Kerry Dooley Young

Only about one in three patients seen in the emergency department of an academic health system for acute gout had a follow-up visit that addressed this condition, Lesley Jackson, MD, of the University of Alabama at Birmingham, reported at the annual research symposium of the Gout, Hyperuricemia, and Crystal Associated Disease Network (G-CAN).

Dr. Jackson presented research done on patients seen within her university’s health system, looking at 72 patients seen in the ED between September 2021 and February 2022. Medications prescribed at discharge from the ED included corticosteroids (46 patients, or 64%), opioids (45 patients, 63%), NSAIDs (31 patients, 43%), and colchicine (23 patients, 32%).

Only 26 patients, or about 36%, had a subsequent outpatient visit in the UAB health system addressing gout, she said. Of 33 patients with any outpatient follow-up visit within the UAB system, 21 were within 1 month after the index ED visit, followed by 3 more prior to 3 months, and 9 more after 3 months.

The limitations of the study includes its collection of data from a single institution. But the results highlight the need for improved quality of care for gout, with too many people being treated for this condition primarily in the ED, she said.

In an email exchange arranged by the Arthritis Foundation, Herbert S. B. Baraf, MD, said he agreed that patients too often limit their treatment for gout to seeking care for acute attacks in the ED.

Because of competing demands, physicians working there are more to take a “Band-Aid” approach and not impress upon patients that gout is a lifelong condition that needs follow-up and monitoring, said Dr. Baraf, clinical professor of medicine at George Washington University, Washington, and an associate clinical professor at the University of Maryland, Baltimore. He retired from private practice in 2022.

“This problem is akin to the patient who has a hip fracture due to osteoporosis who gets a surgical repair but is never referred for osteoporotic management,” wrote Dr. Baraf, who is a former board member of the Arthritis Foundation.

He suggested viewing gout as a form of arthritis that has two components.

“The first, that which brings the patient to seek medical care, is the often exquisitely painful attack of pain and swelling in a joint or joints that comes on acutely,” he wrote. “Calming these attacks are the focus of the patient and the doctor, who does the evaluation as relief of pain and inflammation is the most pressing task at hand.”

But equally important is the second element, addressing the cause of these flare ups of arthritis, he wrote. Elevated uric acid leads to crystalline deposits of urate in the joints, particularly in the feet, ankles, knees, and hands. Over time, these deposits generate seemingly random flare ups of acute joint pain in one or more of these areas.

“Thus, when a patient presents to an emergency room with a first or second attack of gout, pain relief is the primary focus of the visit,” Dr. Baraf wrote. “But if over time that is the only focus, and the elevation of serum uric acid is not addressed, deposits will continue to mount and flare ups will occur with increasing frequency and severity.”

This study was supported by a grant from the National Institute of Arthritis and Musculoskeletal and Skin Diseases. Dr. Jackson has no relevant financial disclosures.

Only about one in three patients seen in the emergency department of an academic health system for acute gout had a follow-up visit that addressed this condition, Lesley Jackson, MD, of the University of Alabama at Birmingham, reported at the annual research symposium of the Gout, Hyperuricemia, and Crystal Associated Disease Network (G-CAN).

Dr. Jackson presented research done on patients seen within her university’s health system, looking at 72 patients seen in the ED between September 2021 and February 2022. Medications prescribed at discharge from the ED included corticosteroids (46 patients, or 64%), opioids (45 patients, 63%), NSAIDs (31 patients, 43%), and colchicine (23 patients, 32%).

Only 26 patients, or about 36%, had a subsequent outpatient visit in the UAB health system addressing gout, she said. Of 33 patients with any outpatient follow-up visit within the UAB system, 21 were within 1 month after the index ED visit, followed by 3 more prior to 3 months, and 9 more after 3 months.

The limitations of the study includes its collection of data from a single institution. But the results highlight the need for improved quality of care for gout, with too many people being treated for this condition primarily in the ED, she said.

In an email exchange arranged by the Arthritis Foundation, Herbert S. B. Baraf, MD, said he agreed that patients too often limit their treatment for gout to seeking care for acute attacks in the ED.

Because of competing demands, physicians working there are more to take a “Band-Aid” approach and not impress upon patients that gout is a lifelong condition that needs follow-up and monitoring, said Dr. Baraf, clinical professor of medicine at George Washington University, Washington, and an associate clinical professor at the University of Maryland, Baltimore. He retired from private practice in 2022.

“This problem is akin to the patient who has a hip fracture due to osteoporosis who gets a surgical repair but is never referred for osteoporotic management,” wrote Dr. Baraf, who is a former board member of the Arthritis Foundation.

He suggested viewing gout as a form of arthritis that has two components.

“The first, that which brings the patient to seek medical care, is the often exquisitely painful attack of pain and swelling in a joint or joints that comes on acutely,” he wrote. “Calming these attacks are the focus of the patient and the doctor, who does the evaluation as relief of pain and inflammation is the most pressing task at hand.”

But equally important is the second element, addressing the cause of these flare ups of arthritis, he wrote. Elevated uric acid leads to crystalline deposits of urate in the joints, particularly in the feet, ankles, knees, and hands. Over time, these deposits generate seemingly random flare ups of acute joint pain in one or more of these areas.

“Thus, when a patient presents to an emergency room with a first or second attack of gout, pain relief is the primary focus of the visit,” Dr. Baraf wrote. “But if over time that is the only focus, and the elevation of serum uric acid is not addressed, deposits will continue to mount and flare ups will occur with increasing frequency and severity.”

This study was supported by a grant from the National Institute of Arthritis and Musculoskeletal and Skin Diseases. Dr. Jackson has no relevant financial disclosures.

Only about one in three patients seen in the emergency department of an academic health system for acute gout had a follow-up visit that addressed this condition, Lesley Jackson, MD, of the University of Alabama at Birmingham, reported at the annual research symposium of the Gout, Hyperuricemia, and Crystal Associated Disease Network (G-CAN).

Dr. Jackson presented research done on patients seen within her university’s health system, looking at 72 patients seen in the ED between September 2021 and February 2022. Medications prescribed at discharge from the ED included corticosteroids (46 patients, or 64%), opioids (45 patients, 63%), NSAIDs (31 patients, 43%), and colchicine (23 patients, 32%).

Only 26 patients, or about 36%, had a subsequent outpatient visit in the UAB health system addressing gout, she said. Of 33 patients with any outpatient follow-up visit within the UAB system, 21 were within 1 month after the index ED visit, followed by 3 more prior to 3 months, and 9 more after 3 months.

The limitations of the study includes its collection of data from a single institution. But the results highlight the need for improved quality of care for gout, with too many people being treated for this condition primarily in the ED, she said.

In an email exchange arranged by the Arthritis Foundation, Herbert S. B. Baraf, MD, said he agreed that patients too often limit their treatment for gout to seeking care for acute attacks in the ED.

Because of competing demands, physicians working there are more to take a “Band-Aid” approach and not impress upon patients that gout is a lifelong condition that needs follow-up and monitoring, said Dr. Baraf, clinical professor of medicine at George Washington University, Washington, and an associate clinical professor at the University of Maryland, Baltimore. He retired from private practice in 2022.

“This problem is akin to the patient who has a hip fracture due to osteoporosis who gets a surgical repair but is never referred for osteoporotic management,” wrote Dr. Baraf, who is a former board member of the Arthritis Foundation.

He suggested viewing gout as a form of arthritis that has two components.

“The first, that which brings the patient to seek medical care, is the often exquisitely painful attack of pain and swelling in a joint or joints that comes on acutely,” he wrote. “Calming these attacks are the focus of the patient and the doctor, who does the evaluation as relief of pain and inflammation is the most pressing task at hand.”

But equally important is the second element, addressing the cause of these flare ups of arthritis, he wrote. Elevated uric acid leads to crystalline deposits of urate in the joints, particularly in the feet, ankles, knees, and hands. Over time, these deposits generate seemingly random flare ups of acute joint pain in one or more of these areas.

“Thus, when a patient presents to an emergency room with a first or second attack of gout, pain relief is the primary focus of the visit,” Dr. Baraf wrote. “But if over time that is the only focus, and the elevation of serum uric acid is not addressed, deposits will continue to mount and flare ups will occur with increasing frequency and severity.”

This study was supported by a grant from the National Institute of Arthritis and Musculoskeletal and Skin Diseases. Dr. Jackson has no relevant financial disclosures.

A new study based on U.S. veterans’ medical records adds to the evidence for a link between gout – especially poorly controlled cases – and cardiovascular disease (CVD) risk, Tate Johnson, MD, reported at the annual research symposium of the Gout, Hyperuricemia, and Crystal Associated Disease Network.

Gout was associated with a 68% increased risk of heart failure (HF) hospitalization, 25% increased risk of HF-related death, and a 22% increased risk of major adverse cardiovascular events (MACE), said Dr. Johnson, of the division of rheumatology at the University of Nebraska, Omaha.

Poorly controlled serum urate was associated with a higher risk of cardiovascular events, regardless of the use of urate-lowering therapy (ULT). He said more research is needed to see if there is a causal link between gout, hyperuricemia – or its treatment – and CVD risk.

Dr. Johnson and colleagues used records from the Veterans Health Administration for this study. They created a retrospective, matched cohort study that looked at records dating from January 1999 to September 2015. Patients with gout (≥ 2 ICD-9 codes) were matched 1:10 on age, sex, and year of VHA enrollment to patients without a gout ICD-9 code or a record of receiving ULT. They matched 559,243 people with gout to 5,407,379 people who did not have a diagnosis or a recorded treatment for this condition.

Over 43,331,604 person-years, Dr. Johnson and colleagues observed 137,162 CVD events in gout (incidence rate 33.96 per 1,000 person-years) vs. 879,903 in non-gout patients (IR 22.37 per 1,000 person-years). Gout was most strongly associated with HF hospitalization, with a nearly threefold higher risk (hazard ratio, 2.78; 95% confidence interval, 2.73-2.83), which attenuated but persisted after adjustment for additional CVD risk factors (adjusted hazard ratio, 1.68; 95% CI, 1.65-1.70) and excluding patients with prevalent HF (aHR, 1.60; 95% CI, 1.57-1.64).

People with gout were also at higher risk of HF-related death (aHR, 1.25; 95% CI, 1.21-1.29), MACE (aHR, 1.22; 95% CI, 1.21-1.23), and coronary artery disease–related death (aHR, 1.21; 95% CI, 1.20-1.22).

Among people with gout in the study, poor serum urate control was associated with a higher risk of all CVD events, with the highest CVD risk occurring in patients with inadequately controlled serum urate despite receipt of ULT, particularly related to HF hospitalization (aHR, 1.43; 95% CI, 1.34-1.52) and HF-related death (aHR, 1.47; 95% CI, 1.34-1.61).

Limits of the study include the generalizability of the study population. Reflecting the VHA’s patient population, 99% of the cohort were men, with 62% of the gout group and 59.4% of the control group identifying as White and non-Hispanic.

The study provides evidence that may be found only by studying medical records, Richard J. Johnson, MD, of the University of Colorado at Denver, Aurora, said in an interview.

Dr. Richard Johnson, who is not related to the author, said that only about one-third of people with gout are adequately treated, and about another one-third take urate-lowering therapy (ULT) but fail to get their serum urate level under control. But it would be unethical to design a clinical trial to study CVD risk and poorly controlled serum urate without ULT treatment.

“The only way you can figure out if uric acid lowering is going to help these guys is to actually do a study like this where you see the ones who don’t get adequate treatment versus adequate treatment and you show that there’s going to be a difference in outcome,” he said.

Dr. Richard Johnson contrasted this approach with the one used in the recently reported study that appeared to cast doubt on the link between serum uric acid levels and cardiovascular disease. The ALL-HEART trial found that allopurinol, a drug commonly used to treat gout, provided no benefit in terms of reducing cardiovascular events in patients with ischemic heart disease. But these patients did not have gout, and that was a critical difference, he said.

He noted that it was not surprising that the results of ALL-HEART were negative, given the study design.

“The ALL-HEART study treated people regardless of their uric acid level, and they also excluded subjects who had a history of gout,” he said. “Yet the risk associated with uric acid occurs primarily among those with elevated serum uric acid levels and those with gout.”

The study received funding from the Rheumatology Research Foundation and the VHA. Neither Dr. Tate Johnson nor Dr. Richard Johnson had any relevant disclosures.

A new study based on U.S. veterans’ medical records adds to the evidence for a link between gout – especially poorly controlled cases – and cardiovascular disease (CVD) risk, Tate Johnson, MD, reported at the annual research symposium of the Gout, Hyperuricemia, and Crystal Associated Disease Network.

Gout was associated with a 68% increased risk of heart failure (HF) hospitalization, 25% increased risk of HF-related death, and a 22% increased risk of major adverse cardiovascular events (MACE), said Dr. Johnson, of the division of rheumatology at the University of Nebraska, Omaha.

Poorly controlled serum urate was associated with a higher risk of cardiovascular events, regardless of the use of urate-lowering therapy (ULT). He said more research is needed to see if there is a causal link between gout, hyperuricemia – or its treatment – and CVD risk.

Dr. Johnson and colleagues used records from the Veterans Health Administration for this study. They created a retrospective, matched cohort study that looked at records dating from January 1999 to September 2015. Patients with gout (≥ 2 ICD-9 codes) were matched 1:10 on age, sex, and year of VHA enrollment to patients without a gout ICD-9 code or a record of receiving ULT. They matched 559,243 people with gout to 5,407,379 people who did not have a diagnosis or a recorded treatment for this condition.

Over 43,331,604 person-years, Dr. Johnson and colleagues observed 137,162 CVD events in gout (incidence rate 33.96 per 1,000 person-years) vs. 879,903 in non-gout patients (IR 22.37 per 1,000 person-years). Gout was most strongly associated with HF hospitalization, with a nearly threefold higher risk (hazard ratio, 2.78; 95% confidence interval, 2.73-2.83), which attenuated but persisted after adjustment for additional CVD risk factors (adjusted hazard ratio, 1.68; 95% CI, 1.65-1.70) and excluding patients with prevalent HF (aHR, 1.60; 95% CI, 1.57-1.64).

People with gout were also at higher risk of HF-related death (aHR, 1.25; 95% CI, 1.21-1.29), MACE (aHR, 1.22; 95% CI, 1.21-1.23), and coronary artery disease–related death (aHR, 1.21; 95% CI, 1.20-1.22).

Among people with gout in the study, poor serum urate control was associated with a higher risk of all CVD events, with the highest CVD risk occurring in patients with inadequately controlled serum urate despite receipt of ULT, particularly related to HF hospitalization (aHR, 1.43; 95% CI, 1.34-1.52) and HF-related death (aHR, 1.47; 95% CI, 1.34-1.61).

Limits of the study include the generalizability of the study population. Reflecting the VHA’s patient population, 99% of the cohort were men, with 62% of the gout group and 59.4% of the control group identifying as White and non-Hispanic.

The study provides evidence that may be found only by studying medical records, Richard J. Johnson, MD, of the University of Colorado at Denver, Aurora, said in an interview.

Dr. Richard Johnson, who is not related to the author, said that only about one-third of people with gout are adequately treated, and about another one-third take urate-lowering therapy (ULT) but fail to get their serum urate level under control. But it would be unethical to design a clinical trial to study CVD risk and poorly controlled serum urate without ULT treatment.

“The only way you can figure out if uric acid lowering is going to help these guys is to actually do a study like this where you see the ones who don’t get adequate treatment versus adequate treatment and you show that there’s going to be a difference in outcome,” he said.

Dr. Richard Johnson contrasted this approach with the one used in the recently reported study that appeared to cast doubt on the link between serum uric acid levels and cardiovascular disease. The ALL-HEART trial found that allopurinol, a drug commonly used to treat gout, provided no benefit in terms of reducing cardiovascular events in patients with ischemic heart disease. But these patients did not have gout, and that was a critical difference, he said.

He noted that it was not surprising that the results of ALL-HEART were negative, given the study design.

“The ALL-HEART study treated people regardless of their uric acid level, and they also excluded subjects who had a history of gout,” he said. “Yet the risk associated with uric acid occurs primarily among those with elevated serum uric acid levels and those with gout.”

The study received funding from the Rheumatology Research Foundation and the VHA. Neither Dr. Tate Johnson nor Dr. Richard Johnson had any relevant disclosures.

A new study based on U.S. veterans’ medical records adds to the evidence for a link between gout – especially poorly controlled cases – and cardiovascular disease (CVD) risk, Tate Johnson, MD, reported at the annual research symposium of the Gout, Hyperuricemia, and Crystal Associated Disease Network.

Gout was associated with a 68% increased risk of heart failure (HF) hospitalization, 25% increased risk of HF-related death, and a 22% increased risk of major adverse cardiovascular events (MACE), said Dr. Johnson, of the division of rheumatology at the University of Nebraska, Omaha.

Poorly controlled serum urate was associated with a higher risk of cardiovascular events, regardless of the use of urate-lowering therapy (ULT). He said more research is needed to see if there is a causal link between gout, hyperuricemia – or its treatment – and CVD risk.

Dr. Johnson and colleagues used records from the Veterans Health Administration for this study. They created a retrospective, matched cohort study that looked at records dating from January 1999 to September 2015. Patients with gout (≥ 2 ICD-9 codes) were matched 1:10 on age, sex, and year of VHA enrollment to patients without a gout ICD-9 code or a record of receiving ULT. They matched 559,243 people with gout to 5,407,379 people who did not have a diagnosis or a recorded treatment for this condition.

Over 43,331,604 person-years, Dr. Johnson and colleagues observed 137,162 CVD events in gout (incidence rate 33.96 per 1,000 person-years) vs. 879,903 in non-gout patients (IR 22.37 per 1,000 person-years). Gout was most strongly associated with HF hospitalization, with a nearly threefold higher risk (hazard ratio, 2.78; 95% confidence interval, 2.73-2.83), which attenuated but persisted after adjustment for additional CVD risk factors (adjusted hazard ratio, 1.68; 95% CI, 1.65-1.70) and excluding patients with prevalent HF (aHR, 1.60; 95% CI, 1.57-1.64).

People with gout were also at higher risk of HF-related death (aHR, 1.25; 95% CI, 1.21-1.29), MACE (aHR, 1.22; 95% CI, 1.21-1.23), and coronary artery disease–related death (aHR, 1.21; 95% CI, 1.20-1.22).

Among people with gout in the study, poor serum urate control was associated with a higher risk of all CVD events, with the highest CVD risk occurring in patients with inadequately controlled serum urate despite receipt of ULT, particularly related to HF hospitalization (aHR, 1.43; 95% CI, 1.34-1.52) and HF-related death (aHR, 1.47; 95% CI, 1.34-1.61).

Limits of the study include the generalizability of the study population. Reflecting the VHA’s patient population, 99% of the cohort were men, with 62% of the gout group and 59.4% of the control group identifying as White and non-Hispanic.

The study provides evidence that may be found only by studying medical records, Richard J. Johnson, MD, of the University of Colorado at Denver, Aurora, said in an interview.

Dr. Richard Johnson, who is not related to the author, said that only about one-third of people with gout are adequately treated, and about another one-third take urate-lowering therapy (ULT) but fail to get their serum urate level under control. But it would be unethical to design a clinical trial to study CVD risk and poorly controlled serum urate without ULT treatment.

“The only way you can figure out if uric acid lowering is going to help these guys is to actually do a study like this where you see the ones who don’t get adequate treatment versus adequate treatment and you show that there’s going to be a difference in outcome,” he said.

Dr. Richard Johnson contrasted this approach with the one used in the recently reported study that appeared to cast doubt on the link between serum uric acid levels and cardiovascular disease. The ALL-HEART trial found that allopurinol, a drug commonly used to treat gout, provided no benefit in terms of reducing cardiovascular events in patients with ischemic heart disease. But these patients did not have gout, and that was a critical difference, he said.

He noted that it was not surprising that the results of ALL-HEART were negative, given the study design.

“The ALL-HEART study treated people regardless of their uric acid level, and they also excluded subjects who had a history of gout,” he said. “Yet the risk associated with uric acid occurs primarily among those with elevated serum uric acid levels and those with gout.”

The study received funding from the Rheumatology Research Foundation and the VHA. Neither Dr. Tate Johnson nor Dr. Richard Johnson had any relevant disclosures.

Comorbidities may play a greater role than genetics women with gout, although this appears not to be true for men, Nicholas Sumpter, MSc, of the University of Alabama at Birmingham said at the annual research symposium of the Gout, Hyperuricemia, and Crystal Associated Disease Network (G-CAN).

Mr. Sumpter was among the authors of a recent paper in Arthritis & Rheumatology that suggested that earlier gout onset involves the accumulation of certain allelic variants in men. This genetic risk was shared across multiple ancestral groups in the study, conducted with men of European and Polynesian ancestry, Mr. Sumpter and colleagues reported.

“There might be more than one factor in gout in men, but in women we’ve been getting at this idea that comorbidities are the big thing,” he said.

During his presentation, Mr. Sumpter offered a hypothesis that in men there might be a kind of “two-pronged attack,” with increases in serum urate linked to genetic risk, but comorbidities also playing a role. “But that may not be the case for women.”

In his presentation, Mr. Sumpter noted a paper published in March 2022 from his University of Alabama at Birmingham colleagues, Aakash V. Patel, MD, and Angelo L. Gaffo, MD. In the article, Dr. Patel and Dr. Gaffo delved into the challenges of treating women with gout given “the paucity of appropriately well-powered, randomized-controlled trials investigating the efficacy” of commonly used treatments.

“This poses major challenges for the management of female gout patients since they carry a greater burden of cardiovascular and renal morbidity, which is known to modulate the pathophysiology of gout; as such, conclusions regarding the efficacy of treatments for females cannot be extrapolated from investigative studies that are predominantly male,” they wrote, calling for increased efforts to enroll women in studies of treatments for this condition.

There’s increased interest in how gout affects women, including findings in a paper published in September in Arthritis & Rheumatology that found people with gout, especially women, appear to be at higher risk for poor COVID-19 outcomes, including hospitalization and death, regardless of COVID-19 vaccination status.

Gout has become more common in women, although this remains a condition that is far more likely to strike men.

The age-standardized prevalence of gout among women rose from 233.52 per 100,000 in 1990 to 253.49 in 2017, a gain of about 9%, according to a systematic analysis of the Global Burden of Disease Study.

That topped the roughly 5% gain seen for men in the same time frame, with the rate going from 747.48 per 100,000 to 790.90. With the aging of the global population, gout’s burden in terms of prevalence and disability is expected to increase.

Impact of obesity and healthy eating patterns

Obesity, or excess adiposity, appears to be of particular concern for women in terms of gout risk.

While obesity and genetic predisposition both are strongly associated with a higher risk of gout, the excess risk of both combined was higher than the sum of each, particularly among women, Natalie McCormick, PhD, of Massachusetts General Hospital, Boston, and coauthors reported in Annals of the Rheumatic Diseases.

These findings suggested that “addressing excess adiposity could prevent a large proportion of female gout cases in particular, as well as its cardiometabolic comorbidities, and the benefit could be greater in genetically predisposed women,” they wrote.

In general, there’s a need to re-examine the advice given by many clinicians in the past that people with gout, or those at risk for it, should follow a low-protein diet to avoid purines, Dr. McCormick said in an interview.

“Now we’re finding that a healthier diet that balances protein as well as fat intake can actually be better both for cardiovascular health and for gout prevention,” she said.

Dr. McCormick’s research on this topic includes a 2022 JAMA Internal Medicine article, and a 2021 article in Current Rheumatology Reports. In the latter article, Dr. McCormick and colleagues examined the benefits of changing habits for patients, such as following one of several well-established healthy eating patterns, including the Mediterranean and DASH diets.

With excess weight and associated cardiovascular and endocrine risks already elevated among people with gout, especially women, the “conventional low-purine (i.e., low-protein) approach to gout dietary guidance is neither helpful nor sustainable and may lead to detrimental effects related to worsening insulin resistance as a result of substitution of healthy proteins with unhealthy carbohydrates or fats,” they wrote. “Rather, by focusing our dietary recommendations on healthy eating patterns which have been proven to reduce cardiometabolic risk factors, as opposed to singular ‘good’ or ‘bad’ food items or groups, the beneficial effects of such diets on relevant gout endpoints should naturally follow for the majority of typical gout cases, mediated through changes in insulin resistance.”

Mr. Sumpter and Dr. McCormick had no competing interests to declare.

Comorbidities may play a greater role than genetics women with gout, although this appears not to be true for men, Nicholas Sumpter, MSc, of the University of Alabama at Birmingham said at the annual research symposium of the Gout, Hyperuricemia, and Crystal Associated Disease Network (G-CAN).

Mr. Sumpter was among the authors of a recent paper in Arthritis & Rheumatology that suggested that earlier gout onset involves the accumulation of certain allelic variants in men. This genetic risk was shared across multiple ancestral groups in the study, conducted with men of European and Polynesian ancestry, Mr. Sumpter and colleagues reported.

“There might be more than one factor in gout in men, but in women we’ve been getting at this idea that comorbidities are the big thing,” he said.

During his presentation, Mr. Sumpter offered a hypothesis that in men there might be a kind of “two-pronged attack,” with increases in serum urate linked to genetic risk, but comorbidities also playing a role. “But that may not be the case for women.”

In his presentation, Mr. Sumpter noted a paper published in March 2022 from his University of Alabama at Birmingham colleagues, Aakash V. Patel, MD, and Angelo L. Gaffo, MD. In the article, Dr. Patel and Dr. Gaffo delved into the challenges of treating women with gout given “the paucity of appropriately well-powered, randomized-controlled trials investigating the efficacy” of commonly used treatments.

“This poses major challenges for the management of female gout patients since they carry a greater burden of cardiovascular and renal morbidity, which is known to modulate the pathophysiology of gout; as such, conclusions regarding the efficacy of treatments for females cannot be extrapolated from investigative studies that are predominantly male,” they wrote, calling for increased efforts to enroll women in studies of treatments for this condition.

There’s increased interest in how gout affects women, including findings in a paper published in September in Arthritis & Rheumatology that found people with gout, especially women, appear to be at higher risk for poor COVID-19 outcomes, including hospitalization and death, regardless of COVID-19 vaccination status.

Gout has become more common in women, although this remains a condition that is far more likely to strike men.

The age-standardized prevalence of gout among women rose from 233.52 per 100,000 in 1990 to 253.49 in 2017, a gain of about 9%, according to a systematic analysis of the Global Burden of Disease Study.

That topped the roughly 5% gain seen for men in the same time frame, with the rate going from 747.48 per 100,000 to 790.90. With the aging of the global population, gout’s burden in terms of prevalence and disability is expected to increase.

Impact of obesity and healthy eating patterns

Obesity, or excess adiposity, appears to be of particular concern for women in terms of gout risk.

While obesity and genetic predisposition both are strongly associated with a higher risk of gout, the excess risk of both combined was higher than the sum of each, particularly among women, Natalie McCormick, PhD, of Massachusetts General Hospital, Boston, and coauthors reported in Annals of the Rheumatic Diseases.

These findings suggested that “addressing excess adiposity could prevent a large proportion of female gout cases in particular, as well as its cardiometabolic comorbidities, and the benefit could be greater in genetically predisposed women,” they wrote.

In general, there’s a need to re-examine the advice given by many clinicians in the past that people with gout, or those at risk for it, should follow a low-protein diet to avoid purines, Dr. McCormick said in an interview.

“Now we’re finding that a healthier diet that balances protein as well as fat intake can actually be better both for cardiovascular health and for gout prevention,” she said.

Dr. McCormick’s research on this topic includes a 2022 JAMA Internal Medicine article, and a 2021 article in Current Rheumatology Reports. In the latter article, Dr. McCormick and colleagues examined the benefits of changing habits for patients, such as following one of several well-established healthy eating patterns, including the Mediterranean and DASH diets.

With excess weight and associated cardiovascular and endocrine risks already elevated among people with gout, especially women, the “conventional low-purine (i.e., low-protein) approach to gout dietary guidance is neither helpful nor sustainable and may lead to detrimental effects related to worsening insulin resistance as a result of substitution of healthy proteins with unhealthy carbohydrates or fats,” they wrote. “Rather, by focusing our dietary recommendations on healthy eating patterns which have been proven to reduce cardiometabolic risk factors, as opposed to singular ‘good’ or ‘bad’ food items or groups, the beneficial effects of such diets on relevant gout endpoints should naturally follow for the majority of typical gout cases, mediated through changes in insulin resistance.”

Mr. Sumpter and Dr. McCormick had no competing interests to declare.

Comorbidities may play a greater role than genetics women with gout, although this appears not to be true for men, Nicholas Sumpter, MSc, of the University of Alabama at Birmingham said at the annual research symposium of the Gout, Hyperuricemia, and Crystal Associated Disease Network (G-CAN).

Mr. Sumpter was among the authors of a recent paper in Arthritis & Rheumatology that suggested that earlier gout onset involves the accumulation of certain allelic variants in men. This genetic risk was shared across multiple ancestral groups in the study, conducted with men of European and Polynesian ancestry, Mr. Sumpter and colleagues reported.

“There might be more than one factor in gout in men, but in women we’ve been getting at this idea that comorbidities are the big thing,” he said.

During his presentation, Mr. Sumpter offered a hypothesis that in men there might be a kind of “two-pronged attack,” with increases in serum urate linked to genetic risk, but comorbidities also playing a role. “But that may not be the case for women.”

In his presentation, Mr. Sumpter noted a paper published in March 2022 from his University of Alabama at Birmingham colleagues, Aakash V. Patel, MD, and Angelo L. Gaffo, MD. In the article, Dr. Patel and Dr. Gaffo delved into the challenges of treating women with gout given “the paucity of appropriately well-powered, randomized-controlled trials investigating the efficacy” of commonly used treatments.

“This poses major challenges for the management of female gout patients since they carry a greater burden of cardiovascular and renal morbidity, which is known to modulate the pathophysiology of gout; as such, conclusions regarding the efficacy of treatments for females cannot be extrapolated from investigative studies that are predominantly male,” they wrote, calling for increased efforts to enroll women in studies of treatments for this condition.

There’s increased interest in how gout affects women, including findings in a paper published in September in Arthritis & Rheumatology that found people with gout, especially women, appear to be at higher risk for poor COVID-19 outcomes, including hospitalization and death, regardless of COVID-19 vaccination status.

Gout has become more common in women, although this remains a condition that is far more likely to strike men.

The age-standardized prevalence of gout among women rose from 233.52 per 100,000 in 1990 to 253.49 in 2017, a gain of about 9%, according to a systematic analysis of the Global Burden of Disease Study.

That topped the roughly 5% gain seen for men in the same time frame, with the rate going from 747.48 per 100,000 to 790.90. With the aging of the global population, gout’s burden in terms of prevalence and disability is expected to increase.

Impact of obesity and healthy eating patterns

Obesity, or excess adiposity, appears to be of particular concern for women in terms of gout risk.

While obesity and genetic predisposition both are strongly associated with a higher risk of gout, the excess risk of both combined was higher than the sum of each, particularly among women, Natalie McCormick, PhD, of Massachusetts General Hospital, Boston, and coauthors reported in Annals of the Rheumatic Diseases.

These findings suggested that “addressing excess adiposity could prevent a large proportion of female gout cases in particular, as well as its cardiometabolic comorbidities, and the benefit could be greater in genetically predisposed women,” they wrote.

In general, there’s a need to re-examine the advice given by many clinicians in the past that people with gout, or those at risk for it, should follow a low-protein diet to avoid purines, Dr. McCormick said in an interview.

“Now we’re finding that a healthier diet that balances protein as well as fat intake can actually be better both for cardiovascular health and for gout prevention,” she said.

Dr. McCormick’s research on this topic includes a 2022 JAMA Internal Medicine article, and a 2021 article in Current Rheumatology Reports. In the latter article, Dr. McCormick and colleagues examined the benefits of changing habits for patients, such as following one of several well-established healthy eating patterns, including the Mediterranean and DASH diets.

With excess weight and associated cardiovascular and endocrine risks already elevated among people with gout, especially women, the “conventional low-purine (i.e., low-protein) approach to gout dietary guidance is neither helpful nor sustainable and may lead to detrimental effects related to worsening insulin resistance as a result of substitution of healthy proteins with unhealthy carbohydrates or fats,” they wrote. “Rather, by focusing our dietary recommendations on healthy eating patterns which have been proven to reduce cardiometabolic risk factors, as opposed to singular ‘good’ or ‘bad’ food items or groups, the beneficial effects of such diets on relevant gout endpoints should naturally follow for the majority of typical gout cases, mediated through changes in insulin resistance.”

Mr. Sumpter and Dr. McCormick had no competing interests to declare.

A federal advisory panel recommended the United States withdraw from the market an injection given to women at risk for giving birth prematurely. Many of its members argued this step is needed to allow further testing to see if this drug actually works.

The Food and Drug Administration has been seeking to pull the approval of hydroxyprogesterone caproate (17P) injection (Makena, Covis) since 2020, after the drug failed to show a benefit in the PROLONG study. This study was meant as a confirmatory trial for the accelerated approval the FDA granted Makena in 2011 based on promising results from an earlier small study, known as the Meis trial. The manufacturer, Covis, contends that the flaws in the PROLONG study made Makena appear ineffective.

The FDA asked its Obstetrics, Reproductive and Urologic Drugs Advisory Committee to review the evidence gathered to date on Makena at a hearing that ran from Oct. 17 to Oct. 19. At the conclusion, the FDA asked the committee to vote on whether the agency should allow Makena to remain on the market while an appropriate confirmatory study is designed and conducted.

The vote was 14-1 against this plan.

There needs to be another study as a “tiebreaker” to determine which of the previous Makena trials was correct, said FDA panelist Michael K. Lindsay, MD, MPH, who is also director of the division of maternal-fetal medicine for Grady and Emory University Hospital Midtown, Atlanta.

“I think there needs to be another trial,” Dr. Lindsay said. “If you can do the trial without the medication being FDA approved, then I am supportive of that.”

Members of the FDA panel noted the difficulties that would ensue if Covis attempted further study of Makena with the drug still approved, including difficulties in recruiting patients. Indeed, there were delays in recruiting patients for the PROLONG trial in part because Makena was perceived as the standard of care for pregnant women who had a prior spontaneous preterm birth. That led to efforts to enroll patients outside of the United States, particularly in Eastern European countries.

Panelist Cassandra E. Henderson, MD, of the New York-based Garden OB/GYN practice, was the dissenter in the 14-1 vote.

Withdrawing the approval of Makena may lead to increased use of pharmacy-compounded versions of this medicine, as women look for options to try to extend their pregnancies, she said.

“They may seek it in other ways and get something that we don’t have any control over, and we don’t know what the fetus may be exposed to,” Dr. Henderson said.

Dr. Henderson also said there should be greater discussion with patients about questions of potential “intergenerational risk” because of fetal exposure to the medicine. Covis could add a registry similar to the University of Chicago’s DES Program to its research program for Makena, she said.
 

Race-based argument

Covis has been fighting to keep the Makena approval by offering theories for why the PROLONG study failed to show a benefit for the drug.

Covis emphasizes the different racial make-up of patients in the two trials. Black women composed 59% of the Meis study population, compared with only 6.7% for the PROLONG study, Covis said in its briefing document for the hearing. The Luxembourg-based company also says that there may have been unreliable estimates of the gestational age in the PROLONG trial, which enrolled many subjects in Ukraine and Russia.

During deliberations among panelists on Oct. 19, Dr. Henderson emphasized a need to consider other factors that may have been involved and encouraged continued study of the drug in Black women. She dismissed the idea of a race-based difference being the explanation for the difference between the two trials, but instead stressed that race serves as a marker for inequities, which are known to increase risk for preterm birth.

“Targeting a population that is at risk, particularly Black women in the United States, may show something that would be beneficial” from Makena, Dr. Henderson said.

Other physicians have argued that this approach would actually put Black women and children at greater risk of an ineffective drug with potential side effects.

“The drug is not proven to work so keeping it on the market to be injected into Black women to see what subgroups it might work in essentially amounts to experimentation,” said Adam Urato, MD, chief of maternal-fetal medicine at MetroWest Medical Center in Framingham, Mass., during the public comment session of the hearing.

The vote marks the second time that the FDA’s advisers on reproductive health have told the agency that the evidence gathered on the drug does not support its use. An advisory committee also cast votes against the drug at a 2019 meeting.

The rate of preterm birth in Black women in 2020 was 14.4%, significantly higher than the rate of preterm birth in White or Hispanic women, 9.1% and 9.8%, respectively, according to the Centers for Disease Control and Prevention. The potential for harm to children from premature birth led the FDA to clear Makena through the accelerated approval pathway, said Patrizia Cavazzoni, MD, the director of FDA’s Center for Drug Evaluation and Research, in the opening session of the hearing.

“We once thought Makena was likely to be part of the answer to that problem,” Dr. Cavazzoni said. “Unfortunately we no longer do, based on the evidence available.”

A federal advisory panel recommended the United States withdraw from the market an injection given to women at risk for giving birth prematurely. Many of its members argued this step is needed to allow further testing to see if this drug actually works.

The Food and Drug Administration has been seeking to pull the approval of hydroxyprogesterone caproate (17P) injection (Makena, Covis) since 2020, after the drug failed to show a benefit in the PROLONG study. This study was meant as a confirmatory trial for the accelerated approval the FDA granted Makena in 2011 based on promising results from an earlier small study, known as the Meis trial. The manufacturer, Covis, contends that the flaws in the PROLONG study made Makena appear ineffective.

The FDA asked its Obstetrics, Reproductive and Urologic Drugs Advisory Committee to review the evidence gathered to date on Makena at a hearing that ran from Oct. 17 to Oct. 19. At the conclusion, the FDA asked the committee to vote on whether the agency should allow Makena to remain on the market while an appropriate confirmatory study is designed and conducted.

The vote was 14-1 against this plan.

There needs to be another study as a “tiebreaker” to determine which of the previous Makena trials was correct, said FDA panelist Michael K. Lindsay, MD, MPH, who is also director of the division of maternal-fetal medicine for Grady and Emory University Hospital Midtown, Atlanta.

“I think there needs to be another trial,” Dr. Lindsay said. “If you can do the trial without the medication being FDA approved, then I am supportive of that.”

Members of the FDA panel noted the difficulties that would ensue if Covis attempted further study of Makena with the drug still approved, including difficulties in recruiting patients. Indeed, there were delays in recruiting patients for the PROLONG trial in part because Makena was perceived as the standard of care for pregnant women who had a prior spontaneous preterm birth. That led to efforts to enroll patients outside of the United States, particularly in Eastern European countries.

Panelist Cassandra E. Henderson, MD, of the New York-based Garden OB/GYN practice, was the dissenter in the 14-1 vote.

Withdrawing the approval of Makena may lead to increased use of pharmacy-compounded versions of this medicine, as women look for options to try to extend their pregnancies, she said.

“They may seek it in other ways and get something that we don’t have any control over, and we don’t know what the fetus may be exposed to,” Dr. Henderson said.

Dr. Henderson also said there should be greater discussion with patients about questions of potential “intergenerational risk” because of fetal exposure to the medicine. Covis could add a registry similar to the University of Chicago’s DES Program to its research program for Makena, she said.
 

Race-based argument

Covis has been fighting to keep the Makena approval by offering theories for why the PROLONG study failed to show a benefit for the drug.

Covis emphasizes the different racial make-up of patients in the two trials. Black women composed 59% of the Meis study population, compared with only 6.7% for the PROLONG study, Covis said in its briefing document for the hearing. The Luxembourg-based company also says that there may have been unreliable estimates of the gestational age in the PROLONG trial, which enrolled many subjects in Ukraine and Russia.

During deliberations among panelists on Oct. 19, Dr. Henderson emphasized a need to consider other factors that may have been involved and encouraged continued study of the drug in Black women. She dismissed the idea of a race-based difference being the explanation for the difference between the two trials, but instead stressed that race serves as a marker for inequities, which are known to increase risk for preterm birth.

“Targeting a population that is at risk, particularly Black women in the United States, may show something that would be beneficial” from Makena, Dr. Henderson said.

Other physicians have argued that this approach would actually put Black women and children at greater risk of an ineffective drug with potential side effects.

“The drug is not proven to work so keeping it on the market to be injected into Black women to see what subgroups it might work in essentially amounts to experimentation,” said Adam Urato, MD, chief of maternal-fetal medicine at MetroWest Medical Center in Framingham, Mass., during the public comment session of the hearing.

The vote marks the second time that the FDA’s advisers on reproductive health have told the agency that the evidence gathered on the drug does not support its use. An advisory committee also cast votes against the drug at a 2019 meeting.

The rate of preterm birth in Black women in 2020 was 14.4%, significantly higher than the rate of preterm birth in White or Hispanic women, 9.1% and 9.8%, respectively, according to the Centers for Disease Control and Prevention. The potential for harm to children from premature birth led the FDA to clear Makena through the accelerated approval pathway, said Patrizia Cavazzoni, MD, the director of FDA’s Center for Drug Evaluation and Research, in the opening session of the hearing.

“We once thought Makena was likely to be part of the answer to that problem,” Dr. Cavazzoni said. “Unfortunately we no longer do, based on the evidence available.”

A federal advisory panel recommended the United States withdraw from the market an injection given to women at risk for giving birth prematurely. Many of its members argued this step is needed to allow further testing to see if this drug actually works.

The Food and Drug Administration has been seeking to pull the approval of hydroxyprogesterone caproate (17P) injection (Makena, Covis) since 2020, after the drug failed to show a benefit in the PROLONG study. This study was meant as a confirmatory trial for the accelerated approval the FDA granted Makena in 2011 based on promising results from an earlier small study, known as the Meis trial. The manufacturer, Covis, contends that the flaws in the PROLONG study made Makena appear ineffective.

The FDA asked its Obstetrics, Reproductive and Urologic Drugs Advisory Committee to review the evidence gathered to date on Makena at a hearing that ran from Oct. 17 to Oct. 19. At the conclusion, the FDA asked the committee to vote on whether the agency should allow Makena to remain on the market while an appropriate confirmatory study is designed and conducted.

The vote was 14-1 against this plan.

There needs to be another study as a “tiebreaker” to determine which of the previous Makena trials was correct, said FDA panelist Michael K. Lindsay, MD, MPH, who is also director of the division of maternal-fetal medicine for Grady and Emory University Hospital Midtown, Atlanta.

“I think there needs to be another trial,” Dr. Lindsay said. “If you can do the trial without the medication being FDA approved, then I am supportive of that.”

Members of the FDA panel noted the difficulties that would ensue if Covis attempted further study of Makena with the drug still approved, including difficulties in recruiting patients. Indeed, there were delays in recruiting patients for the PROLONG trial in part because Makena was perceived as the standard of care for pregnant women who had a prior spontaneous preterm birth. That led to efforts to enroll patients outside of the United States, particularly in Eastern European countries.

Panelist Cassandra E. Henderson, MD, of the New York-based Garden OB/GYN practice, was the dissenter in the 14-1 vote.

Withdrawing the approval of Makena may lead to increased use of pharmacy-compounded versions of this medicine, as women look for options to try to extend their pregnancies, she said.

“They may seek it in other ways and get something that we don’t have any control over, and we don’t know what the fetus may be exposed to,” Dr. Henderson said.

Dr. Henderson also said there should be greater discussion with patients about questions of potential “intergenerational risk” because of fetal exposure to the medicine. Covis could add a registry similar to the University of Chicago’s DES Program to its research program for Makena, she said.
 

Race-based argument

Covis has been fighting to keep the Makena approval by offering theories for why the PROLONG study failed to show a benefit for the drug.

Covis emphasizes the different racial make-up of patients in the two trials. Black women composed 59% of the Meis study population, compared with only 6.7% for the PROLONG study, Covis said in its briefing document for the hearing. The Luxembourg-based company also says that there may have been unreliable estimates of the gestational age in the PROLONG trial, which enrolled many subjects in Ukraine and Russia.

During deliberations among panelists on Oct. 19, Dr. Henderson emphasized a need to consider other factors that may have been involved and encouraged continued study of the drug in Black women. She dismissed the idea of a race-based difference being the explanation for the difference between the two trials, but instead stressed that race serves as a marker for inequities, which are known to increase risk for preterm birth.

“Targeting a population that is at risk, particularly Black women in the United States, may show something that would be beneficial” from Makena, Dr. Henderson said.

Other physicians have argued that this approach would actually put Black women and children at greater risk of an ineffective drug with potential side effects.

“The drug is not proven to work so keeping it on the market to be injected into Black women to see what subgroups it might work in essentially amounts to experimentation,” said Adam Urato, MD, chief of maternal-fetal medicine at MetroWest Medical Center in Framingham, Mass., during the public comment session of the hearing.

The vote marks the second time that the FDA’s advisers on reproductive health have told the agency that the evidence gathered on the drug does not support its use. An advisory committee also cast votes against the drug at a 2019 meeting.

The rate of preterm birth in Black women in 2020 was 14.4%, significantly higher than the rate of preterm birth in White or Hispanic women, 9.1% and 9.8%, respectively, according to the Centers for Disease Control and Prevention. The potential for harm to children from premature birth led the FDA to clear Makena through the accelerated approval pathway, said Patrizia Cavazzoni, MD, the director of FDA’s Center for Drug Evaluation and Research, in the opening session of the hearing.

“We once thought Makena was likely to be part of the answer to that problem,” Dr. Cavazzoni said. “Unfortunately we no longer do, based on the evidence available.”

Women with repeated attempts at weight loss, even if the weight is regained, have modestly greater weight loss at an obesity management clinic than women without such a history, data suggest.

In a retrospective study of data for more than 11,000 participants in a weight-management program, the frequency of weight loss was significantly correlated with the total lifetime weight loss in men (r = 0.61, P < .0001) and women (r = 0.60, P < .0001).

“It should be harder for you to lose weight when you’re older, as opposed to younger. That’s just biology,” study author Sean Wharton, MD, PharmD, medical director of the Wharton Medical Clinic, Burlington, Ont., told this news organization. But older people “have practiced a whole lot more than younger people. That’s probably one of the big things” in their favor, he added.

Dr. Wharton also is a clinical adjunct professor at York University, Toronto, and the lead author of 2020 Canadian clinical practice guidelines on obesity.

The current data were published in Obesity.
 

Practice makes perfect?

The prevalence of obesity is increasing. It is uncertain whether frequent weight losses help or hinder future weight-loss attempts. The effect of age at overweight on future weight loss attempts is also unclear.

To examine these questions, the current researchers analyzed the experiences of patients with obesity treated at the Wharton Medical Clinic Weight Management Program, Hamilton, Ont. At enrollment, participants responded to a questionnaire that elicited information about basic demographics, past weight loss and health practices, medical history, and family medical history. Patients did not receive any stipend for their participation and consented to the use of their medical data for research purposes. The investigators assessed weight change through a retrospective review of electronic medical records.

The study examined a data set that included 36,124 patients who were predominantly White, middle-aged women. “Although this is reflective of the demographic that is most commonly seeking obesity management in North America, the applicability of these findings to other groups is unclear,” wrote the investigators.

As a group, women under age 40 lost 1.7 kg, while those from ages 40 to 60 lost 3.2 kg, and women older than 60 lost 4.2 kg. Weight loss among men was greater and followed a similar pattern. Men under age 40 lost 3.0 kg, those between ages 40 and 60 lost 4.2 kg, and those older than 60 lost 5.2 kg.

To examine how long participants had been trying to lose weight, the investigators analyzed their age of overweight onset. Most participants reported having become overweight before age 40 and having lost at least 4.5 kg at least once in their lifetime. Older women with a longer history of losing weight had better results during the study.

In middle-aged and older women, but not men or younger women, earlier age of overweight onset and lifetime weight loss were associated with modestly greater weight loss at the clinic. When the researchers assessed women age 60 and older, they found that those who had an age of overweight onset before age 10 lost 4.9 kg on average, while those whose age of overweight onset was between ages 20 and 39 lost 4.3 kg. Women with an age of overweight onset above 40 had a weight loss of 3.5 kg.

The finding of greater weight loss in older women who were experienced in dieting was surprising, said Dr. Wharton. It may reflect the effects of perseverance and lifestyle changes. “The other thing is that [older women] also have more time. They have more availability. They make more appointments. They have the ability to be more focused,” said Dr. Wharton.

The Wharton Medical Clinic operates within the Ontario Health Insurance Plan, and all services are provided at no charge to the patient, which may reduce the selection bias against patients with low socioeconomic status, wrote the investigators.
 

Inclusive population

Lesley D. Lutes, PhD, director of the Center for Obesity and Well-Being Research Excellence (CORE) at the University of British Columbia, Vancouver, said that one of its strengths was its reflection of real-world experience.

Too often, study populations do not reflect well the experiences of people battling obesity, she added. Many potential participants are excluded because of common medical comorbidities such as heart conditions. “So, you don’t see the real-world outcomes for the majority of people” from these studies, said Dr. Lutes.

Furthermore, researchers sometimes draw conclusions about obesity based on data that draws from only a “tiny slice” of the group of patients who can qualify for studies, she added. The resulting recommendations may not suit most patients.

In contrast, the current research was based on a more inclusive set of patient data. “That was an incredible strength of this study, that there [were] no exclusionary criteria” in terms of medical conditions, she said.

No outside funding for the study was reported. Dr. Wharton is the medical director of the Wharton Medical Clinic.

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

Women with repeated attempts at weight loss, even if the weight is regained, have modestly greater weight loss at an obesity management clinic than women without such a history, data suggest.

In a retrospective study of data for more than 11,000 participants in a weight-management program, the frequency of weight loss was significantly correlated with the total lifetime weight loss in men (r = 0.61, P < .0001) and women (r = 0.60, P < .0001).

“It should be harder for you to lose weight when you’re older, as opposed to younger. That’s just biology,” study author Sean Wharton, MD, PharmD, medical director of the Wharton Medical Clinic, Burlington, Ont., told this news organization. But older people “have practiced a whole lot more than younger people. That’s probably one of the big things” in their favor, he added.

Dr. Wharton also is a clinical adjunct professor at York University, Toronto, and the lead author of 2020 Canadian clinical practice guidelines on obesity.

The current data were published in Obesity.
 

Practice makes perfect?

The prevalence of obesity is increasing. It is uncertain whether frequent weight losses help or hinder future weight-loss attempts. The effect of age at overweight on future weight loss attempts is also unclear.

To examine these questions, the current researchers analyzed the experiences of patients with obesity treated at the Wharton Medical Clinic Weight Management Program, Hamilton, Ont. At enrollment, participants responded to a questionnaire that elicited information about basic demographics, past weight loss and health practices, medical history, and family medical history. Patients did not receive any stipend for their participation and consented to the use of their medical data for research purposes. The investigators assessed weight change through a retrospective review of electronic medical records.

The study examined a data set that included 36,124 patients who were predominantly White, middle-aged women. “Although this is reflective of the demographic that is most commonly seeking obesity management in North America, the applicability of these findings to other groups is unclear,” wrote the investigators.

As a group, women under age 40 lost 1.7 kg, while those from ages 40 to 60 lost 3.2 kg, and women older than 60 lost 4.2 kg. Weight loss among men was greater and followed a similar pattern. Men under age 40 lost 3.0 kg, those between ages 40 and 60 lost 4.2 kg, and those older than 60 lost 5.2 kg.

To examine how long participants had been trying to lose weight, the investigators analyzed their age of overweight onset. Most participants reported having become overweight before age 40 and having lost at least 4.5 kg at least once in their lifetime. Older women with a longer history of losing weight had better results during the study.

In middle-aged and older women, but not men or younger women, earlier age of overweight onset and lifetime weight loss were associated with modestly greater weight loss at the clinic. When the researchers assessed women age 60 and older, they found that those who had an age of overweight onset before age 10 lost 4.9 kg on average, while those whose age of overweight onset was between ages 20 and 39 lost 4.3 kg. Women with an age of overweight onset above 40 had a weight loss of 3.5 kg.

The finding of greater weight loss in older women who were experienced in dieting was surprising, said Dr. Wharton. It may reflect the effects of perseverance and lifestyle changes. “The other thing is that [older women] also have more time. They have more availability. They make more appointments. They have the ability to be more focused,” said Dr. Wharton.

The Wharton Medical Clinic operates within the Ontario Health Insurance Plan, and all services are provided at no charge to the patient, which may reduce the selection bias against patients with low socioeconomic status, wrote the investigators.
 

Inclusive population

Lesley D. Lutes, PhD, director of the Center for Obesity and Well-Being Research Excellence (CORE) at the University of British Columbia, Vancouver, said that one of its strengths was its reflection of real-world experience.

Too often, study populations do not reflect well the experiences of people battling obesity, she added. Many potential participants are excluded because of common medical comorbidities such as heart conditions. “So, you don’t see the real-world outcomes for the majority of people” from these studies, said Dr. Lutes.

Furthermore, researchers sometimes draw conclusions about obesity based on data that draws from only a “tiny slice” of the group of patients who can qualify for studies, she added. The resulting recommendations may not suit most patients.

In contrast, the current research was based on a more inclusive set of patient data. “That was an incredible strength of this study, that there [were] no exclusionary criteria” in terms of medical conditions, she said.

No outside funding for the study was reported. Dr. Wharton is the medical director of the Wharton Medical Clinic.

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

Women with repeated attempts at weight loss, even if the weight is regained, have modestly greater weight loss at an obesity management clinic than women without such a history, data suggest.

In a retrospective study of data for more than 11,000 participants in a weight-management program, the frequency of weight loss was significantly correlated with the total lifetime weight loss in men (r = 0.61, P < .0001) and women (r = 0.60, P < .0001).

“It should be harder for you to lose weight when you’re older, as opposed to younger. That’s just biology,” study author Sean Wharton, MD, PharmD, medical director of the Wharton Medical Clinic, Burlington, Ont., told this news organization. But older people “have practiced a whole lot more than younger people. That’s probably one of the big things” in their favor, he added.

Dr. Wharton also is a clinical adjunct professor at York University, Toronto, and the lead author of 2020 Canadian clinical practice guidelines on obesity.

The current data were published in Obesity.
 

Practice makes perfect?

The prevalence of obesity is increasing. It is uncertain whether frequent weight losses help or hinder future weight-loss attempts. The effect of age at overweight on future weight loss attempts is also unclear.

To examine these questions, the current researchers analyzed the experiences of patients with obesity treated at the Wharton Medical Clinic Weight Management Program, Hamilton, Ont. At enrollment, participants responded to a questionnaire that elicited information about basic demographics, past weight loss and health practices, medical history, and family medical history. Patients did not receive any stipend for their participation and consented to the use of their medical data for research purposes. The investigators assessed weight change through a retrospective review of electronic medical records.

The study examined a data set that included 36,124 patients who were predominantly White, middle-aged women. “Although this is reflective of the demographic that is most commonly seeking obesity management in North America, the applicability of these findings to other groups is unclear,” wrote the investigators.

As a group, women under age 40 lost 1.7 kg, while those from ages 40 to 60 lost 3.2 kg, and women older than 60 lost 4.2 kg. Weight loss among men was greater and followed a similar pattern. Men under age 40 lost 3.0 kg, those between ages 40 and 60 lost 4.2 kg, and those older than 60 lost 5.2 kg.

To examine how long participants had been trying to lose weight, the investigators analyzed their age of overweight onset. Most participants reported having become overweight before age 40 and having lost at least 4.5 kg at least once in their lifetime. Older women with a longer history of losing weight had better results during the study.

In middle-aged and older women, but not men or younger women, earlier age of overweight onset and lifetime weight loss were associated with modestly greater weight loss at the clinic. When the researchers assessed women age 60 and older, they found that those who had an age of overweight onset before age 10 lost 4.9 kg on average, while those whose age of overweight onset was between ages 20 and 39 lost 4.3 kg. Women with an age of overweight onset above 40 had a weight loss of 3.5 kg.

The finding of greater weight loss in older women who were experienced in dieting was surprising, said Dr. Wharton. It may reflect the effects of perseverance and lifestyle changes. “The other thing is that [older women] also have more time. They have more availability. They make more appointments. They have the ability to be more focused,” said Dr. Wharton.

The Wharton Medical Clinic operates within the Ontario Health Insurance Plan, and all services are provided at no charge to the patient, which may reduce the selection bias against patients with low socioeconomic status, wrote the investigators.
 

Inclusive population

Lesley D. Lutes, PhD, director of the Center for Obesity and Well-Being Research Excellence (CORE) at the University of British Columbia, Vancouver, said that one of its strengths was its reflection of real-world experience.

Too often, study populations do not reflect well the experiences of people battling obesity, she added. Many potential participants are excluded because of common medical comorbidities such as heart conditions. “So, you don’t see the real-world outcomes for the majority of people” from these studies, said Dr. Lutes.

Furthermore, researchers sometimes draw conclusions about obesity based on data that draws from only a “tiny slice” of the group of patients who can qualify for studies, she added. The resulting recommendations may not suit most patients.

In contrast, the current research was based on a more inclusive set of patient data. “That was an incredible strength of this study, that there [were] no exclusionary criteria” in terms of medical conditions, she said.

No outside funding for the study was reported. Dr. Wharton is the medical director of the Wharton Medical Clinic.

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

The path through the U.S. Senate is not yet certain for a bill intended to speed the prior authorization process of insurer-run Medicare Advantage plans, despite the measure having breezed through the House.

House leaders opted to move the Improving Seniors’ Timely Access to Care Act of 2021 (H.R. 3173) without requiring a roll-call vote. The measure was passed on Sept. 14 by a voice vote, an approach used in general with only uncontroversial measures that have broad support. The bill has 191 Democratic and 135 Republican sponsors, representing about three-quarters of the members of the House.

Alicia Ault/Frontline Medical News

“There is no reason that patients should be waiting for medically appropriate care, especially when we know that this can lead to worse outcomes,” Rep. Earl Blumenauer (D-Ore.) said in a Sept. 14 speech on the House floor. “The fundamental promise of Medicare Advantage is undermined when people are delaying care, getting sicker, and ultimately costing Medicare more money.”

Rep. Greg Murphy, MD (R-N.C.), spoke on the House floor that day as well, bringing up cases he has seen in his own urology practice in which prior authorization delays disrupted medical care. One patient wound up in the hospital with abscess after an insurer denied an antibiotic prescription, Rep. Murphy said.

The Senate currently appears unlikely to move the prior authorization bill as a standalone measure. Instead, the bill may become part of a larger legislative package focused on health care that the Senate Finance Committee intends to prepare later this year.

The House-passed bill would require insurer-run Medicare plans to respond to expedited requests for prior authorization of services within 24 hours and to other requests within 7 days. This bill also would establish an electronic program for prior authorizations and mandate increased transparency as to how insurers use this tool.
 

CBO: Cost of change would be billions

In seeking to mandate changes in prior authorization, lawmakers likely will need to contend with the issue of a $16 billion cumulative cost estimate for the bill from the Congressional Budget Office. Members of Congress often seek to offset new spending by pairing bills that add to expected costs for the federal government with ones expected to produce savings.

Unlike Rep. Blumenauer, Rep. Murphy, and other backers of the prior authorization streamlining bill, CBO staff estimates that making the mandated changes would raise federal spending, inasmuch as there would be “a greater use of services.”

On Sept. 14, CBO issued a one-page report on the costs of the bill. The CBO report concerns only the bill in question, as is common practice with the office’s estimates.

Prior authorization changes would begin in fiscal 2025 and would add $899 million in spending, or outlays, that year, CBO said. The annual costs from the streamlined prior authorization practices through fiscal 2026 to 2032 range from $1.6 billion to $2.7 billion.

Looking at the CBO estimate against a backdrop of total Medicare Advantage costs may provide important context.

The increases in spending estimated by CBO may suggest that there would be little change in federal spending as a result of streamlining prior authorization practices. These estimates of increased annual spending of $1.6 billion–$2.7 billion are only a small fraction of the current annual cost of insurer-run Medicare, and they represent an even smaller share of the projected expense.

The federal government last year spent about $350 billion on insurer-run plans, excluding Part D drug plan payments, according to the Medicare Advisory Payment Commission (MedPAC).

As of 2021, about 27 million people were enrolled in these plans, accounting for about 46% of the total Medicare population. Enrollment has doubled since 2010, MedPAC said, and it is expected to continue to grow. By 2027, insurer-run Medicare could cover 50% of the program’s population, a figure that may reach 53% by 2031.

Federal payments to these plans will accelerate in the years ahead as insurers attract more people eligible for Medicare as customers. Payments to these private health plans could rise from an expected $418 billion this year to $940.6 billion by 2031, according to the most recent Medicare trustees report.
 

Good intentions, poor implementation?

Insurer-run Medicare has long enjoyed deep bipartisan support in Congress. That’s due in part to its potential for reducing spending on what are considered low-value treatments, or ones considered unlikely to provide a significant medical benefit, but Rep. Blumenauer is among the members of Congress who see insurer-run Medicare as a path for preserving the giant federal health program. Traditional Medicare has far fewer restrictions on services, which sometimes opens a path for tests and treatments that offer less value for patients.

“I believe that the way traditional fee-for-service Medicare operates is not sustainable and that Medicare Advantage is one of the tools we can use to demonstrate how we can incentivize value,” Rep. Blumenauer said on the House floor. “But this is only possible when the program operates as intended. I have been deeply concerned about the reports of delays in care” caused by the clunky prior authorization processes.

He highlighted a recent report from the internal watchdog group for the Department of Health & Human Services that raises concerns about denials of appropriate care. About 18% of a set of payment denials examined by the Office of Inspector General of HHS in April actually met Medicare coverage rules and plan billing rules.

“For patients and their families, being told that you need to wait longer for care that your doctor tells you that you need is incredibly frustrating and frightening,” Rep. Blumenauer said. “There’s no comfort to be found in the fact that your insurance company needs time to decide if your doctor is right.”
 

Trends in prior authorization

The CBO report does not provide detail on what kind of medical spending would increase under a streamlined prior authorization process in insurer-run Medicare plans.

From trends reported in prior authorization, though, two factors could be at play in what appear to be relatively small estimated increases in Medicare spending from streamlined prior authorization.

The work already underway to create less burdensome electronic systems for these requests, such as the Fast Prior Authorization Technology Highway initiative run by the America’s Health Insurance Plans trade association.

The other factor could be the number of cases in which prior authorization merely causes delays in treatments and tests and thus simply postpones spending while adding to clinicians’ administrative work.

An analysis of prior authorization requests for dermatologic practices affiliated with the University of Utah may represent an extreme example. In a report published in JAMA Dermatology in 2020, researchers described what happened with requests made during 1 month, September 2016.

The approval rate for procedures was 99.6% – 100% (95 of 95) for Mohs surgery, and 96% (130 of 131, with 4 additional cases pending) for excisions. These findings supported calls for simplifying prior authorization procedures, “perhaps first by eliminating unnecessary PAs [prior authorizations] and appeals,” Aaron M. Secrest, MD, PhD, of the University of Utah, Salt Lake City, and coauthors wrote in the article.

Still, there is some evidence that insurer-run Medicare policies reduce the use of low-value care.

In a study published in JAMA Health Forum, Emily Boudreau, PhD, of insurer Humana Inc, and coauthors from Tufts University, Boston, and the University of Pennsylvania, Philadelphia investigated whether insurer-run Medicare could do a better job in reducing the amount of low-value care delivered than the traditional program. They analyzed a set of claims data from 2017 to 2019 for people enrolled in insurer-run and traditional Medicare.

They reported a rate of 23.07 low-value services provided per 100 people in insurer-run Medicare, compared with 25.39 for those in traditional Medicare. Some of the biggest differences reported in the article were in cancer screenings for older people.

As an example, the U.S. Preventive Services Task Force recommends that women older than 65 years not be screened for cervical cancer if they have undergone adequate screening in the past and are not at high risk for cervical cancer. There was an annual count of 1.76 screenings for cervical cancer per 100 women older than 65 in the insurer-run Medicare group versus 3.18 for those in traditional Medicare.

The Better Medicare Alliance issued a statement in favor of the House passage of the Improving Seniors’ Timely Access to Care Act.

In it, the group said the measure would “modernize prior authorization while protecting its essential function in facilitating safe, high-value, evidence-based care.” The alliance promotes use of insurer-run Medicare. The board of the Better Medicare Alliance includes executives who serve with firms that run Advantage plans as well as medical organizations and universities.

“With studies showing that up to one-quarter of all health care expenditures are wasted on services with no benefit to the patient, we need a robust, next-generation prior authorization program to deter low-value, and even harmful, care while protecting access to needed treatment and effective therapies,” said A. Mark Fendrick, MD, director of the University of Michigan’s Center for Value-Based Insurance Design in Ann Arbor, in a statement issued by the Better Medicare Alliance. He is a member of the group’s council of scholars.

On the House floor on September 14, Rep. Ami Bera, MD (D-Calif.), said he has heard from former colleagues and his medical school classmates that they now spend as much as 40% of their time on administrative work. These distractions from patient care are helping drive physicians away from the practice of medicine.

Still, the internist defended the basic premise of prior authorization while strongly appealing for better systems of handling it.

“Yes, there is a role for prior authorization in limited cases. There is also a role to go back and retrospectively look at how care is being delivered,” Rep. Bera said. “But what is happening today is a travesty. It wasn’t the intention of prior authorization. It is a prior authorization process gone awry.”

AGA’s stance: This is a huge victory for patients! Advocating for prior authorization reform has been AGA’s top priority. Learn more about prior authorization and how it impacts gastroenterology on the AGA website. 

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

The path through the U.S. Senate is not yet certain for a bill intended to speed the prior authorization process of insurer-run Medicare Advantage plans, despite the measure having breezed through the House.

House leaders opted to move the Improving Seniors’ Timely Access to Care Act of 2021 (H.R. 3173) without requiring a roll-call vote. The measure was passed on Sept. 14 by a voice vote, an approach used in general with only uncontroversial measures that have broad support. The bill has 191 Democratic and 135 Republican sponsors, representing about three-quarters of the members of the House.

Alicia Ault/Frontline Medical News

“There is no reason that patients should be waiting for medically appropriate care, especially when we know that this can lead to worse outcomes,” Rep. Earl Blumenauer (D-Ore.) said in a Sept. 14 speech on the House floor. “The fundamental promise of Medicare Advantage is undermined when people are delaying care, getting sicker, and ultimately costing Medicare more money.”

Rep. Greg Murphy, MD (R-N.C.), spoke on the House floor that day as well, bringing up cases he has seen in his own urology practice in which prior authorization delays disrupted medical care. One patient wound up in the hospital with abscess after an insurer denied an antibiotic prescription, Rep. Murphy said.

The Senate currently appears unlikely to move the prior authorization bill as a standalone measure. Instead, the bill may become part of a larger legislative package focused on health care that the Senate Finance Committee intends to prepare later this year.

The House-passed bill would require insurer-run Medicare plans to respond to expedited requests for prior authorization of services within 24 hours and to other requests within 7 days. This bill also would establish an electronic program for prior authorizations and mandate increased transparency as to how insurers use this tool.
 

CBO: Cost of change would be billions

In seeking to mandate changes in prior authorization, lawmakers likely will need to contend with the issue of a $16 billion cumulative cost estimate for the bill from the Congressional Budget Office. Members of Congress often seek to offset new spending by pairing bills that add to expected costs for the federal government with ones expected to produce savings.

Unlike Rep. Blumenauer, Rep. Murphy, and other backers of the prior authorization streamlining bill, CBO staff estimates that making the mandated changes would raise federal spending, inasmuch as there would be “a greater use of services.”

On Sept. 14, CBO issued a one-page report on the costs of the bill. The CBO report concerns only the bill in question, as is common practice with the office’s estimates.

Prior authorization changes would begin in fiscal 2025 and would add $899 million in spending, or outlays, that year, CBO said. The annual costs from the streamlined prior authorization practices through fiscal 2026 to 2032 range from $1.6 billion to $2.7 billion.

Looking at the CBO estimate against a backdrop of total Medicare Advantage costs may provide important context.

The increases in spending estimated by CBO may suggest that there would be little change in federal spending as a result of streamlining prior authorization practices. These estimates of increased annual spending of $1.6 billion–$2.7 billion are only a small fraction of the current annual cost of insurer-run Medicare, and they represent an even smaller share of the projected expense.

The federal government last year spent about $350 billion on insurer-run plans, excluding Part D drug plan payments, according to the Medicare Advisory Payment Commission (MedPAC).

As of 2021, about 27 million people were enrolled in these plans, accounting for about 46% of the total Medicare population. Enrollment has doubled since 2010, MedPAC said, and it is expected to continue to grow. By 2027, insurer-run Medicare could cover 50% of the program’s population, a figure that may reach 53% by 2031.

Federal payments to these plans will accelerate in the years ahead as insurers attract more people eligible for Medicare as customers. Payments to these private health plans could rise from an expected $418 billion this year to $940.6 billion by 2031, according to the most recent Medicare trustees report.
 

Good intentions, poor implementation?

Insurer-run Medicare has long enjoyed deep bipartisan support in Congress. That’s due in part to its potential for reducing spending on what are considered low-value treatments, or ones considered unlikely to provide a significant medical benefit, but Rep. Blumenauer is among the members of Congress who see insurer-run Medicare as a path for preserving the giant federal health program. Traditional Medicare has far fewer restrictions on services, which sometimes opens a path for tests and treatments that offer less value for patients.

“I believe that the way traditional fee-for-service Medicare operates is not sustainable and that Medicare Advantage is one of the tools we can use to demonstrate how we can incentivize value,” Rep. Blumenauer said on the House floor. “But this is only possible when the program operates as intended. I have been deeply concerned about the reports of delays in care” caused by the clunky prior authorization processes.

He highlighted a recent report from the internal watchdog group for the Department of Health & Human Services that raises concerns about denials of appropriate care. About 18% of a set of payment denials examined by the Office of Inspector General of HHS in April actually met Medicare coverage rules and plan billing rules.

“For patients and their families, being told that you need to wait longer for care that your doctor tells you that you need is incredibly frustrating and frightening,” Rep. Blumenauer said. “There’s no comfort to be found in the fact that your insurance company needs time to decide if your doctor is right.”
 

Trends in prior authorization

The CBO report does not provide detail on what kind of medical spending would increase under a streamlined prior authorization process in insurer-run Medicare plans.

From trends reported in prior authorization, though, two factors could be at play in what appear to be relatively small estimated increases in Medicare spending from streamlined prior authorization.

The work already underway to create less burdensome electronic systems for these requests, such as the Fast Prior Authorization Technology Highway initiative run by the America’s Health Insurance Plans trade association.

The other factor could be the number of cases in which prior authorization merely causes delays in treatments and tests and thus simply postpones spending while adding to clinicians’ administrative work.

An analysis of prior authorization requests for dermatologic practices affiliated with the University of Utah may represent an extreme example. In a report published in JAMA Dermatology in 2020, researchers described what happened with requests made during 1 month, September 2016.

The approval rate for procedures was 99.6% – 100% (95 of 95) for Mohs surgery, and 96% (130 of 131, with 4 additional cases pending) for excisions. These findings supported calls for simplifying prior authorization procedures, “perhaps first by eliminating unnecessary PAs [prior authorizations] and appeals,” Aaron M. Secrest, MD, PhD, of the University of Utah, Salt Lake City, and coauthors wrote in the article.

Still, there is some evidence that insurer-run Medicare policies reduce the use of low-value care.

In a study published in JAMA Health Forum, Emily Boudreau, PhD, of insurer Humana Inc, and coauthors from Tufts University, Boston, and the University of Pennsylvania, Philadelphia investigated whether insurer-run Medicare could do a better job in reducing the amount of low-value care delivered than the traditional program. They analyzed a set of claims data from 2017 to 2019 for people enrolled in insurer-run and traditional Medicare.

They reported a rate of 23.07 low-value services provided per 100 people in insurer-run Medicare, compared with 25.39 for those in traditional Medicare. Some of the biggest differences reported in the article were in cancer screenings for older people.

As an example, the U.S. Preventive Services Task Force recommends that women older than 65 years not be screened for cervical cancer if they have undergone adequate screening in the past and are not at high risk for cervical cancer. There was an annual count of 1.76 screenings for cervical cancer per 100 women older than 65 in the insurer-run Medicare group versus 3.18 for those in traditional Medicare.

The Better Medicare Alliance issued a statement in favor of the House passage of the Improving Seniors’ Timely Access to Care Act.

In it, the group said the measure would “modernize prior authorization while protecting its essential function in facilitating safe, high-value, evidence-based care.” The alliance promotes use of insurer-run Medicare. The board of the Better Medicare Alliance includes executives who serve with firms that run Advantage plans as well as medical organizations and universities.

“With studies showing that up to one-quarter of all health care expenditures are wasted on services with no benefit to the patient, we need a robust, next-generation prior authorization program to deter low-value, and even harmful, care while protecting access to needed treatment and effective therapies,” said A. Mark Fendrick, MD, director of the University of Michigan’s Center for Value-Based Insurance Design in Ann Arbor, in a statement issued by the Better Medicare Alliance. He is a member of the group’s council of scholars.

On the House floor on September 14, Rep. Ami Bera, MD (D-Calif.), said he has heard from former colleagues and his medical school classmates that they now spend as much as 40% of their time on administrative work. These distractions from patient care are helping drive physicians away from the practice of medicine.

Still, the internist defended the basic premise of prior authorization while strongly appealing for better systems of handling it.

“Yes, there is a role for prior authorization in limited cases. There is also a role to go back and retrospectively look at how care is being delivered,” Rep. Bera said. “But what is happening today is a travesty. It wasn’t the intention of prior authorization. It is a prior authorization process gone awry.”

AGA’s stance: This is a huge victory for patients! Advocating for prior authorization reform has been AGA’s top priority. Learn more about prior authorization and how it impacts gastroenterology on the AGA website. 

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

The path through the U.S. Senate is not yet certain for a bill intended to speed the prior authorization process of insurer-run Medicare Advantage plans, despite the measure having breezed through the House.

House leaders opted to move the Improving Seniors’ Timely Access to Care Act of 2021 (H.R. 3173) without requiring a roll-call vote. The measure was passed on Sept. 14 by a voice vote, an approach used in general with only uncontroversial measures that have broad support. The bill has 191 Democratic and 135 Republican sponsors, representing about three-quarters of the members of the House.

Alicia Ault/Frontline Medical News

“There is no reason that patients should be waiting for medically appropriate care, especially when we know that this can lead to worse outcomes,” Rep. Earl Blumenauer (D-Ore.) said in a Sept. 14 speech on the House floor. “The fundamental promise of Medicare Advantage is undermined when people are delaying care, getting sicker, and ultimately costing Medicare more money.”

Rep. Greg Murphy, MD (R-N.C.), spoke on the House floor that day as well, bringing up cases he has seen in his own urology practice in which prior authorization delays disrupted medical care. One patient wound up in the hospital with abscess after an insurer denied an antibiotic prescription, Rep. Murphy said.

The Senate currently appears unlikely to move the prior authorization bill as a standalone measure. Instead, the bill may become part of a larger legislative package focused on health care that the Senate Finance Committee intends to prepare later this year.

The House-passed bill would require insurer-run Medicare plans to respond to expedited requests for prior authorization of services within 24 hours and to other requests within 7 days. This bill also would establish an electronic program for prior authorizations and mandate increased transparency as to how insurers use this tool.
 

CBO: Cost of change would be billions

In seeking to mandate changes in prior authorization, lawmakers likely will need to contend with the issue of a $16 billion cumulative cost estimate for the bill from the Congressional Budget Office. Members of Congress often seek to offset new spending by pairing bills that add to expected costs for the federal government with ones expected to produce savings.

Unlike Rep. Blumenauer, Rep. Murphy, and other backers of the prior authorization streamlining bill, CBO staff estimates that making the mandated changes would raise federal spending, inasmuch as there would be “a greater use of services.”

On Sept. 14, CBO issued a one-page report on the costs of the bill. The CBO report concerns only the bill in question, as is common practice with the office’s estimates.

Prior authorization changes would begin in fiscal 2025 and would add $899 million in spending, or outlays, that year, CBO said. The annual costs from the streamlined prior authorization practices through fiscal 2026 to 2032 range from $1.6 billion to $2.7 billion.

Looking at the CBO estimate against a backdrop of total Medicare Advantage costs may provide important context.

The increases in spending estimated by CBO may suggest that there would be little change in federal spending as a result of streamlining prior authorization practices. These estimates of increased annual spending of $1.6 billion–$2.7 billion are only a small fraction of the current annual cost of insurer-run Medicare, and they represent an even smaller share of the projected expense.

The federal government last year spent about $350 billion on insurer-run plans, excluding Part D drug plan payments, according to the Medicare Advisory Payment Commission (MedPAC).

As of 2021, about 27 million people were enrolled in these plans, accounting for about 46% of the total Medicare population. Enrollment has doubled since 2010, MedPAC said, and it is expected to continue to grow. By 2027, insurer-run Medicare could cover 50% of the program’s population, a figure that may reach 53% by 2031.

Federal payments to these plans will accelerate in the years ahead as insurers attract more people eligible for Medicare as customers. Payments to these private health plans could rise from an expected $418 billion this year to $940.6 billion by 2031, according to the most recent Medicare trustees report.
 

Good intentions, poor implementation?

Insurer-run Medicare has long enjoyed deep bipartisan support in Congress. That’s due in part to its potential for reducing spending on what are considered low-value treatments, or ones considered unlikely to provide a significant medical benefit, but Rep. Blumenauer is among the members of Congress who see insurer-run Medicare as a path for preserving the giant federal health program. Traditional Medicare has far fewer restrictions on services, which sometimes opens a path for tests and treatments that offer less value for patients.

“I believe that the way traditional fee-for-service Medicare operates is not sustainable and that Medicare Advantage is one of the tools we can use to demonstrate how we can incentivize value,” Rep. Blumenauer said on the House floor. “But this is only possible when the program operates as intended. I have been deeply concerned about the reports of delays in care” caused by the clunky prior authorization processes.

He highlighted a recent report from the internal watchdog group for the Department of Health & Human Services that raises concerns about denials of appropriate care. About 18% of a set of payment denials examined by the Office of Inspector General of HHS in April actually met Medicare coverage rules and plan billing rules.

“For patients and their families, being told that you need to wait longer for care that your doctor tells you that you need is incredibly frustrating and frightening,” Rep. Blumenauer said. “There’s no comfort to be found in the fact that your insurance company needs time to decide if your doctor is right.”
 

Trends in prior authorization

The CBO report does not provide detail on what kind of medical spending would increase under a streamlined prior authorization process in insurer-run Medicare plans.

From trends reported in prior authorization, though, two factors could be at play in what appear to be relatively small estimated increases in Medicare spending from streamlined prior authorization.

The work already underway to create less burdensome electronic systems for these requests, such as the Fast Prior Authorization Technology Highway initiative run by the America’s Health Insurance Plans trade association.

The other factor could be the number of cases in which prior authorization merely causes delays in treatments and tests and thus simply postpones spending while adding to clinicians’ administrative work.

An analysis of prior authorization requests for dermatologic practices affiliated with the University of Utah may represent an extreme example. In a report published in JAMA Dermatology in 2020, researchers described what happened with requests made during 1 month, September 2016.

The approval rate for procedures was 99.6% – 100% (95 of 95) for Mohs surgery, and 96% (130 of 131, with 4 additional cases pending) for excisions. These findings supported calls for simplifying prior authorization procedures, “perhaps first by eliminating unnecessary PAs [prior authorizations] and appeals,” Aaron M. Secrest, MD, PhD, of the University of Utah, Salt Lake City, and coauthors wrote in the article.

Still, there is some evidence that insurer-run Medicare policies reduce the use of low-value care.

In a study published in JAMA Health Forum, Emily Boudreau, PhD, of insurer Humana Inc, and coauthors from Tufts University, Boston, and the University of Pennsylvania, Philadelphia investigated whether insurer-run Medicare could do a better job in reducing the amount of low-value care delivered than the traditional program. They analyzed a set of claims data from 2017 to 2019 for people enrolled in insurer-run and traditional Medicare.

They reported a rate of 23.07 low-value services provided per 100 people in insurer-run Medicare, compared with 25.39 for those in traditional Medicare. Some of the biggest differences reported in the article were in cancer screenings for older people.

As an example, the U.S. Preventive Services Task Force recommends that women older than 65 years not be screened for cervical cancer if they have undergone adequate screening in the past and are not at high risk for cervical cancer. There was an annual count of 1.76 screenings for cervical cancer per 100 women older than 65 in the insurer-run Medicare group versus 3.18 for those in traditional Medicare.

The Better Medicare Alliance issued a statement in favor of the House passage of the Improving Seniors’ Timely Access to Care Act.

In it, the group said the measure would “modernize prior authorization while protecting its essential function in facilitating safe, high-value, evidence-based care.” The alliance promotes use of insurer-run Medicare. The board of the Better Medicare Alliance includes executives who serve with firms that run Advantage plans as well as medical organizations and universities.

“With studies showing that up to one-quarter of all health care expenditures are wasted on services with no benefit to the patient, we need a robust, next-generation prior authorization program to deter low-value, and even harmful, care while protecting access to needed treatment and effective therapies,” said A. Mark Fendrick, MD, director of the University of Michigan’s Center for Value-Based Insurance Design in Ann Arbor, in a statement issued by the Better Medicare Alliance. He is a member of the group’s council of scholars.

On the House floor on September 14, Rep. Ami Bera, MD (D-Calif.), said he has heard from former colleagues and his medical school classmates that they now spend as much as 40% of their time on administrative work. These distractions from patient care are helping drive physicians away from the practice of medicine.

Still, the internist defended the basic premise of prior authorization while strongly appealing for better systems of handling it.

“Yes, there is a role for prior authorization in limited cases. There is also a role to go back and retrospectively look at how care is being delivered,” Rep. Bera said. “But what is happening today is a travesty. It wasn’t the intention of prior authorization. It is a prior authorization process gone awry.”

AGA’s stance: This is a huge victory for patients! Advocating for prior authorization reform has been AGA’s top priority. Learn more about prior authorization and how it impacts gastroenterology on the AGA website. 

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

The path through the U.S. Senate is not yet certain for a bill intended to speed the prior authorization process of insurer-run Medicare Advantage plans, despite the measure having breezed through the House.

House leaders opted to move the Improving Seniors’ Timely Access to Care Act of 2021 (HR 3173) without requiring a roll-call vote. The measure was passed on Sept. 14 by a voice vote, an approach used in general with only uncontroversial measures that have broad support. The bill has 191 Democratic and 135 Republican sponsors, representing about three-quarters of the members of the House.

Alicia Ault/Frontline Medical News

“There is no reason that patients should be waiting for medically appropriate care, especially when we know that this can lead to worse outcomes,” Rep. Earl Blumenauer (D-Ore.) said in a Sept. 14 speech on the House floor. “The fundamental promise of Medicare Advantage is undermined when people are delaying care, getting sicker, and ultimately costing Medicare more money.”

Rep. Greg Murphy, MD (R-N.C.), spoke on the House floor that day as well, bringing up cases he has seen in his own urology practice in which prior authorization delays disrupted medical care. One patient wound up in the hospital with abscess after an insurer denied an antibiotic prescription, Rep. Murphy said.

But the Senate appears unlikely at this time to move the prior authorization bill as a standalone measure. Instead, the bill may become part of a larger legislative package focused on health care that the Senate Finance Committee intends to prepare later this year.

The House-passed bill would require insurer-run Medicare plans to respond to expedited requests for prior authorization of services within 24 hours and to other requests within 7 days. This bill also would establish an electronic program for prior authorizations and mandate increased transparency as to how insurers use this tool.
 

CBO: Cost of change would be billions

In seeking to mandate changes in prior authorization, lawmakers likely will need to contend with the issue of a $16 billion cumulative cost estimate for the bill from the Congressional Budget Office. Members of Congress often seek to offset new spending by pairing bills that add to expected costs for the federal government with ones expected to produce savings.

Unlike Rep. Blumenauer, Rep. Murphy, and other backers of the prior authorization streamlining bill, CBO staff estimates that making the mandated changes would raise federal spending, inasmuch as there would be “a greater use of services.”

On Sept. 14, CBO issued a one-page report on the costs of the bill. The CBO report concerns only the bill in question, as is common practice with the office’s estimates.

Prior authorization changes would begin in fiscal 2025 and would add $899 million in spending, or outlays, that year, CBO said. The annual costs from the streamlined prior authorization practices through fiscal 2026 to 2032 range from $1.6 billion to $2.7 billion.

Looking at the CBO estimate against a backdrop of total Medicare Advantage costs, though, may provide important context.

The increases in spending estimated by CBO may suggest that there would be little change in federal spending as a result of streamlining prior authorization practices. These estimates of increased annual spending of $1.6 billion–$2.7 billion are only a small fraction of the current annual cost of insurer-run Medicare, and they represent an even smaller share of the projected expense.

The federal government last year spent about $350 billion on insurer-run plans, excluding Part D drug plan payments, according to the Medicare Advisory Payment Commission (MedPAC).

As of 2021, about 27 million people were enrolled in these plans, accounting for about 46% of the total Medicare population. Enrollment has doubled since 2010, MedPAC said, and it is expected to continue to grow. By 2027, insurer-run Medicare could cover 50% of the program’s population, a figure that may reach 53% by 2031.

Federal payments to these plans will accelerate in the years ahead as insurers attract more people eligible for Medicare as customers. Payments to these private health plans could rise from an expected $418 billion this year to $940.6 billion by 2031, according to the most recent Medicare trustees report.

Good intentions, poor implementation?

Insurer-run Medicare has long enjoyed deep bipartisan support in Congress. That’s due in part to its potential for reducing spending on what are considered low-value treatments, or ones considered unlikely to provide a significant medical benefit, but Rep. Blumenauer is among the members of Congress who see insurer-run Medicare as a path for preserving the giant federal health program. Traditional Medicare has far fewer restrictions on services, which sometimes opens a path for tests and treatments that offer less value for patients.

“I believe that the way traditional fee-for-service Medicare operates is not sustainable and that Medicare Advantage is one of the tools we can use to demonstrate how we can incentivize value,” Rep. Blumenauer said on the House floor. “But this is only possible when the program operates as intended. I have been deeply concerned about the reports of delays in care” caused by the clunky prior authorization processes.

He highlighted a recent report from the internal watchdog group for the Department of Health & Human Services that raises concerns about denials of appropriate care. About 18% of a set of payment denials examined by the Office of Inspector General of HHS in April actually met Medicare coverage rules and plan billing rules.

“For patients and their families, being told that you need to wait longer for care that your doctor tells you that you need is incredibly frustrating and frightening,” Rep. Blumenauer said. “There’s no comfort to be found in the fact that your insurance company needs time to decide if your doctor is right.”
 

Trends in prior authorization

The CBO report does not provide detail on what kind of medical spending would increase under a streamlined prior authorization process in insurer-run Medicare plans.

From trends reported in prior authorization, though, two factors could be at play in what appear to be relatively small estimated increases in Medicare spending from streamlined prior authorization.

One is the work already underway to create less burdensome electronic systems for these requests, such as the Fast Prior Authorization Technology Highway initiative run by the trade association America’s Health Insurance Plans.

The other factor could be the number of cases in which prior authorization merely causes delays in treatments and tests and thus simply postpones spending while adding to clinicians’ administrative work.

An analysis of prior authorization requests for dermatologic practices affiliated with the University of Utah may represent an extreme example. In a report published in JAMA Dermatology in 2020, researchers described what happened with requests made during 1 month, September 2016.

The approval rate for procedures was 99.6% – 100% (95 of 95) for Mohs surgery, and 96% (130 of 131, with 4 additional cases pending) for excisions. These findings supported calls for simplifying prior authorization procedures, “perhaps first by eliminating unnecessary PAs [prior authorizations] and appeals,” Aaron M. Secrest, MD, PhD, of the University of Utah, Salt Lake City, and coauthors wrote in the article.

Still, there is some evidence that insurer-run Medicare policies reduce the use of low-value care.

In a study published in JAMA Health Forum, Emily Boudreau, PhD, of insurer Humana Inc, and coauthors from Tufts University, Boston, and the University of Pennsylvania, Philadelphia investigated whether insurer-run Medicare could do a better job in reducing the amount of low-value care delivered than the traditional program. They analyzed a set of claims data from 2017 to 2019 for people enrolled in insurer-run and traditional Medicare.

They reported a rate of 23.07 low-value services provided per 100 people in insurer-run Medicare, compared with 25.39 for those in traditional Medicare. Some of the biggest differences reported in the article were in cancer screenings for older people.

As an example, the U.S. Preventive Services Task Force recommends that women older than 65 years not be screened for cervical cancer if they have undergone adequate screening in the past and are not at high risk for cervical cancer. There was an annual count of 1.76 screenings for cervical cancer per 100 women older than 65 in the insurer-run Medicare group versus 3.18 for those in traditional Medicare.

The Better Medicare Alliance issued a statement in favor of the House passage of the Improving Seniors’ Timely Access to Care Act.

In it, the group said the measure would “modernize prior authorization while protecting its essential function in facilitating safe, high-value, evidence-based care.” The alliance promotes use of insurer-run Medicare. The board of the Better Medicare Alliance includes executives who serve with firms that run Advantage plans as well as medical organizations and universities.

“With studies showing that up to one-quarter of all health care expenditures are wasted on services with no benefit to the patient, we need a robust, next-generation prior authorization program to deter low-value, and even harmful, care while protecting access to needed treatment and effective therapies,” said A. Mark Fendrick, MD, director of the University of Michigan’s Center for Value-Based Insurance Design in Ann Arbor, in a statement issued by the Better Medicare Alliance. He is a member of the group’s council of scholars.

On the House floor on September 14, Rep. Ami Bera, MD (D-Calif.), said he has heard from former colleagues and his medical school classmates that they now spend as much as 40% of their time on administrative work. These distractions from patient care are helping drive physicians away from the practice of medicine.

Still, the internist defended the basic premise of prior authorization while strongly appealing for better systems of handling it.

“Yes, there is a role for prior authorization in limited cases. There is also a role to go back and retrospectively look at how care is being delivered,” Rep. Bera said. “But what is happening today is a travesty. It wasn’t the intention of prior authorization. It is a prior authorization process gone awry.”

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

The path through the U.S. Senate is not yet certain for a bill intended to speed the prior authorization process of insurer-run Medicare Advantage plans, despite the measure having breezed through the House.

House leaders opted to move the Improving Seniors’ Timely Access to Care Act of 2021 (HR 3173) without requiring a roll-call vote. The measure was passed on Sept. 14 by a voice vote, an approach used in general with only uncontroversial measures that have broad support. The bill has 191 Democratic and 135 Republican sponsors, representing about three-quarters of the members of the House.

Alicia Ault/Frontline Medical News

“There is no reason that patients should be waiting for medically appropriate care, especially when we know that this can lead to worse outcomes,” Rep. Earl Blumenauer (D-Ore.) said in a Sept. 14 speech on the House floor. “The fundamental promise of Medicare Advantage is undermined when people are delaying care, getting sicker, and ultimately costing Medicare more money.”

Rep. Greg Murphy, MD (R-N.C.), spoke on the House floor that day as well, bringing up cases he has seen in his own urology practice in which prior authorization delays disrupted medical care. One patient wound up in the hospital with abscess after an insurer denied an antibiotic prescription, Rep. Murphy said.

But the Senate appears unlikely at this time to move the prior authorization bill as a standalone measure. Instead, the bill may become part of a larger legislative package focused on health care that the Senate Finance Committee intends to prepare later this year.

The House-passed bill would require insurer-run Medicare plans to respond to expedited requests for prior authorization of services within 24 hours and to other requests within 7 days. This bill also would establish an electronic program for prior authorizations and mandate increased transparency as to how insurers use this tool.
 

CBO: Cost of change would be billions

In seeking to mandate changes in prior authorization, lawmakers likely will need to contend with the issue of a $16 billion cumulative cost estimate for the bill from the Congressional Budget Office. Members of Congress often seek to offset new spending by pairing bills that add to expected costs for the federal government with ones expected to produce savings.

Unlike Rep. Blumenauer, Rep. Murphy, and other backers of the prior authorization streamlining bill, CBO staff estimates that making the mandated changes would raise federal spending, inasmuch as there would be “a greater use of services.”

On Sept. 14, CBO issued a one-page report on the costs of the bill. The CBO report concerns only the bill in question, as is common practice with the office’s estimates.

Prior authorization changes would begin in fiscal 2025 and would add $899 million in spending, or outlays, that year, CBO said. The annual costs from the streamlined prior authorization practices through fiscal 2026 to 2032 range from $1.6 billion to $2.7 billion.

Looking at the CBO estimate against a backdrop of total Medicare Advantage costs, though, may provide important context.

The increases in spending estimated by CBO may suggest that there would be little change in federal spending as a result of streamlining prior authorization practices. These estimates of increased annual spending of $1.6 billion–$2.7 billion are only a small fraction of the current annual cost of insurer-run Medicare, and they represent an even smaller share of the projected expense.

The federal government last year spent about $350 billion on insurer-run plans, excluding Part D drug plan payments, according to the Medicare Advisory Payment Commission (MedPAC).

As of 2021, about 27 million people were enrolled in these plans, accounting for about 46% of the total Medicare population. Enrollment has doubled since 2010, MedPAC said, and it is expected to continue to grow. By 2027, insurer-run Medicare could cover 50% of the program’s population, a figure that may reach 53% by 2031.

Federal payments to these plans will accelerate in the years ahead as insurers attract more people eligible for Medicare as customers. Payments to these private health plans could rise from an expected $418 billion this year to $940.6 billion by 2031, according to the most recent Medicare trustees report.

Good intentions, poor implementation?

Insurer-run Medicare has long enjoyed deep bipartisan support in Congress. That’s due in part to its potential for reducing spending on what are considered low-value treatments, or ones considered unlikely to provide a significant medical benefit, but Rep. Blumenauer is among the members of Congress who see insurer-run Medicare as a path for preserving the giant federal health program. Traditional Medicare has far fewer restrictions on services, which sometimes opens a path for tests and treatments that offer less value for patients.

“I believe that the way traditional fee-for-service Medicare operates is not sustainable and that Medicare Advantage is one of the tools we can use to demonstrate how we can incentivize value,” Rep. Blumenauer said on the House floor. “But this is only possible when the program operates as intended. I have been deeply concerned about the reports of delays in care” caused by the clunky prior authorization processes.

He highlighted a recent report from the internal watchdog group for the Department of Health & Human Services that raises concerns about denials of appropriate care. About 18% of a set of payment denials examined by the Office of Inspector General of HHS in April actually met Medicare coverage rules and plan billing rules.

“For patients and their families, being told that you need to wait longer for care that your doctor tells you that you need is incredibly frustrating and frightening,” Rep. Blumenauer said. “There’s no comfort to be found in the fact that your insurance company needs time to decide if your doctor is right.”
 

Trends in prior authorization

The CBO report does not provide detail on what kind of medical spending would increase under a streamlined prior authorization process in insurer-run Medicare plans.

From trends reported in prior authorization, though, two factors could be at play in what appear to be relatively small estimated increases in Medicare spending from streamlined prior authorization.

One is the work already underway to create less burdensome electronic systems for these requests, such as the Fast Prior Authorization Technology Highway initiative run by the trade association America’s Health Insurance Plans.

The other factor could be the number of cases in which prior authorization merely causes delays in treatments and tests and thus simply postpones spending while adding to clinicians’ administrative work.

An analysis of prior authorization requests for dermatologic practices affiliated with the University of Utah may represent an extreme example. In a report published in JAMA Dermatology in 2020, researchers described what happened with requests made during 1 month, September 2016.

The approval rate for procedures was 99.6% – 100% (95 of 95) for Mohs surgery, and 96% (130 of 131, with 4 additional cases pending) for excisions. These findings supported calls for simplifying prior authorization procedures, “perhaps first by eliminating unnecessary PAs [prior authorizations] and appeals,” Aaron M. Secrest, MD, PhD, of the University of Utah, Salt Lake City, and coauthors wrote in the article.

Still, there is some evidence that insurer-run Medicare policies reduce the use of low-value care.

In a study published in JAMA Health Forum, Emily Boudreau, PhD, of insurer Humana Inc, and coauthors from Tufts University, Boston, and the University of Pennsylvania, Philadelphia investigated whether insurer-run Medicare could do a better job in reducing the amount of low-value care delivered than the traditional program. They analyzed a set of claims data from 2017 to 2019 for people enrolled in insurer-run and traditional Medicare.

They reported a rate of 23.07 low-value services provided per 100 people in insurer-run Medicare, compared with 25.39 for those in traditional Medicare. Some of the biggest differences reported in the article were in cancer screenings for older people.

As an example, the U.S. Preventive Services Task Force recommends that women older than 65 years not be screened for cervical cancer if they have undergone adequate screening in the past and are not at high risk for cervical cancer. There was an annual count of 1.76 screenings for cervical cancer per 100 women older than 65 in the insurer-run Medicare group versus 3.18 for those in traditional Medicare.

The Better Medicare Alliance issued a statement in favor of the House passage of the Improving Seniors’ Timely Access to Care Act.

In it, the group said the measure would “modernize prior authorization while protecting its essential function in facilitating safe, high-value, evidence-based care.” The alliance promotes use of insurer-run Medicare. The board of the Better Medicare Alliance includes executives who serve with firms that run Advantage plans as well as medical organizations and universities.

“With studies showing that up to one-quarter of all health care expenditures are wasted on services with no benefit to the patient, we need a robust, next-generation prior authorization program to deter low-value, and even harmful, care while protecting access to needed treatment and effective therapies,” said A. Mark Fendrick, MD, director of the University of Michigan’s Center for Value-Based Insurance Design in Ann Arbor, in a statement issued by the Better Medicare Alliance. He is a member of the group’s council of scholars.

On the House floor on September 14, Rep. Ami Bera, MD (D-Calif.), said he has heard from former colleagues and his medical school classmates that they now spend as much as 40% of their time on administrative work. These distractions from patient care are helping drive physicians away from the practice of medicine.

Still, the internist defended the basic premise of prior authorization while strongly appealing for better systems of handling it.

“Yes, there is a role for prior authorization in limited cases. There is also a role to go back and retrospectively look at how care is being delivered,” Rep. Bera said. “But what is happening today is a travesty. It wasn’t the intention of prior authorization. It is a prior authorization process gone awry.”

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

The path through the U.S. Senate is not yet certain for a bill intended to speed the prior authorization process of insurer-run Medicare Advantage plans, despite the measure having breezed through the House.

House leaders opted to move the Improving Seniors’ Timely Access to Care Act of 2021 (HR 3173) without requiring a roll-call vote. The measure was passed on Sept. 14 by a voice vote, an approach used in general with only uncontroversial measures that have broad support. The bill has 191 Democratic and 135 Republican sponsors, representing about three-quarters of the members of the House.

Alicia Ault/Frontline Medical News

“There is no reason that patients should be waiting for medically appropriate care, especially when we know that this can lead to worse outcomes,” Rep. Earl Blumenauer (D-Ore.) said in a Sept. 14 speech on the House floor. “The fundamental promise of Medicare Advantage is undermined when people are delaying care, getting sicker, and ultimately costing Medicare more money.”

Rep. Greg Murphy, MD (R-N.C.), spoke on the House floor that day as well, bringing up cases he has seen in his own urology practice in which prior authorization delays disrupted medical care. One patient wound up in the hospital with abscess after an insurer denied an antibiotic prescription, Rep. Murphy said.

But the Senate appears unlikely at this time to move the prior authorization bill as a standalone measure. Instead, the bill may become part of a larger legislative package focused on health care that the Senate Finance Committee intends to prepare later this year.

The House-passed bill would require insurer-run Medicare plans to respond to expedited requests for prior authorization of services within 24 hours and to other requests within 7 days. This bill also would establish an electronic program for prior authorizations and mandate increased transparency as to how insurers use this tool.
 

CBO: Cost of change would be billions

In seeking to mandate changes in prior authorization, lawmakers likely will need to contend with the issue of a $16 billion cumulative cost estimate for the bill from the Congressional Budget Office. Members of Congress often seek to offset new spending by pairing bills that add to expected costs for the federal government with ones expected to produce savings.

Unlike Rep. Blumenauer, Rep. Murphy, and other backers of the prior authorization streamlining bill, CBO staff estimates that making the mandated changes would raise federal spending, inasmuch as there would be “a greater use of services.”

On Sept. 14, CBO issued a one-page report on the costs of the bill. The CBO report concerns only the bill in question, as is common practice with the office’s estimates.

Prior authorization changes would begin in fiscal 2025 and would add $899 million in spending, or outlays, that year, CBO said. The annual costs from the streamlined prior authorization practices through fiscal 2026 to 2032 range from $1.6 billion to $2.7 billion.

Looking at the CBO estimate against a backdrop of total Medicare Advantage costs, though, may provide important context.

The increases in spending estimated by CBO may suggest that there would be little change in federal spending as a result of streamlining prior authorization practices. These estimates of increased annual spending of $1.6 billion–$2.7 billion are only a small fraction of the current annual cost of insurer-run Medicare, and they represent an even smaller share of the projected expense.

The federal government last year spent about $350 billion on insurer-run plans, excluding Part D drug plan payments, according to the Medicare Advisory Payment Commission (MedPAC).

As of 2021, about 27 million people were enrolled in these plans, accounting for about 46% of the total Medicare population. Enrollment has doubled since 2010, MedPAC said, and it is expected to continue to grow. By 2027, insurer-run Medicare could cover 50% of the program’s population, a figure that may reach 53% by 2031.

Federal payments to these plans will accelerate in the years ahead as insurers attract more people eligible for Medicare as customers. Payments to these private health plans could rise from an expected $418 billion this year to $940.6 billion by 2031, according to the most recent Medicare trustees report.

Good intentions, poor implementation?

Insurer-run Medicare has long enjoyed deep bipartisan support in Congress. That’s due in part to its potential for reducing spending on what are considered low-value treatments, or ones considered unlikely to provide a significant medical benefit, but Rep. Blumenauer is among the members of Congress who see insurer-run Medicare as a path for preserving the giant federal health program. Traditional Medicare has far fewer restrictions on services, which sometimes opens a path for tests and treatments that offer less value for patients.

“I believe that the way traditional fee-for-service Medicare operates is not sustainable and that Medicare Advantage is one of the tools we can use to demonstrate how we can incentivize value,” Rep. Blumenauer said on the House floor. “But this is only possible when the program operates as intended. I have been deeply concerned about the reports of delays in care” caused by the clunky prior authorization processes.

He highlighted a recent report from the internal watchdog group for the Department of Health & Human Services that raises concerns about denials of appropriate care. About 18% of a set of payment denials examined by the Office of Inspector General of HHS in April actually met Medicare coverage rules and plan billing rules.

“For patients and their families, being told that you need to wait longer for care that your doctor tells you that you need is incredibly frustrating and frightening,” Rep. Blumenauer said. “There’s no comfort to be found in the fact that your insurance company needs time to decide if your doctor is right.”
 

Trends in prior authorization

The CBO report does not provide detail on what kind of medical spending would increase under a streamlined prior authorization process in insurer-run Medicare plans.

From trends reported in prior authorization, though, two factors could be at play in what appear to be relatively small estimated increases in Medicare spending from streamlined prior authorization.

One is the work already underway to create less burdensome electronic systems for these requests, such as the Fast Prior Authorization Technology Highway initiative run by the trade association America’s Health Insurance Plans.

The other factor could be the number of cases in which prior authorization merely causes delays in treatments and tests and thus simply postpones spending while adding to clinicians’ administrative work.

An analysis of prior authorization requests for dermatologic practices affiliated with the University of Utah may represent an extreme example. In a report published in JAMA Dermatology in 2020, researchers described what happened with requests made during 1 month, September 2016.

The approval rate for procedures was 99.6% – 100% (95 of 95) for Mohs surgery, and 96% (130 of 131, with 4 additional cases pending) for excisions. These findings supported calls for simplifying prior authorization procedures, “perhaps first by eliminating unnecessary PAs [prior authorizations] and appeals,” Aaron M. Secrest, MD, PhD, of the University of Utah, Salt Lake City, and coauthors wrote in the article.

Still, there is some evidence that insurer-run Medicare policies reduce the use of low-value care.

In a study published in JAMA Health Forum, Emily Boudreau, PhD, of insurer Humana Inc, and coauthors from Tufts University, Boston, and the University of Pennsylvania, Philadelphia investigated whether insurer-run Medicare could do a better job in reducing the amount of low-value care delivered than the traditional program. They analyzed a set of claims data from 2017 to 2019 for people enrolled in insurer-run and traditional Medicare.

They reported a rate of 23.07 low-value services provided per 100 people in insurer-run Medicare, compared with 25.39 for those in traditional Medicare. Some of the biggest differences reported in the article were in cancer screenings for older people.

As an example, the U.S. Preventive Services Task Force recommends that women older than 65 years not be screened for cervical cancer if they have undergone adequate screening in the past and are not at high risk for cervical cancer. There was an annual count of 1.76 screenings for cervical cancer per 100 women older than 65 in the insurer-run Medicare group versus 3.18 for those in traditional Medicare.

The Better Medicare Alliance issued a statement in favor of the House passage of the Improving Seniors’ Timely Access to Care Act.

In it, the group said the measure would “modernize prior authorization while protecting its essential function in facilitating safe, high-value, evidence-based care.” The alliance promotes use of insurer-run Medicare. The board of the Better Medicare Alliance includes executives who serve with firms that run Advantage plans as well as medical organizations and universities.

“With studies showing that up to one-quarter of all health care expenditures are wasted on services with no benefit to the patient, we need a robust, next-generation prior authorization program to deter low-value, and even harmful, care while protecting access to needed treatment and effective therapies,” said A. Mark Fendrick, MD, director of the University of Michigan’s Center for Value-Based Insurance Design in Ann Arbor, in a statement issued by the Better Medicare Alliance. He is a member of the group’s council of scholars.

On the House floor on September 14, Rep. Ami Bera, MD (D-Calif.), said he has heard from former colleagues and his medical school classmates that they now spend as much as 40% of their time on administrative work. These distractions from patient care are helping drive physicians away from the practice of medicine.

Still, the internist defended the basic premise of prior authorization while strongly appealing for better systems of handling it.

“Yes, there is a role for prior authorization in limited cases. There is also a role to go back and retrospectively look at how care is being delivered,” Rep. Bera said. “But what is happening today is a travesty. It wasn’t the intention of prior authorization. It is a prior authorization process gone awry.”

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

Three large physician groups joined a class action lawsuit against Cigna, arguing that there has been intentional underpayment of medical claims submitted by patients for services covered through MultiPlan, the nation’s largest third-party network.

The American Medical Association, the Medical Society of New Jersey, and the Washington State Medical Association on Sept. 12 entered into a legal battle between the giant insurers and patients.

At issue are claims involving the firm MultiPlan as an intermediary. Cigna had not responded to this news organization at press time following multiple requests for comment.

According to the legal complaint AMA and the two state medical societies joined, MultiPlan has contracts with more than 1.2 million clinicians. Under these agreements, medical professionals agree to accept a set percentage of billed charges as payment in full, while not holding patients responsible for the difference between the original billed charges and the discounted rate.

But the complaint alleges that MultiPlan failed to stick with that bargain. In a statement, AMA President Jack Resneck Jr, MD, said the physician groups joined the legal action “to shed light on Cigna’s misconduct and create remedies so that patients and physicians can look forward to getting what they are promised.”

Dr. Resneck said Cigna’s approach “is riddled with conflicts of interest and manipulations that routinely shortchanged payments to MultiPlan Network physicians and interfered with the patient-physician relationship by ignoring the MultiPlan contracts and making incorrect statements to patients about their liability for the unpaid portion of the billed charges.”

According to the complaint, Cigna used a company called Zelis to “unilaterally re-price’’ claims at an amount far lower than that called for by the MultiPlan Contract. The three cases cited in the lawsuit stem from a 2017 spine surgery in Washington and 2018 orthopedic and 2020 breast reconstruction surgeries in New Jersey. The decisions to ignore the previous agreements and cut the reimbursement led the physicians involved to eventually bill patients for some of the money in dispute, according to the complaint.

“The providers were left in a very untenable situation,” D. Brian Hufford, an attorney involved in the case, told this news organization. “Their only choice was to go after the insurance company and sue them or they have to go after the patient. That interferes with the patient-doctor relationship.”

Mr. Hufford, who’s a partner at law firm Zuckerman Spaeder, said that these kinds of cases fall beyond the protections provided by the No Surprises Act. Plaintiffs in these cases were enrolled in what are called self-insured plans provided by employers, through which they were supposed to be allowed to seek out-of-network care.

Highly concerning are the messages that insurers send to patients through explanation of benefits (EOB) statements, Mr. Hufford said. Thus in this case against Cigna, physicians and patients have the “same interest in trying to make sure the insurance companies are paying the appropriate amounts for these services,” he said.

Cigna “is telling the patients that the provider has accepted something, and that the patient does not have to worry about paying for that, when in fact that’s not true,” Mr. Hufford said. “That goes beyond merely not complying with the plan documents, but also engaging in conduct that we believe was inappropriate.”

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

Three large physician groups joined a class action lawsuit against Cigna, arguing that there has been intentional underpayment of medical claims submitted by patients for services covered through MultiPlan, the nation’s largest third-party network.

The American Medical Association, the Medical Society of New Jersey, and the Washington State Medical Association on Sept. 12 entered into a legal battle between the giant insurers and patients.

At issue are claims involving the firm MultiPlan as an intermediary. Cigna had not responded to this news organization at press time following multiple requests for comment.

According to the legal complaint AMA and the two state medical societies joined, MultiPlan has contracts with more than 1.2 million clinicians. Under these agreements, medical professionals agree to accept a set percentage of billed charges as payment in full, while not holding patients responsible for the difference between the original billed charges and the discounted rate.

But the complaint alleges that MultiPlan failed to stick with that bargain. In a statement, AMA President Jack Resneck Jr, MD, said the physician groups joined the legal action “to shed light on Cigna’s misconduct and create remedies so that patients and physicians can look forward to getting what they are promised.”

Dr. Resneck said Cigna’s approach “is riddled with conflicts of interest and manipulations that routinely shortchanged payments to MultiPlan Network physicians and interfered with the patient-physician relationship by ignoring the MultiPlan contracts and making incorrect statements to patients about their liability for the unpaid portion of the billed charges.”

According to the complaint, Cigna used a company called Zelis to “unilaterally re-price’’ claims at an amount far lower than that called for by the MultiPlan Contract. The three cases cited in the lawsuit stem from a 2017 spine surgery in Washington and 2018 orthopedic and 2020 breast reconstruction surgeries in New Jersey. The decisions to ignore the previous agreements and cut the reimbursement led the physicians involved to eventually bill patients for some of the money in dispute, according to the complaint.

“The providers were left in a very untenable situation,” D. Brian Hufford, an attorney involved in the case, told this news organization. “Their only choice was to go after the insurance company and sue them or they have to go after the patient. That interferes with the patient-doctor relationship.”

Mr. Hufford, who’s a partner at law firm Zuckerman Spaeder, said that these kinds of cases fall beyond the protections provided by the No Surprises Act. Plaintiffs in these cases were enrolled in what are called self-insured plans provided by employers, through which they were supposed to be allowed to seek out-of-network care.

Highly concerning are the messages that insurers send to patients through explanation of benefits (EOB) statements, Mr. Hufford said. Thus in this case against Cigna, physicians and patients have the “same interest in trying to make sure the insurance companies are paying the appropriate amounts for these services,” he said.

Cigna “is telling the patients that the provider has accepted something, and that the patient does not have to worry about paying for that, when in fact that’s not true,” Mr. Hufford said. “That goes beyond merely not complying with the plan documents, but also engaging in conduct that we believe was inappropriate.”

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

Three large physician groups joined a class action lawsuit against Cigna, arguing that there has been intentional underpayment of medical claims submitted by patients for services covered through MultiPlan, the nation’s largest third-party network.

The American Medical Association, the Medical Society of New Jersey, and the Washington State Medical Association on Sept. 12 entered into a legal battle between the giant insurers and patients.

At issue are claims involving the firm MultiPlan as an intermediary. Cigna had not responded to this news organization at press time following multiple requests for comment.

According to the legal complaint AMA and the two state medical societies joined, MultiPlan has contracts with more than 1.2 million clinicians. Under these agreements, medical professionals agree to accept a set percentage of billed charges as payment in full, while not holding patients responsible for the difference between the original billed charges and the discounted rate.

But the complaint alleges that MultiPlan failed to stick with that bargain. In a statement, AMA President Jack Resneck Jr, MD, said the physician groups joined the legal action “to shed light on Cigna’s misconduct and create remedies so that patients and physicians can look forward to getting what they are promised.”

Dr. Resneck said Cigna’s approach “is riddled with conflicts of interest and manipulations that routinely shortchanged payments to MultiPlan Network physicians and interfered with the patient-physician relationship by ignoring the MultiPlan contracts and making incorrect statements to patients about their liability for the unpaid portion of the billed charges.”

According to the complaint, Cigna used a company called Zelis to “unilaterally re-price’’ claims at an amount far lower than that called for by the MultiPlan Contract. The three cases cited in the lawsuit stem from a 2017 spine surgery in Washington and 2018 orthopedic and 2020 breast reconstruction surgeries in New Jersey. The decisions to ignore the previous agreements and cut the reimbursement led the physicians involved to eventually bill patients for some of the money in dispute, according to the complaint.

“The providers were left in a very untenable situation,” D. Brian Hufford, an attorney involved in the case, told this news organization. “Their only choice was to go after the insurance company and sue them or they have to go after the patient. That interferes with the patient-doctor relationship.”

Mr. Hufford, who’s a partner at law firm Zuckerman Spaeder, said that these kinds of cases fall beyond the protections provided by the No Surprises Act. Plaintiffs in these cases were enrolled in what are called self-insured plans provided by employers, through which they were supposed to be allowed to seek out-of-network care.

Highly concerning are the messages that insurers send to patients through explanation of benefits (EOB) statements, Mr. Hufford said. Thus in this case against Cigna, physicians and patients have the “same interest in trying to make sure the insurance companies are paying the appropriate amounts for these services,” he said.

Cigna “is telling the patients that the provider has accepted something, and that the patient does not have to worry about paying for that, when in fact that’s not true,” Mr. Hufford said. “That goes beyond merely not complying with the plan documents, but also engaging in conduct that we believe was inappropriate.”

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

The Centers for Disease Control and Prevention on Sept. 1 approved the use of vaccines designed to target both Omicron and the older variants of the coronavirus, a step that may aid a goal of a widespread immunization campaign before winter arrives in the United States.

The CDC’s Advisory Committee on Immunization Practices voted 13-1 on two separate questions. One sought the panel’s backing for the use of a single dose of a new version of the Pfizer COVID-19 vaccines for people aged 12 and older. The second question dealt with a single dose of the reworked Moderna vaccine for people aged 18 and older.

The federal government wants to speed use of revamped COVID-19 shots, which the Food and Drug Administration on Sept. 1 cleared for use in the United States. Hours later, CDC Director Rochelle Walensky, MD, agreed with the panel’s recommendation. 

“The updated COVID-19 boosters are formulated to better protect against the most recently circulating COVID-19 variant,” Dr. Walensky said in a statement. “They can help restore protection that has waned since previous vaccination and were designed to provide broader protection against newer variants. This recommendation followed a comprehensive scientific evaluation and robust scientific discussion. If you are eligible, there is no bad time to get your COVID-19 booster and I strongly encourage you to receive it.”

The FDA vote on Aug. 31 expanded the emergency use authorization EUA for both Moderna and Pfizer’s original COVID-19 vaccines. The new products are also called “updated boosters.” Both contain two mRNA components of SARS-CoV-2 virus, one of the original strain  and another that is found in the BA.4 and BA.5 strains of the Omicron variant, the FDA said.

Basically, the FDA cleared the way for these new boosters after it relied heavily on results of certain blood tests that suggested an immune response boost from the new formulas, plus 18 months of mostly safe use of the original versions of the shots.

What neither the FDA nor the CDC has, however, is evidence from studies in humans on how well these new vaccines work or whether they are as safe as the originals. But the FDA did consider clinical evidence for the older shots and results from studies on the new boosters that were done in mice.

ACIP Committee member Pablo Sanchez, MD, of Ohio State University was the sole “no” vote on each question.  

“It’s a new vaccine, it’s a new platform. There’s a lot of hesitancy already. We need the human data,”  Dr. Sanchez said.

Dr. Sanchez did not doubt that the newer versions of the vaccine would prove safe.

“I personally am in the age group where I’m at high risk and I’m almost sure that I will receive it,” Dr. Sanchez said. “I just feel that this was a bit premature, and I wish that we had seen that data. Having said that, I am comfortable that the vaccine will likely be safe like the others.”

Dr. Sanchez was not alone in raising concerns about backing new COVID-19 shots for which there is not direct clinical evidence from human studies.

Committee member Sarah Long, MD, of Drexel University in Philadelphia, said during the discussion she would “reluctantly” vote in favor of the updated vaccines. She said she believes they will have the potential to reduce hospitalizations and even deaths, even with questions remaining about the data.

Dr. Long joined other committee members in pointing to the approach to updating flu vaccines as a model. In an attempt to keep ahead of influenza, companies seek to defeat new strains through tweaks to their FDA-approved vaccines. There is not much clinical information available about these revised products, Dr. Long said. She compared it to remodeling an existing home.

“It is the same scaffolding, part of the same roof, we’re just putting in some dormers and windows,” with the revisions to the flu vaccine, she said.

Earlier in the day, committee member Jamie Loehr, MD,  of Cayuga Family Medicine in Ithaca, N.Y., also used changes to the annual flu shots as the model for advancing COVID-19 shots.

“So after thinking about it, I am comfortable even though we don’t have human data,” he said.

There were several questions during the meeting about why the FDA had not convened a meeting of its Vaccines and Related Biological Products Advisory Committee (regarding these specific bivalent vaccines). Typically, the FDA committee of advisers considers new vaccines before the agency authorizes their use. In this case, however, the agency acted on its own.

The FDA said the committee considered the new, bivalent COVID-19 boosters in earlier meetings and that was enough outside feedback.

But holding a meeting of advisers on these specific products could have helped build public confidence in these medicines, Dorit Reiss, PhD, of the University of California Hastings College of Law, said during the public comment session of the CDC advisers’ meeting.

“We could wish the vaccines were more effective against infection, but they’re safe and they prevent hospitalization and death,” she said.

The Department of Health and Human Services anticipated the backing of ACIP. The Administration for Strategic Preparedness and Response  on Aug. 31 began distributing “millions of doses of the updated booster to tens of thousands of sites nationwide,” Jason Roos, PhD,  chief operating officer for HHS Coordination Operations and Response Element, wrote in a blog.

“These boosters will be available at tens of thousands of vaccination sites ... including local pharmacies, their physicians’ offices, and vaccine centers operated by state and local health officials,”Dr. Roos wrote.

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

The Centers for Disease Control and Prevention on Sept. 1 approved the use of vaccines designed to target both Omicron and the older variants of the coronavirus, a step that may aid a goal of a widespread immunization campaign before winter arrives in the United States.

The CDC’s Advisory Committee on Immunization Practices voted 13-1 on two separate questions. One sought the panel’s backing for the use of a single dose of a new version of the Pfizer COVID-19 vaccines for people aged 12 and older. The second question dealt with a single dose of the reworked Moderna vaccine for people aged 18 and older.

The federal government wants to speed use of revamped COVID-19 shots, which the Food and Drug Administration on Sept. 1 cleared for use in the United States. Hours later, CDC Director Rochelle Walensky, MD, agreed with the panel’s recommendation. 

“The updated COVID-19 boosters are formulated to better protect against the most recently circulating COVID-19 variant,” Dr. Walensky said in a statement. “They can help restore protection that has waned since previous vaccination and were designed to provide broader protection against newer variants. This recommendation followed a comprehensive scientific evaluation and robust scientific discussion. If you are eligible, there is no bad time to get your COVID-19 booster and I strongly encourage you to receive it.”

The FDA vote on Aug. 31 expanded the emergency use authorization EUA for both Moderna and Pfizer’s original COVID-19 vaccines. The new products are also called “updated boosters.” Both contain two mRNA components of SARS-CoV-2 virus, one of the original strain  and another that is found in the BA.4 and BA.5 strains of the Omicron variant, the FDA said.

Basically, the FDA cleared the way for these new boosters after it relied heavily on results of certain blood tests that suggested an immune response boost from the new formulas, plus 18 months of mostly safe use of the original versions of the shots.

What neither the FDA nor the CDC has, however, is evidence from studies in humans on how well these new vaccines work or whether they are as safe as the originals. But the FDA did consider clinical evidence for the older shots and results from studies on the new boosters that were done in mice.

ACIP Committee member Pablo Sanchez, MD, of Ohio State University was the sole “no” vote on each question.  

“It’s a new vaccine, it’s a new platform. There’s a lot of hesitancy already. We need the human data,”  Dr. Sanchez said.

Dr. Sanchez did not doubt that the newer versions of the vaccine would prove safe.

“I personally am in the age group where I’m at high risk and I’m almost sure that I will receive it,” Dr. Sanchez said. “I just feel that this was a bit premature, and I wish that we had seen that data. Having said that, I am comfortable that the vaccine will likely be safe like the others.”

Dr. Sanchez was not alone in raising concerns about backing new COVID-19 shots for which there is not direct clinical evidence from human studies.

Committee member Sarah Long, MD, of Drexel University in Philadelphia, said during the discussion she would “reluctantly” vote in favor of the updated vaccines. She said she believes they will have the potential to reduce hospitalizations and even deaths, even with questions remaining about the data.

Dr. Long joined other committee members in pointing to the approach to updating flu vaccines as a model. In an attempt to keep ahead of influenza, companies seek to defeat new strains through tweaks to their FDA-approved vaccines. There is not much clinical information available about these revised products, Dr. Long said. She compared it to remodeling an existing home.

“It is the same scaffolding, part of the same roof, we’re just putting in some dormers and windows,” with the revisions to the flu vaccine, she said.

Earlier in the day, committee member Jamie Loehr, MD,  of Cayuga Family Medicine in Ithaca, N.Y., also used changes to the annual flu shots as the model for advancing COVID-19 shots.

“So after thinking about it, I am comfortable even though we don’t have human data,” he said.

There were several questions during the meeting about why the FDA had not convened a meeting of its Vaccines and Related Biological Products Advisory Committee (regarding these specific bivalent vaccines). Typically, the FDA committee of advisers considers new vaccines before the agency authorizes their use. In this case, however, the agency acted on its own.

The FDA said the committee considered the new, bivalent COVID-19 boosters in earlier meetings and that was enough outside feedback.

But holding a meeting of advisers on these specific products could have helped build public confidence in these medicines, Dorit Reiss, PhD, of the University of California Hastings College of Law, said during the public comment session of the CDC advisers’ meeting.

“We could wish the vaccines were more effective against infection, but they’re safe and they prevent hospitalization and death,” she said.

The Department of Health and Human Services anticipated the backing of ACIP. The Administration for Strategic Preparedness and Response  on Aug. 31 began distributing “millions of doses of the updated booster to tens of thousands of sites nationwide,” Jason Roos, PhD,  chief operating officer for HHS Coordination Operations and Response Element, wrote in a blog.

“These boosters will be available at tens of thousands of vaccination sites ... including local pharmacies, their physicians’ offices, and vaccine centers operated by state and local health officials,”Dr. Roos wrote.

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

The Centers for Disease Control and Prevention on Sept. 1 approved the use of vaccines designed to target both Omicron and the older variants of the coronavirus, a step that may aid a goal of a widespread immunization campaign before winter arrives in the United States.

The CDC’s Advisory Committee on Immunization Practices voted 13-1 on two separate questions. One sought the panel’s backing for the use of a single dose of a new version of the Pfizer COVID-19 vaccines for people aged 12 and older. The second question dealt with a single dose of the reworked Moderna vaccine for people aged 18 and older.

The federal government wants to speed use of revamped COVID-19 shots, which the Food and Drug Administration on Sept. 1 cleared for use in the United States. Hours later, CDC Director Rochelle Walensky, MD, agreed with the panel’s recommendation. 

“The updated COVID-19 boosters are formulated to better protect against the most recently circulating COVID-19 variant,” Dr. Walensky said in a statement. “They can help restore protection that has waned since previous vaccination and were designed to provide broader protection against newer variants. This recommendation followed a comprehensive scientific evaluation and robust scientific discussion. If you are eligible, there is no bad time to get your COVID-19 booster and I strongly encourage you to receive it.”

The FDA vote on Aug. 31 expanded the emergency use authorization EUA for both Moderna and Pfizer’s original COVID-19 vaccines. The new products are also called “updated boosters.” Both contain two mRNA components of SARS-CoV-2 virus, one of the original strain  and another that is found in the BA.4 and BA.5 strains of the Omicron variant, the FDA said.

Basically, the FDA cleared the way for these new boosters after it relied heavily on results of certain blood tests that suggested an immune response boost from the new formulas, plus 18 months of mostly safe use of the original versions of the shots.

What neither the FDA nor the CDC has, however, is evidence from studies in humans on how well these new vaccines work or whether they are as safe as the originals. But the FDA did consider clinical evidence for the older shots and results from studies on the new boosters that were done in mice.

ACIP Committee member Pablo Sanchez, MD, of Ohio State University was the sole “no” vote on each question.  

“It’s a new vaccine, it’s a new platform. There’s a lot of hesitancy already. We need the human data,”  Dr. Sanchez said.

Dr. Sanchez did not doubt that the newer versions of the vaccine would prove safe.

“I personally am in the age group where I’m at high risk and I’m almost sure that I will receive it,” Dr. Sanchez said. “I just feel that this was a bit premature, and I wish that we had seen that data. Having said that, I am comfortable that the vaccine will likely be safe like the others.”

Dr. Sanchez was not alone in raising concerns about backing new COVID-19 shots for which there is not direct clinical evidence from human studies.

Committee member Sarah Long, MD, of Drexel University in Philadelphia, said during the discussion she would “reluctantly” vote in favor of the updated vaccines. She said she believes they will have the potential to reduce hospitalizations and even deaths, even with questions remaining about the data.

Dr. Long joined other committee members in pointing to the approach to updating flu vaccines as a model. In an attempt to keep ahead of influenza, companies seek to defeat new strains through tweaks to their FDA-approved vaccines. There is not much clinical information available about these revised products, Dr. Long said. She compared it to remodeling an existing home.

“It is the same scaffolding, part of the same roof, we’re just putting in some dormers and windows,” with the revisions to the flu vaccine, she said.

Earlier in the day, committee member Jamie Loehr, MD,  of Cayuga Family Medicine in Ithaca, N.Y., also used changes to the annual flu shots as the model for advancing COVID-19 shots.

“So after thinking about it, I am comfortable even though we don’t have human data,” he said.

There were several questions during the meeting about why the FDA had not convened a meeting of its Vaccines and Related Biological Products Advisory Committee (regarding these specific bivalent vaccines). Typically, the FDA committee of advisers considers new vaccines before the agency authorizes their use. In this case, however, the agency acted on its own.

The FDA said the committee considered the new, bivalent COVID-19 boosters in earlier meetings and that was enough outside feedback.

But holding a meeting of advisers on these specific products could have helped build public confidence in these medicines, Dorit Reiss, PhD, of the University of California Hastings College of Law, said during the public comment session of the CDC advisers’ meeting.

“We could wish the vaccines were more effective against infection, but they’re safe and they prevent hospitalization and death,” she said.

The Department of Health and Human Services anticipated the backing of ACIP. The Administration for Strategic Preparedness and Response  on Aug. 31 began distributing “millions of doses of the updated booster to tens of thousands of sites nationwide,” Jason Roos, PhD,  chief operating officer for HHS Coordination Operations and Response Element, wrote in a blog.

“These boosters will be available at tens of thousands of vaccination sites ... including local pharmacies, their physicians’ offices, and vaccine centers operated by state and local health officials,”Dr. Roos wrote.

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

Changes in Medicare law will help some patients who need costly rheumatology treatments, including several medicines for which competition has been kept in check for many years.

In fact, this field of medicine includes prime examples of the kinds of products that drove Congress to give the giant federal health program leverage to try to restrain rising pharmaceutical costs through negotiations. The Inflation Reduction Act, signed into law by President Joe Biden on Aug. 16, also provides some fairly quick aid for people enrolled in Medicare who struggle with pharmacy bills.

Getty

As described in an official summary from the Congressional Research Service, the law establishes:

• A cap on annual Medicare Part D out-of-pocket spending that starts in 2025 at $2,000, with planned annual adjustments thereafter.
• A limit on cost-sharing under Medicare Part D for a month’s supply of covered insulin products at $35 for 2023 through 2025, with plans for continued limits on this cost in the years after pegged to negotiated prices.
• A program under which drug manufacturers provide discounts to beneficiaries who have incurred costs above the annual deductible beginning in 2025.
• A requirement that drugmakers issue rebates to Medicare for certain brand-name drugs covered without generic equivalents for which prices increase faster than inflation.
• An obligation for Medicare Part D plans to pay for adult vaccines that are recommended by the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices without requiring cost sharing.

The law’s marquee health provision sets the stage for Medicare, the nation’s largest purchaser of drugs, for the first time to leverage its clout directly in negotiating for lower costs for medicines. Democrats sought to build what amount to guardrails into this program, seeking to spare from competition new and innovative drugs and ones developed by smaller companies. Drugs likely to soon face competition from copycat versions also would fall outside of the pool for negotiations.

In effect, the design of the program would allow Medicare to negotiate in the future in cases such as those seen in recent years with blockbuster medicines often in rheumatology. That’s due in a large part to legal challenges that have helped thwart the introduction of copycat versions of these kinds of products known as biosimilars.

Etanercept (Enbrel) has been sold in the United States since 1998 and adalimumab (Humira) since 2003. Both products face competition from copycat versions called biosimilars in other nations, but the introductions of these products have been delayed in the United States until 2029 for etanercept and 2023 for adalimumab, the Office of Inspector General for the Department of Health & Human Services said in a March 2022 report. The OIG said in the report that the combined 2019 Medicare Part D tab for the two biologics was more than $5 billion.

Rheumatology drugs rival cancer medicines for dominance among the most expensive drugs for people enrolled in Medicare. The average 2020 spending for the most widely used forms of adalimumab by people in Medicare’s Part D pharmacy program topped $51,000, according to federal data. The price per dosage-unit for the drug rose about 7% from 2019 to 2020.

The pharmaceutical industry defends the high introductory costs of medicines and subsequent rising prices as necessary payback for research on products sold and the ones still in development. Since the initial Food and Drug Administration approval of adalimumab on Dec. 31, 2002, Abbott Laboratories and its AbbVie spin-off have made changes to the drug’s administration and paid for studies to expand its approved indications.

Still, the investment in adalimumab appears to have been paid well.

Abbott Labs acquired adalimumab as part of its purchase of BASF’s pharmaceutical operations in 2001, a purchase that also included the thyroid drug Synthroid. Abbott paid $7.2 billion, or roughly $12 billion in current dollars. In 2021 alone, Humira sales were $20.7 billion, with the United States accounting for $17.3 billion of the product’s revenue.
 

Losing access to treatment when moving to Medicare

Sue Lee of Crestwood, Ky., is among the patients waiting to see if the changes in Medicare law might allow her to again afford adalimumab. For now, Ms. Lee said she is hoping her plaque psoriasis stays manageable with the topical ointments and moisturizers she has been using since losing access to adalimumab. Ms. Lee, 80, took the medicine during her working years for her plaque psoriasis.

“I told people: ‘I’m on the wonder drug. Look at me. I can show my skin now. I don’t have all of these sores,’ ” she said in an interview.

But after she retired at 75, she was shocked at the tab she faced after switching from private insurance to Medicare. She said it could have cost her close to $10,000 a year to take Humira. Ms. Lee’s Social Security earnings make her ineligible for certain assistance with drug costs.

“I cried a lot,” she said about the loss of affordable access to the drug.
 

What’s the path ahead?

The American College of Rheumatology and the Coalition of State Rheumatology Organizations are among the physician groups that pressed Congress for years for action to lower drug costs. Their members have been on the frontline of the crisis in the United States among patients unable to afford medicines.

“The financial burden of skyrocketing drug prices has forced many of our patients to spread their treatment out longer than prescribed, delay care, abandon prescriptions, or forgo treatment entirely – all of which risks flare-ups, disease regression, permanent disability, and even premature death,” said Blair Solow, MD, chair of the ACR’s Government Affairs Committee, in a statement on the new Medicare provisions.

In an interview, Dr. Solow, an assistant professor of medicine in the division of rheumatic diseases at University of Texas Southwestern Medical Center, Dallas, noted that there are concerns about how changes in Medicare drug pricing might affect future development of medicines. This has been a chief criticism of the pharmaceutical industry of efforts to allow Medicare to negotiate for lower prices.

“Of note, drug companies research, create, and produce medications that will perform well in the market, not necessarily those that may be most needed,” Dr. Solow wrote. “We can hope the new medications put forth by manufacturers are those that improve the lives of patients.”

In July, the Congressional Budget Office released a report on an earlier version of the Democrats’ plans for Medicare drug negotiations that suggested the potential loss to drugmakers’ productivity may be relatively small. The CBO expects that about 1,300 drugs will be approved over the next 30 years. The legislation as proposed in July might reduce the tally by 15 drugs. The CBO said these estimates fell in the middle of the distribution of possible outcomes and are subject to uncertainty, and it is still working on an estimate of the expects effects of the final version of the law.

“CBO did not predict what kind of drugs would be affected or analyze the effects of forgone innovation on public health,” the agency said.

Dr. Solow also said there may be some challenges for physicians in explaining to patients the timeline for the new law’s Medicare provisions. People need to be aware of how long it will take to implement the plan and the potential for changes or delays.

“I think this is important, because the interpretation of the law can be done in a way that was not necessarily what Congress intended, and depending on the control of Congress and the Administration, this could impact downstream effects in how this law plays out,” she said in an interview.

CMS has substantial work ahead of it in choosing the drugs for which there will be subject to negotiations. The new law limits the number of drugs that can be negotiated to 10 annually in 2026, increasing to 20 drugs annually by 2029. Drugs would be eligible for negotiated prices from 9 years after drug approval or 13 years for biologics, until entry of a generic or biosimilar competitor.

The new law calls for taxes and other penalties for companies that refuse to negotiate or offer the agreed price, Thomas J. Hwang, MD; Aaron S. Kesselheim, MD, JD, MPH; and Benjamin N. Rome, MD, MPH, all of Harvard Medical School, Boston, wrote in an Aug. 19 viewpoint article in JAMA. U.S. lawmakers took a different approach to negotiations about drug prices than those used in other countries, they wrote.

“Notably, the Inflation Reduction Act shields new drugs from negotiated prices for the first 9-13 years on the market,” they wrote. “In contrast, most other peer countries typically negotiate drug prices at the time of market entry, and no peer country limits the number of drugs negotiated.”


 

Missed opportunities

Madelaine Feldman, MD, president of the CSRO and a rheumatologist in private practice with The Rheumatology Group in New Orleans, said in an interview that she welcomes many of the provisions of the new law, as they will help her rheumatology patients afford their medicine.

But she considers one of the provisions of the law to be a disappointment. The law further delays the start date for a federal rule intended to allow people on Medicare Part D to directly benefit from discounts negotiated on drugs. This is a point often overlooked in news reports on the law.

Insurers use what are called pharmacy benefit manager (PBM) services to obtain rebates on medicines, but they don’t fully or directly share these price reductions with people enrolled in Part D plans. Instead, people in the Part D plans have their cost sharing pegged closer to listed prices, the ones set before the rebates obtained by PBMs. The PBM industry argues that the rebates, often based on the list price of the drug, serve to keep monthly insurance premiums low. But there’s been concern about perverse incentives in this approach, where more expensive drugs are preferred by PBMs, leading to higher rebates.

Congress had already delayed its implementation of the PBM rule, which would apply savings more directly to patients, until 2027 and did so again in the Inflation Reduction Act.

Implementing this rule on Medicare Part D prescription drug rebates would be a help for patients struggling to pay for costly drugs, such as those used in rheumatology, Dr. Feldman said.

“It just doesn’t make any sense to hold off on these changes if you really want to cut Medicare’s beneficiaries’ cost sharing and attempt to stop the perverse incentive that puts higher priced drugs on Part D formularies,” she said.

Changes in Medicare law will help some patients who need costly rheumatology treatments, including several medicines for which competition has been kept in check for many years.

In fact, this field of medicine includes prime examples of the kinds of products that drove Congress to give the giant federal health program leverage to try to restrain rising pharmaceutical costs through negotiations. The Inflation Reduction Act, signed into law by President Joe Biden on Aug. 16, also provides some fairly quick aid for people enrolled in Medicare who struggle with pharmacy bills.

Getty

As described in an official summary from the Congressional Research Service, the law establishes:

• A cap on annual Medicare Part D out-of-pocket spending that starts in 2025 at $2,000, with planned annual adjustments thereafter.
• A limit on cost-sharing under Medicare Part D for a month’s supply of covered insulin products at $35 for 2023 through 2025, with plans for continued limits on this cost in the years after pegged to negotiated prices.
• A program under which drug manufacturers provide discounts to beneficiaries who have incurred costs above the annual deductible beginning in 2025.
• A requirement that drugmakers issue rebates to Medicare for certain brand-name drugs covered without generic equivalents for which prices increase faster than inflation.
• An obligation for Medicare Part D plans to pay for adult vaccines that are recommended by the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices without requiring cost sharing.

The law’s marquee health provision sets the stage for Medicare, the nation’s largest purchaser of drugs, for the first time to leverage its clout directly in negotiating for lower costs for medicines. Democrats sought to build what amount to guardrails into this program, seeking to spare from competition new and innovative drugs and ones developed by smaller companies. Drugs likely to soon face competition from copycat versions also would fall outside of the pool for negotiations.

In effect, the design of the program would allow Medicare to negotiate in the future in cases such as those seen in recent years with blockbuster medicines often in rheumatology. That’s due in a large part to legal challenges that have helped thwart the introduction of copycat versions of these kinds of products known as biosimilars.

Etanercept (Enbrel) has been sold in the United States since 1998 and adalimumab (Humira) since 2003. Both products face competition from copycat versions called biosimilars in other nations, but the introductions of these products have been delayed in the United States until 2029 for etanercept and 2023 for adalimumab, the Office of Inspector General for the Department of Health & Human Services said in a March 2022 report. The OIG said in the report that the combined 2019 Medicare Part D tab for the two biologics was more than $5 billion.

Rheumatology drugs rival cancer medicines for dominance among the most expensive drugs for people enrolled in Medicare. The average 2020 spending for the most widely used forms of adalimumab by people in Medicare’s Part D pharmacy program topped $51,000, according to federal data. The price per dosage-unit for the drug rose about 7% from 2019 to 2020.

The pharmaceutical industry defends the high introductory costs of medicines and subsequent rising prices as necessary payback for research on products sold and the ones still in development. Since the initial Food and Drug Administration approval of adalimumab on Dec. 31, 2002, Abbott Laboratories and its AbbVie spin-off have made changes to the drug’s administration and paid for studies to expand its approved indications.

Still, the investment in adalimumab appears to have been paid well.

Abbott Labs acquired adalimumab as part of its purchase of BASF’s pharmaceutical operations in 2001, a purchase that also included the thyroid drug Synthroid. Abbott paid $7.2 billion, or roughly $12 billion in current dollars. In 2021 alone, Humira sales were $20.7 billion, with the United States accounting for $17.3 billion of the product’s revenue.
 

Losing access to treatment when moving to Medicare

Sue Lee of Crestwood, Ky., is among the patients waiting to see if the changes in Medicare law might allow her to again afford adalimumab. For now, Ms. Lee said she is hoping her plaque psoriasis stays manageable with the topical ointments and moisturizers she has been using since losing access to adalimumab. Ms. Lee, 80, took the medicine during her working years for her plaque psoriasis.

“I told people: ‘I’m on the wonder drug. Look at me. I can show my skin now. I don’t have all of these sores,’ ” she said in an interview.

But after she retired at 75, she was shocked at the tab she faced after switching from private insurance to Medicare. She said it could have cost her close to $10,000 a year to take Humira. Ms. Lee’s Social Security earnings make her ineligible for certain assistance with drug costs.

“I cried a lot,” she said about the loss of affordable access to the drug.
 

What’s the path ahead?

The American College of Rheumatology and the Coalition of State Rheumatology Organizations are among the physician groups that pressed Congress for years for action to lower drug costs. Their members have been on the frontline of the crisis in the United States among patients unable to afford medicines.

“The financial burden of skyrocketing drug prices has forced many of our patients to spread their treatment out longer than prescribed, delay care, abandon prescriptions, or forgo treatment entirely – all of which risks flare-ups, disease regression, permanent disability, and even premature death,” said Blair Solow, MD, chair of the ACR’s Government Affairs Committee, in a statement on the new Medicare provisions.

In an interview, Dr. Solow, an assistant professor of medicine in the division of rheumatic diseases at University of Texas Southwestern Medical Center, Dallas, noted that there are concerns about how changes in Medicare drug pricing might affect future development of medicines. This has been a chief criticism of the pharmaceutical industry of efforts to allow Medicare to negotiate for lower prices.

“Of note, drug companies research, create, and produce medications that will perform well in the market, not necessarily those that may be most needed,” Dr. Solow wrote. “We can hope the new medications put forth by manufacturers are those that improve the lives of patients.”

In July, the Congressional Budget Office released a report on an earlier version of the Democrats’ plans for Medicare drug negotiations that suggested the potential loss to drugmakers’ productivity may be relatively small. The CBO expects that about 1,300 drugs will be approved over the next 30 years. The legislation as proposed in July might reduce the tally by 15 drugs. The CBO said these estimates fell in the middle of the distribution of possible outcomes and are subject to uncertainty, and it is still working on an estimate of the expects effects of the final version of the law.

“CBO did not predict what kind of drugs would be affected or analyze the effects of forgone innovation on public health,” the agency said.

Dr. Solow also said there may be some challenges for physicians in explaining to patients the timeline for the new law’s Medicare provisions. People need to be aware of how long it will take to implement the plan and the potential for changes or delays.

“I think this is important, because the interpretation of the law can be done in a way that was not necessarily what Congress intended, and depending on the control of Congress and the Administration, this could impact downstream effects in how this law plays out,” she said in an interview.

CMS has substantial work ahead of it in choosing the drugs for which there will be subject to negotiations. The new law limits the number of drugs that can be negotiated to 10 annually in 2026, increasing to 20 drugs annually by 2029. Drugs would be eligible for negotiated prices from 9 years after drug approval or 13 years for biologics, until entry of a generic or biosimilar competitor.

The new law calls for taxes and other penalties for companies that refuse to negotiate or offer the agreed price, Thomas J. Hwang, MD; Aaron S. Kesselheim, MD, JD, MPH; and Benjamin N. Rome, MD, MPH, all of Harvard Medical School, Boston, wrote in an Aug. 19 viewpoint article in JAMA. U.S. lawmakers took a different approach to negotiations about drug prices than those used in other countries, they wrote.

“Notably, the Inflation Reduction Act shields new drugs from negotiated prices for the first 9-13 years on the market,” they wrote. “In contrast, most other peer countries typically negotiate drug prices at the time of market entry, and no peer country limits the number of drugs negotiated.”


 

Missed opportunities

Madelaine Feldman, MD, president of the CSRO and a rheumatologist in private practice with The Rheumatology Group in New Orleans, said in an interview that she welcomes many of the provisions of the new law, as they will help her rheumatology patients afford their medicine.

But she considers one of the provisions of the law to be a disappointment. The law further delays the start date for a federal rule intended to allow people on Medicare Part D to directly benefit from discounts negotiated on drugs. This is a point often overlooked in news reports on the law.

Insurers use what are called pharmacy benefit manager (PBM) services to obtain rebates on medicines, but they don’t fully or directly share these price reductions with people enrolled in Part D plans. Instead, people in the Part D plans have their cost sharing pegged closer to listed prices, the ones set before the rebates obtained by PBMs. The PBM industry argues that the rebates, often based on the list price of the drug, serve to keep monthly insurance premiums low. But there’s been concern about perverse incentives in this approach, where more expensive drugs are preferred by PBMs, leading to higher rebates.

Congress had already delayed its implementation of the PBM rule, which would apply savings more directly to patients, until 2027 and did so again in the Inflation Reduction Act.

Implementing this rule on Medicare Part D prescription drug rebates would be a help for patients struggling to pay for costly drugs, such as those used in rheumatology, Dr. Feldman said.

“It just doesn’t make any sense to hold off on these changes if you really want to cut Medicare’s beneficiaries’ cost sharing and attempt to stop the perverse incentive that puts higher priced drugs on Part D formularies,” she said.

Changes in Medicare law will help some patients who need costly rheumatology treatments, including several medicines for which competition has been kept in check for many years.

In fact, this field of medicine includes prime examples of the kinds of products that drove Congress to give the giant federal health program leverage to try to restrain rising pharmaceutical costs through negotiations. The Inflation Reduction Act, signed into law by President Joe Biden on Aug. 16, also provides some fairly quick aid for people enrolled in Medicare who struggle with pharmacy bills.

Getty

As described in an official summary from the Congressional Research Service, the law establishes:

• A cap on annual Medicare Part D out-of-pocket spending that starts in 2025 at $2,000, with planned annual adjustments thereafter.
• A limit on cost-sharing under Medicare Part D for a month’s supply of covered insulin products at $35 for 2023 through 2025, with plans for continued limits on this cost in the years after pegged to negotiated prices.
• A program under which drug manufacturers provide discounts to beneficiaries who have incurred costs above the annual deductible beginning in 2025.
• A requirement that drugmakers issue rebates to Medicare for certain brand-name drugs covered without generic equivalents for which prices increase faster than inflation.
• An obligation for Medicare Part D plans to pay for adult vaccines that are recommended by the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices without requiring cost sharing.

The law’s marquee health provision sets the stage for Medicare, the nation’s largest purchaser of drugs, for the first time to leverage its clout directly in negotiating for lower costs for medicines. Democrats sought to build what amount to guardrails into this program, seeking to spare from competition new and innovative drugs and ones developed by smaller companies. Drugs likely to soon face competition from copycat versions also would fall outside of the pool for negotiations.

In effect, the design of the program would allow Medicare to negotiate in the future in cases such as those seen in recent years with blockbuster medicines often in rheumatology. That’s due in a large part to legal challenges that have helped thwart the introduction of copycat versions of these kinds of products known as biosimilars.

Etanercept (Enbrel) has been sold in the United States since 1998 and adalimumab (Humira) since 2003. Both products face competition from copycat versions called biosimilars in other nations, but the introductions of these products have been delayed in the United States until 2029 for etanercept and 2023 for adalimumab, the Office of Inspector General for the Department of Health & Human Services said in a March 2022 report. The OIG said in the report that the combined 2019 Medicare Part D tab for the two biologics was more than $5 billion.

Rheumatology drugs rival cancer medicines for dominance among the most expensive drugs for people enrolled in Medicare. The average 2020 spending for the most widely used forms of adalimumab by people in Medicare’s Part D pharmacy program topped $51,000, according to federal data. The price per dosage-unit for the drug rose about 7% from 2019 to 2020.

The pharmaceutical industry defends the high introductory costs of medicines and subsequent rising prices as necessary payback for research on products sold and the ones still in development. Since the initial Food and Drug Administration approval of adalimumab on Dec. 31, 2002, Abbott Laboratories and its AbbVie spin-off have made changes to the drug’s administration and paid for studies to expand its approved indications.

Still, the investment in adalimumab appears to have been paid well.

Abbott Labs acquired adalimumab as part of its purchase of BASF’s pharmaceutical operations in 2001, a purchase that also included the thyroid drug Synthroid. Abbott paid $7.2 billion, or roughly $12 billion in current dollars. In 2021 alone, Humira sales were $20.7 billion, with the United States accounting for $17.3 billion of the product’s revenue.
 

Losing access to treatment when moving to Medicare

Sue Lee of Crestwood, Ky., is among the patients waiting to see if the changes in Medicare law might allow her to again afford adalimumab. For now, Ms. Lee said she is hoping her plaque psoriasis stays manageable with the topical ointments and moisturizers she has been using since losing access to adalimumab. Ms. Lee, 80, took the medicine during her working years for her plaque psoriasis.

“I told people: ‘I’m on the wonder drug. Look at me. I can show my skin now. I don’t have all of these sores,’ ” she said in an interview.

But after she retired at 75, she was shocked at the tab she faced after switching from private insurance to Medicare. She said it could have cost her close to $10,000 a year to take Humira. Ms. Lee’s Social Security earnings make her ineligible for certain assistance with drug costs.

“I cried a lot,” she said about the loss of affordable access to the drug.
 

What’s the path ahead?

The American College of Rheumatology and the Coalition of State Rheumatology Organizations are among the physician groups that pressed Congress for years for action to lower drug costs. Their members have been on the frontline of the crisis in the United States among patients unable to afford medicines.

“The financial burden of skyrocketing drug prices has forced many of our patients to spread their treatment out longer than prescribed, delay care, abandon prescriptions, or forgo treatment entirely – all of which risks flare-ups, disease regression, permanent disability, and even premature death,” said Blair Solow, MD, chair of the ACR’s Government Affairs Committee, in a statement on the new Medicare provisions.

In an interview, Dr. Solow, an assistant professor of medicine in the division of rheumatic diseases at University of Texas Southwestern Medical Center, Dallas, noted that there are concerns about how changes in Medicare drug pricing might affect future development of medicines. This has been a chief criticism of the pharmaceutical industry of efforts to allow Medicare to negotiate for lower prices.

“Of note, drug companies research, create, and produce medications that will perform well in the market, not necessarily those that may be most needed,” Dr. Solow wrote. “We can hope the new medications put forth by manufacturers are those that improve the lives of patients.”

In July, the Congressional Budget Office released a report on an earlier version of the Democrats’ plans for Medicare drug negotiations that suggested the potential loss to drugmakers’ productivity may be relatively small. The CBO expects that about 1,300 drugs will be approved over the next 30 years. The legislation as proposed in July might reduce the tally by 15 drugs. The CBO said these estimates fell in the middle of the distribution of possible outcomes and are subject to uncertainty, and it is still working on an estimate of the expects effects of the final version of the law.

“CBO did not predict what kind of drugs would be affected or analyze the effects of forgone innovation on public health,” the agency said.

Dr. Solow also said there may be some challenges for physicians in explaining to patients the timeline for the new law’s Medicare provisions. People need to be aware of how long it will take to implement the plan and the potential for changes or delays.

“I think this is important, because the interpretation of the law can be done in a way that was not necessarily what Congress intended, and depending on the control of Congress and the Administration, this could impact downstream effects in how this law plays out,” she said in an interview.

CMS has substantial work ahead of it in choosing the drugs for which there will be subject to negotiations. The new law limits the number of drugs that can be negotiated to 10 annually in 2026, increasing to 20 drugs annually by 2029. Drugs would be eligible for negotiated prices from 9 years after drug approval or 13 years for biologics, until entry of a generic or biosimilar competitor.

The new law calls for taxes and other penalties for companies that refuse to negotiate or offer the agreed price, Thomas J. Hwang, MD; Aaron S. Kesselheim, MD, JD, MPH; and Benjamin N. Rome, MD, MPH, all of Harvard Medical School, Boston, wrote in an Aug. 19 viewpoint article in JAMA. U.S. lawmakers took a different approach to negotiations about drug prices than those used in other countries, they wrote.

“Notably, the Inflation Reduction Act shields new drugs from negotiated prices for the first 9-13 years on the market,” they wrote. “In contrast, most other peer countries typically negotiate drug prices at the time of market entry, and no peer country limits the number of drugs negotiated.”


 

Missed opportunities

Madelaine Feldman, MD, president of the CSRO and a rheumatologist in private practice with The Rheumatology Group in New Orleans, said in an interview that she welcomes many of the provisions of the new law, as they will help her rheumatology patients afford their medicine.

But she considers one of the provisions of the law to be a disappointment. The law further delays the start date for a federal rule intended to allow people on Medicare Part D to directly benefit from discounts negotiated on drugs. This is a point often overlooked in news reports on the law.

Insurers use what are called pharmacy benefit manager (PBM) services to obtain rebates on medicines, but they don’t fully or directly share these price reductions with people enrolled in Part D plans. Instead, people in the Part D plans have their cost sharing pegged closer to listed prices, the ones set before the rebates obtained by PBMs. The PBM industry argues that the rebates, often based on the list price of the drug, serve to keep monthly insurance premiums low. But there’s been concern about perverse incentives in this approach, where more expensive drugs are preferred by PBMs, leading to higher rebates.

Congress had already delayed its implementation of the PBM rule, which would apply savings more directly to patients, until 2027 and did so again in the Inflation Reduction Act.

Implementing this rule on Medicare Part D prescription drug rebates would be a help for patients struggling to pay for costly drugs, such as those used in rheumatology, Dr. Feldman said.

“It just doesn’t make any sense to hold off on these changes if you really want to cut Medicare’s beneficiaries’ cost sharing and attempt to stop the perverse incentive that puts higher priced drugs on Part D formularies,” she said.