Over the last several years, the United States has seen a substantial increase in proposed legislation directed toward transgender individuals, particularly youth.¹ One type of this legislation aims to prevent participation of transgender girls on female sports teams. While at first glance these bills may seem like common sense protections, in reality they are based on little evidence and serve to further marginalize an already-vulnerable population.

The majority of the population, and thus the majority of athletes, are cisgender.² According a limited data set from the 2017 Youth Risk Behavior Survey, only 1.8% of high school students identify as transgender.^3,4 Overall, this is a very small percentage and it is unlikely that all of them, or even a majority, participate in athletics. In fact, many transgender individuals avoid athletics as it worsens their dysphoria. Winners are no more likely to be transgender than cisgender.

While proponents of this legislation say that trans women have an unfair advantage because of elevated testosterone levels (and thus theoretically increased muscle mass), there is no clear relationship between higher testosterone levels in athletes and improved athletic performance.² In fact, there are plenty of sports in which a smaller physique may be beneficial, such as gymnastics. A systematic review showed “no direct or consistent research suggesting transgender female individuals ... have an athletic advantage at any stage of their transition.”⁵ Furthermore, trans women are not the only women with elevated testosterone levels. Many cisgender women who have polycystic ovary syndrome or a disorder of sexual differentiation can have higher levels of testosterone and theoretically may have higher muscle mass. Who is to decide which team would be most appropriate for them? Is the plan to require a karyotype, other genetic testing, or an invasive physical exam for every young athlete? Even if the concern is with regards to testosterone levels and muscle mass, this ignores that fact that appropriate medical intervention for transgender adolescents will alter these attributes. If a transgender girl began gonadotropin-releasing hormone agonists early in puberty, she is unlikely to have increased muscle mass or a higher testosterone level than a cisgender girl. Those trans girls who take estradiol also experience a decrease in muscle mass. Additionally, adolescents grow and develop at different rates – surely there is already significant variability among hormone levels, muscle mass, sexual maturity ratings, and ability among individual athletes, regardless of gender identity? The argument that trans women should be excluded based on a theoretical genetic advantage is reminiscent of the argument that Black athletes should be excluded because of genetic advantage. Just as with cisgender athletes, transgender athletes will naturally vary in ability.⁶

In addition, there are many places and organizations that already have trans-inclusive policies in place for sports, yet we have not seen transgender individuals dominate their peers. In the 8 years since implementation of a trans-inclusive sports policy in California, a trans woman has never dominated a sport.⁷ The same is true for Canada since the institution of their policy 2 years ago. While transgender people can participate in the Olympics, this year marks the first time a trans woman has ever qualified (Laurel Hubbard, New Zealand, women’s weightlifting). The lack of transgender Olympians may be in part because of problematic requirements (such as duration of hormone therapy and surgery requirements) for transgender individuals, which may be so onerous that they are functionally excluded.^2,5

In reality, athletes are improving over time and the performance gap between genders is shrinking. For example, in 1970 Mark Spitz swam the 100-meter freestyle in 51.94 seconds, a time that has now been surpassed by both men and women, such as Sarah Sjöström (women’s world record holder at 51.71 seconds). Athletes’ physical attributes are often less important than their training and dedication to their sport.

More importantly, this discussion raises the philosophical question of the purpose of athletics for youth and young adults. Winning and good performance can – though rarely – lead to college scholarships and professional careers, the biggest benefit of athletics comes from participation. We encourage youth to play sports not to win, but to learn about leadership, dedication, and collegiality, as well as for the health benefits of exercise. Inclusion in sports and other extracurricular activities improves depression, anxiety, and suicide rates. In fact, participation in sports has been associated with improved grades, greater homework completion, higher educational and occupational aspirations, and improved self-esteem.^8-12 Excluding a population that already experiences such drastic marginalization will cause more damage. Values of nondiscrimination and inclusion should be promoted among all student athletes, rather than “other-ism.”

Forcing trans women to compete with men will worsen their dysphoria and further ostracize the most vulnerable, giving credence to those that believe they are not “real women.” Allowing transgender individuals to play on the team consistent with their gender identity is appropriate, not only for scientific reasons but also for humanitarian ones. Such laws are based not on evidence, but on discrimination. Not only do trans women not do better than cisgender women in sports, but such proposed legislation also ignores the normal variability among individuals as well as the intense training and dedication involved in becoming a top athlete. Limiting trans women’s participation in sports does not raise up cisgender women, but rather brings us all down. Please advocate for your patients to participate in athletics in accordance with their gender identity to promote both their physical and emotional well-being.

Dr. Lawlis is assistant professor of pediatrics at the University of Oklahoma Health Sciences Center, Oklahoma City, and an adolescent medicine specialist at OU Children’s. She has no relevant financial disclosures.

References

1. Cooper MB. Pediatric News. 2020 Dec 11, 2020.

2. Turban J. Scientific American. 2021 May 21.

3. Redfield RR et al. Morbid Mortal Wkly Rep. 2018;67(8):1-11.

4. Johns MM et al. Morbid Mortal Wkly Rep. 2019;68(3):67-71.

5. Jones BA et al. Sports Med (Auckland, New Zealand). 2017;47(4):701-16.

6. Strangio C et al. ACLU News. 2020 Apr 30.

7. Strauss L. USA Today. 2021 Apr 9.

8. Darling N et al. J Leisure Res. 2005;37(1):51-76.

9. Fredricks JA et al. Dev Psych. 2006;42(4):698-713.

10. Marsh HW et al. J Sport Exerc Psychol. 2003;25(2):205.

11. Nelson MC et al. Pediatrics. 2006;117(4):1281-90.

12. Ortega FB et al. Int J Obes. 2008;32(1):1-11.

Over the last several years, the United States has seen a substantial increase in proposed legislation directed toward transgender individuals, particularly youth.¹ One type of this legislation aims to prevent participation of transgender girls on female sports teams. While at first glance these bills may seem like common sense protections, in reality they are based on little evidence and serve to further marginalize an already-vulnerable population.

The majority of the population, and thus the majority of athletes, are cisgender.² According a limited data set from the 2017 Youth Risk Behavior Survey, only 1.8% of high school students identify as transgender.^3,4 Overall, this is a very small percentage and it is unlikely that all of them, or even a majority, participate in athletics. In fact, many transgender individuals avoid athletics as it worsens their dysphoria. Winners are no more likely to be transgender than cisgender.

While proponents of this legislation say that trans women have an unfair advantage because of elevated testosterone levels (and thus theoretically increased muscle mass), there is no clear relationship between higher testosterone levels in athletes and improved athletic performance.² In fact, there are plenty of sports in which a smaller physique may be beneficial, such as gymnastics. A systematic review showed “no direct or consistent research suggesting transgender female individuals ... have an athletic advantage at any stage of their transition.”⁵ Furthermore, trans women are not the only women with elevated testosterone levels. Many cisgender women who have polycystic ovary syndrome or a disorder of sexual differentiation can have higher levels of testosterone and theoretically may have higher muscle mass. Who is to decide which team would be most appropriate for them? Is the plan to require a karyotype, other genetic testing, or an invasive physical exam for every young athlete? Even if the concern is with regards to testosterone levels and muscle mass, this ignores that fact that appropriate medical intervention for transgender adolescents will alter these attributes. If a transgender girl began gonadotropin-releasing hormone agonists early in puberty, she is unlikely to have increased muscle mass or a higher testosterone level than a cisgender girl. Those trans girls who take estradiol also experience a decrease in muscle mass. Additionally, adolescents grow and develop at different rates – surely there is already significant variability among hormone levels, muscle mass, sexual maturity ratings, and ability among individual athletes, regardless of gender identity? The argument that trans women should be excluded based on a theoretical genetic advantage is reminiscent of the argument that Black athletes should be excluded because of genetic advantage. Just as with cisgender athletes, transgender athletes will naturally vary in ability.⁶

In addition, there are many places and organizations that already have trans-inclusive policies in place for sports, yet we have not seen transgender individuals dominate their peers. In the 8 years since implementation of a trans-inclusive sports policy in California, a trans woman has never dominated a sport.⁷ The same is true for Canada since the institution of their policy 2 years ago. While transgender people can participate in the Olympics, this year marks the first time a trans woman has ever qualified (Laurel Hubbard, New Zealand, women’s weightlifting). The lack of transgender Olympians may be in part because of problematic requirements (such as duration of hormone therapy and surgery requirements) for transgender individuals, which may be so onerous that they are functionally excluded.^2,5

In reality, athletes are improving over time and the performance gap between genders is shrinking. For example, in 1970 Mark Spitz swam the 100-meter freestyle in 51.94 seconds, a time that has now been surpassed by both men and women, such as Sarah Sjöström (women’s world record holder at 51.71 seconds). Athletes’ physical attributes are often less important than their training and dedication to their sport.

More importantly, this discussion raises the philosophical question of the purpose of athletics for youth and young adults. Winning and good performance can – though rarely – lead to college scholarships and professional careers, the biggest benefit of athletics comes from participation. We encourage youth to play sports not to win, but to learn about leadership, dedication, and collegiality, as well as for the health benefits of exercise. Inclusion in sports and other extracurricular activities improves depression, anxiety, and suicide rates. In fact, participation in sports has been associated with improved grades, greater homework completion, higher educational and occupational aspirations, and improved self-esteem.^8-12 Excluding a population that already experiences such drastic marginalization will cause more damage. Values of nondiscrimination and inclusion should be promoted among all student athletes, rather than “other-ism.”

Forcing trans women to compete with men will worsen their dysphoria and further ostracize the most vulnerable, giving credence to those that believe they are not “real women.” Allowing transgender individuals to play on the team consistent with their gender identity is appropriate, not only for scientific reasons but also for humanitarian ones. Such laws are based not on evidence, but on discrimination. Not only do trans women not do better than cisgender women in sports, but such proposed legislation also ignores the normal variability among individuals as well as the intense training and dedication involved in becoming a top athlete. Limiting trans women’s participation in sports does not raise up cisgender women, but rather brings us all down. Please advocate for your patients to participate in athletics in accordance with their gender identity to promote both their physical and emotional well-being.

Dr. Lawlis is assistant professor of pediatrics at the University of Oklahoma Health Sciences Center, Oklahoma City, and an adolescent medicine specialist at OU Children’s. She has no relevant financial disclosures.

References

1. Cooper MB. Pediatric News. 2020 Dec 11, 2020.

2. Turban J. Scientific American. 2021 May 21.

3. Redfield RR et al. Morbid Mortal Wkly Rep. 2018;67(8):1-11.

4. Johns MM et al. Morbid Mortal Wkly Rep. 2019;68(3):67-71.

5. Jones BA et al. Sports Med (Auckland, New Zealand). 2017;47(4):701-16.

6. Strangio C et al. ACLU News. 2020 Apr 30.

7. Strauss L. USA Today. 2021 Apr 9.

8. Darling N et al. J Leisure Res. 2005;37(1):51-76.

9. Fredricks JA et al. Dev Psych. 2006;42(4):698-713.

10. Marsh HW et al. J Sport Exerc Psychol. 2003;25(2):205.

11. Nelson MC et al. Pediatrics. 2006;117(4):1281-90.

12. Ortega FB et al. Int J Obes. 2008;32(1):1-11.

Over the last several years, the United States has seen a substantial increase in proposed legislation directed toward transgender individuals, particularly youth.¹ One type of this legislation aims to prevent participation of transgender girls on female sports teams. While at first glance these bills may seem like common sense protections, in reality they are based on little evidence and serve to further marginalize an already-vulnerable population.

The majority of the population, and thus the majority of athletes, are cisgender.² According a limited data set from the 2017 Youth Risk Behavior Survey, only 1.8% of high school students identify as transgender.^3,4 Overall, this is a very small percentage and it is unlikely that all of them, or even a majority, participate in athletics. In fact, many transgender individuals avoid athletics as it worsens their dysphoria. Winners are no more likely to be transgender than cisgender.

While proponents of this legislation say that trans women have an unfair advantage because of elevated testosterone levels (and thus theoretically increased muscle mass), there is no clear relationship between higher testosterone levels in athletes and improved athletic performance.² In fact, there are plenty of sports in which a smaller physique may be beneficial, such as gymnastics. A systematic review showed “no direct or consistent research suggesting transgender female individuals ... have an athletic advantage at any stage of their transition.”⁵ Furthermore, trans women are not the only women with elevated testosterone levels. Many cisgender women who have polycystic ovary syndrome or a disorder of sexual differentiation can have higher levels of testosterone and theoretically may have higher muscle mass. Who is to decide which team would be most appropriate for them? Is the plan to require a karyotype, other genetic testing, or an invasive physical exam for every young athlete? Even if the concern is with regards to testosterone levels and muscle mass, this ignores that fact that appropriate medical intervention for transgender adolescents will alter these attributes. If a transgender girl began gonadotropin-releasing hormone agonists early in puberty, she is unlikely to have increased muscle mass or a higher testosterone level than a cisgender girl. Those trans girls who take estradiol also experience a decrease in muscle mass. Additionally, adolescents grow and develop at different rates – surely there is already significant variability among hormone levels, muscle mass, sexual maturity ratings, and ability among individual athletes, regardless of gender identity? The argument that trans women should be excluded based on a theoretical genetic advantage is reminiscent of the argument that Black athletes should be excluded because of genetic advantage. Just as with cisgender athletes, transgender athletes will naturally vary in ability.⁶

In addition, there are many places and organizations that already have trans-inclusive policies in place for sports, yet we have not seen transgender individuals dominate their peers. In the 8 years since implementation of a trans-inclusive sports policy in California, a trans woman has never dominated a sport.⁷ The same is true for Canada since the institution of their policy 2 years ago. While transgender people can participate in the Olympics, this year marks the first time a trans woman has ever qualified (Laurel Hubbard, New Zealand, women’s weightlifting). The lack of transgender Olympians may be in part because of problematic requirements (such as duration of hormone therapy and surgery requirements) for transgender individuals, which may be so onerous that they are functionally excluded.^2,5

In reality, athletes are improving over time and the performance gap between genders is shrinking. For example, in 1970 Mark Spitz swam the 100-meter freestyle in 51.94 seconds, a time that has now been surpassed by both men and women, such as Sarah Sjöström (women’s world record holder at 51.71 seconds). Athletes’ physical attributes are often less important than their training and dedication to their sport.

More importantly, this discussion raises the philosophical question of the purpose of athletics for youth and young adults. Winning and good performance can – though rarely – lead to college scholarships and professional careers, the biggest benefit of athletics comes from participation. We encourage youth to play sports not to win, but to learn about leadership, dedication, and collegiality, as well as for the health benefits of exercise. Inclusion in sports and other extracurricular activities improves depression, anxiety, and suicide rates. In fact, participation in sports has been associated with improved grades, greater homework completion, higher educational and occupational aspirations, and improved self-esteem.^8-12 Excluding a population that already experiences such drastic marginalization will cause more damage. Values of nondiscrimination and inclusion should be promoted among all student athletes, rather than “other-ism.”

Forcing trans women to compete with men will worsen their dysphoria and further ostracize the most vulnerable, giving credence to those that believe they are not “real women.” Allowing transgender individuals to play on the team consistent with their gender identity is appropriate, not only for scientific reasons but also for humanitarian ones. Such laws are based not on evidence, but on discrimination. Not only do trans women not do better than cisgender women in sports, but such proposed legislation also ignores the normal variability among individuals as well as the intense training and dedication involved in becoming a top athlete. Limiting trans women’s participation in sports does not raise up cisgender women, but rather brings us all down. Please advocate for your patients to participate in athletics in accordance with their gender identity to promote both their physical and emotional well-being.

Dr. Lawlis is assistant professor of pediatrics at the University of Oklahoma Health Sciences Center, Oklahoma City, and an adolescent medicine specialist at OU Children’s. She has no relevant financial disclosures.

References

1. Cooper MB. Pediatric News. 2020 Dec 11, 2020.

2. Turban J. Scientific American. 2021 May 21.

3. Redfield RR et al. Morbid Mortal Wkly Rep. 2018;67(8):1-11.

4. Johns MM et al. Morbid Mortal Wkly Rep. 2019;68(3):67-71.

5. Jones BA et al. Sports Med (Auckland, New Zealand). 2017;47(4):701-16.

6. Strangio C et al. ACLU News. 2020 Apr 30.

7. Strauss L. USA Today. 2021 Apr 9.

8. Darling N et al. J Leisure Res. 2005;37(1):51-76.

9. Fredricks JA et al. Dev Psych. 2006;42(4):698-713.

10. Marsh HW et al. J Sport Exerc Psychol. 2003;25(2):205.

11. Nelson MC et al. Pediatrics. 2006;117(4):1281-90.

12. Ortega FB et al. Int J Obes. 2008;32(1):1-11.

A 46-year-old woman presents with fatigue. She reports that she has had unusually heavy periods for the past 6 months. Her blood work shows a hematocrit level of 32, a mean corpuscular volume of 77, a platelet count of 390,000, and a ferritin level of 5.

What would you recommend for iron replacement?

A. FeSO₄ 325 mg three times a day with vitamin C

B. FeSO₄ 325 mg daily with vitamin C

C. FeSO₄ 325 mg every other day

Recommendations and supporting research

I think I would start with choice C, FeSO₄ every other day.

Treatment of iron deficiency with oral iron has traditionally been done by giving 150-200 mg of elemental iron (which is equal to three 325 mg tablets of iron sulfate).¹ This dosing regimen has considerable gastrointestinal side effects. Recent evidence has shown that iron absorption is diminished the more frequently it is given.

Stoffel and colleagues found that fractional iron absorption was higher in iron-deficient women who were given iron every other day, compared with those who received daily iron.² They also found that the more frequently iron was administered, the higher the hepcidin levels were, and the lower the iron absorption.

Karacok and colleagues studied every other day iron versus daily iron for the treatment of iron-deficiency anemia of pregnancy.³ A total of 217 women completed randomization and participated in the study, with all women receiving 100 mg of elemental iron, either daily (111) or every other day (106). There was no significant difference in increase in ferritin levels, or hemoglobin increase between the groups. The daily iron group had more gastrointestinal symptoms (41.4%) than the every other day iron group (15.1%) (P < .0057).

Düzen Oflas and colleagues looked at the same question in nonpregnant women with iron deficiency anemia.⁴ Study patients either received 80 mg iron sulfate twice a day, 80 mg once a day, or 80 mg every other day. There was no statistically significant difference in hemoglobin improvement between groups, but the group that received twice a day dosing of iron had statistically significantly higher ferritin levels than the daily or every other day iron groups. This improvement in ferritin levels came at a cost, though, as 68% of patients in the twice daily iron group had gastrointestinal symptoms, compared with only 10% in the every other day iron group (P < .01).

Vitamin C is often recommended to be taken with iron to promote absorption. The evidence for this practice is scant, and dates back almost 50 years.^5,6

Cook and Reddy found there was no significant difference in mean iron absorption among the three dietary periods studied in 12 patients despite a range of mean daily intakes of dietary vitamin C of 51-247 mg/d.⁷

Hunt and colleagues studied 25 non pregnant, healthy women with low ferritin levels.⁸ The women’s meals were supplemented with vitamin C (500 mg, three times a day) for 5 of the 10 weeks, in a double-blind, crossover design. Vitamin C supplementation did not lead to a difference in iron absorption, lab indices of iron deficiency, or the biological half-life of iron.

Li and colleagues looked at the effect of vitamin C supplementation on iron levels in women with iron deficiency anemia.⁹ A total of 440 women were recruited, with 432 completing the trial. Women were randomized to receive iron supplements plus vitamin C or iron supplements only. Their findings were that oral iron supplements alone were equivalent to oral iron supplements plus vitamin C in improving hemoglobin recovery and iron absorption.
 

Bottom line

Less frequent administration of iron supplements (every other day) is as effective as more frequent administration, with less GI symptoms. Also, adding vitamin C does not appear to improve absorption of iron supplements.

Dr. Paauw is professor of medicine in the division of general internal medicine at the University of Washington, Seattle, and he serves as third-year medical student clerkship director at the University of Washington. He is a member of the editorial advisory board of Internal Medicine News. Dr. Paauw has no conflicts to disclose. Contact him at imnews@mdedge.com.

References

1. 1. Fairbanks VF and Beutler E. Iron deficiency, in “Williams Textbook of Hematology, 6th ed.” (New York: McGraw-Hill, 2001).

2. Stoffel N et al. Lancet Haematology. 2017;4: e524-33.

3. Karakoc G et al. J Matern Fetal Neonatal Med. 2021 Apr 18:1-5

4. Düzen Oflas N et al. Intern Med J. 2020 Jul;50(7):854-8

5. Cook JD and Monsen ER. Am J Clin Nutr. 1977;30:235-41.

6. Hallberg L etal. Hum Nutr Appl Nutr. 1986;40: 97-113.

7. Cook JD and Reddy M. Am J Clin Nutr. 2001;73:93-8.

8. Hunt JR et al. Am J Clin Nutr. 1994 Jun;59(6):1381-5.

9. Li N et al. JAMA Netw Open. 2020 Nov 2;3(11):e2023644.

A 46-year-old woman presents with fatigue. She reports that she has had unusually heavy periods for the past 6 months. Her blood work shows a hematocrit level of 32, a mean corpuscular volume of 77, a platelet count of 390,000, and a ferritin level of 5.

What would you recommend for iron replacement?

A. FeSO₄ 325 mg three times a day with vitamin C

B. FeSO₄ 325 mg daily with vitamin C

C. FeSO₄ 325 mg every other day

Recommendations and supporting research

I think I would start with choice C, FeSO₄ every other day.

Treatment of iron deficiency with oral iron has traditionally been done by giving 150-200 mg of elemental iron (which is equal to three 325 mg tablets of iron sulfate).¹ This dosing regimen has considerable gastrointestinal side effects. Recent evidence has shown that iron absorption is diminished the more frequently it is given.

Stoffel and colleagues found that fractional iron absorption was higher in iron-deficient women who were given iron every other day, compared with those who received daily iron.² They also found that the more frequently iron was administered, the higher the hepcidin levels were, and the lower the iron absorption.

Karacok and colleagues studied every other day iron versus daily iron for the treatment of iron-deficiency anemia of pregnancy.³ A total of 217 women completed randomization and participated in the study, with all women receiving 100 mg of elemental iron, either daily (111) or every other day (106). There was no significant difference in increase in ferritin levels, or hemoglobin increase between the groups. The daily iron group had more gastrointestinal symptoms (41.4%) than the every other day iron group (15.1%) (P < .0057).

Düzen Oflas and colleagues looked at the same question in nonpregnant women with iron deficiency anemia.⁴ Study patients either received 80 mg iron sulfate twice a day, 80 mg once a day, or 80 mg every other day. There was no statistically significant difference in hemoglobin improvement between groups, but the group that received twice a day dosing of iron had statistically significantly higher ferritin levels than the daily or every other day iron groups. This improvement in ferritin levels came at a cost, though, as 68% of patients in the twice daily iron group had gastrointestinal symptoms, compared with only 10% in the every other day iron group (P < .01).

Vitamin C is often recommended to be taken with iron to promote absorption. The evidence for this practice is scant, and dates back almost 50 years.^5,6

Cook and Reddy found there was no significant difference in mean iron absorption among the three dietary periods studied in 12 patients despite a range of mean daily intakes of dietary vitamin C of 51-247 mg/d.⁷

Hunt and colleagues studied 25 non pregnant, healthy women with low ferritin levels.⁸ The women’s meals were supplemented with vitamin C (500 mg, three times a day) for 5 of the 10 weeks, in a double-blind, crossover design. Vitamin C supplementation did not lead to a difference in iron absorption, lab indices of iron deficiency, or the biological half-life of iron.

Li and colleagues looked at the effect of vitamin C supplementation on iron levels in women with iron deficiency anemia.⁹ A total of 440 women were recruited, with 432 completing the trial. Women were randomized to receive iron supplements plus vitamin C or iron supplements only. Their findings were that oral iron supplements alone were equivalent to oral iron supplements plus vitamin C in improving hemoglobin recovery and iron absorption.
 

Bottom line

Less frequent administration of iron supplements (every other day) is as effective as more frequent administration, with less GI symptoms. Also, adding vitamin C does not appear to improve absorption of iron supplements.

Dr. Paauw is professor of medicine in the division of general internal medicine at the University of Washington, Seattle, and he serves as third-year medical student clerkship director at the University of Washington. He is a member of the editorial advisory board of Internal Medicine News. Dr. Paauw has no conflicts to disclose. Contact him at imnews@mdedge.com.

References

1. 1. Fairbanks VF and Beutler E. Iron deficiency, in “Williams Textbook of Hematology, 6th ed.” (New York: McGraw-Hill, 2001).

2. Stoffel N et al. Lancet Haematology. 2017;4: e524-33.

3. Karakoc G et al. J Matern Fetal Neonatal Med. 2021 Apr 18:1-5

4. Düzen Oflas N et al. Intern Med J. 2020 Jul;50(7):854-8

5. Cook JD and Monsen ER. Am J Clin Nutr. 1977;30:235-41.

6. Hallberg L etal. Hum Nutr Appl Nutr. 1986;40: 97-113.

7. Cook JD and Reddy M. Am J Clin Nutr. 2001;73:93-8.

8. Hunt JR et al. Am J Clin Nutr. 1994 Jun;59(6):1381-5.

9. Li N et al. JAMA Netw Open. 2020 Nov 2;3(11):e2023644.

A 46-year-old woman presents with fatigue. She reports that she has had unusually heavy periods for the past 6 months. Her blood work shows a hematocrit level of 32, a mean corpuscular volume of 77, a platelet count of 390,000, and a ferritin level of 5.

What would you recommend for iron replacement?

A. FeSO₄ 325 mg three times a day with vitamin C

B. FeSO₄ 325 mg daily with vitamin C

C. FeSO₄ 325 mg every other day

Recommendations and supporting research

I think I would start with choice C, FeSO₄ every other day.

Treatment of iron deficiency with oral iron has traditionally been done by giving 150-200 mg of elemental iron (which is equal to three 325 mg tablets of iron sulfate).¹ This dosing regimen has considerable gastrointestinal side effects. Recent evidence has shown that iron absorption is diminished the more frequently it is given.

Stoffel and colleagues found that fractional iron absorption was higher in iron-deficient women who were given iron every other day, compared with those who received daily iron.² They also found that the more frequently iron was administered, the higher the hepcidin levels were, and the lower the iron absorption.

Karacok and colleagues studied every other day iron versus daily iron for the treatment of iron-deficiency anemia of pregnancy.³ A total of 217 women completed randomization and participated in the study, with all women receiving 100 mg of elemental iron, either daily (111) or every other day (106). There was no significant difference in increase in ferritin levels, or hemoglobin increase between the groups. The daily iron group had more gastrointestinal symptoms (41.4%) than the every other day iron group (15.1%) (P < .0057).

Düzen Oflas and colleagues looked at the same question in nonpregnant women with iron deficiency anemia.⁴ Study patients either received 80 mg iron sulfate twice a day, 80 mg once a day, or 80 mg every other day. There was no statistically significant difference in hemoglobin improvement between groups, but the group that received twice a day dosing of iron had statistically significantly higher ferritin levels than the daily or every other day iron groups. This improvement in ferritin levels came at a cost, though, as 68% of patients in the twice daily iron group had gastrointestinal symptoms, compared with only 10% in the every other day iron group (P < .01).

Vitamin C is often recommended to be taken with iron to promote absorption. The evidence for this practice is scant, and dates back almost 50 years.^5,6

Cook and Reddy found there was no significant difference in mean iron absorption among the three dietary periods studied in 12 patients despite a range of mean daily intakes of dietary vitamin C of 51-247 mg/d.⁷

Hunt and colleagues studied 25 non pregnant, healthy women with low ferritin levels.⁸ The women’s meals were supplemented with vitamin C (500 mg, three times a day) for 5 of the 10 weeks, in a double-blind, crossover design. Vitamin C supplementation did not lead to a difference in iron absorption, lab indices of iron deficiency, or the biological half-life of iron.

Li and colleagues looked at the effect of vitamin C supplementation on iron levels in women with iron deficiency anemia.⁹ A total of 440 women were recruited, with 432 completing the trial. Women were randomized to receive iron supplements plus vitamin C or iron supplements only. Their findings were that oral iron supplements alone were equivalent to oral iron supplements plus vitamin C in improving hemoglobin recovery and iron absorption.
 

Bottom line

Less frequent administration of iron supplements (every other day) is as effective as more frequent administration, with less GI symptoms. Also, adding vitamin C does not appear to improve absorption of iron supplements.

Dr. Paauw is professor of medicine in the division of general internal medicine at the University of Washington, Seattle, and he serves as third-year medical student clerkship director at the University of Washington. He is a member of the editorial advisory board of Internal Medicine News. Dr. Paauw has no conflicts to disclose. Contact him at imnews@mdedge.com.

References

1. 1. Fairbanks VF and Beutler E. Iron deficiency, in “Williams Textbook of Hematology, 6th ed.” (New York: McGraw-Hill, 2001).

2. Stoffel N et al. Lancet Haematology. 2017;4: e524-33.

3. Karakoc G et al. J Matern Fetal Neonatal Med. 2021 Apr 18:1-5

4. Düzen Oflas N et al. Intern Med J. 2020 Jul;50(7):854-8

5. Cook JD and Monsen ER. Am J Clin Nutr. 1977;30:235-41.

6. Hallberg L etal. Hum Nutr Appl Nutr. 1986;40: 97-113.

7. Cook JD and Reddy M. Am J Clin Nutr. 2001;73:93-8.

8. Hunt JR et al. Am J Clin Nutr. 1994 Jun;59(6):1381-5.

9. Li N et al. JAMA Netw Open. 2020 Nov 2;3(11):e2023644.

More Americans died from drug overdoses in 2020 than in any other year, the CDC said July 14.

Fatal overdoses rose by nearly 30% last year to a total of more than 93,000 deaths, according to the provisional data the National Center for Health Statistics reported.

The spikes are largely attributed to the rise in use of fentanyl and other synthetic opioids.

The Washington Post reported that more than 69,000 overdose deaths involved opioids, up from 50,963 in 2019.

Amid the crush of overdoses, the White House announced that President Joe Biden has nominated Rahul Gupta, MD, to lead the White House Office of National Drug Control Policy.

Dr. Gupta is a former health commissioner of West Virginia, and is chief medical and health officer for the March of Dimes.

“Dr. Gupta led efforts in West Virginia to address the opioid crisis, gaining national prominence as a leader in tackling this issue,” March of Dimes President and CEO Stacey Stewart said in a statement. “At March of Dimes, he has advocated for policies and programs to prevent and treat substance use, with a focus on the safety and care of pregnant women and infants.”

Healthday contributed to this report. A version of this article first appeared on WebMD.com.

More Americans died from drug overdoses in 2020 than in any other year, the CDC said July 14.

Fatal overdoses rose by nearly 30% last year to a total of more than 93,000 deaths, according to the provisional data the National Center for Health Statistics reported.

The spikes are largely attributed to the rise in use of fentanyl and other synthetic opioids.

The Washington Post reported that more than 69,000 overdose deaths involved opioids, up from 50,963 in 2019.

Amid the crush of overdoses, the White House announced that President Joe Biden has nominated Rahul Gupta, MD, to lead the White House Office of National Drug Control Policy.

Dr. Gupta is a former health commissioner of West Virginia, and is chief medical and health officer for the March of Dimes.

“Dr. Gupta led efforts in West Virginia to address the opioid crisis, gaining national prominence as a leader in tackling this issue,” March of Dimes President and CEO Stacey Stewart said in a statement. “At March of Dimes, he has advocated for policies and programs to prevent and treat substance use, with a focus on the safety and care of pregnant women and infants.”

Healthday contributed to this report. A version of this article first appeared on WebMD.com.

More Americans died from drug overdoses in 2020 than in any other year, the CDC said July 14.

Fatal overdoses rose by nearly 30% last year to a total of more than 93,000 deaths, according to the provisional data the National Center for Health Statistics reported.

The spikes are largely attributed to the rise in use of fentanyl and other synthetic opioids.

The Washington Post reported that more than 69,000 overdose deaths involved opioids, up from 50,963 in 2019.

Amid the crush of overdoses, the White House announced that President Joe Biden has nominated Rahul Gupta, MD, to lead the White House Office of National Drug Control Policy.

Dr. Gupta is a former health commissioner of West Virginia, and is chief medical and health officer for the March of Dimes.

“Dr. Gupta led efforts in West Virginia to address the opioid crisis, gaining national prominence as a leader in tackling this issue,” March of Dimes President and CEO Stacey Stewart said in a statement. “At March of Dimes, he has advocated for policies and programs to prevent and treat substance use, with a focus on the safety and care of pregnant women and infants.”

Healthday contributed to this report. A version of this article first appeared on WebMD.com.

The overactive bladder treatment mirabegron (Myrbetriq) is one of three new drugs to be linked to cases of drug-associated antineutrophil cytoplasmic antibody–associated vasculitis (DA-AAV) according to pharmacovigilance data.

Artfoliophoto/Thinkstock

The other two drugs are the antiviral agent sofosbuvir (Sovaldi) and the tyrosine kinase inhibitor nintedanib (Ofev), which is indicated for chronic fibrosing interstitial lung diseases (ILDs) with a progressive phenotype.

The study findings also strengthen previously suspected associations, Samuel Deshayes, MD, of Caen (France) University Hospital and coauthors report in Arthritis & Rheumatology. This includes associations between hydralazine, propylthiouracil, thiamazole, minocycline, and carbimazole to name a few more of the 15 drugs where associations were found.

“These data imply specific prescriber attention to these drugs and argue for experimental studies on AAV pathophysiology with [the] recent drugs,” Dr. Deshayes and colleagues wrote.

Identifying whether AAV could be due to drug treatment is important as there have been suggestions that this may confer a better prognosis than for primary AAV. In addition, “withdrawal of the culprit drug” may be enough to treat the patient in milder cases, the researchers suggested.

That said, the researchers acknowledged that it can be difficult to attribute AAV to a specific drug, particularly as data are often from case reports or small series of patients and, until now, research had considered older medications.

To update current knowledge and include newer treatments, Dr. Deshayes and associates took data from the World Health Organization pharmacovigilance database (VigiBase) and performed a retrospective analysis.

They collected data on all adverse drug reactions (ADRs) reported using the Medical Dictionary for Drug Regulatory Activities preferred term ‘anti-neutrophil’ cytoplasmic antibody positive vasculitis’ from its introduction in 2006 up until November 2020.

Drugs used in the management of AAV, such as azathioprine, cyclophosphamide, leflunomide, and methotrexate, among others, were not included in the analysis “due to potential indication bias,” they explained.

Among 483 individual “deduplicated” case safety reports, most cases of DA-AAV were reported in women (71.2% of cases) and the median age at onset was 62 years. The median time to develop AAV after drug initiation was 9 months.

DA-AAV was considered serious in almost all (98%) of the reported cases, meaning that it was life-threatening, had resulted in or had prolonged hospital treatment, caused significant or persistent disability or other anomalies such as birth defects, or resulted in the death of the individual. With regard to the latter, DA-AAV was reported as fatal in 8.9% of cases.

The highest rates of reported DA-AAV were seen in people treated with the antihypertensive drug hydralazine, the antithyroid drugs propylthiouracil, thiamazole, and carbimazole, the antibiotic minocycline, mirabegron, sofosbuvir, and nintedanib.

A further seven drugs were also linked to cases of AAV, bringing the total to list to 15 drugs associated with overreporting of AAV. This included the heavy metal antagonist penicillamine, the influenza vaccine, the gout medication allopurinol, the anti-tuberculosis drug rifampin, the antiviral agent peginterferon alfa-2b, the anti-asthma drug montelukast, and the anti-cholesterol agent rosuvastatin.

Dr. Deshayes and coauthors pointed out that the associations do not imply causality. The data mining approach used allowed for the “automated detection of drug safety signals associated with rare events such as AAV,” they said.

There are limitations, they acknowledged, which are common to studies that use pharmacovigilance data. For one, “notoriety bias” could be at play. This is where there is an “increased number of reports after safety alerts in the media.” Missing data, “including delay between the introduction of the drug and AAV,” could be a factor, as could “bias related to its retrospective and declarative design.”

The study received no commercial funding. All study authors declared no competing interests.

The overactive bladder treatment mirabegron (Myrbetriq) is one of three new drugs to be linked to cases of drug-associated antineutrophil cytoplasmic antibody–associated vasculitis (DA-AAV) according to pharmacovigilance data.

Artfoliophoto/Thinkstock

The other two drugs are the antiviral agent sofosbuvir (Sovaldi) and the tyrosine kinase inhibitor nintedanib (Ofev), which is indicated for chronic fibrosing interstitial lung diseases (ILDs) with a progressive phenotype.

The study findings also strengthen previously suspected associations, Samuel Deshayes, MD, of Caen (France) University Hospital and coauthors report in Arthritis & Rheumatology. This includes associations between hydralazine, propylthiouracil, thiamazole, minocycline, and carbimazole to name a few more of the 15 drugs where associations were found.

“These data imply specific prescriber attention to these drugs and argue for experimental studies on AAV pathophysiology with [the] recent drugs,” Dr. Deshayes and colleagues wrote.

Identifying whether AAV could be due to drug treatment is important as there have been suggestions that this may confer a better prognosis than for primary AAV. In addition, “withdrawal of the culprit drug” may be enough to treat the patient in milder cases, the researchers suggested.

That said, the researchers acknowledged that it can be difficult to attribute AAV to a specific drug, particularly as data are often from case reports or small series of patients and, until now, research had considered older medications.

To update current knowledge and include newer treatments, Dr. Deshayes and associates took data from the World Health Organization pharmacovigilance database (VigiBase) and performed a retrospective analysis.

They collected data on all adverse drug reactions (ADRs) reported using the Medical Dictionary for Drug Regulatory Activities preferred term ‘anti-neutrophil’ cytoplasmic antibody positive vasculitis’ from its introduction in 2006 up until November 2020.

Drugs used in the management of AAV, such as azathioprine, cyclophosphamide, leflunomide, and methotrexate, among others, were not included in the analysis “due to potential indication bias,” they explained.

Among 483 individual “deduplicated” case safety reports, most cases of DA-AAV were reported in women (71.2% of cases) and the median age at onset was 62 years. The median time to develop AAV after drug initiation was 9 months.

DA-AAV was considered serious in almost all (98%) of the reported cases, meaning that it was life-threatening, had resulted in or had prolonged hospital treatment, caused significant or persistent disability or other anomalies such as birth defects, or resulted in the death of the individual. With regard to the latter, DA-AAV was reported as fatal in 8.9% of cases.

The highest rates of reported DA-AAV were seen in people treated with the antihypertensive drug hydralazine, the antithyroid drugs propylthiouracil, thiamazole, and carbimazole, the antibiotic minocycline, mirabegron, sofosbuvir, and nintedanib.

A further seven drugs were also linked to cases of AAV, bringing the total to list to 15 drugs associated with overreporting of AAV. This included the heavy metal antagonist penicillamine, the influenza vaccine, the gout medication allopurinol, the anti-tuberculosis drug rifampin, the antiviral agent peginterferon alfa-2b, the anti-asthma drug montelukast, and the anti-cholesterol agent rosuvastatin.

Dr. Deshayes and coauthors pointed out that the associations do not imply causality. The data mining approach used allowed for the “automated detection of drug safety signals associated with rare events such as AAV,” they said.

There are limitations, they acknowledged, which are common to studies that use pharmacovigilance data. For one, “notoriety bias” could be at play. This is where there is an “increased number of reports after safety alerts in the media.” Missing data, “including delay between the introduction of the drug and AAV,” could be a factor, as could “bias related to its retrospective and declarative design.”

The study received no commercial funding. All study authors declared no competing interests.

The overactive bladder treatment mirabegron (Myrbetriq) is one of three new drugs to be linked to cases of drug-associated antineutrophil cytoplasmic antibody–associated vasculitis (DA-AAV) according to pharmacovigilance data.

Artfoliophoto/Thinkstock

The other two drugs are the antiviral agent sofosbuvir (Sovaldi) and the tyrosine kinase inhibitor nintedanib (Ofev), which is indicated for chronic fibrosing interstitial lung diseases (ILDs) with a progressive phenotype.

The study findings also strengthen previously suspected associations, Samuel Deshayes, MD, of Caen (France) University Hospital and coauthors report in Arthritis & Rheumatology. This includes associations between hydralazine, propylthiouracil, thiamazole, minocycline, and carbimazole to name a few more of the 15 drugs where associations were found.

“These data imply specific prescriber attention to these drugs and argue for experimental studies on AAV pathophysiology with [the] recent drugs,” Dr. Deshayes and colleagues wrote.

Identifying whether AAV could be due to drug treatment is important as there have been suggestions that this may confer a better prognosis than for primary AAV. In addition, “withdrawal of the culprit drug” may be enough to treat the patient in milder cases, the researchers suggested.

That said, the researchers acknowledged that it can be difficult to attribute AAV to a specific drug, particularly as data are often from case reports or small series of patients and, until now, research had considered older medications.

To update current knowledge and include newer treatments, Dr. Deshayes and associates took data from the World Health Organization pharmacovigilance database (VigiBase) and performed a retrospective analysis.

They collected data on all adverse drug reactions (ADRs) reported using the Medical Dictionary for Drug Regulatory Activities preferred term ‘anti-neutrophil’ cytoplasmic antibody positive vasculitis’ from its introduction in 2006 up until November 2020.

Drugs used in the management of AAV, such as azathioprine, cyclophosphamide, leflunomide, and methotrexate, among others, were not included in the analysis “due to potential indication bias,” they explained.

Among 483 individual “deduplicated” case safety reports, most cases of DA-AAV were reported in women (71.2% of cases) and the median age at onset was 62 years. The median time to develop AAV after drug initiation was 9 months.

DA-AAV was considered serious in almost all (98%) of the reported cases, meaning that it was life-threatening, had resulted in or had prolonged hospital treatment, caused significant or persistent disability or other anomalies such as birth defects, or resulted in the death of the individual. With regard to the latter, DA-AAV was reported as fatal in 8.9% of cases.

The highest rates of reported DA-AAV were seen in people treated with the antihypertensive drug hydralazine, the antithyroid drugs propylthiouracil, thiamazole, and carbimazole, the antibiotic minocycline, mirabegron, sofosbuvir, and nintedanib.

A further seven drugs were also linked to cases of AAV, bringing the total to list to 15 drugs associated with overreporting of AAV. This included the heavy metal antagonist penicillamine, the influenza vaccine, the gout medication allopurinol, the anti-tuberculosis drug rifampin, the antiviral agent peginterferon alfa-2b, the anti-asthma drug montelukast, and the anti-cholesterol agent rosuvastatin.

Dr. Deshayes and coauthors pointed out that the associations do not imply causality. The data mining approach used allowed for the “automated detection of drug safety signals associated with rare events such as AAV,” they said.

There are limitations, they acknowledged, which are common to studies that use pharmacovigilance data. For one, “notoriety bias” could be at play. This is where there is an “increased number of reports after safety alerts in the media.” Missing data, “including delay between the introduction of the drug and AAV,” could be a factor, as could “bias related to its retrospective and declarative design.”

The study received no commercial funding. All study authors declared no competing interests.

On July 12, federal officials announced they are seeking to establish a national coverage policy for aducanumab (Aduhelm) for Alzheimer’s disease (AD), a process that will take until next year to complete.

The Centers for Medicare & Medicaid Services said it will accept public comments about how Medicare should cover aducanumab through Aug. 11. The agency intends to post a draft decision memo on its coverage approach by Jan. 12, 2022, and then finalize this policy by April 12. Coverage decisions about aducanumab now are being made at the local level by Medicare’s administrative contractors, CMS said in a press release.

The announcement followed separate public calls for such a review by America’s Health Insurance Plans (AHIP) and the Alzheimer’s Association.

On June 30, AHIP submitted a formal request to the CMS. In it, AHIP requests that CMS take “swift action” on a national coverage determination for aducanumab. In the request, the organization specifically urged CMS to use a policy known as coverage with evidence development (CED) for Aduhelm.

This CED approach would allow access for patients considered most likely to benefit from the drug while Biogen continues research needed to definitively show its clinical benefit, said AHIP chief executive Matt Eyles.

In June, the Food and Drug Administration approved aducanumab based on data suggesting the drug might slow AD progression using the surrogate marker of a reduction in amyloid plaque.

The FDA’s accelerated approval letter set a 2030 deadline for Biogen to produce evidence from a phase 3 clinical trial definitively proving the drug’s efficacy.
 

Hefty price tag

Even if Biogen meets the FDA’s deadline, patients with AD, their families, clinicians, and insurers likely will wrestle for years with questions about whether to use this costly drug without clear evidence of benefit. The drug is estimated to cost $56,000 per year.

In addition, patients taking the drug will be required to undergo MRI scans to monitor for brain swelling or bleeding, complications that were experienced by those participating in previous studies of the drug, Mr. Eyles noted in his letter to CMS, which AHIP provided to this news organization.

About 80% of those eligible for aducanumab in the United States are enrolled in Medicare, write James D. Chambers, PhD, MPharm, Tufts University, Boston, and coauthors in a June article in the journal Health Affairs. Like AHIP, these authors also recommended CMS consider the CED path for the drug.

CMS has used the CED approach since 2003 to evaluate interventions such as amyloid PET for clinical evaluation of AD to implantable cardioverter defibrillators.

Applying CED to aducanumab “would provide the medical community, patients, caregivers, and payers with additional information long before the FDA’s required postapproval studies are completed,” Dr. Chambers and coauthors wrote. “It would also ensure that data on every patient treated would add to the knowledge base about how aducanumab impacts patient outcomes such as cognition, function, and quality of life.”

In the AHIP request to CMS, Mr. Eyles also noted that an independent review organization, the Institute for Clinical and Economic Review, said the evidence from studies done to date on aducanumab is “insufficient” to show a net health benefit for patients with mild cognitive impairment because of AD or mild AD.

At the ICER meeting, which will take place July 15, one of ICER’s expert panels, the California Technology Assessment Forum, said it will further consider all of the available scientific data on aducanumab and vote on a series of questions about its efficacy and value.

ICER’s reports have clout because insurers use its recommendations to help determine how to cover drugs and medical treatments. Among the questions ICER has posted online ahead of the meeting is one about the relative effects of aducanumab plus supportive care versus supportive care alone.
 

‘Dark irony’

Even as the medical community waits for Biogen to present clear evidence of a benefit for aducanumab, clinics specializing in AD may get a financial boost, said Jason Karlawish, MD, professor of medicine, medical ethics, health policy, and neurology at the University of Pennsylvania, Philadelphia, and codirector of Penn’s Memory Center.

Some clinicians see the arrival of the drug as a “win” for the field despite lingering concerns about its approval, said Dr. Karlawish at a panel discussion held July 12 by the nonprofit Hastings Center, a bioethics research institute. Dr. Karlawish is a fellow at Hastings.

In May, Dr. Karlawish published an article in STAT titled “If the FDA approves Biogen’s Alzheimer’s treatment, I won’t prescribe it.” Dr. Karlawish told this news organization that he was a site investigator for Biogen studies of aducanumab and has worked on studies sponsored by Lilly and Eisai.

During the discussion July 12, Dr. Karlawish said he had altered his view and now might be a “reluctant prescriber.” This shift is because of his commitment “to preserve, protect and defend their autonomy” of patients with AD.

He also noted the drug could draw more money into the field to help care for patients with AD by providing increased access to diagnostics. Additionally, funds provided to clinics for administering aducanumab will aid specialty memory centers, “which have been basically impoverished since their creation,” Dr. Karlawish said.

“There is a dark irony that it takes a questionably beneficial drug to bring in the revenue to finally get memory centers up and functioning,” Dr. Karlawish said, adding that there needs to be “a larger conversation about how a big, vast, and problematic disease is being treated.”

Aducanumab’s approval shows that diseases in the U.S. are not fully considered as diseases until they have “a business model, and much of that business model relies on the pharmaceutical industry,” he noted.
 

Dr. Woodcock’s ‘personal commitment’

In early July, the FDA took two highly publicized steps to address criticism of its handling of the aducanumab approval. It revised the drug’s label to limit its use to patients with mild cognitive impairment likely related to AD or those in the mild stages of the disease.

In addition, Janet Woodcock, MD, the FDA’s acting commissioner, took to Twitter and posted a letter she sent to the Office of the Inspector General that called for a federal investigation into the drug’s approval that would examine agency staff interactions with Biogen.

AHIP spokesperson Kristine Grow said July 12 that her organization is still seeking a national Medicare coverage decision, but that the label revision was a “step in the right direction.”

“Patients with Alzheimer’s disease, and their families and caregivers, deserve safe, effective treatments. We applaud the FDA for this label adjustment, which brings indicated patients a bit closer to those included in clinical trials,” Ms. Grow said in an interview.

“At the same time, we remain concerned about the limited clinical evidence demonstrating efficacy and the serious safety risks that aducanumab poses for patients. We look forward to additional information from the FDA and other regulators, including CMS’ coverage guidance for patients who are Medicare eligible,” she added.

The controversy surrounding the approval of aducanumab is drawing more attention to the lack of a confirmed FDA commissioner. But in her letter to OIG, Dr. Woodcock wrote as if she intends to remain at the helm of the agency for at least a while longer. She wrote in her letter that OIG has her “personal commitment” that the FDA will fully cooperate if the investigative unit decides to undertake a review.

Dr. Woodcock also urged that a review be conducted as soon as possible, noting “should such a review result in actionable items, you also have my commitment to addressing these issues.”

A former FDA adviser who resigned over the agency’s handling of aducanumab said July 12 there needs to be a broader investigation of the FDA’s actions.

Attending the Hastings Center event was Aaron S. Kesselheim, MD, JD, MPH, of Harvard Medical School, Boston, one of three former members of an FDA advisory committee who resigned over the agency’s handling of aducanumab. Dr. Kesselheim said in an interview that he has no financial relationships to disclose in connection with this discussion.

“I would suggest that instead all aspects of this approval process should be investigated,” Dr. Kesselheim said, including the relationship between FDA and Biogen.

Dr. Karlawish said he was also concerned that Dr. Woodcock’s request for an investigation was “very narrow,” and noted members of Congress have said they are examining the FDA’s handling of this drug.

In a July 9 joint statement, House Committee on Energy and Commerce Chairman Frank Pallone Jr (D-N.J.), and House Committee on Oversight and Reform Chairwoman Carolyn B. Maloney (D-N.Y.) said they were “pleased” by Dr. Woodcock’s announcement, but they will keep digging into ongoing questions about the drug. In their view, the OIG review of FDA staff interactions with Biogen officials would complement their committees’ “robust investigation of this matter.”

“We continue to have concerns about the approval process for Aduhelm, how Biogen set its price, and the implications for seniors, providers, and taxpayers,” Mr. Pallone and Ms. Maloney added.
 

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

On July 12, federal officials announced they are seeking to establish a national coverage policy for aducanumab (Aduhelm) for Alzheimer’s disease (AD), a process that will take until next year to complete.

The Centers for Medicare & Medicaid Services said it will accept public comments about how Medicare should cover aducanumab through Aug. 11. The agency intends to post a draft decision memo on its coverage approach by Jan. 12, 2022, and then finalize this policy by April 12. Coverage decisions about aducanumab now are being made at the local level by Medicare’s administrative contractors, CMS said in a press release.

The announcement followed separate public calls for such a review by America’s Health Insurance Plans (AHIP) and the Alzheimer’s Association.

On June 30, AHIP submitted a formal request to the CMS. In it, AHIP requests that CMS take “swift action” on a national coverage determination for aducanumab. In the request, the organization specifically urged CMS to use a policy known as coverage with evidence development (CED) for Aduhelm.

This CED approach would allow access for patients considered most likely to benefit from the drug while Biogen continues research needed to definitively show its clinical benefit, said AHIP chief executive Matt Eyles.

In June, the Food and Drug Administration approved aducanumab based on data suggesting the drug might slow AD progression using the surrogate marker of a reduction in amyloid plaque.

The FDA’s accelerated approval letter set a 2030 deadline for Biogen to produce evidence from a phase 3 clinical trial definitively proving the drug’s efficacy.
 

Hefty price tag

Even if Biogen meets the FDA’s deadline, patients with AD, their families, clinicians, and insurers likely will wrestle for years with questions about whether to use this costly drug without clear evidence of benefit. The drug is estimated to cost $56,000 per year.

In addition, patients taking the drug will be required to undergo MRI scans to monitor for brain swelling or bleeding, complications that were experienced by those participating in previous studies of the drug, Mr. Eyles noted in his letter to CMS, which AHIP provided to this news organization.

About 80% of those eligible for aducanumab in the United States are enrolled in Medicare, write James D. Chambers, PhD, MPharm, Tufts University, Boston, and coauthors in a June article in the journal Health Affairs. Like AHIP, these authors also recommended CMS consider the CED path for the drug.

CMS has used the CED approach since 2003 to evaluate interventions such as amyloid PET for clinical evaluation of AD to implantable cardioverter defibrillators.

Applying CED to aducanumab “would provide the medical community, patients, caregivers, and payers with additional information long before the FDA’s required postapproval studies are completed,” Dr. Chambers and coauthors wrote. “It would also ensure that data on every patient treated would add to the knowledge base about how aducanumab impacts patient outcomes such as cognition, function, and quality of life.”

In the AHIP request to CMS, Mr. Eyles also noted that an independent review organization, the Institute for Clinical and Economic Review, said the evidence from studies done to date on aducanumab is “insufficient” to show a net health benefit for patients with mild cognitive impairment because of AD or mild AD.

At the ICER meeting, which will take place July 15, one of ICER’s expert panels, the California Technology Assessment Forum, said it will further consider all of the available scientific data on aducanumab and vote on a series of questions about its efficacy and value.

ICER’s reports have clout because insurers use its recommendations to help determine how to cover drugs and medical treatments. Among the questions ICER has posted online ahead of the meeting is one about the relative effects of aducanumab plus supportive care versus supportive care alone.
 

‘Dark irony’

Even as the medical community waits for Biogen to present clear evidence of a benefit for aducanumab, clinics specializing in AD may get a financial boost, said Jason Karlawish, MD, professor of medicine, medical ethics, health policy, and neurology at the University of Pennsylvania, Philadelphia, and codirector of Penn’s Memory Center.

Some clinicians see the arrival of the drug as a “win” for the field despite lingering concerns about its approval, said Dr. Karlawish at a panel discussion held July 12 by the nonprofit Hastings Center, a bioethics research institute. Dr. Karlawish is a fellow at Hastings.

In May, Dr. Karlawish published an article in STAT titled “If the FDA approves Biogen’s Alzheimer’s treatment, I won’t prescribe it.” Dr. Karlawish told this news organization that he was a site investigator for Biogen studies of aducanumab and has worked on studies sponsored by Lilly and Eisai.

During the discussion July 12, Dr. Karlawish said he had altered his view and now might be a “reluctant prescriber.” This shift is because of his commitment “to preserve, protect and defend their autonomy” of patients with AD.

He also noted the drug could draw more money into the field to help care for patients with AD by providing increased access to diagnostics. Additionally, funds provided to clinics for administering aducanumab will aid specialty memory centers, “which have been basically impoverished since their creation,” Dr. Karlawish said.

“There is a dark irony that it takes a questionably beneficial drug to bring in the revenue to finally get memory centers up and functioning,” Dr. Karlawish said, adding that there needs to be “a larger conversation about how a big, vast, and problematic disease is being treated.”

Aducanumab’s approval shows that diseases in the U.S. are not fully considered as diseases until they have “a business model, and much of that business model relies on the pharmaceutical industry,” he noted.
 

Dr. Woodcock’s ‘personal commitment’

In early July, the FDA took two highly publicized steps to address criticism of its handling of the aducanumab approval. It revised the drug’s label to limit its use to patients with mild cognitive impairment likely related to AD or those in the mild stages of the disease.

In addition, Janet Woodcock, MD, the FDA’s acting commissioner, took to Twitter and posted a letter she sent to the Office of the Inspector General that called for a federal investigation into the drug’s approval that would examine agency staff interactions with Biogen.

AHIP spokesperson Kristine Grow said July 12 that her organization is still seeking a national Medicare coverage decision, but that the label revision was a “step in the right direction.”

“Patients with Alzheimer’s disease, and their families and caregivers, deserve safe, effective treatments. We applaud the FDA for this label adjustment, which brings indicated patients a bit closer to those included in clinical trials,” Ms. Grow said in an interview.

“At the same time, we remain concerned about the limited clinical evidence demonstrating efficacy and the serious safety risks that aducanumab poses for patients. We look forward to additional information from the FDA and other regulators, including CMS’ coverage guidance for patients who are Medicare eligible,” she added.

The controversy surrounding the approval of aducanumab is drawing more attention to the lack of a confirmed FDA commissioner. But in her letter to OIG, Dr. Woodcock wrote as if she intends to remain at the helm of the agency for at least a while longer. She wrote in her letter that OIG has her “personal commitment” that the FDA will fully cooperate if the investigative unit decides to undertake a review.

Dr. Woodcock also urged that a review be conducted as soon as possible, noting “should such a review result in actionable items, you also have my commitment to addressing these issues.”

A former FDA adviser who resigned over the agency’s handling of aducanumab said July 12 there needs to be a broader investigation of the FDA’s actions.

Attending the Hastings Center event was Aaron S. Kesselheim, MD, JD, MPH, of Harvard Medical School, Boston, one of three former members of an FDA advisory committee who resigned over the agency’s handling of aducanumab. Dr. Kesselheim said in an interview that he has no financial relationships to disclose in connection with this discussion.

“I would suggest that instead all aspects of this approval process should be investigated,” Dr. Kesselheim said, including the relationship between FDA and Biogen.

Dr. Karlawish said he was also concerned that Dr. Woodcock’s request for an investigation was “very narrow,” and noted members of Congress have said they are examining the FDA’s handling of this drug.

In a July 9 joint statement, House Committee on Energy and Commerce Chairman Frank Pallone Jr (D-N.J.), and House Committee on Oversight and Reform Chairwoman Carolyn B. Maloney (D-N.Y.) said they were “pleased” by Dr. Woodcock’s announcement, but they will keep digging into ongoing questions about the drug. In their view, the OIG review of FDA staff interactions with Biogen officials would complement their committees’ “robust investigation of this matter.”

“We continue to have concerns about the approval process for Aduhelm, how Biogen set its price, and the implications for seniors, providers, and taxpayers,” Mr. Pallone and Ms. Maloney added.
 

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

On July 12, federal officials announced they are seeking to establish a national coverage policy for aducanumab (Aduhelm) for Alzheimer’s disease (AD), a process that will take until next year to complete.

The Centers for Medicare & Medicaid Services said it will accept public comments about how Medicare should cover aducanumab through Aug. 11. The agency intends to post a draft decision memo on its coverage approach by Jan. 12, 2022, and then finalize this policy by April 12. Coverage decisions about aducanumab now are being made at the local level by Medicare’s administrative contractors, CMS said in a press release.

The announcement followed separate public calls for such a review by America’s Health Insurance Plans (AHIP) and the Alzheimer’s Association.

On June 30, AHIP submitted a formal request to the CMS. In it, AHIP requests that CMS take “swift action” on a national coverage determination for aducanumab. In the request, the organization specifically urged CMS to use a policy known as coverage with evidence development (CED) for Aduhelm.

This CED approach would allow access for patients considered most likely to benefit from the drug while Biogen continues research needed to definitively show its clinical benefit, said AHIP chief executive Matt Eyles.

In June, the Food and Drug Administration approved aducanumab based on data suggesting the drug might slow AD progression using the surrogate marker of a reduction in amyloid plaque.

The FDA’s accelerated approval letter set a 2030 deadline for Biogen to produce evidence from a phase 3 clinical trial definitively proving the drug’s efficacy.
 

Hefty price tag

Even if Biogen meets the FDA’s deadline, patients with AD, their families, clinicians, and insurers likely will wrestle for years with questions about whether to use this costly drug without clear evidence of benefit. The drug is estimated to cost $56,000 per year.

In addition, patients taking the drug will be required to undergo MRI scans to monitor for brain swelling or bleeding, complications that were experienced by those participating in previous studies of the drug, Mr. Eyles noted in his letter to CMS, which AHIP provided to this news organization.

About 80% of those eligible for aducanumab in the United States are enrolled in Medicare, write James D. Chambers, PhD, MPharm, Tufts University, Boston, and coauthors in a June article in the journal Health Affairs. Like AHIP, these authors also recommended CMS consider the CED path for the drug.

CMS has used the CED approach since 2003 to evaluate interventions such as amyloid PET for clinical evaluation of AD to implantable cardioverter defibrillators.

Applying CED to aducanumab “would provide the medical community, patients, caregivers, and payers with additional information long before the FDA’s required postapproval studies are completed,” Dr. Chambers and coauthors wrote. “It would also ensure that data on every patient treated would add to the knowledge base about how aducanumab impacts patient outcomes such as cognition, function, and quality of life.”

In the AHIP request to CMS, Mr. Eyles also noted that an independent review organization, the Institute for Clinical and Economic Review, said the evidence from studies done to date on aducanumab is “insufficient” to show a net health benefit for patients with mild cognitive impairment because of AD or mild AD.

At the ICER meeting, which will take place July 15, one of ICER’s expert panels, the California Technology Assessment Forum, said it will further consider all of the available scientific data on aducanumab and vote on a series of questions about its efficacy and value.

ICER’s reports have clout because insurers use its recommendations to help determine how to cover drugs and medical treatments. Among the questions ICER has posted online ahead of the meeting is one about the relative effects of aducanumab plus supportive care versus supportive care alone.
 

‘Dark irony’

Even as the medical community waits for Biogen to present clear evidence of a benefit for aducanumab, clinics specializing in AD may get a financial boost, said Jason Karlawish, MD, professor of medicine, medical ethics, health policy, and neurology at the University of Pennsylvania, Philadelphia, and codirector of Penn’s Memory Center.

Some clinicians see the arrival of the drug as a “win” for the field despite lingering concerns about its approval, said Dr. Karlawish at a panel discussion held July 12 by the nonprofit Hastings Center, a bioethics research institute. Dr. Karlawish is a fellow at Hastings.

In May, Dr. Karlawish published an article in STAT titled “If the FDA approves Biogen’s Alzheimer’s treatment, I won’t prescribe it.” Dr. Karlawish told this news organization that he was a site investigator for Biogen studies of aducanumab and has worked on studies sponsored by Lilly and Eisai.

During the discussion July 12, Dr. Karlawish said he had altered his view and now might be a “reluctant prescriber.” This shift is because of his commitment “to preserve, protect and defend their autonomy” of patients with AD.

He also noted the drug could draw more money into the field to help care for patients with AD by providing increased access to diagnostics. Additionally, funds provided to clinics for administering aducanumab will aid specialty memory centers, “which have been basically impoverished since their creation,” Dr. Karlawish said.

“There is a dark irony that it takes a questionably beneficial drug to bring in the revenue to finally get memory centers up and functioning,” Dr. Karlawish said, adding that there needs to be “a larger conversation about how a big, vast, and problematic disease is being treated.”

Aducanumab’s approval shows that diseases in the U.S. are not fully considered as diseases until they have “a business model, and much of that business model relies on the pharmaceutical industry,” he noted.
 

Dr. Woodcock’s ‘personal commitment’

In early July, the FDA took two highly publicized steps to address criticism of its handling of the aducanumab approval. It revised the drug’s label to limit its use to patients with mild cognitive impairment likely related to AD or those in the mild stages of the disease.

In addition, Janet Woodcock, MD, the FDA’s acting commissioner, took to Twitter and posted a letter she sent to the Office of the Inspector General that called for a federal investigation into the drug’s approval that would examine agency staff interactions with Biogen.

AHIP spokesperson Kristine Grow said July 12 that her organization is still seeking a national Medicare coverage decision, but that the label revision was a “step in the right direction.”

“Patients with Alzheimer’s disease, and their families and caregivers, deserve safe, effective treatments. We applaud the FDA for this label adjustment, which brings indicated patients a bit closer to those included in clinical trials,” Ms. Grow said in an interview.

“At the same time, we remain concerned about the limited clinical evidence demonstrating efficacy and the serious safety risks that aducanumab poses for patients. We look forward to additional information from the FDA and other regulators, including CMS’ coverage guidance for patients who are Medicare eligible,” she added.

The controversy surrounding the approval of aducanumab is drawing more attention to the lack of a confirmed FDA commissioner. But in her letter to OIG, Dr. Woodcock wrote as if she intends to remain at the helm of the agency for at least a while longer. She wrote in her letter that OIG has her “personal commitment” that the FDA will fully cooperate if the investigative unit decides to undertake a review.

Dr. Woodcock also urged that a review be conducted as soon as possible, noting “should such a review result in actionable items, you also have my commitment to addressing these issues.”

A former FDA adviser who resigned over the agency’s handling of aducanumab said July 12 there needs to be a broader investigation of the FDA’s actions.

Attending the Hastings Center event was Aaron S. Kesselheim, MD, JD, MPH, of Harvard Medical School, Boston, one of three former members of an FDA advisory committee who resigned over the agency’s handling of aducanumab. Dr. Kesselheim said in an interview that he has no financial relationships to disclose in connection with this discussion.

“I would suggest that instead all aspects of this approval process should be investigated,” Dr. Kesselheim said, including the relationship between FDA and Biogen.

Dr. Karlawish said he was also concerned that Dr. Woodcock’s request for an investigation was “very narrow,” and noted members of Congress have said they are examining the FDA’s handling of this drug.

In a July 9 joint statement, House Committee on Energy and Commerce Chairman Frank Pallone Jr (D-N.J.), and House Committee on Oversight and Reform Chairwoman Carolyn B. Maloney (D-N.Y.) said they were “pleased” by Dr. Woodcock’s announcement, but they will keep digging into ongoing questions about the drug. In their view, the OIG review of FDA staff interactions with Biogen officials would complement their committees’ “robust investigation of this matter.”

“We continue to have concerns about the approval process for Aduhelm, how Biogen set its price, and the implications for seniors, providers, and taxpayers,” Mr. Pallone and Ms. Maloney added.
 

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

Congenital onychodysplasia of the index finger (COIF), or Iso-Kikuchi syndrome, is a rare disorder characterized by malformation of one or both nails of the index fingers. The various anomalies described are anonychia, micronychia, polyonychia, malalignment, or hemi-onychogryphosis. It may be associated with abnormalities of the underlying phalangeal bone, the most masked being bifurcation of the terminal phalange.¹ Initially thought to be nonhereditary and nonfamilial,² it is now known that COIF can be inherited in an autosomal-dominant fashion.³ Millman and Strier³ described a family of 9 patients with COIF. It rarely is described outside of Japan. Padmavathy et al⁴ described a case in an Indian patient with COIF that was associated with the absence of a ring finger in addition to anomalies of the metacarpal bones.

Congenital onychodysplasia of the index finger has a broad spectrum regarding its etiology and clinical features.⁵ The pathogenesis of COIF still is poorly understood. Deficient circulation in digital arteries is thought to be a putative mechanism for developing a deformed nail. The nail is affected on the radial side of the index finger, likely because of the smaller caliber of the artery on that side.⁵ Hereditary as well as nonhereditary sporadic cases have been reported. In addition to the various fingernail anomalies, skeletal abnormalities also have been reported. Baran and Stroud⁶ have reported deformed lunulae as a manifestation of COIF.

The Diagnosis: Congenital Onychodysplasia of the Index Finger

The differential diagnosis of COIF includes hidrotic ectodermal dysplasia, nail-patella syndrome, Poland syndrome, and DOOR syndrome. Hidrotic ectodermal dysplasia exhibits onychodystrophy, generalized hypotrichosis, palmoplantar keratoderma, and dental anomalies.⁷ Nail-patella syndrome presents with hypoplasia of the fingernails and toenails, triangular nail lunulae, absent or hypoplastic patellae, and elbow and iliac horn dysplasia. Poland syndrome is distinguished from COIF by the congenital absence of the pectoralis major muscle on the ipsilateral side of the involved digits. The DOOR syndrome tetrad is comprised of deafness, onychodystrophy, osteodystrophy, and mental retardation.⁸ Unlike these conditions, COIF does not involve systems other than the nails and phalanges.

Treatment of this condition is mainly conservative, as patients typically do not have symptoms.⁹ Surgical interventions can be considered for cosmetic concerns. Knowledge of this congenital entity and its clinical findings is essential to prevent unnecessary procedures and workup.

Congenital onychodysplasia of the index finger (COIF), or Iso-Kikuchi syndrome, is a rare disorder characterized by malformation of one or both nails of the index fingers. The various anomalies described are anonychia, micronychia, polyonychia, malalignment, or hemi-onychogryphosis. It may be associated with abnormalities of the underlying phalangeal bone, the most masked being bifurcation of the terminal phalange.¹ Initially thought to be nonhereditary and nonfamilial,² it is now known that COIF can be inherited in an autosomal-dominant fashion.³ Millman and Strier³ described a family of 9 patients with COIF. It rarely is described outside of Japan. Padmavathy et al⁴ described a case in an Indian patient with COIF that was associated with the absence of a ring finger in addition to anomalies of the metacarpal bones.

Congenital onychodysplasia of the index finger has a broad spectrum regarding its etiology and clinical features.⁵ The pathogenesis of COIF still is poorly understood. Deficient circulation in digital arteries is thought to be a putative mechanism for developing a deformed nail. The nail is affected on the radial side of the index finger, likely because of the smaller caliber of the artery on that side.⁵ Hereditary as well as nonhereditary sporadic cases have been reported. In addition to the various fingernail anomalies, skeletal abnormalities also have been reported. Baran and Stroud⁶ have reported deformed lunulae as a manifestation of COIF.

The Diagnosis: Congenital Onychodysplasia of the Index Finger

The differential diagnosis of COIF includes hidrotic ectodermal dysplasia, nail-patella syndrome, Poland syndrome, and DOOR syndrome. Hidrotic ectodermal dysplasia exhibits onychodystrophy, generalized hypotrichosis, palmoplantar keratoderma, and dental anomalies.⁷ Nail-patella syndrome presents with hypoplasia of the fingernails and toenails, triangular nail lunulae, absent or hypoplastic patellae, and elbow and iliac horn dysplasia. Poland syndrome is distinguished from COIF by the congenital absence of the pectoralis major muscle on the ipsilateral side of the involved digits. The DOOR syndrome tetrad is comprised of deafness, onychodystrophy, osteodystrophy, and mental retardation.⁸ Unlike these conditions, COIF does not involve systems other than the nails and phalanges.

Treatment of this condition is mainly conservative, as patients typically do not have symptoms.⁹ Surgical interventions can be considered for cosmetic concerns. Knowledge of this congenital entity and its clinical findings is essential to prevent unnecessary procedures and workup.

Congenital onychodysplasia of the index finger (COIF), or Iso-Kikuchi syndrome, is a rare disorder characterized by malformation of one or both nails of the index fingers. The various anomalies described are anonychia, micronychia, polyonychia, malalignment, or hemi-onychogryphosis. It may be associated with abnormalities of the underlying phalangeal bone, the most masked being bifurcation of the terminal phalange.¹ Initially thought to be nonhereditary and nonfamilial,² it is now known that COIF can be inherited in an autosomal-dominant fashion.³ Millman and Strier³ described a family of 9 patients with COIF. It rarely is described outside of Japan. Padmavathy et al⁴ described a case in an Indian patient with COIF that was associated with the absence of a ring finger in addition to anomalies of the metacarpal bones.

Congenital onychodysplasia of the index finger has a broad spectrum regarding its etiology and clinical features.⁵ The pathogenesis of COIF still is poorly understood. Deficient circulation in digital arteries is thought to be a putative mechanism for developing a deformed nail. The nail is affected on the radial side of the index finger, likely because of the smaller caliber of the artery on that side.⁵ Hereditary as well as nonhereditary sporadic cases have been reported. In addition to the various fingernail anomalies, skeletal abnormalities also have been reported. Baran and Stroud⁶ have reported deformed lunulae as a manifestation of COIF.

The Diagnosis: Congenital Onychodysplasia of the Index Finger

The differential diagnosis of COIF includes hidrotic ectodermal dysplasia, nail-patella syndrome, Poland syndrome, and DOOR syndrome. Hidrotic ectodermal dysplasia exhibits onychodystrophy, generalized hypotrichosis, palmoplantar keratoderma, and dental anomalies.⁷ Nail-patella syndrome presents with hypoplasia of the fingernails and toenails, triangular nail lunulae, absent or hypoplastic patellae, and elbow and iliac horn dysplasia. Poland syndrome is distinguished from COIF by the congenital absence of the pectoralis major muscle on the ipsilateral side of the involved digits. The DOOR syndrome tetrad is comprised of deafness, onychodystrophy, osteodystrophy, and mental retardation.⁸ Unlike these conditions, COIF does not involve systems other than the nails and phalanges.

Treatment of this condition is mainly conservative, as patients typically do not have symptoms.⁹ Surgical interventions can be considered for cosmetic concerns. Knowledge of this congenital entity and its clinical findings is essential to prevent unnecessary procedures and workup.

Dancing helps slow the progression of motor and nonmotor symptoms and improves quality of life for patients with Parkinson’s disease (PD), new research shows.

Over 3 years, weekly participation in dance training classes “drastically” reduced the expected decline in motor function and significantly improved speech, tremors, balance, and stiffness, the researchers reported.

Dance training also appeared to have benefits regarding cognition, hallucinations, depression, and anxiety.

“These findings strongly suggest the benefits of dance for people with PD as a supplement to a normal treatment regimen,” the investigators noted.

Although the mechanism of benefit is unclear, dance training may help “train neural network nodes that helps either strengthen networks damaged or builds neural road maps that pass the damage,” study investigator Joseph DeSouza, PhD, principal investigator and associate professor, department of psychology, York University, Toronto, said in an interview.

The study was published online July 7, 2021, in Brain Sciences.
 

Multiple benefits

PD is a neurodegenerative disease associated with progression of motor dysfunction within the first 5 years of diagnosis. The annual rate of motor decline, as determined with the Movement Disorder Society Unified Parkinson’s Disease Rating Scale (MDS-UPDRS), is between 5.2 and 8.9 points.

Prior studies that assessed various styles of dance by patients with PD showed beneficial effects regarding gait speed, balance, locomotion, and aspects of quality of life.

To investigate further, DeSouza and coauthor Karolina Bearss, a PhD candidate at York University, followed 16 patients with mild to moderate PD who participated in a weekly dance class at Canada’s National Ballet School and Trinity St. Paul’s church.

Dance for Parkinson’s Disease, which is an established dance curriculum, involves aerobic and anaerobic movements. The protocol begins with a seated warm-up, followed by barre work, and ends with moving across the floor. All participants learn choreography for an upcoming performance.

In the study, 16 patients with PD who did not participant in the dance classes served as control patients.

Over 3 years, the daily rate of motor decline, as indicated by scores on part III of the MDS-UPDRS, was zero among the dancers (slope = 0.000146), indicating no motor impairment, whereas among the nondancers, the motor decline during follow-up was as expected (P < .01), the researchers reported.

In modeling the data, the researchers determined that after completing 1,000 days of dance training, dancers will have a motor score of 19.07, compared with a score of 28.27 for nondancers.

“Our data further showed that training in dance will slow the rate of PD motor impairment progression, as measured by the UPDRS III, by close to 3 points annually in comparison to our PD subjects who did not train,” the researchers reported.

Dance training also had a beneficial effect on motor or nonmotor aspects of daily living and on motor complications, for which there was no significant decline among the PD dancers.

“For those with Parkinson’s disease, even when it’s mild, motor impairment can impact their daily functioning – how they feel about themselves. Many of these motor symptoms lead to isolation because once they get extreme, these people don’t want to go out,” Dr. DeSouza said in a news release.

“These motor symptoms lead to further psychological issues, depression, social isolation and eventually the symptoms do get worse over time. Our study shows that training with dance and music can slow this down and improve their daily living and daily function,” he added.
 

‘Great potential’

Reached for comment, Demian Kogutek, PhD, director of music therapy, University of Evansville (Indiana), said that these preliminary findings from a longitudinal study are “promising.”

“I believe that dance therapy has a great potential for PD. The longitudinal aspect of this study undoubtedly adds to the current literature. Although it is a standardized assessment, it is somewhat subjective,” Dr. Kogutek said in an interview.

Going forward, Dr. Kogutek said he’d like to see other objective outcomes measured, such as objective assessments of balance, gait, hand strength, and dexterity.

Also weighing in on the results, Karen Lee, PhD, president and CEO of Parkinson Canada, said her organization is “encouraged by these preliminary findings as exercise and healthy activities are important for people with Parkinson’s. This study is part of a growing body of research that explores the link between the impact of activities and both motor and nonmotor symptoms of Parkinson’s.

“This research adds to growing evidence about the importance of exercise as part of the management of Parkinson’s, and we encourage people living with Parkinson’s to incorporate exercise as part of their approach to managing their health,” Dr. Lee said in an interview.

Funding for the project is provided in part by a National Science and Engineering Research Council Discovery Grant and by donations from the Irpinia Club of Toronto and others. Dr. Dr. DeSouza, Ms. Bearss, Dr. Kogutek, and Dr. Lee disclosed no relevant financial relationships.

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

Dancing helps slow the progression of motor and nonmotor symptoms and improves quality of life for patients with Parkinson’s disease (PD), new research shows.

Over 3 years, weekly participation in dance training classes “drastically” reduced the expected decline in motor function and significantly improved speech, tremors, balance, and stiffness, the researchers reported.

Dance training also appeared to have benefits regarding cognition, hallucinations, depression, and anxiety.

“These findings strongly suggest the benefits of dance for people with PD as a supplement to a normal treatment regimen,” the investigators noted.

Although the mechanism of benefit is unclear, dance training may help “train neural network nodes that helps either strengthen networks damaged or builds neural road maps that pass the damage,” study investigator Joseph DeSouza, PhD, principal investigator and associate professor, department of psychology, York University, Toronto, said in an interview.

The study was published online July 7, 2021, in Brain Sciences.
 

Multiple benefits

PD is a neurodegenerative disease associated with progression of motor dysfunction within the first 5 years of diagnosis. The annual rate of motor decline, as determined with the Movement Disorder Society Unified Parkinson’s Disease Rating Scale (MDS-UPDRS), is between 5.2 and 8.9 points.

Prior studies that assessed various styles of dance by patients with PD showed beneficial effects regarding gait speed, balance, locomotion, and aspects of quality of life.

To investigate further, DeSouza and coauthor Karolina Bearss, a PhD candidate at York University, followed 16 patients with mild to moderate PD who participated in a weekly dance class at Canada’s National Ballet School and Trinity St. Paul’s church.

Dance for Parkinson’s Disease, which is an established dance curriculum, involves aerobic and anaerobic movements. The protocol begins with a seated warm-up, followed by barre work, and ends with moving across the floor. All participants learn choreography for an upcoming performance.

In the study, 16 patients with PD who did not participant in the dance classes served as control patients.

Over 3 years, the daily rate of motor decline, as indicated by scores on part III of the MDS-UPDRS, was zero among the dancers (slope = 0.000146), indicating no motor impairment, whereas among the nondancers, the motor decline during follow-up was as expected (P < .01), the researchers reported.

In modeling the data, the researchers determined that after completing 1,000 days of dance training, dancers will have a motor score of 19.07, compared with a score of 28.27 for nondancers.

“Our data further showed that training in dance will slow the rate of PD motor impairment progression, as measured by the UPDRS III, by close to 3 points annually in comparison to our PD subjects who did not train,” the researchers reported.

Dance training also had a beneficial effect on motor or nonmotor aspects of daily living and on motor complications, for which there was no significant decline among the PD dancers.

“For those with Parkinson’s disease, even when it’s mild, motor impairment can impact their daily functioning – how they feel about themselves. Many of these motor symptoms lead to isolation because once they get extreme, these people don’t want to go out,” Dr. DeSouza said in a news release.

“These motor symptoms lead to further psychological issues, depression, social isolation and eventually the symptoms do get worse over time. Our study shows that training with dance and music can slow this down and improve their daily living and daily function,” he added.
 

‘Great potential’

Reached for comment, Demian Kogutek, PhD, director of music therapy, University of Evansville (Indiana), said that these preliminary findings from a longitudinal study are “promising.”

“I believe that dance therapy has a great potential for PD. The longitudinal aspect of this study undoubtedly adds to the current literature. Although it is a standardized assessment, it is somewhat subjective,” Dr. Kogutek said in an interview.

Going forward, Dr. Kogutek said he’d like to see other objective outcomes measured, such as objective assessments of balance, gait, hand strength, and dexterity.

Also weighing in on the results, Karen Lee, PhD, president and CEO of Parkinson Canada, said her organization is “encouraged by these preliminary findings as exercise and healthy activities are important for people with Parkinson’s. This study is part of a growing body of research that explores the link between the impact of activities and both motor and nonmotor symptoms of Parkinson’s.

“This research adds to growing evidence about the importance of exercise as part of the management of Parkinson’s, and we encourage people living with Parkinson’s to incorporate exercise as part of their approach to managing their health,” Dr. Lee said in an interview.

Funding for the project is provided in part by a National Science and Engineering Research Council Discovery Grant and by donations from the Irpinia Club of Toronto and others. Dr. Dr. DeSouza, Ms. Bearss, Dr. Kogutek, and Dr. Lee disclosed no relevant financial relationships.

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

Dancing helps slow the progression of motor and nonmotor symptoms and improves quality of life for patients with Parkinson’s disease (PD), new research shows.

Over 3 years, weekly participation in dance training classes “drastically” reduced the expected decline in motor function and significantly improved speech, tremors, balance, and stiffness, the researchers reported.

Dance training also appeared to have benefits regarding cognition, hallucinations, depression, and anxiety.

“These findings strongly suggest the benefits of dance for people with PD as a supplement to a normal treatment regimen,” the investigators noted.

Although the mechanism of benefit is unclear, dance training may help “train neural network nodes that helps either strengthen networks damaged or builds neural road maps that pass the damage,” study investigator Joseph DeSouza, PhD, principal investigator and associate professor, department of psychology, York University, Toronto, said in an interview.

The study was published online July 7, 2021, in Brain Sciences.
 

Multiple benefits

PD is a neurodegenerative disease associated with progression of motor dysfunction within the first 5 years of diagnosis. The annual rate of motor decline, as determined with the Movement Disorder Society Unified Parkinson’s Disease Rating Scale (MDS-UPDRS), is between 5.2 and 8.9 points.

Prior studies that assessed various styles of dance by patients with PD showed beneficial effects regarding gait speed, balance, locomotion, and aspects of quality of life.

To investigate further, DeSouza and coauthor Karolina Bearss, a PhD candidate at York University, followed 16 patients with mild to moderate PD who participated in a weekly dance class at Canada’s National Ballet School and Trinity St. Paul’s church.

Dance for Parkinson’s Disease, which is an established dance curriculum, involves aerobic and anaerobic movements. The protocol begins with a seated warm-up, followed by barre work, and ends with moving across the floor. All participants learn choreography for an upcoming performance.

In the study, 16 patients with PD who did not participant in the dance classes served as control patients.

Over 3 years, the daily rate of motor decline, as indicated by scores on part III of the MDS-UPDRS, was zero among the dancers (slope = 0.000146), indicating no motor impairment, whereas among the nondancers, the motor decline during follow-up was as expected (P < .01), the researchers reported.

In modeling the data, the researchers determined that after completing 1,000 days of dance training, dancers will have a motor score of 19.07, compared with a score of 28.27 for nondancers.

“Our data further showed that training in dance will slow the rate of PD motor impairment progression, as measured by the UPDRS III, by close to 3 points annually in comparison to our PD subjects who did not train,” the researchers reported.

Dance training also had a beneficial effect on motor or nonmotor aspects of daily living and on motor complications, for which there was no significant decline among the PD dancers.

“For those with Parkinson’s disease, even when it’s mild, motor impairment can impact their daily functioning – how they feel about themselves. Many of these motor symptoms lead to isolation because once they get extreme, these people don’t want to go out,” Dr. DeSouza said in a news release.

“These motor symptoms lead to further psychological issues, depression, social isolation and eventually the symptoms do get worse over time. Our study shows that training with dance and music can slow this down and improve their daily living and daily function,” he added.
 

‘Great potential’

Reached for comment, Demian Kogutek, PhD, director of music therapy, University of Evansville (Indiana), said that these preliminary findings from a longitudinal study are “promising.”

“I believe that dance therapy has a great potential for PD. The longitudinal aspect of this study undoubtedly adds to the current literature. Although it is a standardized assessment, it is somewhat subjective,” Dr. Kogutek said in an interview.

Going forward, Dr. Kogutek said he’d like to see other objective outcomes measured, such as objective assessments of balance, gait, hand strength, and dexterity.

Also weighing in on the results, Karen Lee, PhD, president and CEO of Parkinson Canada, said her organization is “encouraged by these preliminary findings as exercise and healthy activities are important for people with Parkinson’s. This study is part of a growing body of research that explores the link between the impact of activities and both motor and nonmotor symptoms of Parkinson’s.

“This research adds to growing evidence about the importance of exercise as part of the management of Parkinson’s, and we encourage people living with Parkinson’s to incorporate exercise as part of their approach to managing their health,” Dr. Lee said in an interview.

Funding for the project is provided in part by a National Science and Engineering Research Council Discovery Grant and by donations from the Irpinia Club of Toronto and others. Dr. Dr. DeSouza, Ms. Bearss, Dr. Kogutek, and Dr. Lee disclosed no relevant financial relationships.

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

The reintroduction of congressional bills that aim to end seasonal time change and move permanently to daylight saving time (DST) – and action on the issue by 19 states in the last 4 years – signal political momentum and up the ante on sleep medicine to educate others and to more uniformly weigh in on the health consequences of such a change.

This was the message of several sleep scientists and physicians who participated in moderated discussions of DST at the virtual annual meeting of the Associated Professional Sleep Societies.

A position paper issued about a year ago by the American Academy of Sleep Medicine objected to the proposed switch and instead called for elimination of DST in favor of permanent standard time (ST). While there are detrimental health effects with time changes in either direction, there is “abundant” evidence that the transition from standard time to daylight saving time is worse, the AASM statement says.

Some experts have questioned, however, whether the evidence is weighty and comprehensive enough to drive a change in national policy. Others, such as SLEEP 2021 discussant Karin Johnson, MD, say there is unawareness outside of sleep medicine – and even within – of a growing body of literature on circadian misalignment and its associated health risks.

“There’s an educational gap for what’s out there [in the literature],” Dr. Johnson, medical director of the Baystate Health regional sleep program and Baystate Medical Center sleep laboratory in Springfield, Mass., said in an interview after the meeting.

Calls for more research, particularly on the chronic effects of DST and ST, are concerning because discussions of abolishing seasonal time change are “moving forward with or without us,” Kenneth Wright Jr., PhD, director of the chronobiology laboratory at the University of Colorado in Boulder and professor in the university’s department of integrative biology, said at the meeting.

“We don’t have time ... to have the studies we’d need to prove unequivocally that permanent standard time [is best]. We need to consider the scientific evidence before us – what’s known about human biology and health with respect to light and circadian timing,” Dr. Wright said. “The argument that pushing our clocks later is going to be healthier is not tenable. We cannot support that given the vast amount of scientific evidence we have from circadian and sleep science.”

Underscoring the sense of urgency to be engaged in the issue were the messages of Rep. Raymond Ward, MD, PhD, a Utah legislator in the state’s House of Representatives who introduced a bill to permanently observe DST, pending the amendment of federal law to permit such a change, and provided that five other Western states enact the same legislation.

“I chose to support DST because I became convinced this is the only thing that’s politically possible,” said Rep. Ward, a family practice physician at the Ogden Clinic in Bountiful. National polls have shown a “strong preference” to end seasonal time change, he said, and a poll conducted in his district showed that nearly 80% “wanted to stop changing the clocks, and 65% wanted the summer time schedule.”

“To me, the train seems to be moving in one direction,” said Rep. Ward. “The bills open in Congress in both the House and the Senate don’t have enough support yet, but every time another state legislature passes [legislation to establish permanent DST], they pick up a few more supporters.”

The Sunshine Protection Act of 2021 introduced in the House in January by Rep. Vern Buchanan (R-Fla.) has 23 cosponsors, and a bill of the same name introduced in the Senate in March by Marco Rubio (R-Fla.) has 14 cosponsors. Both bills have bipartisan support and are reintroductions of legislation initially put forth in 2019. A press release issued by Sen. Rubio’s office says that “extending DST can benefit the economy and our overall health.”

According to the National Conference of State Legislatures, 19 states have enacted legislation or passed resolutions in the last several years to provide for year-round DST, if Congress were to allow such a change. And according to a Congressional Research Service (CRS) report on DST updated in September 2020, at least 45 states have, since 2015, proposed legislation to change their observance of DST.

These efforts include proposals to exempt a state from DST observance, which is allowable under existing law, and proposals that would establish permanent DST, which would require Congress to amend the Uniform Time Act of 1966, the CRS report says.
 

The state of the science

Shifting from ST to DST has been associated with an increase in cardiovascular morbidity (heart attacks and atrial fibrillation), increased missed medical appointments, increased ED visits, increased mood disturbances and suicide risk, increased risk of fatal car crashes and medical errors – and sleep loss, said Elizabeth Klerman, MD, PhD, professor of neurology in the division of sleep medicine at Harvard Medical School, Boston.

These associations are covered in AASM statement, along with acknowledgment that most studies on the chronic effects of DST have “either been retrospective or addressed the issue indirectly.”

For Dr. Johnson, who refers to DST as “sleep deprivation time,” the most convincing data regarding the dangers of permanent DST come from studies comparing locations within time zones. “The farther you’re off from the meridian, the more you have that ‘social jet lag’ or circadian misalignment [between the innate circadian rhythm, which is synchronized with solar time, and school or work schedules],” she said at the meeting.

Researchers reported in 2017, for instance, that the risk for all cancers and many specific cancers increased from east to west within a time zone, as solar time is progressively delayed. “They documented changes in risk for every 5 degrees west from the meridian,” she said.

Dr. Johnson is a case in point of the “educational gap” that she believes needs attention. Two years ago, as chair of the sleep section of the American Academy of Neurology, she delved into the literature after the AAN asked the section whether it should endorse the AASM’s position paper on DST. “I didn’t know the literature even as a sleep scientist until I got into this,” she said.

“If you’re asked me 2 years ago,” she added in the later interview, “I would have said that permanent DST is fine.”

The sleep section recommended that the AAN endorse permanent ST, but the AAN ultimately decided it “didn’t feel strongly enough to say that standard time is unequivocally the better option,” Dr. Johnson said in an interview. “They agreed that there’s science [in favor of it], but ... it’s a big public policy decision.”

Jamie Zeitzer, PhD, associate professor of psychiatry and behavioral sciences at Stanford (Calif.) University’s Center for Sleep Sciences and Medicine, voiced similar concerns at the meeting about currently advocating a shift in either direction. It’s “absolutely clear that switching clocks, especially since it’s occurring at a population level, is deleterious and we need to get rid of it,” he said. “But before we put forth dictates on public health [with a shift to permanent ST], I think we better be sure we’re correct.”

“I think we’re getting close. I think the data thus far [are indicating] that permanent standard time is better for health,” Dr. Zeitzer said. “But I don’t think there’s a cumulative amount of evidence to really say that we have to subvert all other interests because this is so important for public health. We need at least a few more studies.”

There is not enough evidence, for instance, to conclude that the body clock does not eventually adjust to DST, he said, and it is not yet clear what roles electric light and sunlight each play in the body’s circadian time.

“And we need to think about north-south. What may be important for the upper Midwest, and for Maine, and for Washington, may not be ... good for Florida and Texas and southern California,” Dr. Zeitzer said. “You have very different patterns of light exposure, especially when it deals with seasons.”
 

Historical considerations

In his comments at the meeting, Muhammad Rishi, MBBS, the lead author of the AASM’s position statement, added that circadian misalignment – that “asynchrony between the internal and external clocks” – is associated in studies with an increased risk of obesity, metabolic syndrome, and depression.

But he also emphasized that the “historical evidence” against permanent DST is at least as strong as the medical evidence.

“The U.S. has gone on permanent daylight savings time several times in the past, most recently in the 1970s during the OPEC [oil embargo], and it was so unpopular,” said Dr. Rishi, of the department of pulmonology, critical care and sleep medicine at the Mayo Clinic Health System in Eau Claire, Wis. “England also did it in the 1960s and then abolished it, and most recently Russia did it ... it became so unpopular with increased depression and mood disorders that they abolished it.”

Rep. Ward said that China has offered a large natural experiment with its move decades ago from five time zones to one time zone – Beijing time. “I don’t think we’ve seen any sweeping changes in their health because they have one large time zone,” he said.

Dr. Klerman took issue, saying she “knows someone in China who is trying to get that data about health outcomes and is unable to get it.”

Arguments that DST saves energy hold little to no weight upon scrutiny of the data, Dr. Johnson said. Moreover, research other than oft-cited, older Department of Transportation studies suggests that “permanent DST is bad for energy and bad for the climate,” she said. “This really needs to be more fully evaluated by the government and others.”

Dr. Johnson said after the meeting that it’s important for experts from the energy and climate sectors, education, and medicine – including pediatrics, oncology, and other specialties with “a stake in this” – to come together and share information so “we won’t all be in our silos.” She and other sleep experts in the neurology field are planning to host a summit in 2022 to do just this.

Dr. Johnson and Kin Yuen, MD, of the Sleep Disorders Center at the University of California, San Francisco, both expressed concern at the meeting that adoption of permanent DST would negate the benefits of delayed school start times in middle and high school students.

There is some evidence that delayed start times have led to decreased tardiness and absences, Dr. Yuen said. To have the same impact with permanent DST, “instead of starting at 8:30 a.m., you’d have to start at 9:30,” Dr. Johnson added after the meeting.

The first discussion of DST at the SLEEP 2021 meeting was led by Erin E. Flynn-Evans, PhD, MPH, director of the Fatigue Countermeasures Laboratory at the National Aeronautics and Space Administration Ames Research Center. Dr. Yuen led a later second question-and-answer session. They and each of the eight participants reported that they had no relevant conflicts of interest.

Dr. Yuen and Dr. Flynn-Evans are both coauthors of the AASM’s position statement on DST. Dr. Klerman is a coauthor of the Society for Research on Biological Rhythms 2019 position paper on DST.

The AASM’s statement has been endorsed by 19 organizations, including the American College of Chest Physicians, the SRBR, the American Academy of Cardiovascular Sleep Medicine, the Society of Behavioral Sleep Medicine, the National PTA, and the American College of Occupational and Environmental Medicine.

The reintroduction of congressional bills that aim to end seasonal time change and move permanently to daylight saving time (DST) – and action on the issue by 19 states in the last 4 years – signal political momentum and up the ante on sleep medicine to educate others and to more uniformly weigh in on the health consequences of such a change.

This was the message of several sleep scientists and physicians who participated in moderated discussions of DST at the virtual annual meeting of the Associated Professional Sleep Societies.

A position paper issued about a year ago by the American Academy of Sleep Medicine objected to the proposed switch and instead called for elimination of DST in favor of permanent standard time (ST). While there are detrimental health effects with time changes in either direction, there is “abundant” evidence that the transition from standard time to daylight saving time is worse, the AASM statement says.

Some experts have questioned, however, whether the evidence is weighty and comprehensive enough to drive a change in national policy. Others, such as SLEEP 2021 discussant Karin Johnson, MD, say there is unawareness outside of sleep medicine – and even within – of a growing body of literature on circadian misalignment and its associated health risks.

“There’s an educational gap for what’s out there [in the literature],” Dr. Johnson, medical director of the Baystate Health regional sleep program and Baystate Medical Center sleep laboratory in Springfield, Mass., said in an interview after the meeting.

Calls for more research, particularly on the chronic effects of DST and ST, are concerning because discussions of abolishing seasonal time change are “moving forward with or without us,” Kenneth Wright Jr., PhD, director of the chronobiology laboratory at the University of Colorado in Boulder and professor in the university’s department of integrative biology, said at the meeting.

“We don’t have time ... to have the studies we’d need to prove unequivocally that permanent standard time [is best]. We need to consider the scientific evidence before us – what’s known about human biology and health with respect to light and circadian timing,” Dr. Wright said. “The argument that pushing our clocks later is going to be healthier is not tenable. We cannot support that given the vast amount of scientific evidence we have from circadian and sleep science.”

Underscoring the sense of urgency to be engaged in the issue were the messages of Rep. Raymond Ward, MD, PhD, a Utah legislator in the state’s House of Representatives who introduced a bill to permanently observe DST, pending the amendment of federal law to permit such a change, and provided that five other Western states enact the same legislation.

“I chose to support DST because I became convinced this is the only thing that’s politically possible,” said Rep. Ward, a family practice physician at the Ogden Clinic in Bountiful. National polls have shown a “strong preference” to end seasonal time change, he said, and a poll conducted in his district showed that nearly 80% “wanted to stop changing the clocks, and 65% wanted the summer time schedule.”

“To me, the train seems to be moving in one direction,” said Rep. Ward. “The bills open in Congress in both the House and the Senate don’t have enough support yet, but every time another state legislature passes [legislation to establish permanent DST], they pick up a few more supporters.”

The Sunshine Protection Act of 2021 introduced in the House in January by Rep. Vern Buchanan (R-Fla.) has 23 cosponsors, and a bill of the same name introduced in the Senate in March by Marco Rubio (R-Fla.) has 14 cosponsors. Both bills have bipartisan support and are reintroductions of legislation initially put forth in 2019. A press release issued by Sen. Rubio’s office says that “extending DST can benefit the economy and our overall health.”

According to the National Conference of State Legislatures, 19 states have enacted legislation or passed resolutions in the last several years to provide for year-round DST, if Congress were to allow such a change. And according to a Congressional Research Service (CRS) report on DST updated in September 2020, at least 45 states have, since 2015, proposed legislation to change their observance of DST.

These efforts include proposals to exempt a state from DST observance, which is allowable under existing law, and proposals that would establish permanent DST, which would require Congress to amend the Uniform Time Act of 1966, the CRS report says.
 

The state of the science

Shifting from ST to DST has been associated with an increase in cardiovascular morbidity (heart attacks and atrial fibrillation), increased missed medical appointments, increased ED visits, increased mood disturbances and suicide risk, increased risk of fatal car crashes and medical errors – and sleep loss, said Elizabeth Klerman, MD, PhD, professor of neurology in the division of sleep medicine at Harvard Medical School, Boston.

These associations are covered in AASM statement, along with acknowledgment that most studies on the chronic effects of DST have “either been retrospective or addressed the issue indirectly.”

For Dr. Johnson, who refers to DST as “sleep deprivation time,” the most convincing data regarding the dangers of permanent DST come from studies comparing locations within time zones. “The farther you’re off from the meridian, the more you have that ‘social jet lag’ or circadian misalignment [between the innate circadian rhythm, which is synchronized with solar time, and school or work schedules],” she said at the meeting.

Researchers reported in 2017, for instance, that the risk for all cancers and many specific cancers increased from east to west within a time zone, as solar time is progressively delayed. “They documented changes in risk for every 5 degrees west from the meridian,” she said.

Dr. Johnson is a case in point of the “educational gap” that she believes needs attention. Two years ago, as chair of the sleep section of the American Academy of Neurology, she delved into the literature after the AAN asked the section whether it should endorse the AASM’s position paper on DST. “I didn’t know the literature even as a sleep scientist until I got into this,” she said.

“If you’re asked me 2 years ago,” she added in the later interview, “I would have said that permanent DST is fine.”

The sleep section recommended that the AAN endorse permanent ST, but the AAN ultimately decided it “didn’t feel strongly enough to say that standard time is unequivocally the better option,” Dr. Johnson said in an interview. “They agreed that there’s science [in favor of it], but ... it’s a big public policy decision.”

Jamie Zeitzer, PhD, associate professor of psychiatry and behavioral sciences at Stanford (Calif.) University’s Center for Sleep Sciences and Medicine, voiced similar concerns at the meeting about currently advocating a shift in either direction. It’s “absolutely clear that switching clocks, especially since it’s occurring at a population level, is deleterious and we need to get rid of it,” he said. “But before we put forth dictates on public health [with a shift to permanent ST], I think we better be sure we’re correct.”

“I think we’re getting close. I think the data thus far [are indicating] that permanent standard time is better for health,” Dr. Zeitzer said. “But I don’t think there’s a cumulative amount of evidence to really say that we have to subvert all other interests because this is so important for public health. We need at least a few more studies.”

There is not enough evidence, for instance, to conclude that the body clock does not eventually adjust to DST, he said, and it is not yet clear what roles electric light and sunlight each play in the body’s circadian time.

“And we need to think about north-south. What may be important for the upper Midwest, and for Maine, and for Washington, may not be ... good for Florida and Texas and southern California,” Dr. Zeitzer said. “You have very different patterns of light exposure, especially when it deals with seasons.”
 

Historical considerations

In his comments at the meeting, Muhammad Rishi, MBBS, the lead author of the AASM’s position statement, added that circadian misalignment – that “asynchrony between the internal and external clocks” – is associated in studies with an increased risk of obesity, metabolic syndrome, and depression.

But he also emphasized that the “historical evidence” against permanent DST is at least as strong as the medical evidence.

“The U.S. has gone on permanent daylight savings time several times in the past, most recently in the 1970s during the OPEC [oil embargo], and it was so unpopular,” said Dr. Rishi, of the department of pulmonology, critical care and sleep medicine at the Mayo Clinic Health System in Eau Claire, Wis. “England also did it in the 1960s and then abolished it, and most recently Russia did it ... it became so unpopular with increased depression and mood disorders that they abolished it.”

Rep. Ward said that China has offered a large natural experiment with its move decades ago from five time zones to one time zone – Beijing time. “I don’t think we’ve seen any sweeping changes in their health because they have one large time zone,” he said.

Dr. Klerman took issue, saying she “knows someone in China who is trying to get that data about health outcomes and is unable to get it.”

Arguments that DST saves energy hold little to no weight upon scrutiny of the data, Dr. Johnson said. Moreover, research other than oft-cited, older Department of Transportation studies suggests that “permanent DST is bad for energy and bad for the climate,” she said. “This really needs to be more fully evaluated by the government and others.”

Dr. Johnson said after the meeting that it’s important for experts from the energy and climate sectors, education, and medicine – including pediatrics, oncology, and other specialties with “a stake in this” – to come together and share information so “we won’t all be in our silos.” She and other sleep experts in the neurology field are planning to host a summit in 2022 to do just this.

Dr. Johnson and Kin Yuen, MD, of the Sleep Disorders Center at the University of California, San Francisco, both expressed concern at the meeting that adoption of permanent DST would negate the benefits of delayed school start times in middle and high school students.

There is some evidence that delayed start times have led to decreased tardiness and absences, Dr. Yuen said. To have the same impact with permanent DST, “instead of starting at 8:30 a.m., you’d have to start at 9:30,” Dr. Johnson added after the meeting.

The first discussion of DST at the SLEEP 2021 meeting was led by Erin E. Flynn-Evans, PhD, MPH, director of the Fatigue Countermeasures Laboratory at the National Aeronautics and Space Administration Ames Research Center. Dr. Yuen led a later second question-and-answer session. They and each of the eight participants reported that they had no relevant conflicts of interest.

Dr. Yuen and Dr. Flynn-Evans are both coauthors of the AASM’s position statement on DST. Dr. Klerman is a coauthor of the Society for Research on Biological Rhythms 2019 position paper on DST.

The AASM’s statement has been endorsed by 19 organizations, including the American College of Chest Physicians, the SRBR, the American Academy of Cardiovascular Sleep Medicine, the Society of Behavioral Sleep Medicine, the National PTA, and the American College of Occupational and Environmental Medicine.

The reintroduction of congressional bills that aim to end seasonal time change and move permanently to daylight saving time (DST) – and action on the issue by 19 states in the last 4 years – signal political momentum and up the ante on sleep medicine to educate others and to more uniformly weigh in on the health consequences of such a change.

This was the message of several sleep scientists and physicians who participated in moderated discussions of DST at the virtual annual meeting of the Associated Professional Sleep Societies.

A position paper issued about a year ago by the American Academy of Sleep Medicine objected to the proposed switch and instead called for elimination of DST in favor of permanent standard time (ST). While there are detrimental health effects with time changes in either direction, there is “abundant” evidence that the transition from standard time to daylight saving time is worse, the AASM statement says.

Some experts have questioned, however, whether the evidence is weighty and comprehensive enough to drive a change in national policy. Others, such as SLEEP 2021 discussant Karin Johnson, MD, say there is unawareness outside of sleep medicine – and even within – of a growing body of literature on circadian misalignment and its associated health risks.

“There’s an educational gap for what’s out there [in the literature],” Dr. Johnson, medical director of the Baystate Health regional sleep program and Baystate Medical Center sleep laboratory in Springfield, Mass., said in an interview after the meeting.

Calls for more research, particularly on the chronic effects of DST and ST, are concerning because discussions of abolishing seasonal time change are “moving forward with or without us,” Kenneth Wright Jr., PhD, director of the chronobiology laboratory at the University of Colorado in Boulder and professor in the university’s department of integrative biology, said at the meeting.

“We don’t have time ... to have the studies we’d need to prove unequivocally that permanent standard time [is best]. We need to consider the scientific evidence before us – what’s known about human biology and health with respect to light and circadian timing,” Dr. Wright said. “The argument that pushing our clocks later is going to be healthier is not tenable. We cannot support that given the vast amount of scientific evidence we have from circadian and sleep science.”

Underscoring the sense of urgency to be engaged in the issue were the messages of Rep. Raymond Ward, MD, PhD, a Utah legislator in the state’s House of Representatives who introduced a bill to permanently observe DST, pending the amendment of federal law to permit such a change, and provided that five other Western states enact the same legislation.

“I chose to support DST because I became convinced this is the only thing that’s politically possible,” said Rep. Ward, a family practice physician at the Ogden Clinic in Bountiful. National polls have shown a “strong preference” to end seasonal time change, he said, and a poll conducted in his district showed that nearly 80% “wanted to stop changing the clocks, and 65% wanted the summer time schedule.”

“To me, the train seems to be moving in one direction,” said Rep. Ward. “The bills open in Congress in both the House and the Senate don’t have enough support yet, but every time another state legislature passes [legislation to establish permanent DST], they pick up a few more supporters.”

The Sunshine Protection Act of 2021 introduced in the House in January by Rep. Vern Buchanan (R-Fla.) has 23 cosponsors, and a bill of the same name introduced in the Senate in March by Marco Rubio (R-Fla.) has 14 cosponsors. Both bills have bipartisan support and are reintroductions of legislation initially put forth in 2019. A press release issued by Sen. Rubio’s office says that “extending DST can benefit the economy and our overall health.”

According to the National Conference of State Legislatures, 19 states have enacted legislation or passed resolutions in the last several years to provide for year-round DST, if Congress were to allow such a change. And according to a Congressional Research Service (CRS) report on DST updated in September 2020, at least 45 states have, since 2015, proposed legislation to change their observance of DST.

These efforts include proposals to exempt a state from DST observance, which is allowable under existing law, and proposals that would establish permanent DST, which would require Congress to amend the Uniform Time Act of 1966, the CRS report says.
 

The state of the science

Shifting from ST to DST has been associated with an increase in cardiovascular morbidity (heart attacks and atrial fibrillation), increased missed medical appointments, increased ED visits, increased mood disturbances and suicide risk, increased risk of fatal car crashes and medical errors – and sleep loss, said Elizabeth Klerman, MD, PhD, professor of neurology in the division of sleep medicine at Harvard Medical School, Boston.

These associations are covered in AASM statement, along with acknowledgment that most studies on the chronic effects of DST have “either been retrospective or addressed the issue indirectly.”

For Dr. Johnson, who refers to DST as “sleep deprivation time,” the most convincing data regarding the dangers of permanent DST come from studies comparing locations within time zones. “The farther you’re off from the meridian, the more you have that ‘social jet lag’ or circadian misalignment [between the innate circadian rhythm, which is synchronized with solar time, and school or work schedules],” she said at the meeting.

Researchers reported in 2017, for instance, that the risk for all cancers and many specific cancers increased from east to west within a time zone, as solar time is progressively delayed. “They documented changes in risk for every 5 degrees west from the meridian,” she said.

Dr. Johnson is a case in point of the “educational gap” that she believes needs attention. Two years ago, as chair of the sleep section of the American Academy of Neurology, she delved into the literature after the AAN asked the section whether it should endorse the AASM’s position paper on DST. “I didn’t know the literature even as a sleep scientist until I got into this,” she said.

“If you’re asked me 2 years ago,” she added in the later interview, “I would have said that permanent DST is fine.”

The sleep section recommended that the AAN endorse permanent ST, but the AAN ultimately decided it “didn’t feel strongly enough to say that standard time is unequivocally the better option,” Dr. Johnson said in an interview. “They agreed that there’s science [in favor of it], but ... it’s a big public policy decision.”

Jamie Zeitzer, PhD, associate professor of psychiatry and behavioral sciences at Stanford (Calif.) University’s Center for Sleep Sciences and Medicine, voiced similar concerns at the meeting about currently advocating a shift in either direction. It’s “absolutely clear that switching clocks, especially since it’s occurring at a population level, is deleterious and we need to get rid of it,” he said. “But before we put forth dictates on public health [with a shift to permanent ST], I think we better be sure we’re correct.”

“I think we’re getting close. I think the data thus far [are indicating] that permanent standard time is better for health,” Dr. Zeitzer said. “But I don’t think there’s a cumulative amount of evidence to really say that we have to subvert all other interests because this is so important for public health. We need at least a few more studies.”

There is not enough evidence, for instance, to conclude that the body clock does not eventually adjust to DST, he said, and it is not yet clear what roles electric light and sunlight each play in the body’s circadian time.

“And we need to think about north-south. What may be important for the upper Midwest, and for Maine, and for Washington, may not be ... good for Florida and Texas and southern California,” Dr. Zeitzer said. “You have very different patterns of light exposure, especially when it deals with seasons.”
 

Historical considerations

In his comments at the meeting, Muhammad Rishi, MBBS, the lead author of the AASM’s position statement, added that circadian misalignment – that “asynchrony between the internal and external clocks” – is associated in studies with an increased risk of obesity, metabolic syndrome, and depression.

But he also emphasized that the “historical evidence” against permanent DST is at least as strong as the medical evidence.

“The U.S. has gone on permanent daylight savings time several times in the past, most recently in the 1970s during the OPEC [oil embargo], and it was so unpopular,” said Dr. Rishi, of the department of pulmonology, critical care and sleep medicine at the Mayo Clinic Health System in Eau Claire, Wis. “England also did it in the 1960s and then abolished it, and most recently Russia did it ... it became so unpopular with increased depression and mood disorders that they abolished it.”

Rep. Ward said that China has offered a large natural experiment with its move decades ago from five time zones to one time zone – Beijing time. “I don’t think we’ve seen any sweeping changes in their health because they have one large time zone,” he said.

Dr. Klerman took issue, saying she “knows someone in China who is trying to get that data about health outcomes and is unable to get it.”

Arguments that DST saves energy hold little to no weight upon scrutiny of the data, Dr. Johnson said. Moreover, research other than oft-cited, older Department of Transportation studies suggests that “permanent DST is bad for energy and bad for the climate,” she said. “This really needs to be more fully evaluated by the government and others.”

Dr. Johnson said after the meeting that it’s important for experts from the energy and climate sectors, education, and medicine – including pediatrics, oncology, and other specialties with “a stake in this” – to come together and share information so “we won’t all be in our silos.” She and other sleep experts in the neurology field are planning to host a summit in 2022 to do just this.

Dr. Johnson and Kin Yuen, MD, of the Sleep Disorders Center at the University of California, San Francisco, both expressed concern at the meeting that adoption of permanent DST would negate the benefits of delayed school start times in middle and high school students.

There is some evidence that delayed start times have led to decreased tardiness and absences, Dr. Yuen said. To have the same impact with permanent DST, “instead of starting at 8:30 a.m., you’d have to start at 9:30,” Dr. Johnson added after the meeting.

The first discussion of DST at the SLEEP 2021 meeting was led by Erin E. Flynn-Evans, PhD, MPH, director of the Fatigue Countermeasures Laboratory at the National Aeronautics and Space Administration Ames Research Center. Dr. Yuen led a later second question-and-answer session. They and each of the eight participants reported that they had no relevant conflicts of interest.

Dr. Yuen and Dr. Flynn-Evans are both coauthors of the AASM’s position statement on DST. Dr. Klerman is a coauthor of the Society for Research on Biological Rhythms 2019 position paper on DST.

The AASM’s statement has been endorsed by 19 organizations, including the American College of Chest Physicians, the SRBR, the American Academy of Cardiovascular Sleep Medicine, the Society of Behavioral Sleep Medicine, the National PTA, and the American College of Occupational and Environmental Medicine.

In April, 92 people gathered in Texas for a wedding. To lower the chances of COVID-19 infection, the festivities were held outside under a large, open-air tent. All 92 guests were required to be fully vaccinated.

Despite those precautions, six people tested positive for the coronavirus and one of them died, Forbes magazine reported, citing a preprint published in medRxiv.

Researchers from Baylor College of Medicine said viral sequencing suggests “the strain containing the Delta variant was transmitted to wedding guests from two patients traveling from India. With no history of vaccine failure in these patients, our observations suggest these are true cases of vaccine breakthrough, mediated by the Delta variant.”

Three females and three males aged 53-69 tested positive for COVID-19. Three were overweight, but none had significant comorbidities or a history of failed vaccination.

The first people to get sick were a man and woman who traveled from India, Forbes reported. The man had no health problems, but the woman had diabetes. Both had gotten two doses of the Covaxin BBV152 vaccine before leaving India.

They tested positive for COVID-19 4 days after the wedding, and the man became so ill he was hospitalized. Six days after the wedding, he died, according to Forbes.

Two people who’d gotten the Pfizer/BioNTech vaccine and two people who received the Moderna vaccine interacted with the first two people, and they also tested positive. One of them, a man in his 60s, had to be hospitalized.

The researchers said their findings suggest the Delta variant “may possess immune evasion” in patients that received the Pfizer, Moderna, or Covaxin vaccines.

Forbes summed it up this way: “While the available COVID-19 vaccines can offer good protection against COVID-19, the protection is not perfect. As long as the pandemic is continuing, it is better to maintain multiple layers of COVID-19 precautions when you can.”
 

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

In April, 92 people gathered in Texas for a wedding. To lower the chances of COVID-19 infection, the festivities were held outside under a large, open-air tent. All 92 guests were required to be fully vaccinated.

Despite those precautions, six people tested positive for the coronavirus and one of them died, Forbes magazine reported, citing a preprint published in medRxiv.

Researchers from Baylor College of Medicine said viral sequencing suggests “the strain containing the Delta variant was transmitted to wedding guests from two patients traveling from India. With no history of vaccine failure in these patients, our observations suggest these are true cases of vaccine breakthrough, mediated by the Delta variant.”

Three females and three males aged 53-69 tested positive for COVID-19. Three were overweight, but none had significant comorbidities or a history of failed vaccination.

The first people to get sick were a man and woman who traveled from India, Forbes reported. The man had no health problems, but the woman had diabetes. Both had gotten two doses of the Covaxin BBV152 vaccine before leaving India.

They tested positive for COVID-19 4 days after the wedding, and the man became so ill he was hospitalized. Six days after the wedding, he died, according to Forbes.

Two people who’d gotten the Pfizer/BioNTech vaccine and two people who received the Moderna vaccine interacted with the first two people, and they also tested positive. One of them, a man in his 60s, had to be hospitalized.

The researchers said their findings suggest the Delta variant “may possess immune evasion” in patients that received the Pfizer, Moderna, or Covaxin vaccines.

Forbes summed it up this way: “While the available COVID-19 vaccines can offer good protection against COVID-19, the protection is not perfect. As long as the pandemic is continuing, it is better to maintain multiple layers of COVID-19 precautions when you can.”
 

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

In April, 92 people gathered in Texas for a wedding. To lower the chances of COVID-19 infection, the festivities were held outside under a large, open-air tent. All 92 guests were required to be fully vaccinated.

Despite those precautions, six people tested positive for the coronavirus and one of them died, Forbes magazine reported, citing a preprint published in medRxiv.

Researchers from Baylor College of Medicine said viral sequencing suggests “the strain containing the Delta variant was transmitted to wedding guests from two patients traveling from India. With no history of vaccine failure in these patients, our observations suggest these are true cases of vaccine breakthrough, mediated by the Delta variant.”

Three females and three males aged 53-69 tested positive for COVID-19. Three were overweight, but none had significant comorbidities or a history of failed vaccination.

The first people to get sick were a man and woman who traveled from India, Forbes reported. The man had no health problems, but the woman had diabetes. Both had gotten two doses of the Covaxin BBV152 vaccine before leaving India.

They tested positive for COVID-19 4 days after the wedding, and the man became so ill he was hospitalized. Six days after the wedding, he died, according to Forbes.

Two people who’d gotten the Pfizer/BioNTech vaccine and two people who received the Moderna vaccine interacted with the first two people, and they also tested positive. One of them, a man in his 60s, had to be hospitalized.

The researchers said their findings suggest the Delta variant “may possess immune evasion” in patients that received the Pfizer, Moderna, or Covaxin vaccines.

Forbes summed it up this way: “While the available COVID-19 vaccines can offer good protection against COVID-19, the protection is not perfect. As long as the pandemic is continuing, it is better to maintain multiple layers of COVID-19 precautions when you can.”
 

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

Medicare intends next year to allow physician assistants (PAs) to begin directly billing for their work and to expand coverage of telehealth services. It also intends to change the approach to payments for office visits and for coaching programs for diabetes prevention.

adventtr/iStock/Getty Images Plus

The Centers for Medicare & Medicaid Services recently posted its proposed 2022 physician fee schedule. Running to more than 1,700 pages, the draft rule contains myriad other changes in how the giant federal health program pays for medical care, including revisions to its approach to evaluation and management (E/M) services, which represent many office visits. In addition, Medicare is seeking to increase participation in a program intended to prevent people from developing diabetes.

Physician groups posted quick complaints about a proposed 3.75% reduction to the conversion factor because of budget neutrality requirements. The cut reinstates a reduction Congress prevented in late 2020.

In a statement, Anders Gilberg, senior vice president of government affairs for the Medical Group Management Association, called the draft rule a “mixed bag for physician practices.” Mr. Gilberg said the MGMA will seek congressional intervention to avert the cut for services in 2022.

In keeping with a provision Congress included in a massive spending bill enacted in December, Medicare will let PAs directly bill, as nurse practitioners already can. In a press release, CMS on July 13 described this as a move likely to expand access to care and reduce administrative burden. In 2020, the American Academy of PAs praised the inclusion in the spending bill of the provision allowing its members to directly bill Medicare.

In the draft rule, CMS also intends to remove certain geographic restrictions regarding use of telehealth services for diagnosis, evaluation, and treatment of mental health disorders. CMS also is proposing to allow payment to eligible clinicians for certain mental health and behavioral health services to patients via audio-only telephone calls. These services would include counseling and therapy services provided through opioid treatment programs.

“These changes would be particularly helpful for those in areas with poor broadband infrastructure and among people with Medicare who are not capable of, or do not consent to the use of, devices that permit a two-way, audio/video interaction for their health care visits,” CMS said in a statement.
 

Slimmer Medicare enrollees, bigger payments for coaches?

CMS is seeking to draw more participants to the Medicare Diabetes Prevention Program (MDPP). This program includes organizations that provide structured, coach-led sessions in community and health care settings to help people lose weight and exercise more. During the COVID-19 public health emergency, CMS waived an enrollment fee for new suppliers of services in MDPP. CMS now is proposing to waive this fee for all organizations that submit an application to enroll in Medicare as an MDPP supplier on or after Jan. 1, 2022.

Another proposed change in MDPP services is a restructuring of payments so that organizations involved in coaching would receive larger payments when their participants reach milestones for attendance and for becoming slimmer.

“We propose to increase performance payments for MDPP beneficiary achievement of the 5% weight-loss goal, as well as continued attendance during each core maintenance interval,” CMS said in a statement.

Medicare remains engaged in a review of its payments for E/M services. In the draft rule, CMS is proposing a number of refinements to current policies for split, or shared, E/M visits, critical care services, and services furnished by teaching physicians involving residents. The intention of these changes is to “better reflect the current practice of medicine, the evolving role of nonphysician practitioners as members of the medical team, and to clarify conditions of payment that must be met to bill Medicare for these services,” CMS said.

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

Medicare intends next year to allow physician assistants (PAs) to begin directly billing for their work and to expand coverage of telehealth services. It also intends to change the approach to payments for office visits and for coaching programs for diabetes prevention.

adventtr/iStock/Getty Images Plus

The Centers for Medicare & Medicaid Services recently posted its proposed 2022 physician fee schedule. Running to more than 1,700 pages, the draft rule contains myriad other changes in how the giant federal health program pays for medical care, including revisions to its approach to evaluation and management (E/M) services, which represent many office visits. In addition, Medicare is seeking to increase participation in a program intended to prevent people from developing diabetes.

Physician groups posted quick complaints about a proposed 3.75% reduction to the conversion factor because of budget neutrality requirements. The cut reinstates a reduction Congress prevented in late 2020.

In a statement, Anders Gilberg, senior vice president of government affairs for the Medical Group Management Association, called the draft rule a “mixed bag for physician practices.” Mr. Gilberg said the MGMA will seek congressional intervention to avert the cut for services in 2022.

In keeping with a provision Congress included in a massive spending bill enacted in December, Medicare will let PAs directly bill, as nurse practitioners already can. In a press release, CMS on July 13 described this as a move likely to expand access to care and reduce administrative burden. In 2020, the American Academy of PAs praised the inclusion in the spending bill of the provision allowing its members to directly bill Medicare.

In the draft rule, CMS also intends to remove certain geographic restrictions regarding use of telehealth services for diagnosis, evaluation, and treatment of mental health disorders. CMS also is proposing to allow payment to eligible clinicians for certain mental health and behavioral health services to patients via audio-only telephone calls. These services would include counseling and therapy services provided through opioid treatment programs.

“These changes would be particularly helpful for those in areas with poor broadband infrastructure and among people with Medicare who are not capable of, or do not consent to the use of, devices that permit a two-way, audio/video interaction for their health care visits,” CMS said in a statement.
 

Slimmer Medicare enrollees, bigger payments for coaches?

CMS is seeking to draw more participants to the Medicare Diabetes Prevention Program (MDPP). This program includes organizations that provide structured, coach-led sessions in community and health care settings to help people lose weight and exercise more. During the COVID-19 public health emergency, CMS waived an enrollment fee for new suppliers of services in MDPP. CMS now is proposing to waive this fee for all organizations that submit an application to enroll in Medicare as an MDPP supplier on or after Jan. 1, 2022.

Another proposed change in MDPP services is a restructuring of payments so that organizations involved in coaching would receive larger payments when their participants reach milestones for attendance and for becoming slimmer.

“We propose to increase performance payments for MDPP beneficiary achievement of the 5% weight-loss goal, as well as continued attendance during each core maintenance interval,” CMS said in a statement.

Medicare remains engaged in a review of its payments for E/M services. In the draft rule, CMS is proposing a number of refinements to current policies for split, or shared, E/M visits, critical care services, and services furnished by teaching physicians involving residents. The intention of these changes is to “better reflect the current practice of medicine, the evolving role of nonphysician practitioners as members of the medical team, and to clarify conditions of payment that must be met to bill Medicare for these services,” CMS said.

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

Medicare intends next year to allow physician assistants (PAs) to begin directly billing for their work and to expand coverage of telehealth services. It also intends to change the approach to payments for office visits and for coaching programs for diabetes prevention.

adventtr/iStock/Getty Images Plus

The Centers for Medicare & Medicaid Services recently posted its proposed 2022 physician fee schedule. Running to more than 1,700 pages, the draft rule contains myriad other changes in how the giant federal health program pays for medical care, including revisions to its approach to evaluation and management (E/M) services, which represent many office visits. In addition, Medicare is seeking to increase participation in a program intended to prevent people from developing diabetes.

Physician groups posted quick complaints about a proposed 3.75% reduction to the conversion factor because of budget neutrality requirements. The cut reinstates a reduction Congress prevented in late 2020.

In a statement, Anders Gilberg, senior vice president of government affairs for the Medical Group Management Association, called the draft rule a “mixed bag for physician practices.” Mr. Gilberg said the MGMA will seek congressional intervention to avert the cut for services in 2022.

In keeping with a provision Congress included in a massive spending bill enacted in December, Medicare will let PAs directly bill, as nurse practitioners already can. In a press release, CMS on July 13 described this as a move likely to expand access to care and reduce administrative burden. In 2020, the American Academy of PAs praised the inclusion in the spending bill of the provision allowing its members to directly bill Medicare.

In the draft rule, CMS also intends to remove certain geographic restrictions regarding use of telehealth services for diagnosis, evaluation, and treatment of mental health disorders. CMS also is proposing to allow payment to eligible clinicians for certain mental health and behavioral health services to patients via audio-only telephone calls. These services would include counseling and therapy services provided through opioid treatment programs.

“These changes would be particularly helpful for those in areas with poor broadband infrastructure and among people with Medicare who are not capable of, or do not consent to the use of, devices that permit a two-way, audio/video interaction for their health care visits,” CMS said in a statement.
 

Slimmer Medicare enrollees, bigger payments for coaches?

CMS is seeking to draw more participants to the Medicare Diabetes Prevention Program (MDPP). This program includes organizations that provide structured, coach-led sessions in community and health care settings to help people lose weight and exercise more. During the COVID-19 public health emergency, CMS waived an enrollment fee for new suppliers of services in MDPP. CMS now is proposing to waive this fee for all organizations that submit an application to enroll in Medicare as an MDPP supplier on or after Jan. 1, 2022.

Another proposed change in MDPP services is a restructuring of payments so that organizations involved in coaching would receive larger payments when their participants reach milestones for attendance and for becoming slimmer.

“We propose to increase performance payments for MDPP beneficiary achievement of the 5% weight-loss goal, as well as continued attendance during each core maintenance interval,” CMS said in a statement.

Medicare remains engaged in a review of its payments for E/M services. In the draft rule, CMS is proposing a number of refinements to current policies for split, or shared, E/M visits, critical care services, and services furnished by teaching physicians involving residents. The intention of these changes is to “better reflect the current practice of medicine, the evolving role of nonphysician practitioners as members of the medical team, and to clarify conditions of payment that must be met to bill Medicare for these services,” CMS said.

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