Disaster response, practice operations, transplant, women's health

Disaster Response and Global Health
Epigenetics and Disasters
The configuration of the DNA bordering a gene dictates under what conditions a gene is expressed. Random errors or mutations affecting the neighboring DNA or the gene itself can affect how the gene functions. Epigenetics is an emerging field of science looking at environmental and psychosocial factors that do not directly cause mutations but still affect how genes are expressed with implications for the development and inheritance of disease. These external influences are thought to affect why some segments of DNA become accessible for protein production while other segments may not.

Disasters represent stressors with potential for epigenetic impact. Women who were pregnant during the 1998 Quebec ice storm were found to have a correlation between maternal objective stress and a distinctive pattern of DNA methylation in their children 13 years later (Cao-Lei L, et al. PLoS ONE. 2014;9[9] e10765). Methylation is known to affect the activity of a DNA segment and how genes are expressed. Associations have also been found between the severity of hurricanes and the prevalence of autism in the offspring of pregnant women experiencing these disasters (Kinney DK, et al. J Autism Dev Disord. 2008;38:481).

Anthropogenic hazards may also affect the offspring of survivors as suggested by studies of civil war POWs and Dutch Hunger Winter during WW II (Costa, DL, et al. Proc Nat Acad Sci 2018;. 115:44; Heijmans BT et al. Proc Nat Acad Sci. 2008;105[44]: 17046-9).

Epigenetics represents an area for additional research as natural and man-made disasters increase.

Omesh Toolsie, MBBS
Steering Committee Fellow-in-Training

Practice Operations
Medicare Competitive Bidding Process Update

Medicare’s Competitive Bidding Program (CBP), mandated since 2003, asks providers of specific durable medical equipment (including oxygen) to submit competing proposals for services. The best offer is then awarded a 3-year contract. Recently, several reforms to CBP have been proposed. The payment structure has changed to “lead-item pricing,” where a single bid in each category is selected and payment amounts for each product are then calculated based on pricing ratios and fee schedules (CMS DMEPOS Competitive Bidding).

This is in contrast to the prior method of median pricing, which caused financial difficulty and access concerns (Council for Quality Respiratory Care. The Rationale for Reforming Medicare Home Respiratory Therapy Payment Methodology. 2018). Budget neutrality requirements should relax, and oxygen payment structures improve. These proposed changes also include improved coverage of liquid oxygen and addition of home ventilator supplies.

However, effective January 1, 2019, all CBP is suspended through CMS. During the anticipated 2-year gap, any Medicare-enrolled supplier will be able to provide items until new contracts are awarded. Pricing during the gap period is based on a current single price plus consumer price index. These changes will impact CHEST members and their patients moving forward. During the temporary gap period, some areas are seeing decreased accessibility of some DME due to demand. Once reinstated, the changes to the oxygen payment structure should improve access and reduce out-of-pocket costs. The Practice Operations NetWork will continue to provide updates on this topic as they become available.

Timothy Dempsey, MD, MPH
Steering Committee Fellow-in-Training

Megan Sisk, DO
Steering Committee Member

 

Transplant
Medicare Part D Plans Can Deny Coverage of Select Immunosuppressant Medications in Solid Organ Transplant Recipients
An alarming problem has emerged with some solid organ transplant recipients experiencing immunosuppressant medication claim denials by Medicare Part D plans. Affected patients are those who convert from some other insurance (ie, private insurance or state Medicaid) to Medicare after their transplant and, therefore, rely on Medicare Part D for immunosuppressant drug coverage.

Insurance companies who offer Medicare Part D plans must follow the rules described in the Medicare Prescription Drug Benefit Manual.1 Although the Manual mandates that all immunosuppressant medications are on plan formularies, Part D plans are only required to cover immunosuppressant medications when used for indications approved by the Food and Drug Administration (FDA) or for off-label indications supported by the Centers for Medicare & Medicaid Services (CMS)-approved compendia (Drugdex® and AHFS Drug Information®).

A recent study examining the extent of the problem demonstrated non-renal organ transplant recipients are frequently prescribed and maintained on at least one medication vulnerable to Medicare Part D claim denials at 1 year posttransplant (lung: 71.1%; intestine: 39.7%; pancreas: 36.8%; liver: 19.7%; heart: 18.5%).2 Lung transplant recipients are most vulnerable since no immunosuppressant is FDA-approved for use in lung transplantation, and CMS-approved compendia only support off-label use for tacrolimus and cyclosporine in this population. Therefore, mycophenolate mofetil, mycophenolic acid, azathioprine, everolimus, and sirolimus are vulnerable to denial by Medicare Part D plans when used in lung transplant recipients. Over 95% of lung transplant recipients are maintained on an anti-metabolite, with the majority (88%) maintained on mycophenolate, so this is frequently impacted.2,3 While the transplant community is aware of this issue and has begun work to correct it, it has yet to be solved.2,4 In the meantime, if transplant recipients have been denied for this off-label and off-compendia reason, and appeals of those decisions have also been denied, options for obtaining the denied immunosuppressant medication include discount programs, foundation/grant funding, and industry-sponsored assistance programs.

Jennifer K. McDermott, PharmD
NetWork Member

1. Prescription Drug Benefit Manual. Centers for Medicare & Medicaid Services. Chapter 6: Part D Drugs and Formulary Requirements. Available at: https://www.cms.gov/Medicare/Prescription-Drug-Coverage/PrescriptionDrugCovContra/Downloads/Part-D-Benefits-Manual-Chapter-6.pdf
2. Potter LM et al. Transplant recipients are vulnerable to coverage denial under Medicare Part D. Am J Transplant. 2018;18:1502.
3. Valapour M et al. OPTN/SRTR 2016 Annual Data Report: Lung. Am J Transplant. 2018;18 (Suppl 1): 363.
4. Immunusuppressant Drug Coverage Under Medicare Part D Benefit. American Society of Transplantation. Available at: www.myast.org/public-policy/key-position-statements/immunosuppressant-drug-coverage-under-medicare-part-d-benefit.

 

Women’s Health
Cannabis Use Affects Women Differently

As we enter an era of legalization, cannabis use is increasingly prevalent. Variances in the risks for women and men have been observed. For most age groups, men have higher rates of use or dependence on illicit drugs than women. However, women are equally likely as men to progress to a substance use disorder. Women may be more susceptible to craving and relapse , which are key phases of the addiction cycle. A study on use among adolescents concluded there was preliminary evidence of a faster transition from initiation of marijuana use to regular use in women, when compared with men (Schepis, et al. J Addict Med. 2011;5[1]:65).

Research studies suggest that marijuana impairs spatial memory in women more so than in men. Studies have suggested that teenage girls who use marijuana may have a higher risk of brain structural abnormalities associated with regular marijuana exposure than teenage boys (Tapert, et al. Addict Biol. 2009;14[4]:457).

A study published in Psychoneuroendocrinology showed that cannabinoid receptor binding site densities exhibit sex differences and can be modulated by estradiol in several limbic brain regions. These findings may account for the sex differences observed with respect to the effects of cannabinoids (Riebe, et al. Psychoneuroendocrinology. 2010;35[8]:1265).

Further research is needed to expand our understanding of the interactions between cannabinoids and sex steroids. Detoxification treatments tailored toward women and men with cannabis addiction show a promising future and necessitate further research.

Anita Rajagopal, MD
Steering Committee Member

Disaster Response and Global Health
Epigenetics and Disasters
The configuration of the DNA bordering a gene dictates under what conditions a gene is expressed. Random errors or mutations affecting the neighboring DNA or the gene itself can affect how the gene functions. Epigenetics is an emerging field of science looking at environmental and psychosocial factors that do not directly cause mutations but still affect how genes are expressed with implications for the development and inheritance of disease. These external influences are thought to affect why some segments of DNA become accessible for protein production while other segments may not.

Disasters represent stressors with potential for epigenetic impact. Women who were pregnant during the 1998 Quebec ice storm were found to have a correlation between maternal objective stress and a distinctive pattern of DNA methylation in their children 13 years later (Cao-Lei L, et al. PLoS ONE. 2014;9[9] e10765). Methylation is known to affect the activity of a DNA segment and how genes are expressed. Associations have also been found between the severity of hurricanes and the prevalence of autism in the offspring of pregnant women experiencing these disasters (Kinney DK, et al. J Autism Dev Disord. 2008;38:481).

Anthropogenic hazards may also affect the offspring of survivors as suggested by studies of civil war POWs and Dutch Hunger Winter during WW II (Costa, DL, et al. Proc Nat Acad Sci 2018;. 115:44; Heijmans BT et al. Proc Nat Acad Sci. 2008;105[44]: 17046-9).

Epigenetics represents an area for additional research as natural and man-made disasters increase.

Omesh Toolsie, MBBS
Steering Committee Fellow-in-Training

Practice Operations
Medicare Competitive Bidding Process Update

Medicare’s Competitive Bidding Program (CBP), mandated since 2003, asks providers of specific durable medical equipment (including oxygen) to submit competing proposals for services. The best offer is then awarded a 3-year contract. Recently, several reforms to CBP have been proposed. The payment structure has changed to “lead-item pricing,” where a single bid in each category is selected and payment amounts for each product are then calculated based on pricing ratios and fee schedules (CMS DMEPOS Competitive Bidding).

This is in contrast to the prior method of median pricing, which caused financial difficulty and access concerns (Council for Quality Respiratory Care. The Rationale for Reforming Medicare Home Respiratory Therapy Payment Methodology. 2018). Budget neutrality requirements should relax, and oxygen payment structures improve. These proposed changes also include improved coverage of liquid oxygen and addition of home ventilator supplies.

However, effective January 1, 2019, all CBP is suspended through CMS. During the anticipated 2-year gap, any Medicare-enrolled supplier will be able to provide items until new contracts are awarded. Pricing during the gap period is based on a current single price plus consumer price index. These changes will impact CHEST members and their patients moving forward. During the temporary gap period, some areas are seeing decreased accessibility of some DME due to demand. Once reinstated, the changes to the oxygen payment structure should improve access and reduce out-of-pocket costs. The Practice Operations NetWork will continue to provide updates on this topic as they become available.

Timothy Dempsey, MD, MPH
Steering Committee Fellow-in-Training

Megan Sisk, DO
Steering Committee Member

 

Transplant
Medicare Part D Plans Can Deny Coverage of Select Immunosuppressant Medications in Solid Organ Transplant Recipients
An alarming problem has emerged with some solid organ transplant recipients experiencing immunosuppressant medication claim denials by Medicare Part D plans. Affected patients are those who convert from some other insurance (ie, private insurance or state Medicaid) to Medicare after their transplant and, therefore, rely on Medicare Part D for immunosuppressant drug coverage.

Insurance companies who offer Medicare Part D plans must follow the rules described in the Medicare Prescription Drug Benefit Manual.1 Although the Manual mandates that all immunosuppressant medications are on plan formularies, Part D plans are only required to cover immunosuppressant medications when used for indications approved by the Food and Drug Administration (FDA) or for off-label indications supported by the Centers for Medicare & Medicaid Services (CMS)-approved compendia (Drugdex® and AHFS Drug Information®).

A recent study examining the extent of the problem demonstrated non-renal organ transplant recipients are frequently prescribed and maintained on at least one medication vulnerable to Medicare Part D claim denials at 1 year posttransplant (lung: 71.1%; intestine: 39.7%; pancreas: 36.8%; liver: 19.7%; heart: 18.5%).2 Lung transplant recipients are most vulnerable since no immunosuppressant is FDA-approved for use in lung transplantation, and CMS-approved compendia only support off-label use for tacrolimus and cyclosporine in this population. Therefore, mycophenolate mofetil, mycophenolic acid, azathioprine, everolimus, and sirolimus are vulnerable to denial by Medicare Part D plans when used in lung transplant recipients. Over 95% of lung transplant recipients are maintained on an anti-metabolite, with the majority (88%) maintained on mycophenolate, so this is frequently impacted.2,3 While the transplant community is aware of this issue and has begun work to correct it, it has yet to be solved.2,4 In the meantime, if transplant recipients have been denied for this off-label and off-compendia reason, and appeals of those decisions have also been denied, options for obtaining the denied immunosuppressant medication include discount programs, foundation/grant funding, and industry-sponsored assistance programs.

Jennifer K. McDermott, PharmD
NetWork Member

1. Prescription Drug Benefit Manual. Centers for Medicare & Medicaid Services. Chapter 6: Part D Drugs and Formulary Requirements. Available at: https://www.cms.gov/Medicare/Prescription-Drug-Coverage/PrescriptionDrugCovContra/Downloads/Part-D-Benefits-Manual-Chapter-6.pdf
2. Potter LM et al. Transplant recipients are vulnerable to coverage denial under Medicare Part D. Am J Transplant. 2018;18:1502.
3. Valapour M et al. OPTN/SRTR 2016 Annual Data Report: Lung. Am J Transplant. 2018;18 (Suppl 1): 363.
4. Immunusuppressant Drug Coverage Under Medicare Part D Benefit. American Society of Transplantation. Available at: www.myast.org/public-policy/key-position-statements/immunosuppressant-drug-coverage-under-medicare-part-d-benefit.

 

Women’s Health
Cannabis Use Affects Women Differently

As we enter an era of legalization, cannabis use is increasingly prevalent. Variances in the risks for women and men have been observed. For most age groups, men have higher rates of use or dependence on illicit drugs than women. However, women are equally likely as men to progress to a substance use disorder. Women may be more susceptible to craving and relapse , which are key phases of the addiction cycle. A study on use among adolescents concluded there was preliminary evidence of a faster transition from initiation of marijuana use to regular use in women, when compared with men (Schepis, et al. J Addict Med. 2011;5[1]:65).

Research studies suggest that marijuana impairs spatial memory in women more so than in men. Studies have suggested that teenage girls who use marijuana may have a higher risk of brain structural abnormalities associated with regular marijuana exposure than teenage boys (Tapert, et al. Addict Biol. 2009;14[4]:457).

A study published in Psychoneuroendocrinology showed that cannabinoid receptor binding site densities exhibit sex differences and can be modulated by estradiol in several limbic brain regions. These findings may account for the sex differences observed with respect to the effects of cannabinoids (Riebe, et al. Psychoneuroendocrinology. 2010;35[8]:1265).

Further research is needed to expand our understanding of the interactions between cannabinoids and sex steroids. Detoxification treatments tailored toward women and men with cannabis addiction show a promising future and necessitate further research.

Anita Rajagopal, MD
Steering Committee Member

Disaster Response and Global Health
Epigenetics and Disasters
The configuration of the DNA bordering a gene dictates under what conditions a gene is expressed. Random errors or mutations affecting the neighboring DNA or the gene itself can affect how the gene functions. Epigenetics is an emerging field of science looking at environmental and psychosocial factors that do not directly cause mutations but still affect how genes are expressed with implications for the development and inheritance of disease. These external influences are thought to affect why some segments of DNA become accessible for protein production while other segments may not.

Disasters represent stressors with potential for epigenetic impact. Women who were pregnant during the 1998 Quebec ice storm were found to have a correlation between maternal objective stress and a distinctive pattern of DNA methylation in their children 13 years later (Cao-Lei L, et al. PLoS ONE. 2014;9[9] e10765). Methylation is known to affect the activity of a DNA segment and how genes are expressed. Associations have also been found between the severity of hurricanes and the prevalence of autism in the offspring of pregnant women experiencing these disasters (Kinney DK, et al. J Autism Dev Disord. 2008;38:481).

Anthropogenic hazards may also affect the offspring of survivors as suggested by studies of civil war POWs and Dutch Hunger Winter during WW II (Costa, DL, et al. Proc Nat Acad Sci 2018;. 115:44; Heijmans BT et al. Proc Nat Acad Sci. 2008;105[44]: 17046-9).

Epigenetics represents an area for additional research as natural and man-made disasters increase.

Omesh Toolsie, MBBS
Steering Committee Fellow-in-Training

Practice Operations
Medicare Competitive Bidding Process Update

Medicare’s Competitive Bidding Program (CBP), mandated since 2003, asks providers of specific durable medical equipment (including oxygen) to submit competing proposals for services. The best offer is then awarded a 3-year contract. Recently, several reforms to CBP have been proposed. The payment structure has changed to “lead-item pricing,” where a single bid in each category is selected and payment amounts for each product are then calculated based on pricing ratios and fee schedules (CMS DMEPOS Competitive Bidding).

This is in contrast to the prior method of median pricing, which caused financial difficulty and access concerns (Council for Quality Respiratory Care. The Rationale for Reforming Medicare Home Respiratory Therapy Payment Methodology. 2018). Budget neutrality requirements should relax, and oxygen payment structures improve. These proposed changes also include improved coverage of liquid oxygen and addition of home ventilator supplies.

However, effective January 1, 2019, all CBP is suspended through CMS. During the anticipated 2-year gap, any Medicare-enrolled supplier will be able to provide items until new contracts are awarded. Pricing during the gap period is based on a current single price plus consumer price index. These changes will impact CHEST members and their patients moving forward. During the temporary gap period, some areas are seeing decreased accessibility of some DME due to demand. Once reinstated, the changes to the oxygen payment structure should improve access and reduce out-of-pocket costs. The Practice Operations NetWork will continue to provide updates on this topic as they become available.

Timothy Dempsey, MD, MPH
Steering Committee Fellow-in-Training

Megan Sisk, DO
Steering Committee Member

 

Transplant
Medicare Part D Plans Can Deny Coverage of Select Immunosuppressant Medications in Solid Organ Transplant Recipients
An alarming problem has emerged with some solid organ transplant recipients experiencing immunosuppressant medication claim denials by Medicare Part D plans. Affected patients are those who convert from some other insurance (ie, private insurance or state Medicaid) to Medicare after their transplant and, therefore, rely on Medicare Part D for immunosuppressant drug coverage.

Insurance companies who offer Medicare Part D plans must follow the rules described in the Medicare Prescription Drug Benefit Manual.1 Although the Manual mandates that all immunosuppressant medications are on plan formularies, Part D plans are only required to cover immunosuppressant medications when used for indications approved by the Food and Drug Administration (FDA) or for off-label indications supported by the Centers for Medicare & Medicaid Services (CMS)-approved compendia (Drugdex® and AHFS Drug Information®).

A recent study examining the extent of the problem demonstrated non-renal organ transplant recipients are frequently prescribed and maintained on at least one medication vulnerable to Medicare Part D claim denials at 1 year posttransplant (lung: 71.1%; intestine: 39.7%; pancreas: 36.8%; liver: 19.7%; heart: 18.5%).2 Lung transplant recipients are most vulnerable since no immunosuppressant is FDA-approved for use in lung transplantation, and CMS-approved compendia only support off-label use for tacrolimus and cyclosporine in this population. Therefore, mycophenolate mofetil, mycophenolic acid, azathioprine, everolimus, and sirolimus are vulnerable to denial by Medicare Part D plans when used in lung transplant recipients. Over 95% of lung transplant recipients are maintained on an anti-metabolite, with the majority (88%) maintained on mycophenolate, so this is frequently impacted.2,3 While the transplant community is aware of this issue and has begun work to correct it, it has yet to be solved.2,4 In the meantime, if transplant recipients have been denied for this off-label and off-compendia reason, and appeals of those decisions have also been denied, options for obtaining the denied immunosuppressant medication include discount programs, foundation/grant funding, and industry-sponsored assistance programs.

Jennifer K. McDermott, PharmD
NetWork Member

1. Prescription Drug Benefit Manual. Centers for Medicare & Medicaid Services. Chapter 6: Part D Drugs and Formulary Requirements. Available at: https://www.cms.gov/Medicare/Prescription-Drug-Coverage/PrescriptionDrugCovContra/Downloads/Part-D-Benefits-Manual-Chapter-6.pdf
2. Potter LM et al. Transplant recipients are vulnerable to coverage denial under Medicare Part D. Am J Transplant. 2018;18:1502.
3. Valapour M et al. OPTN/SRTR 2016 Annual Data Report: Lung. Am J Transplant. 2018;18 (Suppl 1): 363.
4. Immunusuppressant Drug Coverage Under Medicare Part D Benefit. American Society of Transplantation. Available at: www.myast.org/public-policy/key-position-statements/immunosuppressant-drug-coverage-under-medicare-part-d-benefit.

 

Women’s Health
Cannabis Use Affects Women Differently

As we enter an era of legalization, cannabis use is increasingly prevalent. Variances in the risks for women and men have been observed. For most age groups, men have higher rates of use or dependence on illicit drugs than women. However, women are equally likely as men to progress to a substance use disorder. Women may be more susceptible to craving and relapse , which are key phases of the addiction cycle. A study on use among adolescents concluded there was preliminary evidence of a faster transition from initiation of marijuana use to regular use in women, when compared with men (Schepis, et al. J Addict Med. 2011;5[1]:65).

Research studies suggest that marijuana impairs spatial memory in women more so than in men. Studies have suggested that teenage girls who use marijuana may have a higher risk of brain structural abnormalities associated with regular marijuana exposure than teenage boys (Tapert, et al. Addict Biol. 2009;14[4]:457).

A study published in Psychoneuroendocrinology showed that cannabinoid receptor binding site densities exhibit sex differences and can be modulated by estradiol in several limbic brain regions. These findings may account for the sex differences observed with respect to the effects of cannabinoids (Riebe, et al. Psychoneuroendocrinology. 2010;35[8]:1265).

Further research is needed to expand our understanding of the interactions between cannabinoids and sex steroids. Detoxification treatments tailored toward women and men with cannabis addiction show a promising future and necessitate further research.

Anita Rajagopal, MD
Steering Committee Member