It was a large and potentially lucrative account: lots of young, healthy students paying premiums in, not too many huge medical reimbursements going out.

But one student was costing United a lot of money. Christopher McNaughton suffered from a crippling case of ulcerative colitis – an ailment that caused him to develop severe arthritis, debilitating diarrhea, numbing fatigue, and life-threatening blood clots. His medical bills were running nearly $2 million a year.

United had flagged Mr. McNaughton’s case as a “high dollar account,” and the company was reviewing whether it needed to keep paying for the expensive cocktail of drugs crafted by a Mayo Clinic specialist that had brought Mr. McNaughton’s disease under control after he’d been through years of misery.

On the 2021 phone call, which was recorded by the company, nurse Victoria Kavanaugh told her colleague that a doctor contracted by United to review the case had concluded that Mr. McNaughton’s treatment was “not medically necessary.” Her colleague, Dave Opperman, reacted to the news with a long laugh.

“I knew that was coming,” said Mr. Opperman, who heads up a United subsidiary that brokered the health insurance contract between United and Penn State. “I did too,” Ms. Kavanaugh replied.

Mr. Opperman then complained about Mr. McNaughton’s mother, whom he referred to as “this woman,” for “screaming and yelling” and “throwing tantrums” during calls with United.

The pair agreed that any appeal of the United doctor’s denial of the treatment would be a waste of the family’s time and money.

“We’re still gonna say no,” Mr. Opperman said.

More than 200 million Americans are covered by private health insurance. But data from state and federal regulators shows that insurers reject about 1 in 7 claims for treatment. Many people, faced with fighting insurance companies, simply give up: One study found that Americans file formal appeals on only 0.1% of claims denied by insurers under the Affordable Care Act.

Insurers have wide discretion in crafting what is covered by their policies, beyond some basic services mandated by federal and state law. They often deny claims for services that they deem not “medically necessary.”

When United refused to pay for Mr. McNaughton’s treatment for that reason, his family did something unusual. They fought back with a lawsuit, which uncovered a trove of materials, including internal emails and tape-recorded exchanges among company employees. Those records offer an extraordinary behind-the-scenes look at how one of America’s leading health care insurers relentlessly fought to reduce spending on care, even as its profits rose to record levels.

As United reviewed Mr. McNaughton’s treatment, he and his family were often in the dark about what was happening or their rights. Meanwhile, United employees misrepresented critical findings and ignored warnings from doctors about the risks of altering Mr. McNaughton’s drug plan.

At one point, court records show, United inaccurately reported to Penn State and the family that Mr. McNaughton’s doctor had agreed to lower the doses of his medication. Another time, a doctor paid by United concluded that denying payments for Mr. McNaughton’s treatment could put his health at risk, but the company buried his report and did not consider its findings. The insurer did, however, consider a report submitted by a company doctor who rubber-stamped the recommendation of a United nurse to reject paying for the treatment.

United declined to answer specific questions about the case, even after Mr. McNaughton signed a release provided by the insurer to allow it to discuss details of his interactions with the company. United noted that it ultimately paid for all of Mr. McNaughton’s treatments. In a written response, United spokesperson Maria Gordon Shydlo wrote that the company’s guiding concern was Mr. McNaughton’s well-being.

“Mr. McNaughton’s treatment involves medication dosages that far exceed [Food and Drug Administration] guidelines,” the statement said. “In cases like this, we review treatment plans based on current clinical guidelines to help ensure patient safety.”

But the records reviewed by ProPublica show that United had another, equally urgent goal in dealing with Mr. McNaughton. In emails, officials calculated what Mr. McNaughton was costing them to keep his crippling disease at bay and how much they would save if they forced him to undergo a cheaper treatment that had already failed him. As the family pressed the company to back down, first through Penn State and then through a lawsuit, the United officials handling the case bristled.

“This is just unbelievable,” Ms. Kavanaugh said of Mr. McNaughton’s family in one call to discuss his case. ”They’re just really pushing the envelope, and I’m surprised, like I don’t even know what to say.”
 

The same meal every day

Now 31, Mr. McNaughton grew up in State College, Pa., just blocks from the Penn State campus. Both of his parents are faculty members at the university.

In the winter of 2014, Mr. McNaughton was halfway through his junior year at Bard College in New York. At 6 feet, 4 inches tall, he was a guard on the basketball team and had started most of the team’s games since the start of his sophomore year. He was majoring in psychology.

When Mr. McNaughton returned to school after the winter holiday break, he started to experience frequent bouts of bloody diarrhea. After just a few days on campus, he went home to State College, where doctors diagnosed him with a severe case of ulcerative colitis.

A chronic inflammatory bowel disease that causes swelling and ulcers in the digestive tract, ulcerative colitis has no cure, and ongoing treatment is needed to alleviate symptoms and prevent serious health complications. The majority of cases produce mild to moderate symptoms. Mr. McNaughton’s case was severe.

Treatments for ulcerative colitis include steroids and special drugs known as biologics that work to reduce inflammation in the large intestine.

Mr. McNaughton, however, failed to get meaningful relief from the drugs his doctors initially prescribed. He was experiencing bloody diarrhea up to 20 times a day, with such severe stomach pain that he spent much of his day curled up on a couch. He had little appetite and lost 50 pounds. Severe anemia left him fatigued. He suffered from other conditions related to his colitis, including crippling arthritis. He was hospitalized several times to treat dangerous blood clots.

For 2 years, in an effort to help alleviate his symptoms, he ate the same meals every day: Rice Chex cereal and scrambled eggs for breakfast, a cup of white rice with plain chicken breast for lunch, and a similar meal for dinner, occasionally swapping in tilapia.

His hometown doctors referred him to a specialist at the University of Pittsburgh, who tried unsuccessfully to bring his disease under control. That doctor ended up referring Mr. McNaughton to Edward V. Loftus Jr., MD, at the Mayo Clinic in Rochester, Minn., which has been ranked as the best gastroenterology hospital in the country every year since 1990 by U.S. News & World Report.

For his first visit with Dr. Loftus in May 2015, Mr. McNaughton and his mother, Janice Light, charted hospitals along the 900-mile drive from Pennsylvania to Minnesota in case they needed medical help along the way.

Mornings were the hardest. Mr. McNaughton often spent several hours in the bathroom at the start of the day. To prepare for his meeting with Dr. Loftus, he set his alarm for 3:30 a.m. so he could be ready for the 7:30 a.m. appointment. Even with that preparation, he had to stop twice to use a bathroom on the 5-minute walk from the hotel to the clinic. When they met, Dr. Loftus looked at Mr. McNaughton and told him that he appeared incapacitated. It was, he told the student, as if Mr. McNaughton were chained to the bathroom, with no outside life. He had not been able to return to school and spent most days indoors, managing his symptoms as best he could.

Mr. McNaughton had tried a number of medications by this point, none of which worked. This pattern would repeat itself during the first couple of years that Dr. Loftus treated him.

In addition to trying to find a treatment that would bring Mr. McNaughton’s colitis into remission, Dr. Loftus wanted to wean him off the steroid prednisone, which he had been taking since his initial diagnosis in 2014. The drug is commonly prescribed to colitis patients to control inflammation, but prolonged use can lead to severe side effects including cataracts, osteoporosis, increased risk of infection, and fatigue. Mr. McNaughton also experienced “moon face,” a side effect caused by the shifting of fat deposits that results in the face becoming puffy and rounder.

In 2018, Dr. Loftus and Mr. McNaughton decided to try an unusual regimen. Many patients with inflammatory bowel diseases such as colitis take a single biologic drug as treatment. Whereas traditional drugs are chemically synthesized, biologics are manufactured in living systems, such as plant or animal cells. A year’s supply of an individual biologic drug can cost up to $500,000. They are often given through infusions in a medical facility, which adds to the cost.

Mr. McNaughton had tried individual biologics, and then two in combination, without much success. He and Dr. Loftus then agreed to try two biologic drugs together at doses well above those recommended by the Food and Drug Administration. The federal Agency for Healthcare Research and Quality estimates one in five prescriptions written today are for off-label uses.

There are drawbacks to the practice. Since some uses and doses of particular drugs have not been extensively studied, the risks and efficacy of using them off-label are not well known. Also, some drug manufacturers have improperly pushed off-label usage of their products to boost sales despite little or no evidence to support their use in those situations. Like many leading experts and researchers in his field, Dr. Loftus has been paid to do consulting related to the biologic drugs taken by Mr. McNaughton. The payments related to those drugs have ranged from a total of $1,440 in 2020 to $51,235 in 2018. Dr. Loftus said much of his work with pharmaceutical companies was related to conducting clinical trials on new drugs.

In cases of off-label prescribing, patients are depending upon their doctors’ expertise and experience with the drug. “In this case, I was comfortable that the potential benefits to Chris outweighed the risks,” Dr. Loftus said.

There was evidence that the treatment plan for Mr. McNaughton might work, including studies that had found dual biologic therapy to be efficacious and safe. The two drugs he takes, Entyvio and Remicade, have the same purpose – to reduce inflammation in the large intestine – but each works differently in the body. Remicade, marketed by Janssen Biotech, targets a protein that causes inflammation. Entyvio, made by Takeda Pharmaceuticals, works by preventing an excess of white blood cells from entering into the gastrointestinal tract.

As for any suggestion by United doctors that his treatment plan for Mr. McNaughton was out of bounds or dangerous, Dr. Loftus said “my treatment of Chris was not clinically inappropriate – as was shown by Chris’ positive outcome.”

The unusual high-dose combination of two biologic drugs produced a remarkable change in Mr. McNaughton. He no longer had blood in his stool, and his trips to the bathroom were cut from 20 times a day to 3 or 4. He was able to eat different foods and put on weight. He had more energy. He tapered off prednisone.

“If you told me in 2015 that I would be living like this, I would have asked where do I sign up,” Mr. McNaughton said of the change he experienced with the new drug regimen.

When he first started the new treatment, Mr. McNaughton was covered under his family’s plan, and all his bills were paid. Mr. McNaughton enrolled at the university in 2020. Before switching to United’s plan for students, Mr. McNaughton and his parents consulted with a health advocacy service offered to faculty members. A benefits specialist assured them the drugs taken by Mr. McNaughton would be covered by United.

Mr. McNaughton joined the student plan in July 2020, and his infusions that month and the following month were paid for by United. In September, the insurer indicated payment on his claims was “pending,” something it did for his other claims that came in during the rest of the year.

Mr. McNaughton and his family were worried. They called United to make sure there wasn’t a problem; the insurer told them, they said, that it only needed to check his medical records. When the family called again, United told them it had the documentation needed, they said. United, in a court filing last year, said it received two calls from the family and each time indicated that all of the necessary medical records had not yet been received.

In January 2021, Mr. McNaughton received a new explanation of benefits for the prior months. All of the claims for his care, beginning in September, were no longer “pending.” They were stamped “DENIED.” The total outstanding bill for his treatment was $807,086.

When Mr. McNaughton’s mother reached a United customer service representative the next day to ask why bills that had been paid in the summer were being denied for the fall, the representative told her the account was being reviewed because of “a high dollar amount on the claims,” according to a recording of the call.


 

Misrepresentations

With United refusing to pay, the family was terrified of being stuck with medical bills that would bankrupt them and deprive Mr. McNaughton of treatment that they considered miraculous.

They turned to Penn State for help. Ms. Light and Mr. McNaughton’s father, David McNaughton, hoped their position as faculty members would make the school more willing to intervene on their behalf.

“After more than 30 years on faculty, my husband and I know that this is not how Penn State would want its students to be treated,” Ms. Light wrote to a school official in February 2021.

In response to questions from ProPublica, Penn State spokesperson Lisa Powers wrote that “supporting the health and well-being of our students is always of primary importance” and that “our hearts go out to any student and family impacted by a serious medical condition.” The university, she wrote, does “not comment on students’ individual circumstances or disclose information from their records.” Mr. McNaughton offered to grant Penn State whatever permissions it needed to speak about his case with ProPublica. The school, however, wrote that it would not comment “even if confidentiality has been waived.”

The family appealed to school administrators. Because the effectiveness of biologics wanes in some patients if doses are skipped, Mr. McNaughton and his parents were worried about even a delay in treatment. His doctor wrote that if he missed scheduled infusions of the drugs, there was “a high likelihood they would no longer be effective.”

During a conference call arranged by Penn State officials on March 5, 2021, United agreed to pay for Mr. McNaughton’s care through the end of the plan year that August. Penn State immediately notified the family of the “wonderful news” while also apologizing for “the stress this has caused Chris and your family.”

Behind the scenes, Mr. McNaughton’s review had “gone all the way to the top” at United’s student health plan division, Ms. Kavanaugh, the nurse, said in a recorded conversation.

The family’s relief was short-lived. A month later, United started another review of Mr. McNaughton’s care, overseen by Ms. Kavanaugh, to determine if it would pay for the treatment in the upcoming plan year.

The nurse sent the Mr. McNaughton case to a company called Medical Review Institute of America. Insurers often turn to companies like MRIoA to review coverage decisions involving expensive treatments or specialized care.

Ms. Kavanaugh, who was assigned to a special investigations unit at United, let her feelings about the matter be known in a recorded telephone call with a representative of MRIoA.

“This school apparently is a big client of ours,” she said. She then shared her opinion of Mr. McNaughton’s treatment. “Really this is a case of a kid who’s getting a drug way too much, like too much of a dose,” Ms. Kavanaugh said. She said it was “insane that they would even think that this is reasonable” and “to be honest with you, they’re awfully pushy considering that we are paying through the end of this school year.”

On a call with an outside contractor, the United nurse claimed Mr. McNaughton was on a higher dose of medication than the FDA approved, which is a common practice.

MRIoA sent the case to Vikas Pabby, MD, a gastroenterologist at UCLA Health and a professor at the university’s medical school. His May 2021 review of Mr. McNaughton’s case was just one of more than 300 Dr. Pabby did for MRIoA that month, for which he was paid $23,000 in total, according to a log of his work produced in the lawsuit.

In a May 4, 2021, report, Dr. Pabby concluded Mr. McNaughton’s treatment was not medically necessary, because United’s policies for the two drugs taken by Mr. McNaughton did not support using them in combination.

Insurers spell out what services they cover in plan policies, lengthy documents that can be confusing and difficult to understand. Many policies, such as Mr. McNaughton’s, contain a provision that treatments and procedures must be “medically necessary” in order to be covered. The definition of medically necessary differs by plan. Some don’t even define the term. Mr. McNaughton’s policy contains a five-part definition, including that the treatment must be “in accordance with the standards of good medical policy” and “the most appropriate supply or level of service which can be safely provided.”

Behind the scenes at United, Mr. Opperman and Ms. Kavanaugh agreed that if Mr. McNaughton were to appeal Dr. Pabby’s decision, the insurer would simply rule against him. “I just think it’s a waste of money and time to appeal and send it to another one when we know we’re gonna get the same answer,” Mr. Opperman said, according to a recording in court files. At Mr. Opperman’s urging, United decided to skip the usual appeals process and arrange for Dr. Pabby to have a so-called “peer-to-peer” discussion with Dr. Loftus, the Mayo physician treating Mr. McNaughton. Such a conversation, in which a patient’s doctor talks with an insurance company’s doctor to advocate for the prescribed treatment, usually occurs only after a customer has appealed a denial and the appeal has been rejected.

When Ms. Kavanaugh called Dr. Loftus’ office to set up a conversation with Dr. Pabby, she explained it was an urgent matter and had been requested by Mr. McNaughton. “You know I’ve just gotten to know Christopher,” she explained, although she had never spoken with him. “We’re trying to advocate and help and get this peer-to-peer set up.”

Mr. McNaughton, meanwhile, had no idea at the time that a United doctor had decided his treatment was unnecessary and that the insurer was trying to set up a phone call with his physician.

In the peer-to-peer conversation, Dr. Loftus told Dr. Pabby that Mr. McNaughton had “a very complicated case” and that lower doses had not worked for him, according to an internal MRIoA memo.

Following his conversation with Dr. Loftus, Dr. Pabby created a second report for United. He recommended the insurer pay for both drugs, but at reduced doses. He added new language saying that the safety of using both drugs at the higher levels “is not established.”

When Ms. Kavanaugh shared the May 12 decision from Dr. Pabby with others at United, her boss responded with an email calling it “great news.”

Then Mr. Opperman sent an email that puzzled the McNaughtons.

In it, Mr. Opperman claimed that Dr. Loftus and Dr. Pabby had agreed that Mr. McNaughton should be on significantly lower doses of both drugs. He said Dr. Loftus “will work with the patient to start titrating them down to a normal dose range.” Mr. Opperman wrote that United would cover Mr. McNaughton’s treatment in the coming year, but only at the reduced doses. Mr. Opperman did not respond to emails and phone messages seeking comment.

Mr. McNaughton didn’t believe a word of it. He had already tried and failed treatment with those drugs at lower doses, and it was Dr. Loftus who had upped the doses, leading to his remission from severe colitis.

The only thing that made sense to Mr. McNaughton was that the treatment United said it would now pay for was dramatically cheaper – saving the company at least hundreds of thousands of dollars a year – than his prescribed treatment because it sliced the size of the doses by more than half.

When the family contacted Dr. Loftus for an explanation, they were outraged by what they heard. Dr. Loftus told them that he had never recommended lowering the dosage. In a letter, Dr. Loftus wrote that changing Mr. McNaughton’s treatment “would have serious detrimental effects on both his short term and long term health and could potentially involve life threatening complications. This would ultimately incur far greater medical costs. Chris was on the doses suggested by United Healthcare before, and they were not at all effective.”

It would not be until the lawsuit that it would become clear how Dr. Loftus’ conversations had been so seriously misrepresented.

Under questioning by Mr. McNaughton’s lawyers, Ms. Kavanaugh acknowledged that she was the source of the incorrect claim that Mr. McNaughton’s doctor had agreed to a change in treatment.

“I incorrectly made an assumption that they had come to some sort of agreement,” she said in a deposition last August. “It was my first peer-to-peer. I did not realize that that simply does not occur.”

Ms. Kavanaugh did not respond to emails and telephone messages seeking comment.

When the McNaughtons first learned of Mr. Opperman’s inaccurate report of the phone call with Dr. Loftus, it unnerved them. They started to question if their case would be fairly reviewed.

“When we got the denial and they lied about what Dr. Loftus said, it just hit me that none of this matters,” Mr. McNaughton said. “They will just say or do anything to get rid of me. It delegitimized the entire review process. When I got that denial, I was crushed.”


 

A buried report

While the family tried to sort out the inaccurate report, United continued putting the McNaughton case in front of more company doctors.

On May 21, 2021, United sent the case to one of its own doctors, Nady Cates, MD, for an additional review. The review was marked “escalated issue.” Dr. Cates is a United medical director, a title used by many insurers for physicians who review cases. It is work he has been doing as an employee of health insurers since 1989 and at United since 2010. He has not practiced medicine since the early 1990s.

Dr. Cates, in a deposition, said he stopped seeing patients because of the long hours involved and because “AIDS was coming around then. I was seeing a lot of military folks who had venereal diseases, and I guess I was concerned about being exposed.” He transitioned to reviewing paperwork for the insurance industry, he said, because “I guess I was a chicken.”

When he had practiced, Dr. Cates said, he hadn’t treated patients with ulcerative colitis and had referred those cases to a gastroenterologist.

He said his review of Mr. McNaughton’s case primarily involved reading a United nurse’s recommendation to deny his care and making sure “that there wasn’t a decimal place that was out of line.” He said he copied and pasted the nurse’s recommendation and typed “agree” on his review of Mr. McNaughton’s case.

Dr. Cates said that he does about a hundred reviews a week. He said that in his reviews he typically checks to see if any medications are prescribed in accordance with the insurer’s guidelines, and if not, he denies it. United’s policies, he said, prevented him from considering that Mr. McNaughton had failed other treatments or that Dr. Loftus was a leading expert in his field.

“You are giving zero weight to the treating doctor’s opinion on the necessity of the treatment regimen?” a lawyer asked Dr. Cates in his deposition. He responded, “Yeah.”

Attempts to contact Dr. Cates for comment were unsuccessful.

At the same time Dr. Cates was looking at Mr. McNaughton’s case, yet another review was underway at MRIoA. United said it sent the case back to MRIoA after the insurer received the letter from Dr. Loftus warning of the life-threatening complications that might occur if the dosages were reduced.

On May 24, 2021, the new report requested by MRIoA arrived. It came to a completely different conclusion than all of the previous reviews.

Nitin Kumar, MD, a gastroenterologist in Illinois, concluded that Mr. McNaughton’s established treatment plan was not only medically necessary and appropriate but that lowering his doses “can result in a lack of effective therapy of Ulcerative Colitis, with complications of uncontrolled disease (including dysplasia leading to colorectal cancer), flare, hospitalization, need for surgery, and toxic megacolon.”

Unlike other doctors who produced reports for United, Dr. Kumar discussed the harm that Mr. McNaughton might suffer if United required him to change his treatment. “His disease is significantly severe, with diagnosis at a young age,” Dr. Kumar wrote. “He has failed every biologic medication class recommended by guidelines. Therefore, guidelines can no longer be applied in this case.” He cited six studies of patients using two biologic drugs together and wrote that they revealed no significant safety issues and found the therapy to be “broadly successful.”

When Ms. Kavanaugh learned of Dr. Kumar’s report, she quickly moved to quash it and get the case returned to Dr. Pabby, according to her deposition.

In a recorded telephone call, Ms. Kavanaugh told an MRIoA representative that “I had asked that this go back through Dr. Pabby, and it went through a different doctor and they had a much different result.” After further discussion, the MRIoA representative agreed to send the case back to Dr. Pabby. “I appreciate that,” Ms. Kavanaugh replied. “I just want to make sure, because, I mean, it’s obviously a very different result than what we’ve been getting on this case.”

MRIoA case notes show that at 7:04 a.m. on May 25, 2021, Dr. Pabby was assigned to take a look at the case for the third time. At 7:27 a.m., the notes indicate, Dr. Pabby again rejected Mr. McNaughton’s treatment plan. While noting it was “difficult to control” Mr. McNaughton’s ulcerative colitis, Dr. Pabby added that his doses “far exceed what is approved by literature” and that the “safety of the requested doses is not supported by literature.”

In a deposition, Ms. Kavanaugh said that after she opened the Kumar report and read that he was supporting Mr. McNaughton’s current treatment plan, she immediately spoke to her supervisor, who told her to call MRIoA and have the case sent back to Dr. Pabby for review.

Ms. Kavanaugh said she didn’t save a copy of the Kumar report, nor did she forward it to anyone at United or to officials at Penn State who had been inquiring about the McNaughton case. “I didn’t because it shouldn’t have existed,” she said. “It should have gone back to Dr. Pabby.”

When asked if the Kumar report caused her any concerns given his warning that Mr. McNaughton risked cancer or hospitalization if his regimen were changed, Ms. Kavanaugh said she didn’t read his full report. “I saw that it was not the correct doctor, I saw the initial outcome and I was asked to send it back,” she said. Ms. Kavanaugh added, “I have a lot of empathy for this member, but it needed to go back to the peer-to-peer reviewer.”

In a court filing, United said Ms. Kavanaugh was correct in insisting that Dr. Pabby conduct the review and that MRIoA confirmed that Dr. Pabby should have been the one doing the review.

The Kumar report was not provided to Mr. McNaughton when his lawyer, Jonathan M. Gesk, first asked United and MRIoA for any reviews of the case. Mr. Gesk discovered it by accident when he was listening to a recorded telephone call produced by United in which Ms. Kavanaugh mentioned a report number Mr. Gesk had not heard before. He then called MRIoA, which confirmed the report existed and eventually provided it to him.

Dr. Pabby asked ProPublica to direct any questions about his involvement in the matter to MRIoA. The company did not respond to questions from ProPublica about the case.
 

A sense of hopelessness

When Mr. McNaughton enrolled at Penn State in 2020, it brought a sense of normalcy that he had lost when he was first diagnosed with colitis. He still needed monthly hours-long infusions and suffered occasional flare-ups and symptoms, but he was attending classes in person and living a life similar to the one he had before his diagnosis.

It was a striking contrast to the previous 6 years, which he had spent largely confined to his parents’ house in State College. The frequent bouts of diarrhea made it difficult to go out. He didn’t talk much to friends and spent as much time as he could studying potential treatments and reviewing ongoing clinical trials. He tried to keep up with the occasional online course, but his disease made it difficult to make any real progress toward a degree.

United, in correspondence with Mr. McNaughton, noted that its review of his care was “not a treatment decision. Treatment decisions are made between you and your physician.” But by threatening not to pay for his medications, or only to pay for a different regimen, Mr. McNaughton said, United was in fact attempting to dictate his treatment. From his perspective, the insurer was playing doctor, making decisions without ever examining him or even speaking to him.

The idea of changing his treatment or stopping it altogether caused constant worry for Mr. McNaughton, exacerbating his colitis and triggering physical symptoms, according to his doctors. Those included a large ulcer on his leg and welts under his skin on his thighs and shin that made his leg muscles stiff and painful to the point where he couldn’t bend his leg or walk properly. There were daily migraines and severe stomach pain. “I was consumed with this situation,” Mr. McNaughton said. “My path was unconventional, but I was proud of myself for fighting back and finishing school and getting my life back on track. I thought they were singling me out. My biggest fear was going back to the hell.”

Mr. McNaughton said he contemplated suicide on several occasions, dreading a return to a life where he was housebound or hospitalized.

Mr. McNaughton and his parents talked about his possibly moving to Canada where his grandmother lived and seeking treatment there under the nation’s government health plan.

Dr. Loftus connected Mr. McNaughton with a psychologist who specializes in helping patients with chronic digestive diseases.

The psychologist, Tiffany Taft, PsyD, said Mr. McNaughton was not an unusual case. About one in three patients with diseases like colitis suffer from medical trauma or PTSD related to it, she said, often the result of issues related to getting appropriate treatment approved by insurers.

“You get into hopelessness,” she said of the depression that accompanies fighting with insurance companies over care. “They feel like ‘I can’t fix that. I am screwed.’ When you can’t control things with what an insurance company is doing, anxiety, PTSD and depression get mixed together.”

In the case of Mr. McNaughton, Dr. Taft said, he was being treated by one of the best gastroenterologists in the world, was doing well with his treatment, and then was suddenly notified he might be on the hook for nearly a million dollars in medical charges without access to his medications. “It sends you immediately into panic about all these horrific things that could happen,” Dr. Taft said. The physical and mental symptoms Mr. McNaughton suffered after his care was threatened were “triggered” by the stress he experienced, she said.

In early June 2021, United informed Mr. McNaughton in a letter that it would not cover the cost of his treatment regimen in the next academic year, starting in August. The insurer said it would pay only for a treatment plan that called for a significant reduction in the doses of the drugs he took.

United wrote that the decision came after his “records have been reviewed three times and the medical reviewers have concluded that the medication as prescribed does not meet the Medical Necessity requirement of the plan.”

In August 2021, Mr. McNaughton filed a federal lawsuit accusing United of acting in bad faith and unreasonably making treatment decisions based on financial concerns and not what was the best and most effective treatment. It claims United had a duty to find information that supported Mr. McNaughton’s claim for treatment rather than looking for ways to deny coverage.

United, in a court filing, said it did not breach any duty it owed to Mr. McNaughton and acted in good faith. On Sept. 20, 2021, a month after filing the lawsuit, and with United again balking at paying for his treatment, Mr. McNaughton asked a judge to grant a temporary restraining order requiring United to pay for his care. With the looming threat of a court hearing on the motion, United quickly agreed to cover the cost of Mr. McNaughton’s treatment through the end of the 2021-2022 academic year. It also dropped a demand requiring Mr. McNaughton to settle the matter as a condition of the insurer paying for his treatment as prescribed by Dr. Loftus, according to an email sent by United’s lawyer.
 

The cost of treatment

It is not surprising that insurers are carefully scrutinizing the care of patients treated with biologics, which are among the most expensive medications on the market. Biologics are considered specialty drugs, a class that includes the best-selling Humira, used to treat arthritis. Specialty drug spending in the United States is expected to reach $505 billion in 2023, according to an estimate from Optum, United’s health services division. The Institute for Clinical and Economic Review, a nonprofit that analyzes the value of drugs, found in 2020 that the biologic drugs used to treat patients like Mr. McNaughton are often effective but overpriced for their therapeutic benefit. To be judged cost-effective by ICER, the biologics should sell at a steep discount to their current market price, the panel found.

A panel convened by ICER to review its analysis cautioned that insurance coverage “should be structured to prevent situations in which patients are forced to choose a treatment approach on the basis of cost.” ICER also found examples where insurance company policies failed to keep pace with updates to clinical practice guidelines based on emerging research.

United officials did not make the cost of treatment an issue when discussing Mr. McNaughton’s care with Penn State administrators or the family.

Bill Truxal, the president of UnitedHealthcare StudentResources, the company’s student health plan division, told a Penn State official that the insurer wanted the “best for the student” and it had “nothing to do with cost,” according to notes the official took of the conversation.

Behind the scenes, however, the price of Mr. McNaughton’s care was front and center at United.

In one email, Mr. Opperman asked about the cost difference if the insurer insisted on paying only for greatly reduced doses of the biologic drugs. Ms. Kavanaugh responded that the insurer had paid $1.1 million in claims for Mr. McNaughton’s care as of the middle of May 2021. If the reduced doses had been in place, the amount would have been cut to $260,218, she wrote.

United was keeping close tabs on Mr. McNaughton at the highest levels of the company. On Aug. 2, 2021, Mr. Opperman notified Mr. Truxal and a United lawyer that Mr. McNaughton “has just purchased the plan again for the 21-22 school year.”

A month later, Ms. Kavanaugh shared another calculation with United executives showing that the insurer spent over $1.7 million on Mr. McNaughton in the prior plan year.

United officials strategized about how to best explain why it was reviewing Mr. McNaughton’s drug regimen, according to an internal email. They pointed to a justification often used by health insurers when denying claims. “As the cost of healthcare continues to climb to soaring heights, it has been determined that a judicious review of these drugs should be included” in order to “make healthcare more affordable for our members,” Ms. Kavanaugh offered as a potential talking point in an April 23, 2021, email.

Three days later, UnitedHealth Group filed an annual statement with the U.S. Securities and Exchange Commission disclosing its pay for top executives in the prior year. Then-CEO David Wichmann was paid $17.9 million in salary and other compensation in 2020. Wichmann retired early the following year, and his total compensation that year exceeded $140 million, according to calculations in a compensation database maintained by the Star Tribune in Minneapolis. The newspaper said the amount was the most paid to an executive in the state since it started tracking pay more than 2 decades ago. About $110 million of that total came from Wichmann exercising stock options accumulated during his stewardship.

The McNaughtons were well aware of the financial situation at United. They looked at publicly available financial results and annual reports. Last year, United reported a profit of $20.1 billion on revenues of $324.2 billion.

When discussing the case with Penn State, Ms. Light said, she told university administrators that United could pay for a year of her son’s treatment using just minutes’ worth of profit.
 

‘Betrayed’

Mr. McNaughton has been able to continue receiving his infusions for now, anyway. In October, United notified him it was once again reviewing his care, although the insurer quickly reversed course when his lawyer intervened. United, in a court filing, said the review was a mistake and that it had erred in putting Mr. McNaughton’s claims into pending status.

Mr. McNaughton said he is fortunate his parents were employed at the same school he was attending, which was critical in getting the attention of administrators there. But that help had its limits.

In June 2021, just a week after United told Mr. McNaughton it would not cover his treatment plan in the upcoming plan year, Penn State essentially walked away from the matter.

In an email to the McNaughtons and United, Penn State Associate Vice President for Student Affairs Andrea Dowhower wrote that administrators “have observed an unfortunate breakdown in communication” between Mr. McNaughton and his family and the university health insurance plan, “which appears from our perspective to have resulted in a standstill between the two parties.” While she proposed some potential steps to help settle the matter, she wrote that “Penn State’s role in this process is as a resource for students like Chris who, for whatever reason, have experienced difficulty navigating the complex world of health insurance.” The university’s role “is limited,” she wrote, and the school “simply must leave” the issue of the best treatment for Mr. McNaughton to “the appropriate health care professionals.”

In a statement, a Penn State spokesperson wrote that “as a third party in this arrangement, the University’s role is limited and Penn State officials can only help a student manage an issue based on information that a student/family, medical personnel, and/or insurance provider give – with the hope that all information is accurate and that the lines of communication remain open between the insured and the insurer.”

Penn State declined to provide financial information about the plan. However, the university and United share at least one tie that they have not publicly disclosed.

When the McNaughtons first reached out to the university for help, they were referred to the school’s student health insurance coordinator. The official, Heather Klinger, wrote in an email to the family in February 2021 that “I appreciate your trusting me to resolve this for you.”

In April 2022, United began paying Ms. Klinger’s salary, an arrangement which is not noted on the university website. Ms. Klinger appears in the online staff directory on the Penn State University Health Services web page, and has a university phone number, a university address, and a Penn State email listed as her contact. The school said she has maintained a part-time status with the university to allow her to access relevant data systems at both the university and United.

The university said students “benefit” from having a United employee to handle questions about insurance coverage and that the arrangement is “not uncommon” for student health plans.

The family was dismayed to learn that Ms. Klinger was now a full-time employee of United.

“We did feel betrayed,” Ms. Light said. Ms. Klinger did not respond to an email seeking comment.

Mr. McNaughton’s fight to maintain his treatment regimen has come at a cost of time, debilitating stress, and depression. “My biggest fear is realizing I might have to do this every year of my life,” he said.

Mr. McNaughton said one motivation for his lawsuit was to expose how insurers like United make decisions about what care they will pay for and what they will not. The case remains pending, a court docket shows.

He has been accepted to Penn State’s law school. He hopes to become a health care lawyer working for patients who find themselves in situations similar to his.

He plans to re-enroll in the United health care plan when he starts school next fall.

This story was originally published on ProPublica. ProPublica is a nonprofit newsroom that investigates abuses of power. Sign up to receive the biggest stories as soon as they’re published.

In May 2021, a nurse at UnitedHealthcare called a colleague to share some welcome news about a problem the two had been grappling with for weeks.

United provided the health insurance plan for students at Penn State University. It was a large and potentially lucrative account: lots of young, healthy students paying premiums in, not too many huge medical reimbursements going out.

But one student was costing United a lot of money. Christopher McNaughton suffered from a crippling case of ulcerative colitis – an ailment that caused him to develop severe arthritis, debilitating diarrhea, numbing fatigue, and life-threatening blood clots. His medical bills were running nearly $2 million a year.

United had flagged Mr. McNaughton’s case as a “high dollar account,” and the company was reviewing whether it needed to keep paying for the expensive cocktail of drugs crafted by a Mayo Clinic specialist that had brought Mr. McNaughton’s disease under control after he’d been through years of misery.

On the 2021 phone call, which was recorded by the company, nurse Victoria Kavanaugh told her colleague that a doctor contracted by United to review the case had concluded that Mr. McNaughton’s treatment was “not medically necessary.” Her colleague, Dave Opperman, reacted to the news with a long laugh.

“I knew that was coming,” said Mr. Opperman, who heads up a United subsidiary that brokered the health insurance contract between United and Penn State. “I did too,” Ms. Kavanaugh replied.

Mr. Opperman then complained about Mr. McNaughton’s mother, whom he referred to as “this woman,” for “screaming and yelling” and “throwing tantrums” during calls with United.

The pair agreed that any appeal of the United doctor’s denial of the treatment would be a waste of the family’s time and money.

“We’re still gonna say no,” Mr. Opperman said.

More than 200 million Americans are covered by private health insurance. But data from state and federal regulators shows that insurers reject about 1 in 7 claims for treatment. Many people, faced with fighting insurance companies, simply give up: One study found that Americans file formal appeals on only 0.1% of claims denied by insurers under the Affordable Care Act.

Insurers have wide discretion in crafting what is covered by their policies, beyond some basic services mandated by federal and state law. They often deny claims for services that they deem not “medically necessary.”

When United refused to pay for Mr. McNaughton’s treatment for that reason, his family did something unusual. They fought back with a lawsuit, which uncovered a trove of materials, including internal emails and tape-recorded exchanges among company employees. Those records offer an extraordinary behind-the-scenes look at how one of America’s leading health care insurers relentlessly fought to reduce spending on care, even as its profits rose to record levels.

As United reviewed Mr. McNaughton’s treatment, he and his family were often in the dark about what was happening or their rights. Meanwhile, United employees misrepresented critical findings and ignored warnings from doctors about the risks of altering Mr. McNaughton’s drug plan.

At one point, court records show, United inaccurately reported to Penn State and the family that Mr. McNaughton’s doctor had agreed to lower the doses of his medication. Another time, a doctor paid by United concluded that denying payments for Mr. McNaughton’s treatment could put his health at risk, but the company buried his report and did not consider its findings. The insurer did, however, consider a report submitted by a company doctor who rubber-stamped the recommendation of a United nurse to reject paying for the treatment.

United declined to answer specific questions about the case, even after Mr. McNaughton signed a release provided by the insurer to allow it to discuss details of his interactions with the company. United noted that it ultimately paid for all of Mr. McNaughton’s treatments. In a written response, United spokesperson Maria Gordon Shydlo wrote that the company’s guiding concern was Mr. McNaughton’s well-being.

“Mr. McNaughton’s treatment involves medication dosages that far exceed [Food and Drug Administration] guidelines,” the statement said. “In cases like this, we review treatment plans based on current clinical guidelines to help ensure patient safety.”

But the records reviewed by ProPublica show that United had another, equally urgent goal in dealing with Mr. McNaughton. In emails, officials calculated what Mr. McNaughton was costing them to keep his crippling disease at bay and how much they would save if they forced him to undergo a cheaper treatment that had already failed him. As the family pressed the company to back down, first through Penn State and then through a lawsuit, the United officials handling the case bristled.

“This is just unbelievable,” Ms. Kavanaugh said of Mr. McNaughton’s family in one call to discuss his case. ”They’re just really pushing the envelope, and I’m surprised, like I don’t even know what to say.”
 

The same meal every day

Now 31, Mr. McNaughton grew up in State College, Pa., just blocks from the Penn State campus. Both of his parents are faculty members at the university.

In the winter of 2014, Mr. McNaughton was halfway through his junior year at Bard College in New York. At 6 feet, 4 inches tall, he was a guard on the basketball team and had started most of the team’s games since the start of his sophomore year. He was majoring in psychology.

When Mr. McNaughton returned to school after the winter holiday break, he started to experience frequent bouts of bloody diarrhea. After just a few days on campus, he went home to State College, where doctors diagnosed him with a severe case of ulcerative colitis.

A chronic inflammatory bowel disease that causes swelling and ulcers in the digestive tract, ulcerative colitis has no cure, and ongoing treatment is needed to alleviate symptoms and prevent serious health complications. The majority of cases produce mild to moderate symptoms. Mr. McNaughton’s case was severe.

Treatments for ulcerative colitis include steroids and special drugs known as biologics that work to reduce inflammation in the large intestine.

Mr. McNaughton, however, failed to get meaningful relief from the drugs his doctors initially prescribed. He was experiencing bloody diarrhea up to 20 times a day, with such severe stomach pain that he spent much of his day curled up on a couch. He had little appetite and lost 50 pounds. Severe anemia left him fatigued. He suffered from other conditions related to his colitis, including crippling arthritis. He was hospitalized several times to treat dangerous blood clots.

For 2 years, in an effort to help alleviate his symptoms, he ate the same meals every day: Rice Chex cereal and scrambled eggs for breakfast, a cup of white rice with plain chicken breast for lunch, and a similar meal for dinner, occasionally swapping in tilapia.

His hometown doctors referred him to a specialist at the University of Pittsburgh, who tried unsuccessfully to bring his disease under control. That doctor ended up referring Mr. McNaughton to Edward V. Loftus Jr., MD, at the Mayo Clinic in Rochester, Minn., which has been ranked as the best gastroenterology hospital in the country every year since 1990 by U.S. News & World Report.

For his first visit with Dr. Loftus in May 2015, Mr. McNaughton and his mother, Janice Light, charted hospitals along the 900-mile drive from Pennsylvania to Minnesota in case they needed medical help along the way.

Mornings were the hardest. Mr. McNaughton often spent several hours in the bathroom at the start of the day. To prepare for his meeting with Dr. Loftus, he set his alarm for 3:30 a.m. so he could be ready for the 7:30 a.m. appointment. Even with that preparation, he had to stop twice to use a bathroom on the 5-minute walk from the hotel to the clinic. When they met, Dr. Loftus looked at Mr. McNaughton and told him that he appeared incapacitated. It was, he told the student, as if Mr. McNaughton were chained to the bathroom, with no outside life. He had not been able to return to school and spent most days indoors, managing his symptoms as best he could.

Mr. McNaughton had tried a number of medications by this point, none of which worked. This pattern would repeat itself during the first couple of years that Dr. Loftus treated him.

In addition to trying to find a treatment that would bring Mr. McNaughton’s colitis into remission, Dr. Loftus wanted to wean him off the steroid prednisone, which he had been taking since his initial diagnosis in 2014. The drug is commonly prescribed to colitis patients to control inflammation, but prolonged use can lead to severe side effects including cataracts, osteoporosis, increased risk of infection, and fatigue. Mr. McNaughton also experienced “moon face,” a side effect caused by the shifting of fat deposits that results in the face becoming puffy and rounder.

In 2018, Dr. Loftus and Mr. McNaughton decided to try an unusual regimen. Many patients with inflammatory bowel diseases such as colitis take a single biologic drug as treatment. Whereas traditional drugs are chemically synthesized, biologics are manufactured in living systems, such as plant or animal cells. A year’s supply of an individual biologic drug can cost up to $500,000. They are often given through infusions in a medical facility, which adds to the cost.

Mr. McNaughton had tried individual biologics, and then two in combination, without much success. He and Dr. Loftus then agreed to try two biologic drugs together at doses well above those recommended by the Food and Drug Administration. The federal Agency for Healthcare Research and Quality estimates one in five prescriptions written today are for off-label uses.

There are drawbacks to the practice. Since some uses and doses of particular drugs have not been extensively studied, the risks and efficacy of using them off-label are not well known. Also, some drug manufacturers have improperly pushed off-label usage of their products to boost sales despite little or no evidence to support their use in those situations. Like many leading experts and researchers in his field, Dr. Loftus has been paid to do consulting related to the biologic drugs taken by Mr. McNaughton. The payments related to those drugs have ranged from a total of $1,440 in 2020 to $51,235 in 2018. Dr. Loftus said much of his work with pharmaceutical companies was related to conducting clinical trials on new drugs.

In cases of off-label prescribing, patients are depending upon their doctors’ expertise and experience with the drug. “In this case, I was comfortable that the potential benefits to Chris outweighed the risks,” Dr. Loftus said.

There was evidence that the treatment plan for Mr. McNaughton might work, including studies that had found dual biologic therapy to be efficacious and safe. The two drugs he takes, Entyvio and Remicade, have the same purpose – to reduce inflammation in the large intestine – but each works differently in the body. Remicade, marketed by Janssen Biotech, targets a protein that causes inflammation. Entyvio, made by Takeda Pharmaceuticals, works by preventing an excess of white blood cells from entering into the gastrointestinal tract.

As for any suggestion by United doctors that his treatment plan for Mr. McNaughton was out of bounds or dangerous, Dr. Loftus said “my treatment of Chris was not clinically inappropriate – as was shown by Chris’ positive outcome.”

The unusual high-dose combination of two biologic drugs produced a remarkable change in Mr. McNaughton. He no longer had blood in his stool, and his trips to the bathroom were cut from 20 times a day to 3 or 4. He was able to eat different foods and put on weight. He had more energy. He tapered off prednisone.

“If you told me in 2015 that I would be living like this, I would have asked where do I sign up,” Mr. McNaughton said of the change he experienced with the new drug regimen.

When he first started the new treatment, Mr. McNaughton was covered under his family’s plan, and all his bills were paid. Mr. McNaughton enrolled at the university in 2020. Before switching to United’s plan for students, Mr. McNaughton and his parents consulted with a health advocacy service offered to faculty members. A benefits specialist assured them the drugs taken by Mr. McNaughton would be covered by United.

Mr. McNaughton joined the student plan in July 2020, and his infusions that month and the following month were paid for by United. In September, the insurer indicated payment on his claims was “pending,” something it did for his other claims that came in during the rest of the year.

Mr. McNaughton and his family were worried. They called United to make sure there wasn’t a problem; the insurer told them, they said, that it only needed to check his medical records. When the family called again, United told them it had the documentation needed, they said. United, in a court filing last year, said it received two calls from the family and each time indicated that all of the necessary medical records had not yet been received.

In January 2021, Mr. McNaughton received a new explanation of benefits for the prior months. All of the claims for his care, beginning in September, were no longer “pending.” They were stamped “DENIED.” The total outstanding bill for his treatment was $807,086.

When Mr. McNaughton’s mother reached a United customer service representative the next day to ask why bills that had been paid in the summer were being denied for the fall, the representative told her the account was being reviewed because of “a high dollar amount on the claims,” according to a recording of the call.


 

Misrepresentations

With United refusing to pay, the family was terrified of being stuck with medical bills that would bankrupt them and deprive Mr. McNaughton of treatment that they considered miraculous.

They turned to Penn State for help. Ms. Light and Mr. McNaughton’s father, David McNaughton, hoped their position as faculty members would make the school more willing to intervene on their behalf.

“After more than 30 years on faculty, my husband and I know that this is not how Penn State would want its students to be treated,” Ms. Light wrote to a school official in February 2021.

In response to questions from ProPublica, Penn State spokesperson Lisa Powers wrote that “supporting the health and well-being of our students is always of primary importance” and that “our hearts go out to any student and family impacted by a serious medical condition.” The university, she wrote, does “not comment on students’ individual circumstances or disclose information from their records.” Mr. McNaughton offered to grant Penn State whatever permissions it needed to speak about his case with ProPublica. The school, however, wrote that it would not comment “even if confidentiality has been waived.”

The family appealed to school administrators. Because the effectiveness of biologics wanes in some patients if doses are skipped, Mr. McNaughton and his parents were worried about even a delay in treatment. His doctor wrote that if he missed scheduled infusions of the drugs, there was “a high likelihood they would no longer be effective.”

During a conference call arranged by Penn State officials on March 5, 2021, United agreed to pay for Mr. McNaughton’s care through the end of the plan year that August. Penn State immediately notified the family of the “wonderful news” while also apologizing for “the stress this has caused Chris and your family.”

Behind the scenes, Mr. McNaughton’s review had “gone all the way to the top” at United’s student health plan division, Ms. Kavanaugh, the nurse, said in a recorded conversation.

The family’s relief was short-lived. A month later, United started another review of Mr. McNaughton’s care, overseen by Ms. Kavanaugh, to determine if it would pay for the treatment in the upcoming plan year.

The nurse sent the Mr. McNaughton case to a company called Medical Review Institute of America. Insurers often turn to companies like MRIoA to review coverage decisions involving expensive treatments or specialized care.

Ms. Kavanaugh, who was assigned to a special investigations unit at United, let her feelings about the matter be known in a recorded telephone call with a representative of MRIoA.

“This school apparently is a big client of ours,” she said. She then shared her opinion of Mr. McNaughton’s treatment. “Really this is a case of a kid who’s getting a drug way too much, like too much of a dose,” Ms. Kavanaugh said. She said it was “insane that they would even think that this is reasonable” and “to be honest with you, they’re awfully pushy considering that we are paying through the end of this school year.”

On a call with an outside contractor, the United nurse claimed Mr. McNaughton was on a higher dose of medication than the FDA approved, which is a common practice.

MRIoA sent the case to Vikas Pabby, MD, a gastroenterologist at UCLA Health and a professor at the university’s medical school. His May 2021 review of Mr. McNaughton’s case was just one of more than 300 Dr. Pabby did for MRIoA that month, for which he was paid $23,000 in total, according to a log of his work produced in the lawsuit.

In a May 4, 2021, report, Dr. Pabby concluded Mr. McNaughton’s treatment was not medically necessary, because United’s policies for the two drugs taken by Mr. McNaughton did not support using them in combination.

Insurers spell out what services they cover in plan policies, lengthy documents that can be confusing and difficult to understand. Many policies, such as Mr. McNaughton’s, contain a provision that treatments and procedures must be “medically necessary” in order to be covered. The definition of medically necessary differs by plan. Some don’t even define the term. Mr. McNaughton’s policy contains a five-part definition, including that the treatment must be “in accordance with the standards of good medical policy” and “the most appropriate supply or level of service which can be safely provided.”

Behind the scenes at United, Mr. Opperman and Ms. Kavanaugh agreed that if Mr. McNaughton were to appeal Dr. Pabby’s decision, the insurer would simply rule against him. “I just think it’s a waste of money and time to appeal and send it to another one when we know we’re gonna get the same answer,” Mr. Opperman said, according to a recording in court files. At Mr. Opperman’s urging, United decided to skip the usual appeals process and arrange for Dr. Pabby to have a so-called “peer-to-peer” discussion with Dr. Loftus, the Mayo physician treating Mr. McNaughton. Such a conversation, in which a patient’s doctor talks with an insurance company’s doctor to advocate for the prescribed treatment, usually occurs only after a customer has appealed a denial and the appeal has been rejected.

When Ms. Kavanaugh called Dr. Loftus’ office to set up a conversation with Dr. Pabby, she explained it was an urgent matter and had been requested by Mr. McNaughton. “You know I’ve just gotten to know Christopher,” she explained, although she had never spoken with him. “We’re trying to advocate and help and get this peer-to-peer set up.”

Mr. McNaughton, meanwhile, had no idea at the time that a United doctor had decided his treatment was unnecessary and that the insurer was trying to set up a phone call with his physician.

In the peer-to-peer conversation, Dr. Loftus told Dr. Pabby that Mr. McNaughton had “a very complicated case” and that lower doses had not worked for him, according to an internal MRIoA memo.

Following his conversation with Dr. Loftus, Dr. Pabby created a second report for United. He recommended the insurer pay for both drugs, but at reduced doses. He added new language saying that the safety of using both drugs at the higher levels “is not established.”

When Ms. Kavanaugh shared the May 12 decision from Dr. Pabby with others at United, her boss responded with an email calling it “great news.”

Then Mr. Opperman sent an email that puzzled the McNaughtons.

In it, Mr. Opperman claimed that Dr. Loftus and Dr. Pabby had agreed that Mr. McNaughton should be on significantly lower doses of both drugs. He said Dr. Loftus “will work with the patient to start titrating them down to a normal dose range.” Mr. Opperman wrote that United would cover Mr. McNaughton’s treatment in the coming year, but only at the reduced doses. Mr. Opperman did not respond to emails and phone messages seeking comment.

Mr. McNaughton didn’t believe a word of it. He had already tried and failed treatment with those drugs at lower doses, and it was Dr. Loftus who had upped the doses, leading to his remission from severe colitis.

The only thing that made sense to Mr. McNaughton was that the treatment United said it would now pay for was dramatically cheaper – saving the company at least hundreds of thousands of dollars a year – than his prescribed treatment because it sliced the size of the doses by more than half.

When the family contacted Dr. Loftus for an explanation, they were outraged by what they heard. Dr. Loftus told them that he had never recommended lowering the dosage. In a letter, Dr. Loftus wrote that changing Mr. McNaughton’s treatment “would have serious detrimental effects on both his short term and long term health and could potentially involve life threatening complications. This would ultimately incur far greater medical costs. Chris was on the doses suggested by United Healthcare before, and they were not at all effective.”

It would not be until the lawsuit that it would become clear how Dr. Loftus’ conversations had been so seriously misrepresented.

Under questioning by Mr. McNaughton’s lawyers, Ms. Kavanaugh acknowledged that she was the source of the incorrect claim that Mr. McNaughton’s doctor had agreed to a change in treatment.

“I incorrectly made an assumption that they had come to some sort of agreement,” she said in a deposition last August. “It was my first peer-to-peer. I did not realize that that simply does not occur.”

Ms. Kavanaugh did not respond to emails and telephone messages seeking comment.

When the McNaughtons first learned of Mr. Opperman’s inaccurate report of the phone call with Dr. Loftus, it unnerved them. They started to question if their case would be fairly reviewed.

“When we got the denial and they lied about what Dr. Loftus said, it just hit me that none of this matters,” Mr. McNaughton said. “They will just say or do anything to get rid of me. It delegitimized the entire review process. When I got that denial, I was crushed.”


 

A buried report

While the family tried to sort out the inaccurate report, United continued putting the McNaughton case in front of more company doctors.

On May 21, 2021, United sent the case to one of its own doctors, Nady Cates, MD, for an additional review. The review was marked “escalated issue.” Dr. Cates is a United medical director, a title used by many insurers for physicians who review cases. It is work he has been doing as an employee of health insurers since 1989 and at United since 2010. He has not practiced medicine since the early 1990s.

Dr. Cates, in a deposition, said he stopped seeing patients because of the long hours involved and because “AIDS was coming around then. I was seeing a lot of military folks who had venereal diseases, and I guess I was concerned about being exposed.” He transitioned to reviewing paperwork for the insurance industry, he said, because “I guess I was a chicken.”

When he had practiced, Dr. Cates said, he hadn’t treated patients with ulcerative colitis and had referred those cases to a gastroenterologist.

He said his review of Mr. McNaughton’s case primarily involved reading a United nurse’s recommendation to deny his care and making sure “that there wasn’t a decimal place that was out of line.” He said he copied and pasted the nurse’s recommendation and typed “agree” on his review of Mr. McNaughton’s case.

Dr. Cates said that he does about a hundred reviews a week. He said that in his reviews he typically checks to see if any medications are prescribed in accordance with the insurer’s guidelines, and if not, he denies it. United’s policies, he said, prevented him from considering that Mr. McNaughton had failed other treatments or that Dr. Loftus was a leading expert in his field.

“You are giving zero weight to the treating doctor’s opinion on the necessity of the treatment regimen?” a lawyer asked Dr. Cates in his deposition. He responded, “Yeah.”

Attempts to contact Dr. Cates for comment were unsuccessful.

At the same time Dr. Cates was looking at Mr. McNaughton’s case, yet another review was underway at MRIoA. United said it sent the case back to MRIoA after the insurer received the letter from Dr. Loftus warning of the life-threatening complications that might occur if the dosages were reduced.

On May 24, 2021, the new report requested by MRIoA arrived. It came to a completely different conclusion than all of the previous reviews.

Nitin Kumar, MD, a gastroenterologist in Illinois, concluded that Mr. McNaughton’s established treatment plan was not only medically necessary and appropriate but that lowering his doses “can result in a lack of effective therapy of Ulcerative Colitis, with complications of uncontrolled disease (including dysplasia leading to colorectal cancer), flare, hospitalization, need for surgery, and toxic megacolon.”

Unlike other doctors who produced reports for United, Dr. Kumar discussed the harm that Mr. McNaughton might suffer if United required him to change his treatment. “His disease is significantly severe, with diagnosis at a young age,” Dr. Kumar wrote. “He has failed every biologic medication class recommended by guidelines. Therefore, guidelines can no longer be applied in this case.” He cited six studies of patients using two biologic drugs together and wrote that they revealed no significant safety issues and found the therapy to be “broadly successful.”

When Ms. Kavanaugh learned of Dr. Kumar’s report, she quickly moved to quash it and get the case returned to Dr. Pabby, according to her deposition.

In a recorded telephone call, Ms. Kavanaugh told an MRIoA representative that “I had asked that this go back through Dr. Pabby, and it went through a different doctor and they had a much different result.” After further discussion, the MRIoA representative agreed to send the case back to Dr. Pabby. “I appreciate that,” Ms. Kavanaugh replied. “I just want to make sure, because, I mean, it’s obviously a very different result than what we’ve been getting on this case.”

MRIoA case notes show that at 7:04 a.m. on May 25, 2021, Dr. Pabby was assigned to take a look at the case for the third time. At 7:27 a.m., the notes indicate, Dr. Pabby again rejected Mr. McNaughton’s treatment plan. While noting it was “difficult to control” Mr. McNaughton’s ulcerative colitis, Dr. Pabby added that his doses “far exceed what is approved by literature” and that the “safety of the requested doses is not supported by literature.”

In a deposition, Ms. Kavanaugh said that after she opened the Kumar report and read that he was supporting Mr. McNaughton’s current treatment plan, she immediately spoke to her supervisor, who told her to call MRIoA and have the case sent back to Dr. Pabby for review.

Ms. Kavanaugh said she didn’t save a copy of the Kumar report, nor did she forward it to anyone at United or to officials at Penn State who had been inquiring about the McNaughton case. “I didn’t because it shouldn’t have existed,” she said. “It should have gone back to Dr. Pabby.”

When asked if the Kumar report caused her any concerns given his warning that Mr. McNaughton risked cancer or hospitalization if his regimen were changed, Ms. Kavanaugh said she didn’t read his full report. “I saw that it was not the correct doctor, I saw the initial outcome and I was asked to send it back,” she said. Ms. Kavanaugh added, “I have a lot of empathy for this member, but it needed to go back to the peer-to-peer reviewer.”

In a court filing, United said Ms. Kavanaugh was correct in insisting that Dr. Pabby conduct the review and that MRIoA confirmed that Dr. Pabby should have been the one doing the review.

The Kumar report was not provided to Mr. McNaughton when his lawyer, Jonathan M. Gesk, first asked United and MRIoA for any reviews of the case. Mr. Gesk discovered it by accident when he was listening to a recorded telephone call produced by United in which Ms. Kavanaugh mentioned a report number Mr. Gesk had not heard before. He then called MRIoA, which confirmed the report existed and eventually provided it to him.

Dr. Pabby asked ProPublica to direct any questions about his involvement in the matter to MRIoA. The company did not respond to questions from ProPublica about the case.
 

A sense of hopelessness

When Mr. McNaughton enrolled at Penn State in 2020, it brought a sense of normalcy that he had lost when he was first diagnosed with colitis. He still needed monthly hours-long infusions and suffered occasional flare-ups and symptoms, but he was attending classes in person and living a life similar to the one he had before his diagnosis.

It was a striking contrast to the previous 6 years, which he had spent largely confined to his parents’ house in State College. The frequent bouts of diarrhea made it difficult to go out. He didn’t talk much to friends and spent as much time as he could studying potential treatments and reviewing ongoing clinical trials. He tried to keep up with the occasional online course, but his disease made it difficult to make any real progress toward a degree.

United, in correspondence with Mr. McNaughton, noted that its review of his care was “not a treatment decision. Treatment decisions are made between you and your physician.” But by threatening not to pay for his medications, or only to pay for a different regimen, Mr. McNaughton said, United was in fact attempting to dictate his treatment. From his perspective, the insurer was playing doctor, making decisions without ever examining him or even speaking to him.

The idea of changing his treatment or stopping it altogether caused constant worry for Mr. McNaughton, exacerbating his colitis and triggering physical symptoms, according to his doctors. Those included a large ulcer on his leg and welts under his skin on his thighs and shin that made his leg muscles stiff and painful to the point where he couldn’t bend his leg or walk properly. There were daily migraines and severe stomach pain. “I was consumed with this situation,” Mr. McNaughton said. “My path was unconventional, but I was proud of myself for fighting back and finishing school and getting my life back on track. I thought they were singling me out. My biggest fear was going back to the hell.”

Mr. McNaughton said he contemplated suicide on several occasions, dreading a return to a life where he was housebound or hospitalized.

Mr. McNaughton and his parents talked about his possibly moving to Canada where his grandmother lived and seeking treatment there under the nation’s government health plan.

Dr. Loftus connected Mr. McNaughton with a psychologist who specializes in helping patients with chronic digestive diseases.

The psychologist, Tiffany Taft, PsyD, said Mr. McNaughton was not an unusual case. About one in three patients with diseases like colitis suffer from medical trauma or PTSD related to it, she said, often the result of issues related to getting appropriate treatment approved by insurers.

“You get into hopelessness,” she said of the depression that accompanies fighting with insurance companies over care. “They feel like ‘I can’t fix that. I am screwed.’ When you can’t control things with what an insurance company is doing, anxiety, PTSD and depression get mixed together.”

In the case of Mr. McNaughton, Dr. Taft said, he was being treated by one of the best gastroenterologists in the world, was doing well with his treatment, and then was suddenly notified he might be on the hook for nearly a million dollars in medical charges without access to his medications. “It sends you immediately into panic about all these horrific things that could happen,” Dr. Taft said. The physical and mental symptoms Mr. McNaughton suffered after his care was threatened were “triggered” by the stress he experienced, she said.

In early June 2021, United informed Mr. McNaughton in a letter that it would not cover the cost of his treatment regimen in the next academic year, starting in August. The insurer said it would pay only for a treatment plan that called for a significant reduction in the doses of the drugs he took.

United wrote that the decision came after his “records have been reviewed three times and the medical reviewers have concluded that the medication as prescribed does not meet the Medical Necessity requirement of the plan.”

In August 2021, Mr. McNaughton filed a federal lawsuit accusing United of acting in bad faith and unreasonably making treatment decisions based on financial concerns and not what was the best and most effective treatment. It claims United had a duty to find information that supported Mr. McNaughton’s claim for treatment rather than looking for ways to deny coverage.

United, in a court filing, said it did not breach any duty it owed to Mr. McNaughton and acted in good faith. On Sept. 20, 2021, a month after filing the lawsuit, and with United again balking at paying for his treatment, Mr. McNaughton asked a judge to grant a temporary restraining order requiring United to pay for his care. With the looming threat of a court hearing on the motion, United quickly agreed to cover the cost of Mr. McNaughton’s treatment through the end of the 2021-2022 academic year. It also dropped a demand requiring Mr. McNaughton to settle the matter as a condition of the insurer paying for his treatment as prescribed by Dr. Loftus, according to an email sent by United’s lawyer.
 

The cost of treatment

It is not surprising that insurers are carefully scrutinizing the care of patients treated with biologics, which are among the most expensive medications on the market. Biologics are considered specialty drugs, a class that includes the best-selling Humira, used to treat arthritis. Specialty drug spending in the United States is expected to reach $505 billion in 2023, according to an estimate from Optum, United’s health services division. The Institute for Clinical and Economic Review, a nonprofit that analyzes the value of drugs, found in 2020 that the biologic drugs used to treat patients like Mr. McNaughton are often effective but overpriced for their therapeutic benefit. To be judged cost-effective by ICER, the biologics should sell at a steep discount to their current market price, the panel found.

A panel convened by ICER to review its analysis cautioned that insurance coverage “should be structured to prevent situations in which patients are forced to choose a treatment approach on the basis of cost.” ICER also found examples where insurance company policies failed to keep pace with updates to clinical practice guidelines based on emerging research.

United officials did not make the cost of treatment an issue when discussing Mr. McNaughton’s care with Penn State administrators or the family.

Bill Truxal, the president of UnitedHealthcare StudentResources, the company’s student health plan division, told a Penn State official that the insurer wanted the “best for the student” and it had “nothing to do with cost,” according to notes the official took of the conversation.

Behind the scenes, however, the price of Mr. McNaughton’s care was front and center at United.

In one email, Mr. Opperman asked about the cost difference if the insurer insisted on paying only for greatly reduced doses of the biologic drugs. Ms. Kavanaugh responded that the insurer had paid $1.1 million in claims for Mr. McNaughton’s care as of the middle of May 2021. If the reduced doses had been in place, the amount would have been cut to $260,218, she wrote.

United was keeping close tabs on Mr. McNaughton at the highest levels of the company. On Aug. 2, 2021, Mr. Opperman notified Mr. Truxal and a United lawyer that Mr. McNaughton “has just purchased the plan again for the 21-22 school year.”

A month later, Ms. Kavanaugh shared another calculation with United executives showing that the insurer spent over $1.7 million on Mr. McNaughton in the prior plan year.

United officials strategized about how to best explain why it was reviewing Mr. McNaughton’s drug regimen, according to an internal email. They pointed to a justification often used by health insurers when denying claims. “As the cost of healthcare continues to climb to soaring heights, it has been determined that a judicious review of these drugs should be included” in order to “make healthcare more affordable for our members,” Ms. Kavanaugh offered as a potential talking point in an April 23, 2021, email.

Three days later, UnitedHealth Group filed an annual statement with the U.S. Securities and Exchange Commission disclosing its pay for top executives in the prior year. Then-CEO David Wichmann was paid $17.9 million in salary and other compensation in 2020. Wichmann retired early the following year, and his total compensation that year exceeded $140 million, according to calculations in a compensation database maintained by the Star Tribune in Minneapolis. The newspaper said the amount was the most paid to an executive in the state since it started tracking pay more than 2 decades ago. About $110 million of that total came from Wichmann exercising stock options accumulated during his stewardship.

The McNaughtons were well aware of the financial situation at United. They looked at publicly available financial results and annual reports. Last year, United reported a profit of $20.1 billion on revenues of $324.2 billion.

When discussing the case with Penn State, Ms. Light said, she told university administrators that United could pay for a year of her son’s treatment using just minutes’ worth of profit.
 

‘Betrayed’

Mr. McNaughton has been able to continue receiving his infusions for now, anyway. In October, United notified him it was once again reviewing his care, although the insurer quickly reversed course when his lawyer intervened. United, in a court filing, said the review was a mistake and that it had erred in putting Mr. McNaughton’s claims into pending status.

Mr. McNaughton said he is fortunate his parents were employed at the same school he was attending, which was critical in getting the attention of administrators there. But that help had its limits.

In June 2021, just a week after United told Mr. McNaughton it would not cover his treatment plan in the upcoming plan year, Penn State essentially walked away from the matter.

In an email to the McNaughtons and United, Penn State Associate Vice President for Student Affairs Andrea Dowhower wrote that administrators “have observed an unfortunate breakdown in communication” between Mr. McNaughton and his family and the university health insurance plan, “which appears from our perspective to have resulted in a standstill between the two parties.” While she proposed some potential steps to help settle the matter, she wrote that “Penn State’s role in this process is as a resource for students like Chris who, for whatever reason, have experienced difficulty navigating the complex world of health insurance.” The university’s role “is limited,” she wrote, and the school “simply must leave” the issue of the best treatment for Mr. McNaughton to “the appropriate health care professionals.”

In a statement, a Penn State spokesperson wrote that “as a third party in this arrangement, the University’s role is limited and Penn State officials can only help a student manage an issue based on information that a student/family, medical personnel, and/or insurance provider give – with the hope that all information is accurate and that the lines of communication remain open between the insured and the insurer.”

Penn State declined to provide financial information about the plan. However, the university and United share at least one tie that they have not publicly disclosed.

When the McNaughtons first reached out to the university for help, they were referred to the school’s student health insurance coordinator. The official, Heather Klinger, wrote in an email to the family in February 2021 that “I appreciate your trusting me to resolve this for you.”

In April 2022, United began paying Ms. Klinger’s salary, an arrangement which is not noted on the university website. Ms. Klinger appears in the online staff directory on the Penn State University Health Services web page, and has a university phone number, a university address, and a Penn State email listed as her contact. The school said she has maintained a part-time status with the university to allow her to access relevant data systems at both the university and United.

The university said students “benefit” from having a United employee to handle questions about insurance coverage and that the arrangement is “not uncommon” for student health plans.

The family was dismayed to learn that Ms. Klinger was now a full-time employee of United.

“We did feel betrayed,” Ms. Light said. Ms. Klinger did not respond to an email seeking comment.

Mr. McNaughton’s fight to maintain his treatment regimen has come at a cost of time, debilitating stress, and depression. “My biggest fear is realizing I might have to do this every year of my life,” he said.

Mr. McNaughton said one motivation for his lawsuit was to expose how insurers like United make decisions about what care they will pay for and what they will not. The case remains pending, a court docket shows.

He has been accepted to Penn State’s law school. He hopes to become a health care lawyer working for patients who find themselves in situations similar to his.

He plans to re-enroll in the United health care plan when he starts school next fall.

This story was originally published on ProPublica. ProPublica is a nonprofit newsroom that investigates abuses of power. Sign up to receive the biggest stories as soon as they’re published.

In May 2021, a nurse at UnitedHealthcare called a colleague to share some welcome news about a problem the two had been grappling with for weeks.

United provided the health insurance plan for students at Penn State University. It was a large and potentially lucrative account: lots of young, healthy students paying premiums in, not too many huge medical reimbursements going out.

But one student was costing United a lot of money. Christopher McNaughton suffered from a crippling case of ulcerative colitis – an ailment that caused him to develop severe arthritis, debilitating diarrhea, numbing fatigue, and life-threatening blood clots. His medical bills were running nearly $2 million a year.

United had flagged Mr. McNaughton’s case as a “high dollar account,” and the company was reviewing whether it needed to keep paying for the expensive cocktail of drugs crafted by a Mayo Clinic specialist that had brought Mr. McNaughton’s disease under control after he’d been through years of misery.

On the 2021 phone call, which was recorded by the company, nurse Victoria Kavanaugh told her colleague that a doctor contracted by United to review the case had concluded that Mr. McNaughton’s treatment was “not medically necessary.” Her colleague, Dave Opperman, reacted to the news with a long laugh.

“I knew that was coming,” said Mr. Opperman, who heads up a United subsidiary that brokered the health insurance contract between United and Penn State. “I did too,” Ms. Kavanaugh replied.

Mr. Opperman then complained about Mr. McNaughton’s mother, whom he referred to as “this woman,” for “screaming and yelling” and “throwing tantrums” during calls with United.

The pair agreed that any appeal of the United doctor’s denial of the treatment would be a waste of the family’s time and money.

“We’re still gonna say no,” Mr. Opperman said.

More than 200 million Americans are covered by private health insurance. But data from state and federal regulators shows that insurers reject about 1 in 7 claims for treatment. Many people, faced with fighting insurance companies, simply give up: One study found that Americans file formal appeals on only 0.1% of claims denied by insurers under the Affordable Care Act.

Insurers have wide discretion in crafting what is covered by their policies, beyond some basic services mandated by federal and state law. They often deny claims for services that they deem not “medically necessary.”

When United refused to pay for Mr. McNaughton’s treatment for that reason, his family did something unusual. They fought back with a lawsuit, which uncovered a trove of materials, including internal emails and tape-recorded exchanges among company employees. Those records offer an extraordinary behind-the-scenes look at how one of America’s leading health care insurers relentlessly fought to reduce spending on care, even as its profits rose to record levels.

As United reviewed Mr. McNaughton’s treatment, he and his family were often in the dark about what was happening or their rights. Meanwhile, United employees misrepresented critical findings and ignored warnings from doctors about the risks of altering Mr. McNaughton’s drug plan.

At one point, court records show, United inaccurately reported to Penn State and the family that Mr. McNaughton’s doctor had agreed to lower the doses of his medication. Another time, a doctor paid by United concluded that denying payments for Mr. McNaughton’s treatment could put his health at risk, but the company buried his report and did not consider its findings. The insurer did, however, consider a report submitted by a company doctor who rubber-stamped the recommendation of a United nurse to reject paying for the treatment.

United declined to answer specific questions about the case, even after Mr. McNaughton signed a release provided by the insurer to allow it to discuss details of his interactions with the company. United noted that it ultimately paid for all of Mr. McNaughton’s treatments. In a written response, United spokesperson Maria Gordon Shydlo wrote that the company’s guiding concern was Mr. McNaughton’s well-being.

“Mr. McNaughton’s treatment involves medication dosages that far exceed [Food and Drug Administration] guidelines,” the statement said. “In cases like this, we review treatment plans based on current clinical guidelines to help ensure patient safety.”

But the records reviewed by ProPublica show that United had another, equally urgent goal in dealing with Mr. McNaughton. In emails, officials calculated what Mr. McNaughton was costing them to keep his crippling disease at bay and how much they would save if they forced him to undergo a cheaper treatment that had already failed him. As the family pressed the company to back down, first through Penn State and then through a lawsuit, the United officials handling the case bristled.

“This is just unbelievable,” Ms. Kavanaugh said of Mr. McNaughton’s family in one call to discuss his case. ”They’re just really pushing the envelope, and I’m surprised, like I don’t even know what to say.”
 

The same meal every day

Now 31, Mr. McNaughton grew up in State College, Pa., just blocks from the Penn State campus. Both of his parents are faculty members at the university.

In the winter of 2014, Mr. McNaughton was halfway through his junior year at Bard College in New York. At 6 feet, 4 inches tall, he was a guard on the basketball team and had started most of the team’s games since the start of his sophomore year. He was majoring in psychology.

When Mr. McNaughton returned to school after the winter holiday break, he started to experience frequent bouts of bloody diarrhea. After just a few days on campus, he went home to State College, where doctors diagnosed him with a severe case of ulcerative colitis.

A chronic inflammatory bowel disease that causes swelling and ulcers in the digestive tract, ulcerative colitis has no cure, and ongoing treatment is needed to alleviate symptoms and prevent serious health complications. The majority of cases produce mild to moderate symptoms. Mr. McNaughton’s case was severe.

Treatments for ulcerative colitis include steroids and special drugs known as biologics that work to reduce inflammation in the large intestine.

Mr. McNaughton, however, failed to get meaningful relief from the drugs his doctors initially prescribed. He was experiencing bloody diarrhea up to 20 times a day, with such severe stomach pain that he spent much of his day curled up on a couch. He had little appetite and lost 50 pounds. Severe anemia left him fatigued. He suffered from other conditions related to his colitis, including crippling arthritis. He was hospitalized several times to treat dangerous blood clots.

For 2 years, in an effort to help alleviate his symptoms, he ate the same meals every day: Rice Chex cereal and scrambled eggs for breakfast, a cup of white rice with plain chicken breast for lunch, and a similar meal for dinner, occasionally swapping in tilapia.

His hometown doctors referred him to a specialist at the University of Pittsburgh, who tried unsuccessfully to bring his disease under control. That doctor ended up referring Mr. McNaughton to Edward V. Loftus Jr., MD, at the Mayo Clinic in Rochester, Minn., which has been ranked as the best gastroenterology hospital in the country every year since 1990 by U.S. News & World Report.

For his first visit with Dr. Loftus in May 2015, Mr. McNaughton and his mother, Janice Light, charted hospitals along the 900-mile drive from Pennsylvania to Minnesota in case they needed medical help along the way.

Mornings were the hardest. Mr. McNaughton often spent several hours in the bathroom at the start of the day. To prepare for his meeting with Dr. Loftus, he set his alarm for 3:30 a.m. so he could be ready for the 7:30 a.m. appointment. Even with that preparation, he had to stop twice to use a bathroom on the 5-minute walk from the hotel to the clinic. When they met, Dr. Loftus looked at Mr. McNaughton and told him that he appeared incapacitated. It was, he told the student, as if Mr. McNaughton were chained to the bathroom, with no outside life. He had not been able to return to school and spent most days indoors, managing his symptoms as best he could.

Mr. McNaughton had tried a number of medications by this point, none of which worked. This pattern would repeat itself during the first couple of years that Dr. Loftus treated him.

In addition to trying to find a treatment that would bring Mr. McNaughton’s colitis into remission, Dr. Loftus wanted to wean him off the steroid prednisone, which he had been taking since his initial diagnosis in 2014. The drug is commonly prescribed to colitis patients to control inflammation, but prolonged use can lead to severe side effects including cataracts, osteoporosis, increased risk of infection, and fatigue. Mr. McNaughton also experienced “moon face,” a side effect caused by the shifting of fat deposits that results in the face becoming puffy and rounder.

In 2018, Dr. Loftus and Mr. McNaughton decided to try an unusual regimen. Many patients with inflammatory bowel diseases such as colitis take a single biologic drug as treatment. Whereas traditional drugs are chemically synthesized, biologics are manufactured in living systems, such as plant or animal cells. A year’s supply of an individual biologic drug can cost up to $500,000. They are often given through infusions in a medical facility, which adds to the cost.

Mr. McNaughton had tried individual biologics, and then two in combination, without much success. He and Dr. Loftus then agreed to try two biologic drugs together at doses well above those recommended by the Food and Drug Administration. The federal Agency for Healthcare Research and Quality estimates one in five prescriptions written today are for off-label uses.

There are drawbacks to the practice. Since some uses and doses of particular drugs have not been extensively studied, the risks and efficacy of using them off-label are not well known. Also, some drug manufacturers have improperly pushed off-label usage of their products to boost sales despite little or no evidence to support their use in those situations. Like many leading experts and researchers in his field, Dr. Loftus has been paid to do consulting related to the biologic drugs taken by Mr. McNaughton. The payments related to those drugs have ranged from a total of $1,440 in 2020 to $51,235 in 2018. Dr. Loftus said much of his work with pharmaceutical companies was related to conducting clinical trials on new drugs.

In cases of off-label prescribing, patients are depending upon their doctors’ expertise and experience with the drug. “In this case, I was comfortable that the potential benefits to Chris outweighed the risks,” Dr. Loftus said.

There was evidence that the treatment plan for Mr. McNaughton might work, including studies that had found dual biologic therapy to be efficacious and safe. The two drugs he takes, Entyvio and Remicade, have the same purpose – to reduce inflammation in the large intestine – but each works differently in the body. Remicade, marketed by Janssen Biotech, targets a protein that causes inflammation. Entyvio, made by Takeda Pharmaceuticals, works by preventing an excess of white blood cells from entering into the gastrointestinal tract.

As for any suggestion by United doctors that his treatment plan for Mr. McNaughton was out of bounds or dangerous, Dr. Loftus said “my treatment of Chris was not clinically inappropriate – as was shown by Chris’ positive outcome.”

The unusual high-dose combination of two biologic drugs produced a remarkable change in Mr. McNaughton. He no longer had blood in his stool, and his trips to the bathroom were cut from 20 times a day to 3 or 4. He was able to eat different foods and put on weight. He had more energy. He tapered off prednisone.

“If you told me in 2015 that I would be living like this, I would have asked where do I sign up,” Mr. McNaughton said of the change he experienced with the new drug regimen.

When he first started the new treatment, Mr. McNaughton was covered under his family’s plan, and all his bills were paid. Mr. McNaughton enrolled at the university in 2020. Before switching to United’s plan for students, Mr. McNaughton and his parents consulted with a health advocacy service offered to faculty members. A benefits specialist assured them the drugs taken by Mr. McNaughton would be covered by United.

Mr. McNaughton joined the student plan in July 2020, and his infusions that month and the following month were paid for by United. In September, the insurer indicated payment on his claims was “pending,” something it did for his other claims that came in during the rest of the year.

Mr. McNaughton and his family were worried. They called United to make sure there wasn’t a problem; the insurer told them, they said, that it only needed to check his medical records. When the family called again, United told them it had the documentation needed, they said. United, in a court filing last year, said it received two calls from the family and each time indicated that all of the necessary medical records had not yet been received.

In January 2021, Mr. McNaughton received a new explanation of benefits for the prior months. All of the claims for his care, beginning in September, were no longer “pending.” They were stamped “DENIED.” The total outstanding bill for his treatment was $807,086.

When Mr. McNaughton’s mother reached a United customer service representative the next day to ask why bills that had been paid in the summer were being denied for the fall, the representative told her the account was being reviewed because of “a high dollar amount on the claims,” according to a recording of the call.


 

Misrepresentations

With United refusing to pay, the family was terrified of being stuck with medical bills that would bankrupt them and deprive Mr. McNaughton of treatment that they considered miraculous.

They turned to Penn State for help. Ms. Light and Mr. McNaughton’s father, David McNaughton, hoped their position as faculty members would make the school more willing to intervene on their behalf.

“After more than 30 years on faculty, my husband and I know that this is not how Penn State would want its students to be treated,” Ms. Light wrote to a school official in February 2021.

In response to questions from ProPublica, Penn State spokesperson Lisa Powers wrote that “supporting the health and well-being of our students is always of primary importance” and that “our hearts go out to any student and family impacted by a serious medical condition.” The university, she wrote, does “not comment on students’ individual circumstances or disclose information from their records.” Mr. McNaughton offered to grant Penn State whatever permissions it needed to speak about his case with ProPublica. The school, however, wrote that it would not comment “even if confidentiality has been waived.”

The family appealed to school administrators. Because the effectiveness of biologics wanes in some patients if doses are skipped, Mr. McNaughton and his parents were worried about even a delay in treatment. His doctor wrote that if he missed scheduled infusions of the drugs, there was “a high likelihood they would no longer be effective.”

During a conference call arranged by Penn State officials on March 5, 2021, United agreed to pay for Mr. McNaughton’s care through the end of the plan year that August. Penn State immediately notified the family of the “wonderful news” while also apologizing for “the stress this has caused Chris and your family.”

Behind the scenes, Mr. McNaughton’s review had “gone all the way to the top” at United’s student health plan division, Ms. Kavanaugh, the nurse, said in a recorded conversation.

The family’s relief was short-lived. A month later, United started another review of Mr. McNaughton’s care, overseen by Ms. Kavanaugh, to determine if it would pay for the treatment in the upcoming plan year.

The nurse sent the Mr. McNaughton case to a company called Medical Review Institute of America. Insurers often turn to companies like MRIoA to review coverage decisions involving expensive treatments or specialized care.

Ms. Kavanaugh, who was assigned to a special investigations unit at United, let her feelings about the matter be known in a recorded telephone call with a representative of MRIoA.

“This school apparently is a big client of ours,” she said. She then shared her opinion of Mr. McNaughton’s treatment. “Really this is a case of a kid who’s getting a drug way too much, like too much of a dose,” Ms. Kavanaugh said. She said it was “insane that they would even think that this is reasonable” and “to be honest with you, they’re awfully pushy considering that we are paying through the end of this school year.”

On a call with an outside contractor, the United nurse claimed Mr. McNaughton was on a higher dose of medication than the FDA approved, which is a common practice.

MRIoA sent the case to Vikas Pabby, MD, a gastroenterologist at UCLA Health and a professor at the university’s medical school. His May 2021 review of Mr. McNaughton’s case was just one of more than 300 Dr. Pabby did for MRIoA that month, for which he was paid $23,000 in total, according to a log of his work produced in the lawsuit.

In a May 4, 2021, report, Dr. Pabby concluded Mr. McNaughton’s treatment was not medically necessary, because United’s policies for the two drugs taken by Mr. McNaughton did not support using them in combination.

Insurers spell out what services they cover in plan policies, lengthy documents that can be confusing and difficult to understand. Many policies, such as Mr. McNaughton’s, contain a provision that treatments and procedures must be “medically necessary” in order to be covered. The definition of medically necessary differs by plan. Some don’t even define the term. Mr. McNaughton’s policy contains a five-part definition, including that the treatment must be “in accordance with the standards of good medical policy” and “the most appropriate supply or level of service which can be safely provided.”

Behind the scenes at United, Mr. Opperman and Ms. Kavanaugh agreed that if Mr. McNaughton were to appeal Dr. Pabby’s decision, the insurer would simply rule against him. “I just think it’s a waste of money and time to appeal and send it to another one when we know we’re gonna get the same answer,” Mr. Opperman said, according to a recording in court files. At Mr. Opperman’s urging, United decided to skip the usual appeals process and arrange for Dr. Pabby to have a so-called “peer-to-peer” discussion with Dr. Loftus, the Mayo physician treating Mr. McNaughton. Such a conversation, in which a patient’s doctor talks with an insurance company’s doctor to advocate for the prescribed treatment, usually occurs only after a customer has appealed a denial and the appeal has been rejected.

When Ms. Kavanaugh called Dr. Loftus’ office to set up a conversation with Dr. Pabby, she explained it was an urgent matter and had been requested by Mr. McNaughton. “You know I’ve just gotten to know Christopher,” she explained, although she had never spoken with him. “We’re trying to advocate and help and get this peer-to-peer set up.”

Mr. McNaughton, meanwhile, had no idea at the time that a United doctor had decided his treatment was unnecessary and that the insurer was trying to set up a phone call with his physician.

In the peer-to-peer conversation, Dr. Loftus told Dr. Pabby that Mr. McNaughton had “a very complicated case” and that lower doses had not worked for him, according to an internal MRIoA memo.

Following his conversation with Dr. Loftus, Dr. Pabby created a second report for United. He recommended the insurer pay for both drugs, but at reduced doses. He added new language saying that the safety of using both drugs at the higher levels “is not established.”

When Ms. Kavanaugh shared the May 12 decision from Dr. Pabby with others at United, her boss responded with an email calling it “great news.”

Then Mr. Opperman sent an email that puzzled the McNaughtons.

In it, Mr. Opperman claimed that Dr. Loftus and Dr. Pabby had agreed that Mr. McNaughton should be on significantly lower doses of both drugs. He said Dr. Loftus “will work with the patient to start titrating them down to a normal dose range.” Mr. Opperman wrote that United would cover Mr. McNaughton’s treatment in the coming year, but only at the reduced doses. Mr. Opperman did not respond to emails and phone messages seeking comment.

Mr. McNaughton didn’t believe a word of it. He had already tried and failed treatment with those drugs at lower doses, and it was Dr. Loftus who had upped the doses, leading to his remission from severe colitis.

The only thing that made sense to Mr. McNaughton was that the treatment United said it would now pay for was dramatically cheaper – saving the company at least hundreds of thousands of dollars a year – than his prescribed treatment because it sliced the size of the doses by more than half.

When the family contacted Dr. Loftus for an explanation, they were outraged by what they heard. Dr. Loftus told them that he had never recommended lowering the dosage. In a letter, Dr. Loftus wrote that changing Mr. McNaughton’s treatment “would have serious detrimental effects on both his short term and long term health and could potentially involve life threatening complications. This would ultimately incur far greater medical costs. Chris was on the doses suggested by United Healthcare before, and they were not at all effective.”

It would not be until the lawsuit that it would become clear how Dr. Loftus’ conversations had been so seriously misrepresented.

Under questioning by Mr. McNaughton’s lawyers, Ms. Kavanaugh acknowledged that she was the source of the incorrect claim that Mr. McNaughton’s doctor had agreed to a change in treatment.

“I incorrectly made an assumption that they had come to some sort of agreement,” she said in a deposition last August. “It was my first peer-to-peer. I did not realize that that simply does not occur.”

Ms. Kavanaugh did not respond to emails and telephone messages seeking comment.

When the McNaughtons first learned of Mr. Opperman’s inaccurate report of the phone call with Dr. Loftus, it unnerved them. They started to question if their case would be fairly reviewed.

“When we got the denial and they lied about what Dr. Loftus said, it just hit me that none of this matters,” Mr. McNaughton said. “They will just say or do anything to get rid of me. It delegitimized the entire review process. When I got that denial, I was crushed.”


 

A buried report

While the family tried to sort out the inaccurate report, United continued putting the McNaughton case in front of more company doctors.

On May 21, 2021, United sent the case to one of its own doctors, Nady Cates, MD, for an additional review. The review was marked “escalated issue.” Dr. Cates is a United medical director, a title used by many insurers for physicians who review cases. It is work he has been doing as an employee of health insurers since 1989 and at United since 2010. He has not practiced medicine since the early 1990s.

Dr. Cates, in a deposition, said he stopped seeing patients because of the long hours involved and because “AIDS was coming around then. I was seeing a lot of military folks who had venereal diseases, and I guess I was concerned about being exposed.” He transitioned to reviewing paperwork for the insurance industry, he said, because “I guess I was a chicken.”

When he had practiced, Dr. Cates said, he hadn’t treated patients with ulcerative colitis and had referred those cases to a gastroenterologist.

He said his review of Mr. McNaughton’s case primarily involved reading a United nurse’s recommendation to deny his care and making sure “that there wasn’t a decimal place that was out of line.” He said he copied and pasted the nurse’s recommendation and typed “agree” on his review of Mr. McNaughton’s case.

Dr. Cates said that he does about a hundred reviews a week. He said that in his reviews he typically checks to see if any medications are prescribed in accordance with the insurer’s guidelines, and if not, he denies it. United’s policies, he said, prevented him from considering that Mr. McNaughton had failed other treatments or that Dr. Loftus was a leading expert in his field.

“You are giving zero weight to the treating doctor’s opinion on the necessity of the treatment regimen?” a lawyer asked Dr. Cates in his deposition. He responded, “Yeah.”

Attempts to contact Dr. Cates for comment were unsuccessful.

At the same time Dr. Cates was looking at Mr. McNaughton’s case, yet another review was underway at MRIoA. United said it sent the case back to MRIoA after the insurer received the letter from Dr. Loftus warning of the life-threatening complications that might occur if the dosages were reduced.

On May 24, 2021, the new report requested by MRIoA arrived. It came to a completely different conclusion than all of the previous reviews.

Nitin Kumar, MD, a gastroenterologist in Illinois, concluded that Mr. McNaughton’s established treatment plan was not only medically necessary and appropriate but that lowering his doses “can result in a lack of effective therapy of Ulcerative Colitis, with complications of uncontrolled disease (including dysplasia leading to colorectal cancer), flare, hospitalization, need for surgery, and toxic megacolon.”

Unlike other doctors who produced reports for United, Dr. Kumar discussed the harm that Mr. McNaughton might suffer if United required him to change his treatment. “His disease is significantly severe, with diagnosis at a young age,” Dr. Kumar wrote. “He has failed every biologic medication class recommended by guidelines. Therefore, guidelines can no longer be applied in this case.” He cited six studies of patients using two biologic drugs together and wrote that they revealed no significant safety issues and found the therapy to be “broadly successful.”

When Ms. Kavanaugh learned of Dr. Kumar’s report, she quickly moved to quash it and get the case returned to Dr. Pabby, according to her deposition.

In a recorded telephone call, Ms. Kavanaugh told an MRIoA representative that “I had asked that this go back through Dr. Pabby, and it went through a different doctor and they had a much different result.” After further discussion, the MRIoA representative agreed to send the case back to Dr. Pabby. “I appreciate that,” Ms. Kavanaugh replied. “I just want to make sure, because, I mean, it’s obviously a very different result than what we’ve been getting on this case.”

MRIoA case notes show that at 7:04 a.m. on May 25, 2021, Dr. Pabby was assigned to take a look at the case for the third time. At 7:27 a.m., the notes indicate, Dr. Pabby again rejected Mr. McNaughton’s treatment plan. While noting it was “difficult to control” Mr. McNaughton’s ulcerative colitis, Dr. Pabby added that his doses “far exceed what is approved by literature” and that the “safety of the requested doses is not supported by literature.”

In a deposition, Ms. Kavanaugh said that after she opened the Kumar report and read that he was supporting Mr. McNaughton’s current treatment plan, she immediately spoke to her supervisor, who told her to call MRIoA and have the case sent back to Dr. Pabby for review.

Ms. Kavanaugh said she didn’t save a copy of the Kumar report, nor did she forward it to anyone at United or to officials at Penn State who had been inquiring about the McNaughton case. “I didn’t because it shouldn’t have existed,” she said. “It should have gone back to Dr. Pabby.”

When asked if the Kumar report caused her any concerns given his warning that Mr. McNaughton risked cancer or hospitalization if his regimen were changed, Ms. Kavanaugh said she didn’t read his full report. “I saw that it was not the correct doctor, I saw the initial outcome and I was asked to send it back,” she said. Ms. Kavanaugh added, “I have a lot of empathy for this member, but it needed to go back to the peer-to-peer reviewer.”

In a court filing, United said Ms. Kavanaugh was correct in insisting that Dr. Pabby conduct the review and that MRIoA confirmed that Dr. Pabby should have been the one doing the review.

The Kumar report was not provided to Mr. McNaughton when his lawyer, Jonathan M. Gesk, first asked United and MRIoA for any reviews of the case. Mr. Gesk discovered it by accident when he was listening to a recorded telephone call produced by United in which Ms. Kavanaugh mentioned a report number Mr. Gesk had not heard before. He then called MRIoA, which confirmed the report existed and eventually provided it to him.

Dr. Pabby asked ProPublica to direct any questions about his involvement in the matter to MRIoA. The company did not respond to questions from ProPublica about the case.
 

A sense of hopelessness

When Mr. McNaughton enrolled at Penn State in 2020, it brought a sense of normalcy that he had lost when he was first diagnosed with colitis. He still needed monthly hours-long infusions and suffered occasional flare-ups and symptoms, but he was attending classes in person and living a life similar to the one he had before his diagnosis.

It was a striking contrast to the previous 6 years, which he had spent largely confined to his parents’ house in State College. The frequent bouts of diarrhea made it difficult to go out. He didn’t talk much to friends and spent as much time as he could studying potential treatments and reviewing ongoing clinical trials. He tried to keep up with the occasional online course, but his disease made it difficult to make any real progress toward a degree.

United, in correspondence with Mr. McNaughton, noted that its review of his care was “not a treatment decision. Treatment decisions are made between you and your physician.” But by threatening not to pay for his medications, or only to pay for a different regimen, Mr. McNaughton said, United was in fact attempting to dictate his treatment. From his perspective, the insurer was playing doctor, making decisions without ever examining him or even speaking to him.

The idea of changing his treatment or stopping it altogether caused constant worry for Mr. McNaughton, exacerbating his colitis and triggering physical symptoms, according to his doctors. Those included a large ulcer on his leg and welts under his skin on his thighs and shin that made his leg muscles stiff and painful to the point where he couldn’t bend his leg or walk properly. There were daily migraines and severe stomach pain. “I was consumed with this situation,” Mr. McNaughton said. “My path was unconventional, but I was proud of myself for fighting back and finishing school and getting my life back on track. I thought they were singling me out. My biggest fear was going back to the hell.”

Mr. McNaughton said he contemplated suicide on several occasions, dreading a return to a life where he was housebound or hospitalized.

Mr. McNaughton and his parents talked about his possibly moving to Canada where his grandmother lived and seeking treatment there under the nation’s government health plan.

Dr. Loftus connected Mr. McNaughton with a psychologist who specializes in helping patients with chronic digestive diseases.

The psychologist, Tiffany Taft, PsyD, said Mr. McNaughton was not an unusual case. About one in three patients with diseases like colitis suffer from medical trauma or PTSD related to it, she said, often the result of issues related to getting appropriate treatment approved by insurers.

“You get into hopelessness,” she said of the depression that accompanies fighting with insurance companies over care. “They feel like ‘I can’t fix that. I am screwed.’ When you can’t control things with what an insurance company is doing, anxiety, PTSD and depression get mixed together.”

In the case of Mr. McNaughton, Dr. Taft said, he was being treated by one of the best gastroenterologists in the world, was doing well with his treatment, and then was suddenly notified he might be on the hook for nearly a million dollars in medical charges without access to his medications. “It sends you immediately into panic about all these horrific things that could happen,” Dr. Taft said. The physical and mental symptoms Mr. McNaughton suffered after his care was threatened were “triggered” by the stress he experienced, she said.

In early June 2021, United informed Mr. McNaughton in a letter that it would not cover the cost of his treatment regimen in the next academic year, starting in August. The insurer said it would pay only for a treatment plan that called for a significant reduction in the doses of the drugs he took.

United wrote that the decision came after his “records have been reviewed three times and the medical reviewers have concluded that the medication as prescribed does not meet the Medical Necessity requirement of the plan.”

In August 2021, Mr. McNaughton filed a federal lawsuit accusing United of acting in bad faith and unreasonably making treatment decisions based on financial concerns and not what was the best and most effective treatment. It claims United had a duty to find information that supported Mr. McNaughton’s claim for treatment rather than looking for ways to deny coverage.

United, in a court filing, said it did not breach any duty it owed to Mr. McNaughton and acted in good faith. On Sept. 20, 2021, a month after filing the lawsuit, and with United again balking at paying for his treatment, Mr. McNaughton asked a judge to grant a temporary restraining order requiring United to pay for his care. With the looming threat of a court hearing on the motion, United quickly agreed to cover the cost of Mr. McNaughton’s treatment through the end of the 2021-2022 academic year. It also dropped a demand requiring Mr. McNaughton to settle the matter as a condition of the insurer paying for his treatment as prescribed by Dr. Loftus, according to an email sent by United’s lawyer.
 

The cost of treatment

It is not surprising that insurers are carefully scrutinizing the care of patients treated with biologics, which are among the most expensive medications on the market. Biologics are considered specialty drugs, a class that includes the best-selling Humira, used to treat arthritis. Specialty drug spending in the United States is expected to reach $505 billion in 2023, according to an estimate from Optum, United’s health services division. The Institute for Clinical and Economic Review, a nonprofit that analyzes the value of drugs, found in 2020 that the biologic drugs used to treat patients like Mr. McNaughton are often effective but overpriced for their therapeutic benefit. To be judged cost-effective by ICER, the biologics should sell at a steep discount to their current market price, the panel found.

A panel convened by ICER to review its analysis cautioned that insurance coverage “should be structured to prevent situations in which patients are forced to choose a treatment approach on the basis of cost.” ICER also found examples where insurance company policies failed to keep pace with updates to clinical practice guidelines based on emerging research.

United officials did not make the cost of treatment an issue when discussing Mr. McNaughton’s care with Penn State administrators or the family.

Bill Truxal, the president of UnitedHealthcare StudentResources, the company’s student health plan division, told a Penn State official that the insurer wanted the “best for the student” and it had “nothing to do with cost,” according to notes the official took of the conversation.

Behind the scenes, however, the price of Mr. McNaughton’s care was front and center at United.

In one email, Mr. Opperman asked about the cost difference if the insurer insisted on paying only for greatly reduced doses of the biologic drugs. Ms. Kavanaugh responded that the insurer had paid $1.1 million in claims for Mr. McNaughton’s care as of the middle of May 2021. If the reduced doses had been in place, the amount would have been cut to $260,218, she wrote.

United was keeping close tabs on Mr. McNaughton at the highest levels of the company. On Aug. 2, 2021, Mr. Opperman notified Mr. Truxal and a United lawyer that Mr. McNaughton “has just purchased the plan again for the 21-22 school year.”

A month later, Ms. Kavanaugh shared another calculation with United executives showing that the insurer spent over $1.7 million on Mr. McNaughton in the prior plan year.

United officials strategized about how to best explain why it was reviewing Mr. McNaughton’s drug regimen, according to an internal email. They pointed to a justification often used by health insurers when denying claims. “As the cost of healthcare continues to climb to soaring heights, it has been determined that a judicious review of these drugs should be included” in order to “make healthcare more affordable for our members,” Ms. Kavanaugh offered as a potential talking point in an April 23, 2021, email.

Three days later, UnitedHealth Group filed an annual statement with the U.S. Securities and Exchange Commission disclosing its pay for top executives in the prior year. Then-CEO David Wichmann was paid $17.9 million in salary and other compensation in 2020. Wichmann retired early the following year, and his total compensation that year exceeded $140 million, according to calculations in a compensation database maintained by the Star Tribune in Minneapolis. The newspaper said the amount was the most paid to an executive in the state since it started tracking pay more than 2 decades ago. About $110 million of that total came from Wichmann exercising stock options accumulated during his stewardship.

The McNaughtons were well aware of the financial situation at United. They looked at publicly available financial results and annual reports. Last year, United reported a profit of $20.1 billion on revenues of $324.2 billion.

When discussing the case with Penn State, Ms. Light said, she told university administrators that United could pay for a year of her son’s treatment using just minutes’ worth of profit.
 

‘Betrayed’

Mr. McNaughton has been able to continue receiving his infusions for now, anyway. In October, United notified him it was once again reviewing his care, although the insurer quickly reversed course when his lawyer intervened. United, in a court filing, said the review was a mistake and that it had erred in putting Mr. McNaughton’s claims into pending status.

Mr. McNaughton said he is fortunate his parents were employed at the same school he was attending, which was critical in getting the attention of administrators there. But that help had its limits.

In June 2021, just a week after United told Mr. McNaughton it would not cover his treatment plan in the upcoming plan year, Penn State essentially walked away from the matter.

In an email to the McNaughtons and United, Penn State Associate Vice President for Student Affairs Andrea Dowhower wrote that administrators “have observed an unfortunate breakdown in communication” between Mr. McNaughton and his family and the university health insurance plan, “which appears from our perspective to have resulted in a standstill between the two parties.” While she proposed some potential steps to help settle the matter, she wrote that “Penn State’s role in this process is as a resource for students like Chris who, for whatever reason, have experienced difficulty navigating the complex world of health insurance.” The university’s role “is limited,” she wrote, and the school “simply must leave” the issue of the best treatment for Mr. McNaughton to “the appropriate health care professionals.”

In a statement, a Penn State spokesperson wrote that “as a third party in this arrangement, the University’s role is limited and Penn State officials can only help a student manage an issue based on information that a student/family, medical personnel, and/or insurance provider give – with the hope that all information is accurate and that the lines of communication remain open between the insured and the insurer.”

Penn State declined to provide financial information about the plan. However, the university and United share at least one tie that they have not publicly disclosed.

When the McNaughtons first reached out to the university for help, they were referred to the school’s student health insurance coordinator. The official, Heather Klinger, wrote in an email to the family in February 2021 that “I appreciate your trusting me to resolve this for you.”

In April 2022, United began paying Ms. Klinger’s salary, an arrangement which is not noted on the university website. Ms. Klinger appears in the online staff directory on the Penn State University Health Services web page, and has a university phone number, a university address, and a Penn State email listed as her contact. The school said she has maintained a part-time status with the university to allow her to access relevant data systems at both the university and United.

The university said students “benefit” from having a United employee to handle questions about insurance coverage and that the arrangement is “not uncommon” for student health plans.

The family was dismayed to learn that Ms. Klinger was now a full-time employee of United.

“We did feel betrayed,” Ms. Light said. Ms. Klinger did not respond to an email seeking comment.

Mr. McNaughton’s fight to maintain his treatment regimen has come at a cost of time, debilitating stress, and depression. “My biggest fear is realizing I might have to do this every year of my life,” he said.

Mr. McNaughton said one motivation for his lawsuit was to expose how insurers like United make decisions about what care they will pay for and what they will not. The case remains pending, a court docket shows.

He has been accepted to Penn State’s law school. He hopes to become a health care lawyer working for patients who find themselves in situations similar to his.

He plans to re-enroll in the United health care plan when he starts school next fall.

This story was originally published on ProPublica. ProPublica is a nonprofit newsroom that investigates abuses of power. Sign up to receive the biggest stories as soon as they’re published.

Pounding heart, sweating, insomnia. Surges of dopamine, norepinephrine, and adrenaline. All symptoms of a very common yet frustrating condition: Falling in love.

The prognosis is vague. A prescription pad and knowledge of biochemistry aren’t helpful when it comes to relationships.

Medical training can consume decades when others are exploring relationships and starting families. There are few recent data on this, but a 2012 longitudinal study of more than 20,000 physicians by the UK Medical Careers Research Group found that, by age 25, the rate of doctors who were in partnerships was far lower than in the general population.

But there is hope! By age 36, the number of doctors in long-term relationships had overtaken everyone else by more than 10% for women and 20% for men. The Medscape 2022 Physician Happiness & Lifestyle Report found that 83% were in committed relationships, and even better, happy ones. At least three-quarters of doctors in every specialty described their partnerships as “very good” or “good.”

How should a single medical student, resident, or attending physician find happiness ever after in 2023? Sometimes Mr./Ms. Right can be found in the anatomy lab or hospital, with sparks flying between students or colleagues. But for many in health care, along with millions of others looking for love, the solution is dating apps.
 

When ‘MD’ is a turnoff

Dr. M, a psychiatry resident in California who prefers not to give her name, hadn’t found a life partner during college, grad school, or medical school. When she passed her final Step 3 board exam, she decided it was time to take the plunge. She signed up for popular dating apps like Hinge, Bumble, and Coffee Meets Bagel, but her dates seemed to follow a disappointing pattern.

“I met lots of guys, but it was incredibly rare to find another physician,” said Dr. M. “I found myself always wanting to talk about my life as a resident. More often than not, the guys would give me this blank stare as I complained about being on call or spoke about spending 12 hours a day studying for a board exam, or even the process of The Match and how I ended up in California.”

Both of Dr. M’s parents are physicians, and she grew up watching how they supported each other through residency, exams, and exhausting schedules. A relationship with another physician, her parents told her, would give both partners the best chance to understand each other’s lives. The problem was how to find one.

That was when Dr. M saw an ad for a dating app with a cute medical name: DownToDate, a play on the clinical evidence resource UpToDate. “I thought it was a meme,” she said. “It was this doctors-only app. I remember thinking, ‘this has to be a joke,’ but then it was very real.”

She signed up and was required to provide a photo of her ID and her NPI number. Immediately, men began “requesting a consult,” the app’s form of “liking” her profile, and sending her “pages” (messages).

DownToDate was created by another physician, Robin Boyer, MD, MBA, a pediatrics resident in Loma Linda, Calif. The inspiration came in 2020 during the initial COVID crisis. Exhausted from long and often heartbreaking shifts, Dr. Boyer was grateful for her husband’s unwavering support. But many of her coresidents weren’t so lucky. The women in particular talked about their dating struggles, and there was a recurring theme. They didn’t feel confident putting “physician” on a dating site profile.

“If you’re male and you tell people you’re a doctor, it seems like it really attracts people,” Dr. Boyer said. “But if you’re female, it brings up a lot of stereotypes where you’re perceived as too intimidating either as the breadwinner, being more educated, or having a [demanding] career. It does make it more difficult.”

Dr. Boyer met her husband in high school, and she had never used a dating app. She convinced a coresident, Celestine Odigwe, MD, to pursue the idea as partners. They began researching the market within their network and heard from over a thousand interested physicians, both men and women, heterosexual and LGBTQ+. They even created fake accounts on other sites to gauge how easy it is to falsify a profile. From these insights, the app took shape. It launched in 2021 and currently has more than 5000 verified users.
 

Branches from the same tree

Around the same time that DownToDate began, Shivani Shah, DO, a pediatric neurology resident at Duke University, Durham, N.C., and her brother, Sagar Shah, an entrepreneur, had a similar idea.

At the time, Dr. Shah was a fourth-year medical student about to move from New Jersey to North Carolina. Friends who were internal medicine residents described the grueling reality of the early COVID pandemic.

“It was just horrible,” said Dr. Shah. “You were isolated from your family, your support system, everything. ... I think the pandemic really pushed us into realizing that this is a very important need, and sometimes it feels like community is lacking in the health care field.”

The sibling duo developed ForeverX, an app for health care workers to find meaningful and long-term romantic connections. It launched in 2021.

Concerned that the medical field was “siloed,” the Shahs chose to open the app to physicians, dentists, nurses, physical therapists, and other health care professionals. “Opening up the doors to more communication” between the health care branches was a priority.

To prevent catfishing, the app uses a twofold vetting system. Each user submits a photo of their driver’s license and a selfie that must match. There is also health care verification through an NPI number, nurse’s ID, or a manual process for those without either. None of the information is stored.

Through personal experience with dating apps, Dr. Shah hopes ForeverX can improve on some of their flaws, particularly the problem of matches being overly filtered by preferences. The “natural way” of meeting people is not filtered. And while most people have a dating checklist in mind, meeting someone face to face might send some of those prerequisites “out the window.”

“You can’t really put into words how you feel with someone ... the vibe,” Dr. Shah said. That is why her goal is to get people off the app and on an actual date IRL. “Something we’ve discussed internally is, how do we make this experience that’s virtual more human?”

She acknowledged that certain requirements, like a desire for children, might be crucial to some users. Many female doctors in their 30’s feel the “time crunch” of a ticking biological clock.
 

Optimize your date-ability

“I think people either love or hate dating apps, and I love them,” said Kevin Jubbal, MD. “I get to meet cool people and schedule dates from the comfort of my home.”

Dr. Jubbal, a former plastic surgery resident who left medicine to become an entrepreneur, is the founder of Med School Insiders, a tutoring and advising resource for premeds, medical students, and residents. His YouTube channel has more than 1.5 million subscribers, and he often receives questions about whether dating is feasible in medical school and how to balance a personal and academic/professional life.

Those who hate dating apps or receive few matches would do well to look inward instead of blaming the process, he said. It helps to view the experience as a learning tool that provides feedback very quickly.

“If you want to find a really amazing person, then you need to be what you want to find,” said Dr. Jubbal. “If you want to find someone who’s fit and intelligent and well read and well traveled, you need to be that. Otherwise, you’re probably not going to attract that person.”
 

An app designed to help single female MDs

Ifie Williams, MD, a psychiatrist in Washington, D.C., believes a wider dating pool is key – provided everyone understands the situation up front. When Dr. Williams started residency in 2014, she was “as single as can be.” She tried many dating apps, but they were extremely time consuming. Even when she set specific preferences, she found herself sifting through “matches” that didn’t fit her criteria.

“Dating nowadays has become almost like a second job,” said Dr. Williams. “Just the amount of time that people are having to spend on apps, swiping left and right and then meeting people. You think they’re interested and then you deal with all these games.”

By 2017, Dr. Williams had invented Miss Doctor, a dating app that would connect female physicians and other doctoral-level professionals with men or women on a similar achievement level.

By definition, these people would not be intimidated by ambitious, busy women. They would be heavily screened and vetted. And one other proviso: they would have to pay for “likes.”

Most dating apps charge a subscription fee. Users are allowed to “like” numerous profiles and perhaps not bother responding to many matches. By contrast, Miss Doctor accounts are free and include a limited number of “likes” to indicate interest. Beyond that, there’s a price.

“We wanted to find a way to make people a little more intentional with how they like people on the app, so they give a little more thought to it,” Dr. Williams said. “So, we monetize it and use that to change behavior.”

After an initial launch in 2017, the app had to take a back seat while Dr. Williams started her psychiatry practice and got married herself. She plans to relaunch it in spring 2023.

Male or female, there is general agreement that finding time to date as a young physician isn’t easy. While DownToDate has had “doctor meets doctor” success stories, many users are still searching for “the one.”

Dr. Boyer believes that career challenges are not a reason to give up. “There are so many single and available people out there,” she said. “And everyone’s deserving of love. Even if you only have an hour a week.”

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

Pounding heart, sweating, insomnia. Surges of dopamine, norepinephrine, and adrenaline. All symptoms of a very common yet frustrating condition: Falling in love.

The prognosis is vague. A prescription pad and knowledge of biochemistry aren’t helpful when it comes to relationships.

Medical training can consume decades when others are exploring relationships and starting families. There are few recent data on this, but a 2012 longitudinal study of more than 20,000 physicians by the UK Medical Careers Research Group found that, by age 25, the rate of doctors who were in partnerships was far lower than in the general population.

But there is hope! By age 36, the number of doctors in long-term relationships had overtaken everyone else by more than 10% for women and 20% for men. The Medscape 2022 Physician Happiness & Lifestyle Report found that 83% were in committed relationships, and even better, happy ones. At least three-quarters of doctors in every specialty described their partnerships as “very good” or “good.”

How should a single medical student, resident, or attending physician find happiness ever after in 2023? Sometimes Mr./Ms. Right can be found in the anatomy lab or hospital, with sparks flying between students or colleagues. But for many in health care, along with millions of others looking for love, the solution is dating apps.
 

When ‘MD’ is a turnoff

Dr. M, a psychiatry resident in California who prefers not to give her name, hadn’t found a life partner during college, grad school, or medical school. When she passed her final Step 3 board exam, she decided it was time to take the plunge. She signed up for popular dating apps like Hinge, Bumble, and Coffee Meets Bagel, but her dates seemed to follow a disappointing pattern.

“I met lots of guys, but it was incredibly rare to find another physician,” said Dr. M. “I found myself always wanting to talk about my life as a resident. More often than not, the guys would give me this blank stare as I complained about being on call or spoke about spending 12 hours a day studying for a board exam, or even the process of The Match and how I ended up in California.”

Both of Dr. M’s parents are physicians, and she grew up watching how they supported each other through residency, exams, and exhausting schedules. A relationship with another physician, her parents told her, would give both partners the best chance to understand each other’s lives. The problem was how to find one.

That was when Dr. M saw an ad for a dating app with a cute medical name: DownToDate, a play on the clinical evidence resource UpToDate. “I thought it was a meme,” she said. “It was this doctors-only app. I remember thinking, ‘this has to be a joke,’ but then it was very real.”

She signed up and was required to provide a photo of her ID and her NPI number. Immediately, men began “requesting a consult,” the app’s form of “liking” her profile, and sending her “pages” (messages).

DownToDate was created by another physician, Robin Boyer, MD, MBA, a pediatrics resident in Loma Linda, Calif. The inspiration came in 2020 during the initial COVID crisis. Exhausted from long and often heartbreaking shifts, Dr. Boyer was grateful for her husband’s unwavering support. But many of her coresidents weren’t so lucky. The women in particular talked about their dating struggles, and there was a recurring theme. They didn’t feel confident putting “physician” on a dating site profile.

“If you’re male and you tell people you’re a doctor, it seems like it really attracts people,” Dr. Boyer said. “But if you’re female, it brings up a lot of stereotypes where you’re perceived as too intimidating either as the breadwinner, being more educated, or having a [demanding] career. It does make it more difficult.”

Dr. Boyer met her husband in high school, and she had never used a dating app. She convinced a coresident, Celestine Odigwe, MD, to pursue the idea as partners. They began researching the market within their network and heard from over a thousand interested physicians, both men and women, heterosexual and LGBTQ+. They even created fake accounts on other sites to gauge how easy it is to falsify a profile. From these insights, the app took shape. It launched in 2021 and currently has more than 5000 verified users.
 

Branches from the same tree

Around the same time that DownToDate began, Shivani Shah, DO, a pediatric neurology resident at Duke University, Durham, N.C., and her brother, Sagar Shah, an entrepreneur, had a similar idea.

At the time, Dr. Shah was a fourth-year medical student about to move from New Jersey to North Carolina. Friends who were internal medicine residents described the grueling reality of the early COVID pandemic.

“It was just horrible,” said Dr. Shah. “You were isolated from your family, your support system, everything. ... I think the pandemic really pushed us into realizing that this is a very important need, and sometimes it feels like community is lacking in the health care field.”

The sibling duo developed ForeverX, an app for health care workers to find meaningful and long-term romantic connections. It launched in 2021.

Concerned that the medical field was “siloed,” the Shahs chose to open the app to physicians, dentists, nurses, physical therapists, and other health care professionals. “Opening up the doors to more communication” between the health care branches was a priority.

To prevent catfishing, the app uses a twofold vetting system. Each user submits a photo of their driver’s license and a selfie that must match. There is also health care verification through an NPI number, nurse’s ID, or a manual process for those without either. None of the information is stored.

Through personal experience with dating apps, Dr. Shah hopes ForeverX can improve on some of their flaws, particularly the problem of matches being overly filtered by preferences. The “natural way” of meeting people is not filtered. And while most people have a dating checklist in mind, meeting someone face to face might send some of those prerequisites “out the window.”

“You can’t really put into words how you feel with someone ... the vibe,” Dr. Shah said. That is why her goal is to get people off the app and on an actual date IRL. “Something we’ve discussed internally is, how do we make this experience that’s virtual more human?”

She acknowledged that certain requirements, like a desire for children, might be crucial to some users. Many female doctors in their 30’s feel the “time crunch” of a ticking biological clock.
 

Optimize your date-ability

“I think people either love or hate dating apps, and I love them,” said Kevin Jubbal, MD. “I get to meet cool people and schedule dates from the comfort of my home.”

Dr. Jubbal, a former plastic surgery resident who left medicine to become an entrepreneur, is the founder of Med School Insiders, a tutoring and advising resource for premeds, medical students, and residents. His YouTube channel has more than 1.5 million subscribers, and he often receives questions about whether dating is feasible in medical school and how to balance a personal and academic/professional life.

Those who hate dating apps or receive few matches would do well to look inward instead of blaming the process, he said. It helps to view the experience as a learning tool that provides feedback very quickly.

“If you want to find a really amazing person, then you need to be what you want to find,” said Dr. Jubbal. “If you want to find someone who’s fit and intelligent and well read and well traveled, you need to be that. Otherwise, you’re probably not going to attract that person.”
 

An app designed to help single female MDs

Ifie Williams, MD, a psychiatrist in Washington, D.C., believes a wider dating pool is key – provided everyone understands the situation up front. When Dr. Williams started residency in 2014, she was “as single as can be.” She tried many dating apps, but they were extremely time consuming. Even when she set specific preferences, she found herself sifting through “matches” that didn’t fit her criteria.

“Dating nowadays has become almost like a second job,” said Dr. Williams. “Just the amount of time that people are having to spend on apps, swiping left and right and then meeting people. You think they’re interested and then you deal with all these games.”

By 2017, Dr. Williams had invented Miss Doctor, a dating app that would connect female physicians and other doctoral-level professionals with men or women on a similar achievement level.

By definition, these people would not be intimidated by ambitious, busy women. They would be heavily screened and vetted. And one other proviso: they would have to pay for “likes.”

Most dating apps charge a subscription fee. Users are allowed to “like” numerous profiles and perhaps not bother responding to many matches. By contrast, Miss Doctor accounts are free and include a limited number of “likes” to indicate interest. Beyond that, there’s a price.

“We wanted to find a way to make people a little more intentional with how they like people on the app, so they give a little more thought to it,” Dr. Williams said. “So, we monetize it and use that to change behavior.”

After an initial launch in 2017, the app had to take a back seat while Dr. Williams started her psychiatry practice and got married herself. She plans to relaunch it in spring 2023.

Male or female, there is general agreement that finding time to date as a young physician isn’t easy. While DownToDate has had “doctor meets doctor” success stories, many users are still searching for “the one.”

Dr. Boyer believes that career challenges are not a reason to give up. “There are so many single and available people out there,” she said. “And everyone’s deserving of love. Even if you only have an hour a week.”

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

Pounding heart, sweating, insomnia. Surges of dopamine, norepinephrine, and adrenaline. All symptoms of a very common yet frustrating condition: Falling in love.

The prognosis is vague. A prescription pad and knowledge of biochemistry aren’t helpful when it comes to relationships.

Medical training can consume decades when others are exploring relationships and starting families. There are few recent data on this, but a 2012 longitudinal study of more than 20,000 physicians by the UK Medical Careers Research Group found that, by age 25, the rate of doctors who were in partnerships was far lower than in the general population.

But there is hope! By age 36, the number of doctors in long-term relationships had overtaken everyone else by more than 10% for women and 20% for men. The Medscape 2022 Physician Happiness & Lifestyle Report found that 83% were in committed relationships, and even better, happy ones. At least three-quarters of doctors in every specialty described their partnerships as “very good” or “good.”

How should a single medical student, resident, or attending physician find happiness ever after in 2023? Sometimes Mr./Ms. Right can be found in the anatomy lab or hospital, with sparks flying between students or colleagues. But for many in health care, along with millions of others looking for love, the solution is dating apps.
 

When ‘MD’ is a turnoff

Dr. M, a psychiatry resident in California who prefers not to give her name, hadn’t found a life partner during college, grad school, or medical school. When she passed her final Step 3 board exam, she decided it was time to take the plunge. She signed up for popular dating apps like Hinge, Bumble, and Coffee Meets Bagel, but her dates seemed to follow a disappointing pattern.

“I met lots of guys, but it was incredibly rare to find another physician,” said Dr. M. “I found myself always wanting to talk about my life as a resident. More often than not, the guys would give me this blank stare as I complained about being on call or spoke about spending 12 hours a day studying for a board exam, or even the process of The Match and how I ended up in California.”

Both of Dr. M’s parents are physicians, and she grew up watching how they supported each other through residency, exams, and exhausting schedules. A relationship with another physician, her parents told her, would give both partners the best chance to understand each other’s lives. The problem was how to find one.

That was when Dr. M saw an ad for a dating app with a cute medical name: DownToDate, a play on the clinical evidence resource UpToDate. “I thought it was a meme,” she said. “It was this doctors-only app. I remember thinking, ‘this has to be a joke,’ but then it was very real.”

She signed up and was required to provide a photo of her ID and her NPI number. Immediately, men began “requesting a consult,” the app’s form of “liking” her profile, and sending her “pages” (messages).

DownToDate was created by another physician, Robin Boyer, MD, MBA, a pediatrics resident in Loma Linda, Calif. The inspiration came in 2020 during the initial COVID crisis. Exhausted from long and often heartbreaking shifts, Dr. Boyer was grateful for her husband’s unwavering support. But many of her coresidents weren’t so lucky. The women in particular talked about their dating struggles, and there was a recurring theme. They didn’t feel confident putting “physician” on a dating site profile.

“If you’re male and you tell people you’re a doctor, it seems like it really attracts people,” Dr. Boyer said. “But if you’re female, it brings up a lot of stereotypes where you’re perceived as too intimidating either as the breadwinner, being more educated, or having a [demanding] career. It does make it more difficult.”

Dr. Boyer met her husband in high school, and she had never used a dating app. She convinced a coresident, Celestine Odigwe, MD, to pursue the idea as partners. They began researching the market within their network and heard from over a thousand interested physicians, both men and women, heterosexual and LGBTQ+. They even created fake accounts on other sites to gauge how easy it is to falsify a profile. From these insights, the app took shape. It launched in 2021 and currently has more than 5000 verified users.
 

Branches from the same tree

Around the same time that DownToDate began, Shivani Shah, DO, a pediatric neurology resident at Duke University, Durham, N.C., and her brother, Sagar Shah, an entrepreneur, had a similar idea.

At the time, Dr. Shah was a fourth-year medical student about to move from New Jersey to North Carolina. Friends who were internal medicine residents described the grueling reality of the early COVID pandemic.

“It was just horrible,” said Dr. Shah. “You were isolated from your family, your support system, everything. ... I think the pandemic really pushed us into realizing that this is a very important need, and sometimes it feels like community is lacking in the health care field.”

The sibling duo developed ForeverX, an app for health care workers to find meaningful and long-term romantic connections. It launched in 2021.

Concerned that the medical field was “siloed,” the Shahs chose to open the app to physicians, dentists, nurses, physical therapists, and other health care professionals. “Opening up the doors to more communication” between the health care branches was a priority.

To prevent catfishing, the app uses a twofold vetting system. Each user submits a photo of their driver’s license and a selfie that must match. There is also health care verification through an NPI number, nurse’s ID, or a manual process for those without either. None of the information is stored.

Through personal experience with dating apps, Dr. Shah hopes ForeverX can improve on some of their flaws, particularly the problem of matches being overly filtered by preferences. The “natural way” of meeting people is not filtered. And while most people have a dating checklist in mind, meeting someone face to face might send some of those prerequisites “out the window.”

“You can’t really put into words how you feel with someone ... the vibe,” Dr. Shah said. That is why her goal is to get people off the app and on an actual date IRL. “Something we’ve discussed internally is, how do we make this experience that’s virtual more human?”

She acknowledged that certain requirements, like a desire for children, might be crucial to some users. Many female doctors in their 30’s feel the “time crunch” of a ticking biological clock.
 

Optimize your date-ability

“I think people either love or hate dating apps, and I love them,” said Kevin Jubbal, MD. “I get to meet cool people and schedule dates from the comfort of my home.”

Dr. Jubbal, a former plastic surgery resident who left medicine to become an entrepreneur, is the founder of Med School Insiders, a tutoring and advising resource for premeds, medical students, and residents. His YouTube channel has more than 1.5 million subscribers, and he often receives questions about whether dating is feasible in medical school and how to balance a personal and academic/professional life.

Those who hate dating apps or receive few matches would do well to look inward instead of blaming the process, he said. It helps to view the experience as a learning tool that provides feedback very quickly.

“If you want to find a really amazing person, then you need to be what you want to find,” said Dr. Jubbal. “If you want to find someone who’s fit and intelligent and well read and well traveled, you need to be that. Otherwise, you’re probably not going to attract that person.”
 

An app designed to help single female MDs

Ifie Williams, MD, a psychiatrist in Washington, D.C., believes a wider dating pool is key – provided everyone understands the situation up front. When Dr. Williams started residency in 2014, she was “as single as can be.” She tried many dating apps, but they were extremely time consuming. Even when she set specific preferences, she found herself sifting through “matches” that didn’t fit her criteria.

“Dating nowadays has become almost like a second job,” said Dr. Williams. “Just the amount of time that people are having to spend on apps, swiping left and right and then meeting people. You think they’re interested and then you deal with all these games.”

By 2017, Dr. Williams had invented Miss Doctor, a dating app that would connect female physicians and other doctoral-level professionals with men or women on a similar achievement level.

By definition, these people would not be intimidated by ambitious, busy women. They would be heavily screened and vetted. And one other proviso: they would have to pay for “likes.”

Most dating apps charge a subscription fee. Users are allowed to “like” numerous profiles and perhaps not bother responding to many matches. By contrast, Miss Doctor accounts are free and include a limited number of “likes” to indicate interest. Beyond that, there’s a price.

“We wanted to find a way to make people a little more intentional with how they like people on the app, so they give a little more thought to it,” Dr. Williams said. “So, we monetize it and use that to change behavior.”

After an initial launch in 2017, the app had to take a back seat while Dr. Williams started her psychiatry practice and got married herself. She plans to relaunch it in spring 2023.

Male or female, there is general agreement that finding time to date as a young physician isn’t easy. While DownToDate has had “doctor meets doctor” success stories, many users are still searching for “the one.”

Dr. Boyer believes that career challenges are not a reason to give up. “There are so many single and available people out there,” she said. “And everyone’s deserving of love. Even if you only have an hour a week.”

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

A new vibrating pill shown to help relieve constipation is now available. 

The drug-free solution is designed for daily use. In a trial, the pill produced at least one additional weekly bowel movement for 41% of participants, compared with at least one additional bowel movement for 23% of participants who took a placebo pill. 

Vibrant was approved by the Food and Drug Administration in August but is just now becoming available for doctors to prescribe, the company announced Wednesday. 

Because it is not a drug, Vibrant is considered a class 2 medical device by the FDA, which is the same class as contact lenses.

Here’s how it works: Around bedtime, the pill is inserted in a pod to activate it, then swallowed. It travels the digestive tract and reaches the large intestine about 14 hours later. 

“Then it goes to work,” the company explained in a news release. “After it’s swallowed, it is active for about 2 hours, goes quiet for around 6, hours and then activates again for another 2 hours.”

“There are little vibrations for 3 seconds on, 3 seconds off,” said Cathy Collis, chief commercial officer for Israel-based Vibrant Gastro, in a statement.

The vibrations help trigger peristalsis, the wave-like muscle contractions that move food through the gastrointestinal tract, the company said. Decreased peristalsis is a cause of constipation, which is defined as having less than three bowel movements per week, according to the Cleveland Clinic. 

About 2.5 million people see their doctor each year for constipation. The pills are made of what the company called “medical-grade material” that is the same as what’s used to make gastroenterology cameras.

In the trial, most people did not report feeling the pill inside of them.

“A minority could feel it,” said Eamonn Quigley, MD, chief of gastroenterology at Houston Methodist Hospital, in a statement. “None of them felt it was being uncomfortable. And none of them stopped taking it because of that.”

Dr. Quigley helped test the capsules and does not have a financial stake in the company, according to Vibrant.

The pills do not dissolve inside a person’s body. Rather, “after they’ve done their job, the person’s body poops them out, and they’re flushed away,” the company said.  

A version of this article first appeared on WebMD.com.

A new vibrating pill shown to help relieve constipation is now available. 

The drug-free solution is designed for daily use. In a trial, the pill produced at least one additional weekly bowel movement for 41% of participants, compared with at least one additional bowel movement for 23% of participants who took a placebo pill. 

Vibrant was approved by the Food and Drug Administration in August but is just now becoming available for doctors to prescribe, the company announced Wednesday. 

Because it is not a drug, Vibrant is considered a class 2 medical device by the FDA, which is the same class as contact lenses.

Here’s how it works: Around bedtime, the pill is inserted in a pod to activate it, then swallowed. It travels the digestive tract and reaches the large intestine about 14 hours later. 

“Then it goes to work,” the company explained in a news release. “After it’s swallowed, it is active for about 2 hours, goes quiet for around 6, hours and then activates again for another 2 hours.”

“There are little vibrations for 3 seconds on, 3 seconds off,” said Cathy Collis, chief commercial officer for Israel-based Vibrant Gastro, in a statement.

The vibrations help trigger peristalsis, the wave-like muscle contractions that move food through the gastrointestinal tract, the company said. Decreased peristalsis is a cause of constipation, which is defined as having less than three bowel movements per week, according to the Cleveland Clinic. 

About 2.5 million people see their doctor each year for constipation. The pills are made of what the company called “medical-grade material” that is the same as what’s used to make gastroenterology cameras.

In the trial, most people did not report feeling the pill inside of them.

“A minority could feel it,” said Eamonn Quigley, MD, chief of gastroenterology at Houston Methodist Hospital, in a statement. “None of them felt it was being uncomfortable. And none of them stopped taking it because of that.”

Dr. Quigley helped test the capsules and does not have a financial stake in the company, according to Vibrant.

The pills do not dissolve inside a person’s body. Rather, “after they’ve done their job, the person’s body poops them out, and they’re flushed away,” the company said.  

A version of this article first appeared on WebMD.com.

A new vibrating pill shown to help relieve constipation is now available. 

The drug-free solution is designed for daily use. In a trial, the pill produced at least one additional weekly bowel movement for 41% of participants, compared with at least one additional bowel movement for 23% of participants who took a placebo pill. 

Vibrant was approved by the Food and Drug Administration in August but is just now becoming available for doctors to prescribe, the company announced Wednesday. 

Because it is not a drug, Vibrant is considered a class 2 medical device by the FDA, which is the same class as contact lenses.

Here’s how it works: Around bedtime, the pill is inserted in a pod to activate it, then swallowed. It travels the digestive tract and reaches the large intestine about 14 hours later. 

“Then it goes to work,” the company explained in a news release. “After it’s swallowed, it is active for about 2 hours, goes quiet for around 6, hours and then activates again for another 2 hours.”

“There are little vibrations for 3 seconds on, 3 seconds off,” said Cathy Collis, chief commercial officer for Israel-based Vibrant Gastro, in a statement.

The vibrations help trigger peristalsis, the wave-like muscle contractions that move food through the gastrointestinal tract, the company said. Decreased peristalsis is a cause of constipation, which is defined as having less than three bowel movements per week, according to the Cleveland Clinic. 

About 2.5 million people see their doctor each year for constipation. The pills are made of what the company called “medical-grade material” that is the same as what’s used to make gastroenterology cameras.

In the trial, most people did not report feeling the pill inside of them.

“A minority could feel it,” said Eamonn Quigley, MD, chief of gastroenterology at Houston Methodist Hospital, in a statement. “None of them felt it was being uncomfortable. And none of them stopped taking it because of that.”

Dr. Quigley helped test the capsules and does not have a financial stake in the company, according to Vibrant.

The pills do not dissolve inside a person’s body. Rather, “after they’ve done their job, the person’s body poops them out, and they’re flushed away,” the company said.  

A version of this article first appeared on WebMD.com.

Outpatient COVID-19 treatment with monoclonal antibodies or antiretroviral medications such as nirmatrelvir-ritonavir (Paxlovid) administered to patients with systemic autoimmune rheumatic disease led to lower odds of having severe outcomes when compared with similar patients who received no outpatient treatment in a real-world, retrospective analysis of cases.

The investigators found that there were nine hospitalizations or deaths (2.1%) among 426 patients who received outpatient treatment, compared with 49 (17.6%) among 278 who did not receive outpatient treatment, yielding an odds ratio of 0.12 (95% confidence interval, 0.05-0.25), after adjusting for age, sex, race, comorbidities, and kidney function. The study was published in Lancet Rheumatology.

“Across the board, there was a really strong association with receiving outpatient treatment and lower risk of severe COVID-19,” senior author Jeffrey A. Sparks, MD, MMSc, assistant professor of medicine, Harvard Medical School and Brigham and Women’s Hospital, Boston, said in an interview. “It is pretty powerful evidence that, in this high-risk group, that treatment still matters related to preventing severe COVID. We found almost all patients who had severe COVID-19, either hospitalized or who had died, were in the untreated group.”
 

Early outpatient treatment an important tool in patients with rheumatic disease

Dr. Sparks noted that he and his coinvestigators conducted the study because the benefit of outpatient COVID-19 treatments in individuals with systemic autoimmune rheumatic disease was not adequately determined in clinical trials because they had infrequent enrollment of such patients.

The analysis included 704 patients with a mean age of 58.4 years who were seen at Mass General Brigham Integrated Health Care System, a multicenter health care system that includes 14 hospitals and primary care or specialty outpatient centers in the Boston area. A majority were female (76%) and White (84%). Nearly half had rheumatoid arthritis. Of the 704, 426 (61%) received outpatient treatment, which included nirmatrelvir-ritonavir (n = 307), monoclonal antibodies (n = 105), molnupiravir (n = 5), remdesivir (n = 3), and combination treatment (n = 6).

The findings underline the need to individualize approaches to outpatient treatment in those who test positive for SARS-CoV-2 to fend off severe COVID-19, according to Dr. Sparks. “It seems if you are vaccinated and in the general population that you are way less likely to have severe COVID-19 in the current environment, but that doesn’t necessarily apply to some high-risk groups like patients on immunosuppression. There are still patients at risk of severe COVID-19, and some of them are in this group of rheumatic patients. This should be part of the discussion related to deciding whether or not to treat.”

Dr. Sparks noted that vaccination against COVID-19 confers protection against developing severe COVID-19 in patients with rheumatic disease as it does in the general population, but patients with rheumatic diseases remain at increased risk for severe presentation. “Certainly, the vaccines really help our patients too, but there’s still a bit of a gap between the risk for our patients with rheumatic diseases and the general population” in developing severe COVID-19.

Dr. Sparks said he hopes the results represent a “call to action” that even among vaccinated patients there are still some who have poor outcomes, and that early outpatient treatment appears to be an important tool in the fight against poor outcomes from SARS-CoV-2 infection.
 

COVID-19 rebound

The study also reported on the phenomenon of COVID-19 rebound (recurrence of symptoms and test positivity after regimen completion) after oral outpatient SARS-CoV-2 treatment. “This [COVID-19 rebound] is a downside to treatment,” he said. COVID rebound was not infrequent: A total of 25 (8%) of 318 patients who received oral outpatient treatment had documented COVID-19 rebound.

“It was reassuring because we found no one who had rebound progressed to have severe COVID-19,” Dr. Sparks said. “On the other hand, [rebound] happened pretty frequently in our data, as 8% of patients are documented to have it.”

Dr. Sparks said he and coinvestigators speculate that more patients in the cohort may have experienced COVID-19 rebound but did not communicate this to their health care providers, and, as such, it was not documented in the medical record. The potential development of COVID-19 rebound “is something to counsel your patients about.” COVID-19 rebound is a phenomenon that is being most commonly observed with nirmatrelvir-ritonavir as outpatient treatment.
 

Possible confounding factors in study

Katie Bechman, MBChB, clinical lecturer in rheumatology at King’s College London, who coauthored an accompanying editorial about the study and its findings, pointed out that the study is limited by its observational design.

“With any study that looks at the efficacy of treatment, especially in an observational cohort, you’re going to have to consider the unmeasured confounding and the difference between these two groups,” Dr. Bechman said. “I know that they did try to adjust for that in this study, but there’s always going to be factors that we can’t [control for]. That is something that needs to be considered. I think that’s always something we need to consider when we’re looking at observational data.”

In lieu of a randomized, controlled trial, Dr. Bechman noted that the study and its associated findings serve as “the best data we have,” and she described the results as “very informative and positive.”

She added that the large number of patients represents a strength of the study, as does the robust method employed for identifying which patients had COVID-19.

The learnings from this study with respect to outpatient treatment can be applied to more common illnesses that patients with rheumatic disease may develop, such as the flu, according to Dr. Bechman.

“One of the positive aspects from this pandemic is that we’ve learned a huge amount about how best to treat certain viruses and prevent them in patients,” she said. “It would be worth thinking towards the future, what we can do for illnesses that we see very commonly in these populations. There may be treatment regimens that we haven’t really considered until now. You could hypothesize that in the next couple of years, if we have an influenza breakout, that we should be providing some prehospital antiviral treatment to patients, especially the ones that are at high risk.”

The study was conducted without outside funding. Dr. Sparks has received research support from Bristol-Myers Squibb and consulted for AbbVie, Amgen, Boehringer Ingelheim, Bristol-Myers Squibb, Gilead, Inova Diagnostics, Janssen, Optum, and Pfizer unrelated to this work. Dr. Bechman reported no relevant financial relationships.

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

Outpatient COVID-19 treatment with monoclonal antibodies or antiretroviral medications such as nirmatrelvir-ritonavir (Paxlovid) administered to patients with systemic autoimmune rheumatic disease led to lower odds of having severe outcomes when compared with similar patients who received no outpatient treatment in a real-world, retrospective analysis of cases.

The investigators found that there were nine hospitalizations or deaths (2.1%) among 426 patients who received outpatient treatment, compared with 49 (17.6%) among 278 who did not receive outpatient treatment, yielding an odds ratio of 0.12 (95% confidence interval, 0.05-0.25), after adjusting for age, sex, race, comorbidities, and kidney function. The study was published in Lancet Rheumatology.

“Across the board, there was a really strong association with receiving outpatient treatment and lower risk of severe COVID-19,” senior author Jeffrey A. Sparks, MD, MMSc, assistant professor of medicine, Harvard Medical School and Brigham and Women’s Hospital, Boston, said in an interview. “It is pretty powerful evidence that, in this high-risk group, that treatment still matters related to preventing severe COVID. We found almost all patients who had severe COVID-19, either hospitalized or who had died, were in the untreated group.”
 

Early outpatient treatment an important tool in patients with rheumatic disease

Dr. Sparks noted that he and his coinvestigators conducted the study because the benefit of outpatient COVID-19 treatments in individuals with systemic autoimmune rheumatic disease was not adequately determined in clinical trials because they had infrequent enrollment of such patients.

The analysis included 704 patients with a mean age of 58.4 years who were seen at Mass General Brigham Integrated Health Care System, a multicenter health care system that includes 14 hospitals and primary care or specialty outpatient centers in the Boston area. A majority were female (76%) and White (84%). Nearly half had rheumatoid arthritis. Of the 704, 426 (61%) received outpatient treatment, which included nirmatrelvir-ritonavir (n = 307), monoclonal antibodies (n = 105), molnupiravir (n = 5), remdesivir (n = 3), and combination treatment (n = 6).

The findings underline the need to individualize approaches to outpatient treatment in those who test positive for SARS-CoV-2 to fend off severe COVID-19, according to Dr. Sparks. “It seems if you are vaccinated and in the general population that you are way less likely to have severe COVID-19 in the current environment, but that doesn’t necessarily apply to some high-risk groups like patients on immunosuppression. There are still patients at risk of severe COVID-19, and some of them are in this group of rheumatic patients. This should be part of the discussion related to deciding whether or not to treat.”

Dr. Sparks noted that vaccination against COVID-19 confers protection against developing severe COVID-19 in patients with rheumatic disease as it does in the general population, but patients with rheumatic diseases remain at increased risk for severe presentation. “Certainly, the vaccines really help our patients too, but there’s still a bit of a gap between the risk for our patients with rheumatic diseases and the general population” in developing severe COVID-19.

Dr. Sparks said he hopes the results represent a “call to action” that even among vaccinated patients there are still some who have poor outcomes, and that early outpatient treatment appears to be an important tool in the fight against poor outcomes from SARS-CoV-2 infection.
 

COVID-19 rebound

The study also reported on the phenomenon of COVID-19 rebound (recurrence of symptoms and test positivity after regimen completion) after oral outpatient SARS-CoV-2 treatment. “This [COVID-19 rebound] is a downside to treatment,” he said. COVID rebound was not infrequent: A total of 25 (8%) of 318 patients who received oral outpatient treatment had documented COVID-19 rebound.

“It was reassuring because we found no one who had rebound progressed to have severe COVID-19,” Dr. Sparks said. “On the other hand, [rebound] happened pretty frequently in our data, as 8% of patients are documented to have it.”

Dr. Sparks said he and coinvestigators speculate that more patients in the cohort may have experienced COVID-19 rebound but did not communicate this to their health care providers, and, as such, it was not documented in the medical record. The potential development of COVID-19 rebound “is something to counsel your patients about.” COVID-19 rebound is a phenomenon that is being most commonly observed with nirmatrelvir-ritonavir as outpatient treatment.
 

Possible confounding factors in study

Katie Bechman, MBChB, clinical lecturer in rheumatology at King’s College London, who coauthored an accompanying editorial about the study and its findings, pointed out that the study is limited by its observational design.

“With any study that looks at the efficacy of treatment, especially in an observational cohort, you’re going to have to consider the unmeasured confounding and the difference between these two groups,” Dr. Bechman said. “I know that they did try to adjust for that in this study, but there’s always going to be factors that we can’t [control for]. That is something that needs to be considered. I think that’s always something we need to consider when we’re looking at observational data.”

In lieu of a randomized, controlled trial, Dr. Bechman noted that the study and its associated findings serve as “the best data we have,” and she described the results as “very informative and positive.”

She added that the large number of patients represents a strength of the study, as does the robust method employed for identifying which patients had COVID-19.

The learnings from this study with respect to outpatient treatment can be applied to more common illnesses that patients with rheumatic disease may develop, such as the flu, according to Dr. Bechman.

“One of the positive aspects from this pandemic is that we’ve learned a huge amount about how best to treat certain viruses and prevent them in patients,” she said. “It would be worth thinking towards the future, what we can do for illnesses that we see very commonly in these populations. There may be treatment regimens that we haven’t really considered until now. You could hypothesize that in the next couple of years, if we have an influenza breakout, that we should be providing some prehospital antiviral treatment to patients, especially the ones that are at high risk.”

The study was conducted without outside funding. Dr. Sparks has received research support from Bristol-Myers Squibb and consulted for AbbVie, Amgen, Boehringer Ingelheim, Bristol-Myers Squibb, Gilead, Inova Diagnostics, Janssen, Optum, and Pfizer unrelated to this work. Dr. Bechman reported no relevant financial relationships.

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

Outpatient COVID-19 treatment with monoclonal antibodies or antiretroviral medications such as nirmatrelvir-ritonavir (Paxlovid) administered to patients with systemic autoimmune rheumatic disease led to lower odds of having severe outcomes when compared with similar patients who received no outpatient treatment in a real-world, retrospective analysis of cases.

The investigators found that there were nine hospitalizations or deaths (2.1%) among 426 patients who received outpatient treatment, compared with 49 (17.6%) among 278 who did not receive outpatient treatment, yielding an odds ratio of 0.12 (95% confidence interval, 0.05-0.25), after adjusting for age, sex, race, comorbidities, and kidney function. The study was published in Lancet Rheumatology.

“Across the board, there was a really strong association with receiving outpatient treatment and lower risk of severe COVID-19,” senior author Jeffrey A. Sparks, MD, MMSc, assistant professor of medicine, Harvard Medical School and Brigham and Women’s Hospital, Boston, said in an interview. “It is pretty powerful evidence that, in this high-risk group, that treatment still matters related to preventing severe COVID. We found almost all patients who had severe COVID-19, either hospitalized or who had died, were in the untreated group.”
 

Early outpatient treatment an important tool in patients with rheumatic disease

Dr. Sparks noted that he and his coinvestigators conducted the study because the benefit of outpatient COVID-19 treatments in individuals with systemic autoimmune rheumatic disease was not adequately determined in clinical trials because they had infrequent enrollment of such patients.

The analysis included 704 patients with a mean age of 58.4 years who were seen at Mass General Brigham Integrated Health Care System, a multicenter health care system that includes 14 hospitals and primary care or specialty outpatient centers in the Boston area. A majority were female (76%) and White (84%). Nearly half had rheumatoid arthritis. Of the 704, 426 (61%) received outpatient treatment, which included nirmatrelvir-ritonavir (n = 307), monoclonal antibodies (n = 105), molnupiravir (n = 5), remdesivir (n = 3), and combination treatment (n = 6).

The findings underline the need to individualize approaches to outpatient treatment in those who test positive for SARS-CoV-2 to fend off severe COVID-19, according to Dr. Sparks. “It seems if you are vaccinated and in the general population that you are way less likely to have severe COVID-19 in the current environment, but that doesn’t necessarily apply to some high-risk groups like patients on immunosuppression. There are still patients at risk of severe COVID-19, and some of them are in this group of rheumatic patients. This should be part of the discussion related to deciding whether or not to treat.”

Dr. Sparks noted that vaccination against COVID-19 confers protection against developing severe COVID-19 in patients with rheumatic disease as it does in the general population, but patients with rheumatic diseases remain at increased risk for severe presentation. “Certainly, the vaccines really help our patients too, but there’s still a bit of a gap between the risk for our patients with rheumatic diseases and the general population” in developing severe COVID-19.

Dr. Sparks said he hopes the results represent a “call to action” that even among vaccinated patients there are still some who have poor outcomes, and that early outpatient treatment appears to be an important tool in the fight against poor outcomes from SARS-CoV-2 infection.
 

COVID-19 rebound

The study also reported on the phenomenon of COVID-19 rebound (recurrence of symptoms and test positivity after regimen completion) after oral outpatient SARS-CoV-2 treatment. “This [COVID-19 rebound] is a downside to treatment,” he said. COVID rebound was not infrequent: A total of 25 (8%) of 318 patients who received oral outpatient treatment had documented COVID-19 rebound.

“It was reassuring because we found no one who had rebound progressed to have severe COVID-19,” Dr. Sparks said. “On the other hand, [rebound] happened pretty frequently in our data, as 8% of patients are documented to have it.”

Dr. Sparks said he and coinvestigators speculate that more patients in the cohort may have experienced COVID-19 rebound but did not communicate this to their health care providers, and, as such, it was not documented in the medical record. The potential development of COVID-19 rebound “is something to counsel your patients about.” COVID-19 rebound is a phenomenon that is being most commonly observed with nirmatrelvir-ritonavir as outpatient treatment.
 

Possible confounding factors in study

Katie Bechman, MBChB, clinical lecturer in rheumatology at King’s College London, who coauthored an accompanying editorial about the study and its findings, pointed out that the study is limited by its observational design.

“With any study that looks at the efficacy of treatment, especially in an observational cohort, you’re going to have to consider the unmeasured confounding and the difference between these two groups,” Dr. Bechman said. “I know that they did try to adjust for that in this study, but there’s always going to be factors that we can’t [control for]. That is something that needs to be considered. I think that’s always something we need to consider when we’re looking at observational data.”

In lieu of a randomized, controlled trial, Dr. Bechman noted that the study and its associated findings serve as “the best data we have,” and she described the results as “very informative and positive.”

She added that the large number of patients represents a strength of the study, as does the robust method employed for identifying which patients had COVID-19.

The learnings from this study with respect to outpatient treatment can be applied to more common illnesses that patients with rheumatic disease may develop, such as the flu, according to Dr. Bechman.

“One of the positive aspects from this pandemic is that we’ve learned a huge amount about how best to treat certain viruses and prevent them in patients,” she said. “It would be worth thinking towards the future, what we can do for illnesses that we see very commonly in these populations. There may be treatment regimens that we haven’t really considered until now. You could hypothesize that in the next couple of years, if we have an influenza breakout, that we should be providing some prehospital antiviral treatment to patients, especially the ones that are at high risk.”

The study was conducted without outside funding. Dr. Sparks has received research support from Bristol-Myers Squibb and consulted for AbbVie, Amgen, Boehringer Ingelheim, Bristol-Myers Squibb, Gilead, Inova Diagnostics, Janssen, Optum, and Pfizer unrelated to this work. Dr. Bechman reported no relevant financial relationships.

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

Drinking one or two cocktails a day may protect against dementia, while having three or more could increase risk, new research suggests.

Investigators assessed dementia risk using changes in alcohol consumption over a 2-year period in nearly 4 million people in South Korea. After about 7 years, dementia was 21% less likely in mild drinkers and 17% less likely in moderate drinkers. Heavy drinking was linked to an 8% increased risk.

Other studies of the relationship between alcohol and dementia have yielded mixed results, and this study does little to clear those murky waters. Nor do the results mean that drinking is recommended, the investigators note.

But the study does offer new information on how risk changes over time as people change their drinking habits, lead investigator Keun Hye Jeon, MD, assistant professor of family medicine at Cha Gumi Medical Center at Cha University, Gumi, South Korea, told this news organization.

“Although numerous studies have shown a relationship between alcohol consumption and dementia, there is a paucity of understanding as to how the incidence of dementia changes with changes in drinking habits,” Dr. Jeon said.

“By measuring alcohol consumption at two time points, we were able to study the relationship between reducing, ceasing, maintaining, and increasing alcohol consumption and incident dementia,” he added.

The findings were published online in JAMA Network Open.


 

Tracking drinking habits

Researchers analyzed data from nearly 4 million individuals aged 40 years and older in the Korean National Health Insurance Service who completed questionnaires and underwent physical exams in 2009 and 2011.

Study participants completed questionnaires on their drinking habits and were assigned to one of five groups according to change in alcohol consumption during the study period. These groups consisted of sustained nondrinkers; those who stopped drinking (quitters); those who reduced their consumption of alcohol but did not stop drinking (reducers); those who maintained the same level of consumption (sustainers); and those who increased their level of consumption (increasers).

A standard drink in the United States contains 14 g of alcohol. For this study, mild drinking was defined as less than 15 g/day, or one drink; moderate consumption as 15-29.9 g/day, or one to two drinks; and heavy drinking as 30 g/day or more, or three or more drinks.

At baseline, 54.8% of participants were nondrinkers, 26.7% were mild drinkers, 11.0% were moderate drinkers, and 7.5% were heavy drinkers.

From 2009 to 2011, 24.2% of mild drinkers, 8.4% of moderate drinkers, and 7.6% of heavy drinkers became quitters. In the same period, 13.9% of nondrinkers, 16.1% of mild drinkers, and 17.4% of moderate drinkers increased their drinking level.

After a mean follow-up of 6.3 years, 2.5% of participants were diagnosed with dementia, 2.0% with Alzheimer’s disease, and 0.3% with vascular dementia.
 

Unexpected finding

Compared with consistently not drinking, mild and moderate alcohol consumption was associated with a 21% (adjust hazard ratio, 0.79; 95% confidence interval, 0.77-0.81) and 17% (aHR, 0.83; 95% CI, 0.79-0.88) decreased risk for dementia, respectively.

Heavy drinking was linked to an 8% increased risk (aHR, 1.08; 95% CI, 1.03-1.12).

Similar associations were found between alcohol consumption and risk for Alzheimer’s disease and vascular dementia.

Reducing drinking habits from heavy to moderate led to a reduction in risk for dementia and Alzheimer’s, and increasing drinking levels led to an increase in risk for both conditions.

But when the researchers analyzed dementia risk for nondrinkers who began drinking at mild levels during the study period, they found something unexpected – the risk in this group decreased by 7% for dementia (aHR, 0.93; 95% CI, 0.90-0.96) and by 8% for Alzheimer’s (aHR, 0.92; 95% CI, 0.89-0.95), compared with sustained mild drinkers.

“Our study showed that initiation of mild alcohol consumption leads to a reduced risk of all-cause dementia and Alzheimer’s disease, which has never been reported in previous studies,” Dr. Jeon said.

However, Dr. Jeon was quick to point out that this doesn’t mean that people who don’t drink should start.

Previous studies have shown that heavy alcohol use can triple an individual’s dementia risk, while other studies have shown that no amount of alcohol consumption is good for the brain.

“None of the existing health guidelines recommend starting alcohol drinking,” Dr. Jeon said. “Our findings regarding an initiation of mild alcohol consumption cannot be directly translated into clinical recommendations,” but the findings do warrant additional study, he added.
 

Risks persist

Commenting on the findings, Percy Griffin, PhD, director of scientific engagement for the Alzheimer’s Association in Chicago, agrees.

“While this study is interesting, and this topic deserves further study, no one should drink alcohol as a method of reducing risk of Alzheimer’s disease or other dementia based on this study,” said Dr. Griffin, who was not part of the study.

The exact tipping point in alcohol consumption that can lead to problems with cognition or increased dementia risk is unknown, Dr. Griffin said. Nor do researchers understand why mild drinking may have a protective effect.

“We do know, however, that excessive alcohol consumption has negative effects on heart health and general health, which can lead to problems with brain function,” he said. “Clinicians should have discussions with their patients around their alcohol consumption patterns and the risks associated with drinking in excess, including potential damage to their cognition.”

Funding for the study was not disclosed. Dr. Jeon and Dr. Griffin report no relevant financial relationships.

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

Drinking one or two cocktails a day may protect against dementia, while having three or more could increase risk, new research suggests.

Investigators assessed dementia risk using changes in alcohol consumption over a 2-year period in nearly 4 million people in South Korea. After about 7 years, dementia was 21% less likely in mild drinkers and 17% less likely in moderate drinkers. Heavy drinking was linked to an 8% increased risk.

Other studies of the relationship between alcohol and dementia have yielded mixed results, and this study does little to clear those murky waters. Nor do the results mean that drinking is recommended, the investigators note.

But the study does offer new information on how risk changes over time as people change their drinking habits, lead investigator Keun Hye Jeon, MD, assistant professor of family medicine at Cha Gumi Medical Center at Cha University, Gumi, South Korea, told this news organization.

“Although numerous studies have shown a relationship between alcohol consumption and dementia, there is a paucity of understanding as to how the incidence of dementia changes with changes in drinking habits,” Dr. Jeon said.

“By measuring alcohol consumption at two time points, we were able to study the relationship between reducing, ceasing, maintaining, and increasing alcohol consumption and incident dementia,” he added.

The findings were published online in JAMA Network Open.


 

Tracking drinking habits

Researchers analyzed data from nearly 4 million individuals aged 40 years and older in the Korean National Health Insurance Service who completed questionnaires and underwent physical exams in 2009 and 2011.

Study participants completed questionnaires on their drinking habits and were assigned to one of five groups according to change in alcohol consumption during the study period. These groups consisted of sustained nondrinkers; those who stopped drinking (quitters); those who reduced their consumption of alcohol but did not stop drinking (reducers); those who maintained the same level of consumption (sustainers); and those who increased their level of consumption (increasers).

A standard drink in the United States contains 14 g of alcohol. For this study, mild drinking was defined as less than 15 g/day, or one drink; moderate consumption as 15-29.9 g/day, or one to two drinks; and heavy drinking as 30 g/day or more, or three or more drinks.

At baseline, 54.8% of participants were nondrinkers, 26.7% were mild drinkers, 11.0% were moderate drinkers, and 7.5% were heavy drinkers.

From 2009 to 2011, 24.2% of mild drinkers, 8.4% of moderate drinkers, and 7.6% of heavy drinkers became quitters. In the same period, 13.9% of nondrinkers, 16.1% of mild drinkers, and 17.4% of moderate drinkers increased their drinking level.

After a mean follow-up of 6.3 years, 2.5% of participants were diagnosed with dementia, 2.0% with Alzheimer’s disease, and 0.3% with vascular dementia.
 

Unexpected finding

Compared with consistently not drinking, mild and moderate alcohol consumption was associated with a 21% (adjust hazard ratio, 0.79; 95% confidence interval, 0.77-0.81) and 17% (aHR, 0.83; 95% CI, 0.79-0.88) decreased risk for dementia, respectively.

Heavy drinking was linked to an 8% increased risk (aHR, 1.08; 95% CI, 1.03-1.12).

Similar associations were found between alcohol consumption and risk for Alzheimer’s disease and vascular dementia.

Reducing drinking habits from heavy to moderate led to a reduction in risk for dementia and Alzheimer’s, and increasing drinking levels led to an increase in risk for both conditions.

But when the researchers analyzed dementia risk for nondrinkers who began drinking at mild levels during the study period, they found something unexpected – the risk in this group decreased by 7% for dementia (aHR, 0.93; 95% CI, 0.90-0.96) and by 8% for Alzheimer’s (aHR, 0.92; 95% CI, 0.89-0.95), compared with sustained mild drinkers.

“Our study showed that initiation of mild alcohol consumption leads to a reduced risk of all-cause dementia and Alzheimer’s disease, which has never been reported in previous studies,” Dr. Jeon said.

However, Dr. Jeon was quick to point out that this doesn’t mean that people who don’t drink should start.

Previous studies have shown that heavy alcohol use can triple an individual’s dementia risk, while other studies have shown that no amount of alcohol consumption is good for the brain.

“None of the existing health guidelines recommend starting alcohol drinking,” Dr. Jeon said. “Our findings regarding an initiation of mild alcohol consumption cannot be directly translated into clinical recommendations,” but the findings do warrant additional study, he added.
 

Risks persist

Commenting on the findings, Percy Griffin, PhD, director of scientific engagement for the Alzheimer’s Association in Chicago, agrees.

“While this study is interesting, and this topic deserves further study, no one should drink alcohol as a method of reducing risk of Alzheimer’s disease or other dementia based on this study,” said Dr. Griffin, who was not part of the study.

The exact tipping point in alcohol consumption that can lead to problems with cognition or increased dementia risk is unknown, Dr. Griffin said. Nor do researchers understand why mild drinking may have a protective effect.

“We do know, however, that excessive alcohol consumption has negative effects on heart health and general health, which can lead to problems with brain function,” he said. “Clinicians should have discussions with their patients around their alcohol consumption patterns and the risks associated with drinking in excess, including potential damage to their cognition.”

Funding for the study was not disclosed. Dr. Jeon and Dr. Griffin report no relevant financial relationships.

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

Drinking one or two cocktails a day may protect against dementia, while having three or more could increase risk, new research suggests.

Investigators assessed dementia risk using changes in alcohol consumption over a 2-year period in nearly 4 million people in South Korea. After about 7 years, dementia was 21% less likely in mild drinkers and 17% less likely in moderate drinkers. Heavy drinking was linked to an 8% increased risk.

Other studies of the relationship between alcohol and dementia have yielded mixed results, and this study does little to clear those murky waters. Nor do the results mean that drinking is recommended, the investigators note.

But the study does offer new information on how risk changes over time as people change their drinking habits, lead investigator Keun Hye Jeon, MD, assistant professor of family medicine at Cha Gumi Medical Center at Cha University, Gumi, South Korea, told this news organization.

“Although numerous studies have shown a relationship between alcohol consumption and dementia, there is a paucity of understanding as to how the incidence of dementia changes with changes in drinking habits,” Dr. Jeon said.

“By measuring alcohol consumption at two time points, we were able to study the relationship between reducing, ceasing, maintaining, and increasing alcohol consumption and incident dementia,” he added.

The findings were published online in JAMA Network Open.


 

Tracking drinking habits

Researchers analyzed data from nearly 4 million individuals aged 40 years and older in the Korean National Health Insurance Service who completed questionnaires and underwent physical exams in 2009 and 2011.

Study participants completed questionnaires on their drinking habits and were assigned to one of five groups according to change in alcohol consumption during the study period. These groups consisted of sustained nondrinkers; those who stopped drinking (quitters); those who reduced their consumption of alcohol but did not stop drinking (reducers); those who maintained the same level of consumption (sustainers); and those who increased their level of consumption (increasers).

A standard drink in the United States contains 14 g of alcohol. For this study, mild drinking was defined as less than 15 g/day, or one drink; moderate consumption as 15-29.9 g/day, or one to two drinks; and heavy drinking as 30 g/day or more, or three or more drinks.

At baseline, 54.8% of participants were nondrinkers, 26.7% were mild drinkers, 11.0% were moderate drinkers, and 7.5% were heavy drinkers.

From 2009 to 2011, 24.2% of mild drinkers, 8.4% of moderate drinkers, and 7.6% of heavy drinkers became quitters. In the same period, 13.9% of nondrinkers, 16.1% of mild drinkers, and 17.4% of moderate drinkers increased their drinking level.

After a mean follow-up of 6.3 years, 2.5% of participants were diagnosed with dementia, 2.0% with Alzheimer’s disease, and 0.3% with vascular dementia.
 

Unexpected finding

Compared with consistently not drinking, mild and moderate alcohol consumption was associated with a 21% (adjust hazard ratio, 0.79; 95% confidence interval, 0.77-0.81) and 17% (aHR, 0.83; 95% CI, 0.79-0.88) decreased risk for dementia, respectively.

Heavy drinking was linked to an 8% increased risk (aHR, 1.08; 95% CI, 1.03-1.12).

Similar associations were found between alcohol consumption and risk for Alzheimer’s disease and vascular dementia.

Reducing drinking habits from heavy to moderate led to a reduction in risk for dementia and Alzheimer’s, and increasing drinking levels led to an increase in risk for both conditions.

But when the researchers analyzed dementia risk for nondrinkers who began drinking at mild levels during the study period, they found something unexpected – the risk in this group decreased by 7% for dementia (aHR, 0.93; 95% CI, 0.90-0.96) and by 8% for Alzheimer’s (aHR, 0.92; 95% CI, 0.89-0.95), compared with sustained mild drinkers.

“Our study showed that initiation of mild alcohol consumption leads to a reduced risk of all-cause dementia and Alzheimer’s disease, which has never been reported in previous studies,” Dr. Jeon said.

However, Dr. Jeon was quick to point out that this doesn’t mean that people who don’t drink should start.

Previous studies have shown that heavy alcohol use can triple an individual’s dementia risk, while other studies have shown that no amount of alcohol consumption is good for the brain.

“None of the existing health guidelines recommend starting alcohol drinking,” Dr. Jeon said. “Our findings regarding an initiation of mild alcohol consumption cannot be directly translated into clinical recommendations,” but the findings do warrant additional study, he added.
 

Risks persist

Commenting on the findings, Percy Griffin, PhD, director of scientific engagement for the Alzheimer’s Association in Chicago, agrees.

“While this study is interesting, and this topic deserves further study, no one should drink alcohol as a method of reducing risk of Alzheimer’s disease or other dementia based on this study,” said Dr. Griffin, who was not part of the study.

The exact tipping point in alcohol consumption that can lead to problems with cognition or increased dementia risk is unknown, Dr. Griffin said. Nor do researchers understand why mild drinking may have a protective effect.

“We do know, however, that excessive alcohol consumption has negative effects on heart health and general health, which can lead to problems with brain function,” he said. “Clinicians should have discussions with their patients around their alcohol consumption patterns and the risks associated with drinking in excess, including potential damage to their cognition.”

Funding for the study was not disclosed. Dr. Jeon and Dr. Griffin report no relevant financial relationships.

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