Gynecology

If your ObGyn practices are anything like ours, every time there is news coverage of a study regarding mammography or about efforts to pass a breast density inform law, your phone rings with patient calls. In fact, every density inform law enacted in the United States, except for in Illinois, directs patients to their referring provider—generally their ObGyn—to discuss the screening and risk implications of dense breast tissue.

The steady increased awareness of breast density means that we, as ObGyns and other primary care providers (PCPs), have additional responsibilities in managing the breast health of our patients. This includes guiding discussions with patients about what breast density means and whether supplemental screening beyond mammography might be beneficial.

As members of the Medical Advisory Board for DenseBreast-info.org (an online educational resource dedicated to providing breast density information to patients and health care professionals), we are aware of the growing body of evidence demonstrating improved detection of early breast cancer using supplemental screening in dense breasts. However, we know that there is confusion among clinicians about how and when to facilitate tailored screening for women with dense breasts or other breast cancer risk factors. Here we answer 6 questions focusing on how to navigate patient discussions around the topic and the best way to collaborate with radiologists to improve breast care for patients.

Play an active role

1. What role should ObGyns and PCPs play in women’s breast health?

Elizabeth Etkin-Kramer, MD: I am a firm believer that ObGyns and all women’s health providers should be able to assess their patients’ risk of breast cancer and explain the process for managing this risk with their patients. This explanation includes the clinical implications of breast density and when supplemental screening should be employed. It is also important for providers to know when to offer genetic testing and when a patient’s personal or family history indicates supplemental screening with breast magnetic resonance imaging (MRI).

DaCarla M. Albright, MD: I absolutely agree that PCPs, ObGyns, and family practitioners should spend the time to be educated about breast density and supplemental screening options. While the exact role providers play in managing patients’ breast health may vary depending on the practice type or location, the need for knowledge and comfort when talking with patients to help them make informed decisions is critical. Breast health and screening, including the importance of breast density, happen to be a particular interest of mine. I have participated in educational webinars, invited lectures, and breast cancer awareness media events on this topic in the past.

Continue to: Join forces with imaging centers...

Join forces with imaging centers

2. How can ObGyns and radiologists collaborate most effectively to use screening results to personalize breast care for patients?

Dr. Etkin-Kramer: It is important to have a close relationship with the radiologists that read our patients’ mammograms. We need to be able to easily contact the radiologist and quickly get clarification on a patient’s report or discuss next steps. Imaging centers should consider running outreach programs to educate their referring providers on how to risk assess, with this assessment inclusive of breast density. Dinner lectures or grand round meetings are effective to facilitate communication between the radiology community and the ObGyn community. Finally, as we all know, supplemental screening is often subject to copays and deductibles per insurance coverage. If advocacy groups, who are working to eliminate these types of costs, cannot get insurers to waive these payments, we need a less expensive self-pay option.

Dr. Albright: I definitely have and encourage an open line of communication between my practice and breast radiology, as well as our breast surgeons and cancer center to set up consultations as needed. We also invite our radiologists as guests to monthly practice meetings or grand rounds within our department to further improve access and open communication, as this environment is one in which greater provider education on density and adjunctive screening can be achieved.

Know when to refer a high-risk patient

3. Most ObGyns routinely collect family history and perform formal risk assessment. What do you need to know about referring patients to a high-risk program?

Dr. Etkin-Kramer: It is important as ObGyns to be knowledgeable about breast and ovarian cancer risk assessment and genetic testing for cancer susceptibility genes. Our patients expect that of us. I am comfortable doing risk assessment in my office, but I sometimes refer to other specialists in the community if the patient needs additional counseling. For risk assessment, I look at family and personal history, breast density, and other factors that might lead me to believe the patient might carry a hereditary cancer susceptibility gene, including Ashkenazi Jewish ancestry.¹ When indicated, I check lifetime as well as short-term (5- to 10-year) risk, usually using Breast Cancer Surveillance Consortium (BCSC) or Tyrer-Cuzick/International Breast Cancer Intervention Study (IBIS) models, as these include breast density.

I discuss risk-reducing medications. The US Preventive Services Task Force recommends these agents if my patient’s 5-year risk of breast cancer is 1.67% or greater, and I strongly recommend chemoprevention when the patient’s 5-year BCSC risk exceeds 3%, provided likely benefits exceed risks.^2,3 I discuss adding screening breast MRI if lifetime risk by Tyrer-Cuzick exceeds 20%. (Note that Gail and BCSC models are not recommended to be used to determine risk for purposes of supplemental screening with MRI as they do not consider paternal family history nor age of relatives at diagnosis.)

Dr. Albright: ObGyns should be able to ascertain a pertinent history and identify patients at risk for breast cancer based on their personal history, family history, and breast imaging/biopsy history, if relevant. We also need to improve our discussions of supplemental screening for patients who have heterogeneously dense or extremely dense breast tissue. I sense that some ObGyns may rely heavily on the radiologist to suggest supplemental screening, but patients actually look to Ob­Gyns as their providers to have this knowledge and give them direction.

Since I practice at a large academic medical center, I have the opportunity to refer patients to our Breast Cancer Genetics Program because I may be limited on time for counseling in the office and do not want to miss salient details. With all of the information I have ascertained about the patient, I am able to determine and encourage appropriate screening and assure insurance coverage for adjunctive breast MRI when appropriate.

Continue to: Consider how you order patients’ screening to reduce barriers and cost...

4. How would you suggest reducing barriers when referring patients for supplemental screening, such as MRI for high-risk women or ultrasound for those with dense breasts? Would you prefer it if such screening could be performed without additional script/referral? How does insurance coverage factor in?

Dr. Etkin-Kramer: I would love for a screening mammogram with possible ultrasound, on one script, to be the norm. One of the centers that I work with accepts a script written this way. Further, when a patient receives screening at a freestanding facility as opposed to a hospital, the fee for the supplemental screening may be lower because they do not add on a facility fee.

Dr. Albright: We have an order in our electronic health record that allows for screening mammography but adds on diagnostic mammography/bilateral ultrasonography, if indicated by imaging. I am mostly ordering that option now for all of my screening patients; rarely have I had issues with insurance accepting that script. As for when ordering an MRI, I always try to ensure that I have done the patient’s personal risk assessment and included that lifetime breast cancer risk on the order. If the risk is 20% or higher, I typically do not have any insurance coverage issues. If I am ordering MRI as supplemental screening, I typically order the “Fast MRI” protocol that our center offers. This order incurs a $299 out-of-pocket cost for the patient. Any patient with heterogeneously or extremely dense breasts on mammography should have this option, but it requires patient education, discussion with the provider, and an additional cost. I definitely think that insurers need to consider covering supplemental screening, since breast density is reportable in a majority of the US states and will soon be the national standard.

Pearls for guiding patients

5. How do you discuss breast density and the need for supplemental screening with your patients?

Dr. Etkin-Kramer: I strongly feel that my patients need to know when a screening test has limited ability to do its job. This is the case with dense breasts. Visuals help; when discussing breast density, I like the images supplied by DenseBreast-info.org (FIGURE). I explain the two implications of dense tissue:

• First, dense tissue makes it harder to visualize cancers in the breast—the denser the breasts, the less likely the radiologist can pick up a cancer, so mammographic sensitivity for extremely dense breasts can be as low as 25% to 50%.
• Second, high breast density adds to the risk of developing breast cancer. I explain that supplemental screening will pick up additional cancers in women with dense breasts. For example, breast ultrasound will pick up about 2-3/1000 additional breast cancers per year and MRI or molecular breast imaging (MBI) will pick up much more, perhaps 10/1000.

MRI is more invasive than an ultrasound and uses gadolinium, and MBI has more radiation. Supplemental screening is not endorsed by ACOG’s most recent Committee Opinion from 2017; ⁴ however, patients may choose to have it done. This is where shared-decision making is important.

I strongly recommend that all women’s health care providers complete the CME course on the DenseBreast-info.org website. “ Breast Density: Why It Matters ” is a certified educational program for referring physicians that helps health care professionals learn about breast density, its associated risks, and how best to guide patients regarding breast cancer screening.

Continue to: Dr. Albright...

Dr. Albright: When I discuss breast density, I make sure that patients understand that their mammogram determines the density of their breast tissue. I review that in the higher density categories (heterogeneously dense or extremely dense), there is a higher risk of missing cancer, and that these categories are also associated with a higher risk of breast cancer. I also discuss the potential need for supplemental screening, for which my institution primarily offers Fast MRI. However, we can offer breast ultrasonography instead as an option, especially for those concerned about gadolinium exposure. Our center offers either of these supplemental screenings at a cost of $299. I also review the lack of coverage for supplemental screening by some insurance carriers, as both providers and patients may need to advocate for insurer coverage of adjunct studies.

Educational resources

6. What reference materials, illustrations, or other tools do you use to educate your patients?

Dr. Etkin-Kramer: I frequently use handouts printed from the DenseBreast-info.org website, and there is now a brand new patient fact sheet that I have just started using. I also have an example of breast density categories from fatty replaced to extremely dense on my computer, and I am putting it on a new smart board.

Dr. Albright: The extensive resources available at DenseBreast-info.org can improve both patient and provider knowledge of these important issues, so I suggest patients visit that website, and I use many of the images and visuals to help explain breast density. I even use the materials from the website for educating my resident trainees on breast health and screening. ●

If your ObGyn practices are anything like ours, every time there is news coverage of a study regarding mammography or about efforts to pass a breast density inform law, your phone rings with patient calls. In fact, every density inform law enacted in the United States, except for in Illinois, directs patients to their referring provider—generally their ObGyn—to discuss the screening and risk implications of dense breast tissue.

The steady increased awareness of breast density means that we, as ObGyns and other primary care providers (PCPs), have additional responsibilities in managing the breast health of our patients. This includes guiding discussions with patients about what breast density means and whether supplemental screening beyond mammography might be beneficial.

As members of the Medical Advisory Board for DenseBreast-info.org (an online educational resource dedicated to providing breast density information to patients and health care professionals), we are aware of the growing body of evidence demonstrating improved detection of early breast cancer using supplemental screening in dense breasts. However, we know that there is confusion among clinicians about how and when to facilitate tailored screening for women with dense breasts or other breast cancer risk factors. Here we answer 6 questions focusing on how to navigate patient discussions around the topic and the best way to collaborate with radiologists to improve breast care for patients.

Play an active role

1. What role should ObGyns and PCPs play in women’s breast health?

Elizabeth Etkin-Kramer, MD: I am a firm believer that ObGyns and all women’s health providers should be able to assess their patients’ risk of breast cancer and explain the process for managing this risk with their patients. This explanation includes the clinical implications of breast density and when supplemental screening should be employed. It is also important for providers to know when to offer genetic testing and when a patient’s personal or family history indicates supplemental screening with breast magnetic resonance imaging (MRI).

DaCarla M. Albright, MD: I absolutely agree that PCPs, ObGyns, and family practitioners should spend the time to be educated about breast density and supplemental screening options. While the exact role providers play in managing patients’ breast health may vary depending on the practice type or location, the need for knowledge and comfort when talking with patients to help them make informed decisions is critical. Breast health and screening, including the importance of breast density, happen to be a particular interest of mine. I have participated in educational webinars, invited lectures, and breast cancer awareness media events on this topic in the past.

Continue to: Join forces with imaging centers...

Join forces with imaging centers

2. How can ObGyns and radiologists collaborate most effectively to use screening results to personalize breast care for patients?

Dr. Etkin-Kramer: It is important to have a close relationship with the radiologists that read our patients’ mammograms. We need to be able to easily contact the radiologist and quickly get clarification on a patient’s report or discuss next steps. Imaging centers should consider running outreach programs to educate their referring providers on how to risk assess, with this assessment inclusive of breast density. Dinner lectures or grand round meetings are effective to facilitate communication between the radiology community and the ObGyn community. Finally, as we all know, supplemental screening is often subject to copays and deductibles per insurance coverage. If advocacy groups, who are working to eliminate these types of costs, cannot get insurers to waive these payments, we need a less expensive self-pay option.

Dr. Albright: I definitely have and encourage an open line of communication between my practice and breast radiology, as well as our breast surgeons and cancer center to set up consultations as needed. We also invite our radiologists as guests to monthly practice meetings or grand rounds within our department to further improve access and open communication, as this environment is one in which greater provider education on density and adjunctive screening can be achieved.

Know when to refer a high-risk patient

3. Most ObGyns routinely collect family history and perform formal risk assessment. What do you need to know about referring patients to a high-risk program?

Dr. Etkin-Kramer: It is important as ObGyns to be knowledgeable about breast and ovarian cancer risk assessment and genetic testing for cancer susceptibility genes. Our patients expect that of us. I am comfortable doing risk assessment in my office, but I sometimes refer to other specialists in the community if the patient needs additional counseling. For risk assessment, I look at family and personal history, breast density, and other factors that might lead me to believe the patient might carry a hereditary cancer susceptibility gene, including Ashkenazi Jewish ancestry.¹ When indicated, I check lifetime as well as short-term (5- to 10-year) risk, usually using Breast Cancer Surveillance Consortium (BCSC) or Tyrer-Cuzick/International Breast Cancer Intervention Study (IBIS) models, as these include breast density.

I discuss risk-reducing medications. The US Preventive Services Task Force recommends these agents if my patient’s 5-year risk of breast cancer is 1.67% or greater, and I strongly recommend chemoprevention when the patient’s 5-year BCSC risk exceeds 3%, provided likely benefits exceed risks.^2,3 I discuss adding screening breast MRI if lifetime risk by Tyrer-Cuzick exceeds 20%. (Note that Gail and BCSC models are not recommended to be used to determine risk for purposes of supplemental screening with MRI as they do not consider paternal family history nor age of relatives at diagnosis.)

Dr. Albright: ObGyns should be able to ascertain a pertinent history and identify patients at risk for breast cancer based on their personal history, family history, and breast imaging/biopsy history, if relevant. We also need to improve our discussions of supplemental screening for patients who have heterogeneously dense or extremely dense breast tissue. I sense that some ObGyns may rely heavily on the radiologist to suggest supplemental screening, but patients actually look to Ob­Gyns as their providers to have this knowledge and give them direction.

Since I practice at a large academic medical center, I have the opportunity to refer patients to our Breast Cancer Genetics Program because I may be limited on time for counseling in the office and do not want to miss salient details. With all of the information I have ascertained about the patient, I am able to determine and encourage appropriate screening and assure insurance coverage for adjunctive breast MRI when appropriate.

Continue to: Consider how you order patients’ screening to reduce barriers and cost...

4. How would you suggest reducing barriers when referring patients for supplemental screening, such as MRI for high-risk women or ultrasound for those with dense breasts? Would you prefer it if such screening could be performed without additional script/referral? How does insurance coverage factor in?

Dr. Etkin-Kramer: I would love for a screening mammogram with possible ultrasound, on one script, to be the norm. One of the centers that I work with accepts a script written this way. Further, when a patient receives screening at a freestanding facility as opposed to a hospital, the fee for the supplemental screening may be lower because they do not add on a facility fee.

Dr. Albright: We have an order in our electronic health record that allows for screening mammography but adds on diagnostic mammography/bilateral ultrasonography, if indicated by imaging. I am mostly ordering that option now for all of my screening patients; rarely have I had issues with insurance accepting that script. As for when ordering an MRI, I always try to ensure that I have done the patient’s personal risk assessment and included that lifetime breast cancer risk on the order. If the risk is 20% or higher, I typically do not have any insurance coverage issues. If I am ordering MRI as supplemental screening, I typically order the “Fast MRI” protocol that our center offers. This order incurs a $299 out-of-pocket cost for the patient. Any patient with heterogeneously or extremely dense breasts on mammography should have this option, but it requires patient education, discussion with the provider, and an additional cost. I definitely think that insurers need to consider covering supplemental screening, since breast density is reportable in a majority of the US states and will soon be the national standard.

Pearls for guiding patients

5. How do you discuss breast density and the need for supplemental screening with your patients?

Dr. Etkin-Kramer: I strongly feel that my patients need to know when a screening test has limited ability to do its job. This is the case with dense breasts. Visuals help; when discussing breast density, I like the images supplied by DenseBreast-info.org (FIGURE). I explain the two implications of dense tissue:

• First, dense tissue makes it harder to visualize cancers in the breast—the denser the breasts, the less likely the radiologist can pick up a cancer, so mammographic sensitivity for extremely dense breasts can be as low as 25% to 50%.
• Second, high breast density adds to the risk of developing breast cancer. I explain that supplemental screening will pick up additional cancers in women with dense breasts. For example, breast ultrasound will pick up about 2-3/1000 additional breast cancers per year and MRI or molecular breast imaging (MBI) will pick up much more, perhaps 10/1000.

MRI is more invasive than an ultrasound and uses gadolinium, and MBI has more radiation. Supplemental screening is not endorsed by ACOG’s most recent Committee Opinion from 2017; ⁴ however, patients may choose to have it done. This is where shared-decision making is important.

I strongly recommend that all women’s health care providers complete the CME course on the DenseBreast-info.org website. “ Breast Density: Why It Matters ” is a certified educational program for referring physicians that helps health care professionals learn about breast density, its associated risks, and how best to guide patients regarding breast cancer screening.

Continue to: Dr. Albright...

Dr. Albright: When I discuss breast density, I make sure that patients understand that their mammogram determines the density of their breast tissue. I review that in the higher density categories (heterogeneously dense or extremely dense), there is a higher risk of missing cancer, and that these categories are also associated with a higher risk of breast cancer. I also discuss the potential need for supplemental screening, for which my institution primarily offers Fast MRI. However, we can offer breast ultrasonography instead as an option, especially for those concerned about gadolinium exposure. Our center offers either of these supplemental screenings at a cost of $299. I also review the lack of coverage for supplemental screening by some insurance carriers, as both providers and patients may need to advocate for insurer coverage of adjunct studies.

Educational resources

6. What reference materials, illustrations, or other tools do you use to educate your patients?

Dr. Etkin-Kramer: I frequently use handouts printed from the DenseBreast-info.org website, and there is now a brand new patient fact sheet that I have just started using. I also have an example of breast density categories from fatty replaced to extremely dense on my computer, and I am putting it on a new smart board.

Dr. Albright: The extensive resources available at DenseBreast-info.org can improve both patient and provider knowledge of these important issues, so I suggest patients visit that website, and I use many of the images and visuals to help explain breast density. I even use the materials from the website for educating my resident trainees on breast health and screening. ●

If your ObGyn practices are anything like ours, every time there is news coverage of a study regarding mammography or about efforts to pass a breast density inform law, your phone rings with patient calls. In fact, every density inform law enacted in the United States, except for in Illinois, directs patients to their referring provider—generally their ObGyn—to discuss the screening and risk implications of dense breast tissue.

The steady increased awareness of breast density means that we, as ObGyns and other primary care providers (PCPs), have additional responsibilities in managing the breast health of our patients. This includes guiding discussions with patients about what breast density means and whether supplemental screening beyond mammography might be beneficial.

As members of the Medical Advisory Board for DenseBreast-info.org (an online educational resource dedicated to providing breast density information to patients and health care professionals), we are aware of the growing body of evidence demonstrating improved detection of early breast cancer using supplemental screening in dense breasts. However, we know that there is confusion among clinicians about how and when to facilitate tailored screening for women with dense breasts or other breast cancer risk factors. Here we answer 6 questions focusing on how to navigate patient discussions around the topic and the best way to collaborate with radiologists to improve breast care for patients.

Play an active role

1. What role should ObGyns and PCPs play in women’s breast health?

Elizabeth Etkin-Kramer, MD: I am a firm believer that ObGyns and all women’s health providers should be able to assess their patients’ risk of breast cancer and explain the process for managing this risk with their patients. This explanation includes the clinical implications of breast density and when supplemental screening should be employed. It is also important for providers to know when to offer genetic testing and when a patient’s personal or family history indicates supplemental screening with breast magnetic resonance imaging (MRI).

DaCarla M. Albright, MD: I absolutely agree that PCPs, ObGyns, and family practitioners should spend the time to be educated about breast density and supplemental screening options. While the exact role providers play in managing patients’ breast health may vary depending on the practice type or location, the need for knowledge and comfort when talking with patients to help them make informed decisions is critical. Breast health and screening, including the importance of breast density, happen to be a particular interest of mine. I have participated in educational webinars, invited lectures, and breast cancer awareness media events on this topic in the past.

Continue to: Join forces with imaging centers...

Join forces with imaging centers

2. How can ObGyns and radiologists collaborate most effectively to use screening results to personalize breast care for patients?

Dr. Etkin-Kramer: It is important to have a close relationship with the radiologists that read our patients’ mammograms. We need to be able to easily contact the radiologist and quickly get clarification on a patient’s report or discuss next steps. Imaging centers should consider running outreach programs to educate their referring providers on how to risk assess, with this assessment inclusive of breast density. Dinner lectures or grand round meetings are effective to facilitate communication between the radiology community and the ObGyn community. Finally, as we all know, supplemental screening is often subject to copays and deductibles per insurance coverage. If advocacy groups, who are working to eliminate these types of costs, cannot get insurers to waive these payments, we need a less expensive self-pay option.

Dr. Albright: I definitely have and encourage an open line of communication between my practice and breast radiology, as well as our breast surgeons and cancer center to set up consultations as needed. We also invite our radiologists as guests to monthly practice meetings or grand rounds within our department to further improve access and open communication, as this environment is one in which greater provider education on density and adjunctive screening can be achieved.

Know when to refer a high-risk patient

3. Most ObGyns routinely collect family history and perform formal risk assessment. What do you need to know about referring patients to a high-risk program?

Dr. Etkin-Kramer: It is important as ObGyns to be knowledgeable about breast and ovarian cancer risk assessment and genetic testing for cancer susceptibility genes. Our patients expect that of us. I am comfortable doing risk assessment in my office, but I sometimes refer to other specialists in the community if the patient needs additional counseling. For risk assessment, I look at family and personal history, breast density, and other factors that might lead me to believe the patient might carry a hereditary cancer susceptibility gene, including Ashkenazi Jewish ancestry.¹ When indicated, I check lifetime as well as short-term (5- to 10-year) risk, usually using Breast Cancer Surveillance Consortium (BCSC) or Tyrer-Cuzick/International Breast Cancer Intervention Study (IBIS) models, as these include breast density.

I discuss risk-reducing medications. The US Preventive Services Task Force recommends these agents if my patient’s 5-year risk of breast cancer is 1.67% or greater, and I strongly recommend chemoprevention when the patient’s 5-year BCSC risk exceeds 3%, provided likely benefits exceed risks.^2,3 I discuss adding screening breast MRI if lifetime risk by Tyrer-Cuzick exceeds 20%. (Note that Gail and BCSC models are not recommended to be used to determine risk for purposes of supplemental screening with MRI as they do not consider paternal family history nor age of relatives at diagnosis.)

Dr. Albright: ObGyns should be able to ascertain a pertinent history and identify patients at risk for breast cancer based on their personal history, family history, and breast imaging/biopsy history, if relevant. We also need to improve our discussions of supplemental screening for patients who have heterogeneously dense or extremely dense breast tissue. I sense that some ObGyns may rely heavily on the radiologist to suggest supplemental screening, but patients actually look to Ob­Gyns as their providers to have this knowledge and give them direction.

Since I practice at a large academic medical center, I have the opportunity to refer patients to our Breast Cancer Genetics Program because I may be limited on time for counseling in the office and do not want to miss salient details. With all of the information I have ascertained about the patient, I am able to determine and encourage appropriate screening and assure insurance coverage for adjunctive breast MRI when appropriate.

Continue to: Consider how you order patients’ screening to reduce barriers and cost...

4. How would you suggest reducing barriers when referring patients for supplemental screening, such as MRI for high-risk women or ultrasound for those with dense breasts? Would you prefer it if such screening could be performed without additional script/referral? How does insurance coverage factor in?

Dr. Etkin-Kramer: I would love for a screening mammogram with possible ultrasound, on one script, to be the norm. One of the centers that I work with accepts a script written this way. Further, when a patient receives screening at a freestanding facility as opposed to a hospital, the fee for the supplemental screening may be lower because they do not add on a facility fee.

Dr. Albright: We have an order in our electronic health record that allows for screening mammography but adds on diagnostic mammography/bilateral ultrasonography, if indicated by imaging. I am mostly ordering that option now for all of my screening patients; rarely have I had issues with insurance accepting that script. As for when ordering an MRI, I always try to ensure that I have done the patient’s personal risk assessment and included that lifetime breast cancer risk on the order. If the risk is 20% or higher, I typically do not have any insurance coverage issues. If I am ordering MRI as supplemental screening, I typically order the “Fast MRI” protocol that our center offers. This order incurs a $299 out-of-pocket cost for the patient. Any patient with heterogeneously or extremely dense breasts on mammography should have this option, but it requires patient education, discussion with the provider, and an additional cost. I definitely think that insurers need to consider covering supplemental screening, since breast density is reportable in a majority of the US states and will soon be the national standard.

Pearls for guiding patients

5. How do you discuss breast density and the need for supplemental screening with your patients?

Dr. Etkin-Kramer: I strongly feel that my patients need to know when a screening test has limited ability to do its job. This is the case with dense breasts. Visuals help; when discussing breast density, I like the images supplied by DenseBreast-info.org (FIGURE). I explain the two implications of dense tissue:

• First, dense tissue makes it harder to visualize cancers in the breast—the denser the breasts, the less likely the radiologist can pick up a cancer, so mammographic sensitivity for extremely dense breasts can be as low as 25% to 50%.
• Second, high breast density adds to the risk of developing breast cancer. I explain that supplemental screening will pick up additional cancers in women with dense breasts. For example, breast ultrasound will pick up about 2-3/1000 additional breast cancers per year and MRI or molecular breast imaging (MBI) will pick up much more, perhaps 10/1000.

MRI is more invasive than an ultrasound and uses gadolinium, and MBI has more radiation. Supplemental screening is not endorsed by ACOG’s most recent Committee Opinion from 2017; ⁴ however, patients may choose to have it done. This is where shared-decision making is important.

I strongly recommend that all women’s health care providers complete the CME course on the DenseBreast-info.org website. “ Breast Density: Why It Matters ” is a certified educational program for referring physicians that helps health care professionals learn about breast density, its associated risks, and how best to guide patients regarding breast cancer screening.

Continue to: Dr. Albright...

Dr. Albright: When I discuss breast density, I make sure that patients understand that their mammogram determines the density of their breast tissue. I review that in the higher density categories (heterogeneously dense or extremely dense), there is a higher risk of missing cancer, and that these categories are also associated with a higher risk of breast cancer. I also discuss the potential need for supplemental screening, for which my institution primarily offers Fast MRI. However, we can offer breast ultrasonography instead as an option, especially for those concerned about gadolinium exposure. Our center offers either of these supplemental screenings at a cost of $299. I also review the lack of coverage for supplemental screening by some insurance carriers, as both providers and patients may need to advocate for insurer coverage of adjunct studies.

Educational resources

6. What reference materials, illustrations, or other tools do you use to educate your patients?

Dr. Etkin-Kramer: I frequently use handouts printed from the DenseBreast-info.org website, and there is now a brand new patient fact sheet that I have just started using. I also have an example of breast density categories from fatty replaced to extremely dense on my computer, and I am putting it on a new smart board.

Dr. Albright: The extensive resources available at DenseBreast-info.org can improve both patient and provider knowledge of these important issues, so I suggest patients visit that website, and I use many of the images and visuals to help explain breast density. I even use the materials from the website for educating my resident trainees on breast health and screening. ●

During the April 2020 peak of patient admissions to our hospital caused by coronavirus disease 2019 (COVID-19), we severely limited the number of surgical procedures performed to conserve health system resources. During this stressful time, some administrators and physicians began categorizing operations for cancer as "elective" procedures that could be postponed for months. Personally, I think the use of elective to describe cancer surgery is not optimal, even during a pandemic. In reality, the surgeries for patients with cancer were being postponed to ensure that services were available for patients with severe and critical COVID-19 disease, not because the surgeries were "elective." The health system leaders were making the ra­tional decision to prioritize the needs of patients with COVID-19 infections over the needs of patients with cancer. However, they were using an inappropriate description of the rationale for postponing the surgery for patients with cancer—an intellectual short-cut.

This experience prompted me to explore all the medical interventions commonly described as elective. Surprisingly, among medical specialists, obstetricians excel in using the adjective elective to describe our important work. For example, in the medical record we commonly use terms such as “elective induction of labor,” “elective cesarean delivery” (CD) and “elective termination of pregnancy.” I believe it would advance our field if obstetricians stopped using the term elective to describe the important health services we provide.

Stop using the term “elective induction of labor”

Ghartey and Macones recently advocated for all obstetricians to stop using the term elective when describing induction of labor.¹ The ARRIVE trial (A Randomized Trial of Induction vs Expectant Management)² demonstrated that, among nulliparous women at 39 weeks’ gestation, induction of labor resulted in a lower CD rate than expectant management (18.6% vs 22.2%, respectively; relative risk, 0.84; 95% confidence interval [CI], 0.76-0.93). These findings indicate that induction of labor is not elective because it provides a clear health benefit over the alternative of expectant management. Given current expert guidance, induction of labor prior to 39 weeks’ gestation must be based on an accepted medical indication and provide a health benefit; hence, these inductions are medically indicated. Similarly, since induction of labor at 39 weeks’ gestation also provides a clear health benefit it is also medically indicated and not “elective.” Ghartey and Macones conclude¹:

"The words we choose to
describe medical interventions
matter. They send a message
to patients, physicians, nurses,
and hospital administrators.
When the term 'elective' is applied to a medical intervention,
it implies that it is not really
necessary. That is certainly not
the case when it comes to 39-
week nulliparous induction. The
ARRIVE trial provides grade A
(good and consistent) evidence
that labor induction provided
benefit with no harm to women
and their infants. These inductions are not 'elective'."

An alternative descriptor is “medically indicated” induction.

Continue to: Stop using the term “elective cesarean delivery”...

Stop using the term “elective cesarean delivery”

I recently searched PubMed for publications using the key words, “elective cesarean delivery,” and more than 7,000 publications were identified by the National Library of Medicine. “Elective cesarean delivery” is clearly an important term used by obstetrical authorities. What do we mean by elective CD?

At 39 weeks’ gestation, a low-risk nulliparous pregnant woman has a limited number of options:

1. induction of labor
2. expectant management awaiting the onset of labor
3. scheduled CD before the onset of labor.

For a low-risk pregnant woman at 39 weeks’ gestation, the American College of Obstetricians and Gynecologists recommends vaginal delivery because it best balances the risks and benefits for the woman and newborn.³ When a low-risk nulliparous pregnant woman asks a clinician about a scheduled CD, we are trained to thoroughly explore the reasons for the woman’s request, including her intellectual, fact-based, concerns about labor and vaginal birth and her emotional reaction to the thought of a vaginal or cesarean birth. In this situation the clinician will provide information about the risks and benefits of vaginal versus CD. In the vast majority of situations, the pregnant woman will agree to attempting vaginal delivery. In one study of 458,767 births, only 0.2% of women choose a “maternal request cesarean delivery.”⁴

After thorough counseling, if a woman and her clinician jointly agree to schedule a primary CD it will be the result of hours of intensive discussion, not an imprudent and hasty decision. In this case, the delivery is best characterized as a “maternal request cesarean delivery,” not an “elective” CD.

Stop using the terms “elective termination of pregnancy” and “elective abortion”

Janiak and Goldberg have advocated for the elimination of the phrase elective abortion.⁵ They write⁵:

"Support for abortion varies
depending on the reason for
the abortion—whether it is
'elective' or 'indicated.' In the
case of abortion, these terms
generally differentiate between
women seeking abortion for
reasons of maternal or fetal
health (an 'indicated abortion')
defined in contrast to women
seeking abortion for other
reasons (an 'elective abortion').
We argue that such a distinction is impossible to operationalize in a just manner. The use
of the phrase 'elective abortion'
promotes the institutionalization of a false hierarchy of need
among abortion patients."

My experience is that pregnant women never seek an abortion based on whimsy. Most pregnant women who consider an abortion struggle greatly with the choice, using reason and judgment to arrive at their final decision. The choice to seek an abortion is always a difficult one, influenced by a constellation of hard facts that impact the woman’s life. Using the term elective to describe an abortion implies a moral judgment and stigmatizes the choice to have an abortion. Janiak and Goldberg conclude by recommending the elimination of the phrase 'elective abortion' in favor of the phrase “induced abortion.”⁵

Continue to: Time for change...

Time for change

Shockingly, in searching the International Statistical Classification of Diseases and Related Health Problems, 10th revision (ICD10), the word elective is most commonly used in the context of health services provided to pregnant women, including: elective induction of labor (Z34.90), elective cesarean delivery (O82), elective termination of pregnancy (Z33.2), and elective fetal reduction (Z031.30X0). In ICD10, other specialties do not describe the scope of their health services with the adjective elective.

There are many definitions and interpretations of elective. The most benign use of the word in the context of surgery is to contrast procedures that can be scheduled in the future with those that need to be performed urgently. In this context elective only refers to the timing, not the medical necessity, of the procedure. By contrast, describing a procedure as elective may signal that it is not medically necessary and is being performed based on the capricious preference of the patient or physician. Given the confusion and misunderstanding that may be caused by describing our important health services as “elective,” I hope that we can permanently sunset use of the term. ●

During the April 2020 peak of patient admissions to our hospital caused by coronavirus disease 2019 (COVID-19), we severely limited the number of surgical procedures performed to conserve health system resources. During this stressful time, some administrators and physicians began categorizing operations for cancer as "elective" procedures that could be postponed for months. Personally, I think the use of elective to describe cancer surgery is not optimal, even during a pandemic. In reality, the surgeries for patients with cancer were being postponed to ensure that services were available for patients with severe and critical COVID-19 disease, not because the surgeries were "elective." The health system leaders were making the ra­tional decision to prioritize the needs of patients with COVID-19 infections over the needs of patients with cancer. However, they were using an inappropriate description of the rationale for postponing the surgery for patients with cancer—an intellectual short-cut.

This experience prompted me to explore all the medical interventions commonly described as elective. Surprisingly, among medical specialists, obstetricians excel in using the adjective elective to describe our important work. For example, in the medical record we commonly use terms such as “elective induction of labor,” “elective cesarean delivery” (CD) and “elective termination of pregnancy.” I believe it would advance our field if obstetricians stopped using the term elective to describe the important health services we provide.

Stop using the term “elective induction of labor”

Ghartey and Macones recently advocated for all obstetricians to stop using the term elective when describing induction of labor.¹ The ARRIVE trial (A Randomized Trial of Induction vs Expectant Management)² demonstrated that, among nulliparous women at 39 weeks’ gestation, induction of labor resulted in a lower CD rate than expectant management (18.6% vs 22.2%, respectively; relative risk, 0.84; 95% confidence interval [CI], 0.76-0.93). These findings indicate that induction of labor is not elective because it provides a clear health benefit over the alternative of expectant management. Given current expert guidance, induction of labor prior to 39 weeks’ gestation must be based on an accepted medical indication and provide a health benefit; hence, these inductions are medically indicated. Similarly, since induction of labor at 39 weeks’ gestation also provides a clear health benefit it is also medically indicated and not “elective.” Ghartey and Macones conclude¹:

"The words we choose to
describe medical interventions
matter. They send a message
to patients, physicians, nurses,
and hospital administrators.
When the term 'elective' is applied to a medical intervention,
it implies that it is not really
necessary. That is certainly not
the case when it comes to 39-
week nulliparous induction. The
ARRIVE trial provides grade A
(good and consistent) evidence
that labor induction provided
benefit with no harm to women
and their infants. These inductions are not 'elective'."

An alternative descriptor is “medically indicated” induction.

Continue to: Stop using the term “elective cesarean delivery”...

Stop using the term “elective cesarean delivery”

I recently searched PubMed for publications using the key words, “elective cesarean delivery,” and more than 7,000 publications were identified by the National Library of Medicine. “Elective cesarean delivery” is clearly an important term used by obstetrical authorities. What do we mean by elective CD?

At 39 weeks’ gestation, a low-risk nulliparous pregnant woman has a limited number of options:

1. induction of labor
2. expectant management awaiting the onset of labor
3. scheduled CD before the onset of labor.

For a low-risk pregnant woman at 39 weeks’ gestation, the American College of Obstetricians and Gynecologists recommends vaginal delivery because it best balances the risks and benefits for the woman and newborn.³ When a low-risk nulliparous pregnant woman asks a clinician about a scheduled CD, we are trained to thoroughly explore the reasons for the woman’s request, including her intellectual, fact-based, concerns about labor and vaginal birth and her emotional reaction to the thought of a vaginal or cesarean birth. In this situation the clinician will provide information about the risks and benefits of vaginal versus CD. In the vast majority of situations, the pregnant woman will agree to attempting vaginal delivery. In one study of 458,767 births, only 0.2% of women choose a “maternal request cesarean delivery.”⁴

After thorough counseling, if a woman and her clinician jointly agree to schedule a primary CD it will be the result of hours of intensive discussion, not an imprudent and hasty decision. In this case, the delivery is best characterized as a “maternal request cesarean delivery,” not an “elective” CD.

Stop using the terms “elective termination of pregnancy” and “elective abortion”

Janiak and Goldberg have advocated for the elimination of the phrase elective abortion.⁵ They write⁵:

"Support for abortion varies
depending on the reason for
the abortion—whether it is
'elective' or 'indicated.' In the
case of abortion, these terms
generally differentiate between
women seeking abortion for
reasons of maternal or fetal
health (an 'indicated abortion')
defined in contrast to women
seeking abortion for other
reasons (an 'elective abortion').
We argue that such a distinction is impossible to operationalize in a just manner. The use
of the phrase 'elective abortion'
promotes the institutionalization of a false hierarchy of need
among abortion patients."

My experience is that pregnant women never seek an abortion based on whimsy. Most pregnant women who consider an abortion struggle greatly with the choice, using reason and judgment to arrive at their final decision. The choice to seek an abortion is always a difficult one, influenced by a constellation of hard facts that impact the woman’s life. Using the term elective to describe an abortion implies a moral judgment and stigmatizes the choice to have an abortion. Janiak and Goldberg conclude by recommending the elimination of the phrase 'elective abortion' in favor of the phrase “induced abortion.”⁵

Continue to: Time for change...

Time for change

Shockingly, in searching the International Statistical Classification of Diseases and Related Health Problems, 10th revision (ICD10), the word elective is most commonly used in the context of health services provided to pregnant women, including: elective induction of labor (Z34.90), elective cesarean delivery (O82), elective termination of pregnancy (Z33.2), and elective fetal reduction (Z031.30X0). In ICD10, other specialties do not describe the scope of their health services with the adjective elective.

There are many definitions and interpretations of elective. The most benign use of the word in the context of surgery is to contrast procedures that can be scheduled in the future with those that need to be performed urgently. In this context elective only refers to the timing, not the medical necessity, of the procedure. By contrast, describing a procedure as elective may signal that it is not medically necessary and is being performed based on the capricious preference of the patient or physician. Given the confusion and misunderstanding that may be caused by describing our important health services as “elective,” I hope that we can permanently sunset use of the term. ●

During the April 2020 peak of patient admissions to our hospital caused by coronavirus disease 2019 (COVID-19), we severely limited the number of surgical procedures performed to conserve health system resources. During this stressful time, some administrators and physicians began categorizing operations for cancer as "elective" procedures that could be postponed for months. Personally, I think the use of elective to describe cancer surgery is not optimal, even during a pandemic. In reality, the surgeries for patients with cancer were being postponed to ensure that services were available for patients with severe and critical COVID-19 disease, not because the surgeries were "elective." The health system leaders were making the ra­tional decision to prioritize the needs of patients with COVID-19 infections over the needs of patients with cancer. However, they were using an inappropriate description of the rationale for postponing the surgery for patients with cancer—an intellectual short-cut.

This experience prompted me to explore all the medical interventions commonly described as elective. Surprisingly, among medical specialists, obstetricians excel in using the adjective elective to describe our important work. For example, in the medical record we commonly use terms such as “elective induction of labor,” “elective cesarean delivery” (CD) and “elective termination of pregnancy.” I believe it would advance our field if obstetricians stopped using the term elective to describe the important health services we provide.

Stop using the term “elective induction of labor”

Ghartey and Macones recently advocated for all obstetricians to stop using the term elective when describing induction of labor.¹ The ARRIVE trial (A Randomized Trial of Induction vs Expectant Management)² demonstrated that, among nulliparous women at 39 weeks’ gestation, induction of labor resulted in a lower CD rate than expectant management (18.6% vs 22.2%, respectively; relative risk, 0.84; 95% confidence interval [CI], 0.76-0.93). These findings indicate that induction of labor is not elective because it provides a clear health benefit over the alternative of expectant management. Given current expert guidance, induction of labor prior to 39 weeks’ gestation must be based on an accepted medical indication and provide a health benefit; hence, these inductions are medically indicated. Similarly, since induction of labor at 39 weeks’ gestation also provides a clear health benefit it is also medically indicated and not “elective.” Ghartey and Macones conclude¹:

"The words we choose to
describe medical interventions
matter. They send a message
to patients, physicians, nurses,
and hospital administrators.
When the term 'elective' is applied to a medical intervention,
it implies that it is not really
necessary. That is certainly not
the case when it comes to 39-
week nulliparous induction. The
ARRIVE trial provides grade A
(good and consistent) evidence
that labor induction provided
benefit with no harm to women
and their infants. These inductions are not 'elective'."

An alternative descriptor is “medically indicated” induction.

Continue to: Stop using the term “elective cesarean delivery”...

Stop using the term “elective cesarean delivery”

I recently searched PubMed for publications using the key words, “elective cesarean delivery,” and more than 7,000 publications were identified by the National Library of Medicine. “Elective cesarean delivery” is clearly an important term used by obstetrical authorities. What do we mean by elective CD?

At 39 weeks’ gestation, a low-risk nulliparous pregnant woman has a limited number of options:

1. induction of labor
2. expectant management awaiting the onset of labor
3. scheduled CD before the onset of labor.

For a low-risk pregnant woman at 39 weeks’ gestation, the American College of Obstetricians and Gynecologists recommends vaginal delivery because it best balances the risks and benefits for the woman and newborn.³ When a low-risk nulliparous pregnant woman asks a clinician about a scheduled CD, we are trained to thoroughly explore the reasons for the woman’s request, including her intellectual, fact-based, concerns about labor and vaginal birth and her emotional reaction to the thought of a vaginal or cesarean birth. In this situation the clinician will provide information about the risks and benefits of vaginal versus CD. In the vast majority of situations, the pregnant woman will agree to attempting vaginal delivery. In one study of 458,767 births, only 0.2% of women choose a “maternal request cesarean delivery.”⁴

After thorough counseling, if a woman and her clinician jointly agree to schedule a primary CD it will be the result of hours of intensive discussion, not an imprudent and hasty decision. In this case, the delivery is best characterized as a “maternal request cesarean delivery,” not an “elective” CD.

Stop using the terms “elective termination of pregnancy” and “elective abortion”

Janiak and Goldberg have advocated for the elimination of the phrase elective abortion.⁵ They write⁵:

"Support for abortion varies
depending on the reason for
the abortion—whether it is
'elective' or 'indicated.' In the
case of abortion, these terms
generally differentiate between
women seeking abortion for
reasons of maternal or fetal
health (an 'indicated abortion')
defined in contrast to women
seeking abortion for other
reasons (an 'elective abortion').
We argue that such a distinction is impossible to operationalize in a just manner. The use
of the phrase 'elective abortion'
promotes the institutionalization of a false hierarchy of need
among abortion patients."

My experience is that pregnant women never seek an abortion based on whimsy. Most pregnant women who consider an abortion struggle greatly with the choice, using reason and judgment to arrive at their final decision. The choice to seek an abortion is always a difficult one, influenced by a constellation of hard facts that impact the woman’s life. Using the term elective to describe an abortion implies a moral judgment and stigmatizes the choice to have an abortion. Janiak and Goldberg conclude by recommending the elimination of the phrase 'elective abortion' in favor of the phrase “induced abortion.”⁵

Continue to: Time for change...

Time for change

Shockingly, in searching the International Statistical Classification of Diseases and Related Health Problems, 10th revision (ICD10), the word elective is most commonly used in the context of health services provided to pregnant women, including: elective induction of labor (Z34.90), elective cesarean delivery (O82), elective termination of pregnancy (Z33.2), and elective fetal reduction (Z031.30X0). In ICD10, other specialties do not describe the scope of their health services with the adjective elective.

There are many definitions and interpretations of elective. The most benign use of the word in the context of surgery is to contrast procedures that can be scheduled in the future with those that need to be performed urgently. In this context elective only refers to the timing, not the medical necessity, of the procedure. By contrast, describing a procedure as elective may signal that it is not medically necessary and is being performed based on the capricious preference of the patient or physician. Given the confusion and misunderstanding that may be caused by describing our important health services as “elective,” I hope that we can permanently sunset use of the term. ●

A new group of nonhormonal drugs currently in clinical trials shows strong promise for treating menopausal hot flashes as effectively as hormones, researchers told attendees at the virtual North American Menopause Society 2020 Annual Meeting.

“The KNDy [kisspeptin/neurokinin B/dynorphin] neuron manipulation is really exciting and holds great promise for rapid and highly effective amelioration of hot flashes, up to 80%, and improvement in other menopausal symptoms, though we’re still looking at the safety in phase 3 trials,” reported Susan D. Reed, MD, MPH, director of the Women’s Reproductive Health Research Program at the University of Washington, Seattle.

“If we continue to see good safety data, these are going to be the greatest things since sliced bread,” Dr. Reed said in an interview. “I don’t think we’ve seen anything like this in menopause therapeutics in a long time.”

While several nonhormonal drugs are already used to treat vasomotor symptoms in menopausal women with and without breast cancer, none are as effective as hormone treatments.

“For now, the SSRIs, SNRIs [serotonin norepinephrine reuptake inhibitors], and GABAergics are the best frontline nonhormonal options with a moderate effect, and clonidine and oxybutynin are effective, but we see more side effects with these,” Dr. Reed said. She noted the importance of considering patients’ mood, sleep, pain, sexual function, weight gain, overactive bladder, blood pressure, and individual quality of life (QOL) goals in tailoring those therapies.

But women still need more nonhormonal options that are at least as effective as hormonal options, Dr. Reed said. Some women are unable to take hormonal options because they are at risk for blood clots or breast cancer.

“Then there’s preference,” she said. “Sometimes people don’t like the way they feel when they take hormones, or they just don’t want hormones in their body. It’s absolutely critical to have these options available for women.”

Nanette F. Santoro, MD, a professor of ob.gyn. at the University of Colorado at Denver, Aurora, who was not involved in the presentation, said in an interview that physicians may not always realize the extent to which vasomotor symptoms interfere with women’s daily lives.

“They have an eroding effect on QOL that is not appreciated sometimes,” she said. Though hot flashes eventually subside in most women, others may continue to experience them into their 70s, when hormonal therapies can begin causing more harm than benefit.

“It goes underappreciated that, for a proportion of women, hot flashes will never go away, and they’re just as bad [as] when they were in their 50s,” Dr. Santoro said. “They need to be treated, and the nonhormonal treatments do not work for everybody.”
 

Promising KNDy therapeutics

Autopsy studies of postmenopausal women revealed that a complex of neurons in the hypothalamus was “massively hypertrophied” and sits right next to the thermoregulatory center of the brain, Dr. Reed explained.

The complex produces three types of molecules: kisspeptin (a neuropeptide), neurokinin B (a neuropeptide), and dynorphin (a kappa opioid), collectively referred to as the KNDy. The KNDy neural complex is located in the same place as the majority of hormone receptors in the arcuate nucleus, a collection of nerve cells in the hypothalamus.

The current hypothesis is that the KNDy neurons, which communicate with each other, become hyperactivated and cause hot flashes by spilling over to and triggering the thermoregulatory center next door. NKB (kisspeptin and neurokinin B) agonists activate KNDy neurons and dynorphin agonists inactivate KNDy, so the expectation is that NKB antagonists or dynorphin agonists would stop hot flashes.

Indeed, research published in 2015 showed that women taking kappa agonists experienced fewer hot flashes than women in the placebo group. However, no peripherally restricted kappa agonists are currently in clinical trials, so their future as therapeutics is unclear.

Right now, three different NK antagonists are in the pipeline for reducing vasomotor symptoms: MLE 4901 (pavinetant) and ESN364 (fezolinetant) are both NK3R antagonists, and NT-814 is a dual NK1R/NK3R antagonist. All three of these drugs were originally developed to treat schizophrenia.

Phase 2 clinical trials of pavinetant were discontinued in November 2017 by Millendo Therapeutics because 3 of 28 women experienced abnormal liver function, which normalized within 90 days. However, the study had shown an 80% decrease in hot flashes in women taking pavinetant, compared with a 30% decrease in the placebo group.

Fezolinetant, currently in phase 3 trials with Astellas, showed a dose response effect on reproductive hormones in phase 1 studies and a short half-life (4-6 hours) in women. It also showed no concerning side effects.

“There was, in fact, a decrease in the endometrial thickness, a delayed or impeded ovulation and a prolonged cycle duration,” Reed said.

The subsequent phase 2a study showed a reduction of five hot flashes a day (93% decrease), compared with placebo (54% decrease, P <.001) “with an abrupt return to baseline hot flash frequency after cessation,” she said. Improvements also occurred in sleep quality, quality of life, disability, and interference of hot flashes in daily life.

The phase 2b study found no difference in effects between once-daily versus twice-daily doses. However, two severe adverse events occurred: a drug-induced liver injury in one woman and cholelithiasis in another, both on the 60-mg, once-daily dose. Additionally, five women on varying doses had transient increases (above 1000 U/L) in creatinine kinase, though apparently without dose response.

A 52-week, three-arm, phase 3 trial of fezolinetant is currently under way with a goal of enrolling 1,740 participants, and plans to be completed by December 2021. Participants will undergo regular adverse event screening first biweekly, then monthly, with vital signs, blood, and urine monitoring.

Meanwhile, NT-814 from KaNDy Therapeutics, has completed phase 2a and phase 2b trials with phase 3 slated to begin in 2021. Adverse events in phase 1 included sleepiness and headache, and it had a long half-life (about 26 hours) and rapid absorption (an hour).

The phase 2a trial found a reduction of five hot flashes a day, compared with placebo, with main side effects again being sleepiness and headache. No events of abnormal liver function occurred. Phase 2b results have not been published.

So far, existing research suggests that KNDy interventions will involve a single daily oral dose that begins taking effect within 3 days and is fully in effect within 1-2 weeks. The reduction in hot flashes, about five fewer a day, is more effective than any other currently used nonhormonal medications for vasomotor symptoms. SSRIs and SNRIs tend to result in 1.5-2 fewer hot flashes a day, and gabapentin results in about 3 fewer per day. It will take longer-term studies, however, and paying attention to liver concerns for the NK3R antagonists to move into clinic.

“We want to keep our eye on the [luteinizing hormone] because if it decreases too much, it could adversely affect sexual function, and this does appear to be a dose-response finding,” Dr. Reed said. It would also be ideal, she said, to target only the KNDy neurons with NK3 antagonists without effects on the NK3 receptors in the liver.
 

Other nonhormonal options

Oxybutynin is another a nonhormonal agent under investigation for vasomotor symptoms. It’s an anticholinergic that resulted in 80% fewer hot flashes, compared with 30% with placebo in a 2016 trial, but 52% of women complained of dry mouth. A more recent study similarly found high efficacy – a 60%-80% drop in hot flashes, compared with 30% with placebo – but also side effects of dry mouth, difficulty urinating, and abdominal pain.

Finally, Dr. Reed mentioned three other agents under investigation as possible nonhormonal therapeutics, though she has little information about them. They include MT-8554 by Mitsubishi Tanabe; FP-101 by Fervent Pharmaceuticals; and Q-122 by QUE Oncology with Emory University, Atlanta, and the University of Queensland, Brisbane, Australia. 

None of the currently available nonhormonal options provide as high efficacy as hormones, but they do reduce symptoms:

Clonidine is an off-label option some physicians already use as a nonhormonal treatment for vasomotor symptoms, but again, the side effects are problematic: dry mouth, constipation, drowsiness, postural hypotension, and poor sleep.

Paroxetine, at 7.5-10 mg, is the only FDA-approved nonhormonal treatment for vasomotor symptoms, but she listed other off-label options found effective in evidence reviews: gabapentin (100-2,400 mg), venlafaxine (37.5-75 mg), citalopram (10 mg), desvenlafaxine (150 mg), and escitalopram (10 mg).

“I want you to take note of the lower doses in all of these products that are efficacious above those doses that might be used for mood,” Dr. Reed added.

Dr. Reed receives royalties from UpToDate and research funding from Bayer. Dr. Santoro owns stock in MenoGeniX and serves as a consultant or advisor to Ansh Labs, MenoGeniX, and Ogeda/Astellas.

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

A new group of nonhormonal drugs currently in clinical trials shows strong promise for treating menopausal hot flashes as effectively as hormones, researchers told attendees at the virtual North American Menopause Society 2020 Annual Meeting.

“The KNDy [kisspeptin/neurokinin B/dynorphin] neuron manipulation is really exciting and holds great promise for rapid and highly effective amelioration of hot flashes, up to 80%, and improvement in other menopausal symptoms, though we’re still looking at the safety in phase 3 trials,” reported Susan D. Reed, MD, MPH, director of the Women’s Reproductive Health Research Program at the University of Washington, Seattle.

“If we continue to see good safety data, these are going to be the greatest things since sliced bread,” Dr. Reed said in an interview. “I don’t think we’ve seen anything like this in menopause therapeutics in a long time.”

While several nonhormonal drugs are already used to treat vasomotor symptoms in menopausal women with and without breast cancer, none are as effective as hormone treatments.

“For now, the SSRIs, SNRIs [serotonin norepinephrine reuptake inhibitors], and GABAergics are the best frontline nonhormonal options with a moderate effect, and clonidine and oxybutynin are effective, but we see more side effects with these,” Dr. Reed said. She noted the importance of considering patients’ mood, sleep, pain, sexual function, weight gain, overactive bladder, blood pressure, and individual quality of life (QOL) goals in tailoring those therapies.

But women still need more nonhormonal options that are at least as effective as hormonal options, Dr. Reed said. Some women are unable to take hormonal options because they are at risk for blood clots or breast cancer.

“Then there’s preference,” she said. “Sometimes people don’t like the way they feel when they take hormones, or they just don’t want hormones in their body. It’s absolutely critical to have these options available for women.”

Nanette F. Santoro, MD, a professor of ob.gyn. at the University of Colorado at Denver, Aurora, who was not involved in the presentation, said in an interview that physicians may not always realize the extent to which vasomotor symptoms interfere with women’s daily lives.

“They have an eroding effect on QOL that is not appreciated sometimes,” she said. Though hot flashes eventually subside in most women, others may continue to experience them into their 70s, when hormonal therapies can begin causing more harm than benefit.

“It goes underappreciated that, for a proportion of women, hot flashes will never go away, and they’re just as bad [as] when they were in their 50s,” Dr. Santoro said. “They need to be treated, and the nonhormonal treatments do not work for everybody.”
 

Promising KNDy therapeutics

Autopsy studies of postmenopausal women revealed that a complex of neurons in the hypothalamus was “massively hypertrophied” and sits right next to the thermoregulatory center of the brain, Dr. Reed explained.

The complex produces three types of molecules: kisspeptin (a neuropeptide), neurokinin B (a neuropeptide), and dynorphin (a kappa opioid), collectively referred to as the KNDy. The KNDy neural complex is located in the same place as the majority of hormone receptors in the arcuate nucleus, a collection of nerve cells in the hypothalamus.

The current hypothesis is that the KNDy neurons, which communicate with each other, become hyperactivated and cause hot flashes by spilling over to and triggering the thermoregulatory center next door. NKB (kisspeptin and neurokinin B) agonists activate KNDy neurons and dynorphin agonists inactivate KNDy, so the expectation is that NKB antagonists or dynorphin agonists would stop hot flashes.

Indeed, research published in 2015 showed that women taking kappa agonists experienced fewer hot flashes than women in the placebo group. However, no peripherally restricted kappa agonists are currently in clinical trials, so their future as therapeutics is unclear.

Right now, three different NK antagonists are in the pipeline for reducing vasomotor symptoms: MLE 4901 (pavinetant) and ESN364 (fezolinetant) are both NK3R antagonists, and NT-814 is a dual NK1R/NK3R antagonist. All three of these drugs were originally developed to treat schizophrenia.

Phase 2 clinical trials of pavinetant were discontinued in November 2017 by Millendo Therapeutics because 3 of 28 women experienced abnormal liver function, which normalized within 90 days. However, the study had shown an 80% decrease in hot flashes in women taking pavinetant, compared with a 30% decrease in the placebo group.

Fezolinetant, currently in phase 3 trials with Astellas, showed a dose response effect on reproductive hormones in phase 1 studies and a short half-life (4-6 hours) in women. It also showed no concerning side effects.

“There was, in fact, a decrease in the endometrial thickness, a delayed or impeded ovulation and a prolonged cycle duration,” Reed said.

The subsequent phase 2a study showed a reduction of five hot flashes a day (93% decrease), compared with placebo (54% decrease, P <.001) “with an abrupt return to baseline hot flash frequency after cessation,” she said. Improvements also occurred in sleep quality, quality of life, disability, and interference of hot flashes in daily life.

The phase 2b study found no difference in effects between once-daily versus twice-daily doses. However, two severe adverse events occurred: a drug-induced liver injury in one woman and cholelithiasis in another, both on the 60-mg, once-daily dose. Additionally, five women on varying doses had transient increases (above 1000 U/L) in creatinine kinase, though apparently without dose response.

A 52-week, three-arm, phase 3 trial of fezolinetant is currently under way with a goal of enrolling 1,740 participants, and plans to be completed by December 2021. Participants will undergo regular adverse event screening first biweekly, then monthly, with vital signs, blood, and urine monitoring.

Meanwhile, NT-814 from KaNDy Therapeutics, has completed phase 2a and phase 2b trials with phase 3 slated to begin in 2021. Adverse events in phase 1 included sleepiness and headache, and it had a long half-life (about 26 hours) and rapid absorption (an hour).

The phase 2a trial found a reduction of five hot flashes a day, compared with placebo, with main side effects again being sleepiness and headache. No events of abnormal liver function occurred. Phase 2b results have not been published.

So far, existing research suggests that KNDy interventions will involve a single daily oral dose that begins taking effect within 3 days and is fully in effect within 1-2 weeks. The reduction in hot flashes, about five fewer a day, is more effective than any other currently used nonhormonal medications for vasomotor symptoms. SSRIs and SNRIs tend to result in 1.5-2 fewer hot flashes a day, and gabapentin results in about 3 fewer per day. It will take longer-term studies, however, and paying attention to liver concerns for the NK3R antagonists to move into clinic.

“We want to keep our eye on the [luteinizing hormone] because if it decreases too much, it could adversely affect sexual function, and this does appear to be a dose-response finding,” Dr. Reed said. It would also be ideal, she said, to target only the KNDy neurons with NK3 antagonists without effects on the NK3 receptors in the liver.
 

Other nonhormonal options

Oxybutynin is another a nonhormonal agent under investigation for vasomotor symptoms. It’s an anticholinergic that resulted in 80% fewer hot flashes, compared with 30% with placebo in a 2016 trial, but 52% of women complained of dry mouth. A more recent study similarly found high efficacy – a 60%-80% drop in hot flashes, compared with 30% with placebo – but also side effects of dry mouth, difficulty urinating, and abdominal pain.

Finally, Dr. Reed mentioned three other agents under investigation as possible nonhormonal therapeutics, though she has little information about them. They include MT-8554 by Mitsubishi Tanabe; FP-101 by Fervent Pharmaceuticals; and Q-122 by QUE Oncology with Emory University, Atlanta, and the University of Queensland, Brisbane, Australia. 

None of the currently available nonhormonal options provide as high efficacy as hormones, but they do reduce symptoms:

Clonidine is an off-label option some physicians already use as a nonhormonal treatment for vasomotor symptoms, but again, the side effects are problematic: dry mouth, constipation, drowsiness, postural hypotension, and poor sleep.

Paroxetine, at 7.5-10 mg, is the only FDA-approved nonhormonal treatment for vasomotor symptoms, but she listed other off-label options found effective in evidence reviews: gabapentin (100-2,400 mg), venlafaxine (37.5-75 mg), citalopram (10 mg), desvenlafaxine (150 mg), and escitalopram (10 mg).

“I want you to take note of the lower doses in all of these products that are efficacious above those doses that might be used for mood,” Dr. Reed added.

Dr. Reed receives royalties from UpToDate and research funding from Bayer. Dr. Santoro owns stock in MenoGeniX and serves as a consultant or advisor to Ansh Labs, MenoGeniX, and Ogeda/Astellas.

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

A new group of nonhormonal drugs currently in clinical trials shows strong promise for treating menopausal hot flashes as effectively as hormones, researchers told attendees at the virtual North American Menopause Society 2020 Annual Meeting.

“The KNDy [kisspeptin/neurokinin B/dynorphin] neuron manipulation is really exciting and holds great promise for rapid and highly effective amelioration of hot flashes, up to 80%, and improvement in other menopausal symptoms, though we’re still looking at the safety in phase 3 trials,” reported Susan D. Reed, MD, MPH, director of the Women’s Reproductive Health Research Program at the University of Washington, Seattle.

“If we continue to see good safety data, these are going to be the greatest things since sliced bread,” Dr. Reed said in an interview. “I don’t think we’ve seen anything like this in menopause therapeutics in a long time.”

While several nonhormonal drugs are already used to treat vasomotor symptoms in menopausal women with and without breast cancer, none are as effective as hormone treatments.

“For now, the SSRIs, SNRIs [serotonin norepinephrine reuptake inhibitors], and GABAergics are the best frontline nonhormonal options with a moderate effect, and clonidine and oxybutynin are effective, but we see more side effects with these,” Dr. Reed said. She noted the importance of considering patients’ mood, sleep, pain, sexual function, weight gain, overactive bladder, blood pressure, and individual quality of life (QOL) goals in tailoring those therapies.

But women still need more nonhormonal options that are at least as effective as hormonal options, Dr. Reed said. Some women are unable to take hormonal options because they are at risk for blood clots or breast cancer.

“Then there’s preference,” she said. “Sometimes people don’t like the way they feel when they take hormones, or they just don’t want hormones in their body. It’s absolutely critical to have these options available for women.”

Nanette F. Santoro, MD, a professor of ob.gyn. at the University of Colorado at Denver, Aurora, who was not involved in the presentation, said in an interview that physicians may not always realize the extent to which vasomotor symptoms interfere with women’s daily lives.

“They have an eroding effect on QOL that is not appreciated sometimes,” she said. Though hot flashes eventually subside in most women, others may continue to experience them into their 70s, when hormonal therapies can begin causing more harm than benefit.

“It goes underappreciated that, for a proportion of women, hot flashes will never go away, and they’re just as bad [as] when they were in their 50s,” Dr. Santoro said. “They need to be treated, and the nonhormonal treatments do not work for everybody.”
 

Promising KNDy therapeutics

Autopsy studies of postmenopausal women revealed that a complex of neurons in the hypothalamus was “massively hypertrophied” and sits right next to the thermoregulatory center of the brain, Dr. Reed explained.

The complex produces three types of molecules: kisspeptin (a neuropeptide), neurokinin B (a neuropeptide), and dynorphin (a kappa opioid), collectively referred to as the KNDy. The KNDy neural complex is located in the same place as the majority of hormone receptors in the arcuate nucleus, a collection of nerve cells in the hypothalamus.

The current hypothesis is that the KNDy neurons, which communicate with each other, become hyperactivated and cause hot flashes by spilling over to and triggering the thermoregulatory center next door. NKB (kisspeptin and neurokinin B) agonists activate KNDy neurons and dynorphin agonists inactivate KNDy, so the expectation is that NKB antagonists or dynorphin agonists would stop hot flashes.

Indeed, research published in 2015 showed that women taking kappa agonists experienced fewer hot flashes than women in the placebo group. However, no peripherally restricted kappa agonists are currently in clinical trials, so their future as therapeutics is unclear.

Right now, three different NK antagonists are in the pipeline for reducing vasomotor symptoms: MLE 4901 (pavinetant) and ESN364 (fezolinetant) are both NK3R antagonists, and NT-814 is a dual NK1R/NK3R antagonist. All three of these drugs were originally developed to treat schizophrenia.

Phase 2 clinical trials of pavinetant were discontinued in November 2017 by Millendo Therapeutics because 3 of 28 women experienced abnormal liver function, which normalized within 90 days. However, the study had shown an 80% decrease in hot flashes in women taking pavinetant, compared with a 30% decrease in the placebo group.

Fezolinetant, currently in phase 3 trials with Astellas, showed a dose response effect on reproductive hormones in phase 1 studies and a short half-life (4-6 hours) in women. It also showed no concerning side effects.

“There was, in fact, a decrease in the endometrial thickness, a delayed or impeded ovulation and a prolonged cycle duration,” Reed said.

The subsequent phase 2a study showed a reduction of five hot flashes a day (93% decrease), compared with placebo (54% decrease, P <.001) “with an abrupt return to baseline hot flash frequency after cessation,” she said. Improvements also occurred in sleep quality, quality of life, disability, and interference of hot flashes in daily life.

The phase 2b study found no difference in effects between once-daily versus twice-daily doses. However, two severe adverse events occurred: a drug-induced liver injury in one woman and cholelithiasis in another, both on the 60-mg, once-daily dose. Additionally, five women on varying doses had transient increases (above 1000 U/L) in creatinine kinase, though apparently without dose response.

A 52-week, three-arm, phase 3 trial of fezolinetant is currently under way with a goal of enrolling 1,740 participants, and plans to be completed by December 2021. Participants will undergo regular adverse event screening first biweekly, then monthly, with vital signs, blood, and urine monitoring.

Meanwhile, NT-814 from KaNDy Therapeutics, has completed phase 2a and phase 2b trials with phase 3 slated to begin in 2021. Adverse events in phase 1 included sleepiness and headache, and it had a long half-life (about 26 hours) and rapid absorption (an hour).

The phase 2a trial found a reduction of five hot flashes a day, compared with placebo, with main side effects again being sleepiness and headache. No events of abnormal liver function occurred. Phase 2b results have not been published.

So far, existing research suggests that KNDy interventions will involve a single daily oral dose that begins taking effect within 3 days and is fully in effect within 1-2 weeks. The reduction in hot flashes, about five fewer a day, is more effective than any other currently used nonhormonal medications for vasomotor symptoms. SSRIs and SNRIs tend to result in 1.5-2 fewer hot flashes a day, and gabapentin results in about 3 fewer per day. It will take longer-term studies, however, and paying attention to liver concerns for the NK3R antagonists to move into clinic.

“We want to keep our eye on the [luteinizing hormone] because if it decreases too much, it could adversely affect sexual function, and this does appear to be a dose-response finding,” Dr. Reed said. It would also be ideal, she said, to target only the KNDy neurons with NK3 antagonists without effects on the NK3 receptors in the liver.
 

Other nonhormonal options

Oxybutynin is another a nonhormonal agent under investigation for vasomotor symptoms. It’s an anticholinergic that resulted in 80% fewer hot flashes, compared with 30% with placebo in a 2016 trial, but 52% of women complained of dry mouth. A more recent study similarly found high efficacy – a 60%-80% drop in hot flashes, compared with 30% with placebo – but also side effects of dry mouth, difficulty urinating, and abdominal pain.

Finally, Dr. Reed mentioned three other agents under investigation as possible nonhormonal therapeutics, though she has little information about them. They include MT-8554 by Mitsubishi Tanabe; FP-101 by Fervent Pharmaceuticals; and Q-122 by QUE Oncology with Emory University, Atlanta, and the University of Queensland, Brisbane, Australia. 

None of the currently available nonhormonal options provide as high efficacy as hormones, but they do reduce symptoms:

Clonidine is an off-label option some physicians already use as a nonhormonal treatment for vasomotor symptoms, but again, the side effects are problematic: dry mouth, constipation, drowsiness, postural hypotension, and poor sleep.

Paroxetine, at 7.5-10 mg, is the only FDA-approved nonhormonal treatment for vasomotor symptoms, but she listed other off-label options found effective in evidence reviews: gabapentin (100-2,400 mg), venlafaxine (37.5-75 mg), citalopram (10 mg), desvenlafaxine (150 mg), and escitalopram (10 mg).

“I want you to take note of the lower doses in all of these products that are efficacious above those doses that might be used for mood,” Dr. Reed added.

Dr. Reed receives royalties from UpToDate and research funding from Bayer. Dr. Santoro owns stock in MenoGeniX and serves as a consultant or advisor to Ansh Labs, MenoGeniX, and Ogeda/Astellas.

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

The Food and Drug Administration has updated its page on Essure information for patients and health care providers to add additional information on adverse events reported by its manufacturer.

Wikimedia Commons/FitzColinGerald/ Creative Commons License

Essure was a permanent implantable birth control device approved by the FDA in 2002. FDA ordered Bayer in 2016 to conduct a postmarket surveillance study of Essure following reports of safety concerns, and expanded the study from 3 years to 5 years in 2018. Bayer voluntarily removed Essure from the market at the end of 2018, citing low sales after a “black box” warning was placed on the device. All devices were returned to the company by the end of 2019.

Bayer is required to report variances in Medical Device Reporting (MDR) requirements of Essure related to litigation to the FDA, which includes adverse events such death, serious injury, and “malfunction that would be likely to cause or contribute to a death or serious injury if the malfunction were to recur.” The reports are limited to events Bayer becomes aware of between November 2016 and November 2020. Bayer will continue to provide these reports until April 2021.

The FDA emphasized that the collected data are based on social media reports and already may be reported to the FDA, rather than being a collection of new events. “The limited information provided in the reports prevents the ability to draw any conclusions as to whether the device, or its removal, caused or contributed to any of the events in the reports,” Benjamin Fisher, PhD, director of the Reproductive, Gastro-Renal, Urological, General Hospital Device and Human Factors Office in the Center for Devices and Radiological Health, said in an FDA In Brief statement on Aug. 11.

The FDA first uploaded an Essure MDR variance spreadsheet in August 2020, listing 1,453 events, consisting of 53 reports of deaths, 1,376 reports of serious injury, and 24 reports of device malfunction that occurred as of June 2020. In September 2020, FDA uploaded a second variance spreadsheet, which added another 1,934 events that occurred as of July.
 

Interim analysis of postmarketing surveillance study

An interim analysis of 1,128 patients from 67 centers in the Essure postmarket surveillance study, which compared women who received Essure with those who received laparoscopic tubal sterilization, revealed that 94.6% (265 of 280 patients) in the Essure group had a successful implantation of the device, compared with 99.6% of women who achieved bilateral tubal occlusion from laparoscopic tubal sterilization.

Regarding safety, 9.1% of women in the Essure group and 4.5% in the laparoscopic tubal sterilization group reported chronic lower abdominal and/or pelvic pain, and 16.3% in the Essure group and 10.2% in the laparoscopic tubal sterilization group reported new or worsening abnormal uterine bleeding. In the Essure group, 22.3% of women said they experienced hypersensitivity, an allergic reaction, and new “autoimmune-like reactions” compared with 12.5% of women in the laparoscopic tubal sterilization group.

The interim analysis also showed 19.7% of women in the Essure group and 3.0% in the laparoscopic tubal sterilization group underwent gynecologic surgical procedures, which were “driven primarily by Essure removal and endometrial ablation procedures in Essure patients.” Device removal occurred in 6.8% of women with the Essure device.
 

Consistent data on Essure

An FDA search of the Manufacturer and User Facility Device Experience (MAUDE) database in January of 2020 revealed 47,856 medical device reports of Essure between November 2002 and December 2019. The most common adverse events observed during this period were:

• Pain or abdominal pain (32,901 cases).
• Heavy or irregular menses (14,573 cases). Headache (8,570 cases).
• Device fragment or foreign body in a patient (8,501 cases).
• Perforation (7,825 cases).
• Fatigue (7,083 cases).
• Gain or loss in weight (5,980 cases).
• Anxiety and/or depression (5,366 cases).
• Rash and/or hypersensitivity (5,077 cases)
• Hair loss (4,999 cases).

Problems with the device itself included reports of:

• Device incompatibility such as an allergy (7,515 cases).
• The device migrating (4,535 cases).
• The device breaking or fracturing (2,297 cases).
• The device dislodging or dislocating (1,797 cases).
• Improper operation including implant failure and pregnancy (1,058 cases).

In 2019, Essure received 15,083 medical device reports, an increase from 6,000 reports in 2018 and 11,854 reports in 2017.

To date, nearly 39,000 women in the United States have made claims to injuries related to the Essure device. In August, Bayer announced it would pay approximately $1.6 billion U.S. dollars to settle 90% of these cases in exchange for claimants to “dismiss their cases or not file.” Bayer also said in a press release that the settlement is not an admission of wrongdoing or liability on the part of the company.

In an interview, Catherine Cansino, MD, MPH, of the department of obstetrics and gynecology at the University of California, Davis, said the latest adverse event reports show “consistent info from [the] MAUDE database when comparing 2019 to previous years, highlighting most common problems related to pain and heavy or irregular bleeding.”

She emphasized ob.gyns with patients who have an Essure device should “consider Essure-related etiology that may necessitate device removal when evaluating patients with gynecological problems, especially with regard to abdominal/pelvic pain and heavy/irregular bleeding.”

Dr. Cansino reported no relevant financial disclosures. She is a member of the Ob.Gyn. News Editorial Advisory Board.

The Food and Drug Administration has updated its page on Essure information for patients and health care providers to add additional information on adverse events reported by its manufacturer.

Wikimedia Commons/FitzColinGerald/ Creative Commons License

Essure was a permanent implantable birth control device approved by the FDA in 2002. FDA ordered Bayer in 2016 to conduct a postmarket surveillance study of Essure following reports of safety concerns, and expanded the study from 3 years to 5 years in 2018. Bayer voluntarily removed Essure from the market at the end of 2018, citing low sales after a “black box” warning was placed on the device. All devices were returned to the company by the end of 2019.

Bayer is required to report variances in Medical Device Reporting (MDR) requirements of Essure related to litigation to the FDA, which includes adverse events such death, serious injury, and “malfunction that would be likely to cause or contribute to a death or serious injury if the malfunction were to recur.” The reports are limited to events Bayer becomes aware of between November 2016 and November 2020. Bayer will continue to provide these reports until April 2021.

The FDA emphasized that the collected data are based on social media reports and already may be reported to the FDA, rather than being a collection of new events. “The limited information provided in the reports prevents the ability to draw any conclusions as to whether the device, or its removal, caused or contributed to any of the events in the reports,” Benjamin Fisher, PhD, director of the Reproductive, Gastro-Renal, Urological, General Hospital Device and Human Factors Office in the Center for Devices and Radiological Health, said in an FDA In Brief statement on Aug. 11.

The FDA first uploaded an Essure MDR variance spreadsheet in August 2020, listing 1,453 events, consisting of 53 reports of deaths, 1,376 reports of serious injury, and 24 reports of device malfunction that occurred as of June 2020. In September 2020, FDA uploaded a second variance spreadsheet, which added another 1,934 events that occurred as of July.
 

Interim analysis of postmarketing surveillance study

An interim analysis of 1,128 patients from 67 centers in the Essure postmarket surveillance study, which compared women who received Essure with those who received laparoscopic tubal sterilization, revealed that 94.6% (265 of 280 patients) in the Essure group had a successful implantation of the device, compared with 99.6% of women who achieved bilateral tubal occlusion from laparoscopic tubal sterilization.

Regarding safety, 9.1% of women in the Essure group and 4.5% in the laparoscopic tubal sterilization group reported chronic lower abdominal and/or pelvic pain, and 16.3% in the Essure group and 10.2% in the laparoscopic tubal sterilization group reported new or worsening abnormal uterine bleeding. In the Essure group, 22.3% of women said they experienced hypersensitivity, an allergic reaction, and new “autoimmune-like reactions” compared with 12.5% of women in the laparoscopic tubal sterilization group.

The interim analysis also showed 19.7% of women in the Essure group and 3.0% in the laparoscopic tubal sterilization group underwent gynecologic surgical procedures, which were “driven primarily by Essure removal and endometrial ablation procedures in Essure patients.” Device removal occurred in 6.8% of women with the Essure device.
 

Consistent data on Essure

An FDA search of the Manufacturer and User Facility Device Experience (MAUDE) database in January of 2020 revealed 47,856 medical device reports of Essure between November 2002 and December 2019. The most common adverse events observed during this period were:

• Pain or abdominal pain (32,901 cases).
• Heavy or irregular menses (14,573 cases). Headache (8,570 cases).
• Device fragment or foreign body in a patient (8,501 cases).
• Perforation (7,825 cases).
• Fatigue (7,083 cases).
• Gain or loss in weight (5,980 cases).
• Anxiety and/or depression (5,366 cases).
• Rash and/or hypersensitivity (5,077 cases)
• Hair loss (4,999 cases).

Problems with the device itself included reports of:

• Device incompatibility such as an allergy (7,515 cases).
• The device migrating (4,535 cases).
• The device breaking or fracturing (2,297 cases).
• The device dislodging or dislocating (1,797 cases).
• Improper operation including implant failure and pregnancy (1,058 cases).

In 2019, Essure received 15,083 medical device reports, an increase from 6,000 reports in 2018 and 11,854 reports in 2017.

To date, nearly 39,000 women in the United States have made claims to injuries related to the Essure device. In August, Bayer announced it would pay approximately $1.6 billion U.S. dollars to settle 90% of these cases in exchange for claimants to “dismiss their cases or not file.” Bayer also said in a press release that the settlement is not an admission of wrongdoing or liability on the part of the company.

In an interview, Catherine Cansino, MD, MPH, of the department of obstetrics and gynecology at the University of California, Davis, said the latest adverse event reports show “consistent info from [the] MAUDE database when comparing 2019 to previous years, highlighting most common problems related to pain and heavy or irregular bleeding.”

She emphasized ob.gyns with patients who have an Essure device should “consider Essure-related etiology that may necessitate device removal when evaluating patients with gynecological problems, especially with regard to abdominal/pelvic pain and heavy/irregular bleeding.”

Dr. Cansino reported no relevant financial disclosures. She is a member of the Ob.Gyn. News Editorial Advisory Board.

The Food and Drug Administration has updated its page on Essure information for patients and health care providers to add additional information on adverse events reported by its manufacturer.

Wikimedia Commons/FitzColinGerald/ Creative Commons License

Essure was a permanent implantable birth control device approved by the FDA in 2002. FDA ordered Bayer in 2016 to conduct a postmarket surveillance study of Essure following reports of safety concerns, and expanded the study from 3 years to 5 years in 2018. Bayer voluntarily removed Essure from the market at the end of 2018, citing low sales after a “black box” warning was placed on the device. All devices were returned to the company by the end of 2019.

Bayer is required to report variances in Medical Device Reporting (MDR) requirements of Essure related to litigation to the FDA, which includes adverse events such death, serious injury, and “malfunction that would be likely to cause or contribute to a death or serious injury if the malfunction were to recur.” The reports are limited to events Bayer becomes aware of between November 2016 and November 2020. Bayer will continue to provide these reports until April 2021.

The FDA emphasized that the collected data are based on social media reports and already may be reported to the FDA, rather than being a collection of new events. “The limited information provided in the reports prevents the ability to draw any conclusions as to whether the device, or its removal, caused or contributed to any of the events in the reports,” Benjamin Fisher, PhD, director of the Reproductive, Gastro-Renal, Urological, General Hospital Device and Human Factors Office in the Center for Devices and Radiological Health, said in an FDA In Brief statement on Aug. 11.

The FDA first uploaded an Essure MDR variance spreadsheet in August 2020, listing 1,453 events, consisting of 53 reports of deaths, 1,376 reports of serious injury, and 24 reports of device malfunction that occurred as of June 2020. In September 2020, FDA uploaded a second variance spreadsheet, which added another 1,934 events that occurred as of July.
 

Interim analysis of postmarketing surveillance study

An interim analysis of 1,128 patients from 67 centers in the Essure postmarket surveillance study, which compared women who received Essure with those who received laparoscopic tubal sterilization, revealed that 94.6% (265 of 280 patients) in the Essure group had a successful implantation of the device, compared with 99.6% of women who achieved bilateral tubal occlusion from laparoscopic tubal sterilization.

Regarding safety, 9.1% of women in the Essure group and 4.5% in the laparoscopic tubal sterilization group reported chronic lower abdominal and/or pelvic pain, and 16.3% in the Essure group and 10.2% in the laparoscopic tubal sterilization group reported new or worsening abnormal uterine bleeding. In the Essure group, 22.3% of women said they experienced hypersensitivity, an allergic reaction, and new “autoimmune-like reactions” compared with 12.5% of women in the laparoscopic tubal sterilization group.

The interim analysis also showed 19.7% of women in the Essure group and 3.0% in the laparoscopic tubal sterilization group underwent gynecologic surgical procedures, which were “driven primarily by Essure removal and endometrial ablation procedures in Essure patients.” Device removal occurred in 6.8% of women with the Essure device.
 

Consistent data on Essure

An FDA search of the Manufacturer and User Facility Device Experience (MAUDE) database in January of 2020 revealed 47,856 medical device reports of Essure between November 2002 and December 2019. The most common adverse events observed during this period were:

• Pain or abdominal pain (32,901 cases).
• Heavy or irregular menses (14,573 cases). Headache (8,570 cases).
• Device fragment or foreign body in a patient (8,501 cases).
• Perforation (7,825 cases).
• Fatigue (7,083 cases).
• Gain or loss in weight (5,980 cases).
• Anxiety and/or depression (5,366 cases).
• Rash and/or hypersensitivity (5,077 cases)
• Hair loss (4,999 cases).

Problems with the device itself included reports of:

• Device incompatibility such as an allergy (7,515 cases).
• The device migrating (4,535 cases).
• The device breaking or fracturing (2,297 cases).
• The device dislodging or dislocating (1,797 cases).
• Improper operation including implant failure and pregnancy (1,058 cases).

In 2019, Essure received 15,083 medical device reports, an increase from 6,000 reports in 2018 and 11,854 reports in 2017.

To date, nearly 39,000 women in the United States have made claims to injuries related to the Essure device. In August, Bayer announced it would pay approximately $1.6 billion U.S. dollars to settle 90% of these cases in exchange for claimants to “dismiss their cases or not file.” Bayer also said in a press release that the settlement is not an admission of wrongdoing or liability on the part of the company.

In an interview, Catherine Cansino, MD, MPH, of the department of obstetrics and gynecology at the University of California, Davis, said the latest adverse event reports show “consistent info from [the] MAUDE database when comparing 2019 to previous years, highlighting most common problems related to pain and heavy or irregular bleeding.”

She emphasized ob.gyns with patients who have an Essure device should “consider Essure-related etiology that may necessitate device removal when evaluating patients with gynecological problems, especially with regard to abdominal/pelvic pain and heavy/irregular bleeding.”

Dr. Cansino reported no relevant financial disclosures. She is a member of the Ob.Gyn. News Editorial Advisory Board.

Limited data are available to guide treatment of recurrent bacterial vaginosis, but behavioral changes and switching between approved medication regimens may help, according to a presenter at the virtual conference on diseases of the vulva and vagina, hosted by the International Society for the Study of Vulvovaginal Disease.

Investigational treatments – such as a live biotherapeutic product delivered vaginally or vaginal microbiome transplantation – could someday be additional options if they prove safe and effective. “The current research is emphasizing biofilm disruption and products that will reestablish normal acidic vaginal pH,” said Debra L. Birenbaum, MD, assistant professor of obstetrics and gynecology at Dartmouth-Hitchcock Medical Center in Lebanon, N.H.

As for home remedies, Dr. Birenbaum and another presenter at the conference, Cynthia Rasmussen, MD, urged caution during a panel discussion.

“I think the vagina knows its business, and the more you mess with it, the more you invite trouble,” said Dr. Rasmussen, director emerita of vulvovaginal services at Atrius Health in Burlington, Mass. For instance, tea tree oil, often cited as a home remedy, can be an allergen and very irritating.

“I want to know what women are using, but I try and dissuade them,” said Dr. Birenbaum. “I have to be careful what I say, because you’ll antagonize patients” if you come out strongly against home treatments. “I try to encourage them not to go by things they read on the Internet, because I think that’s where many people are finding their home remedies.”

When counseling patients, an analogy shared during the meeting – the vagina is a self-cleaning oven – may help get the point across. “I love the comment,” Dr. Birenbaum said. “I’ve never used that before. I’m going to start saying that.”
 

Possible causes and risk factors

Bacterial vaginosis, also known as vaginal dysbiosis, is the most common cause of discharge in women of reproductive age worldwide. Growth of a biofilm may cause the condition, which is characterized by a shift in vaginal flora from a Lactobacilli-dominant environment to one of other bacterial types.

Risk factors include douching, smoking, sex with an uncircumcised partner, and having multiple sexual partners. Bacterial vaginosis may be associated with various complications and infections, including increased risk of preterm delivery, postpartum endometritis, postabortal infection, Trichomonas, chlamydia, and HIV.

Unlike recurrent yeast, which is characterized by four or more episodes per year, recurrent bacterial vaginosis has no official criteria, Dr. Birenbaum said. However, recurrence of bacterial vaginosis “is extremely common,” she said. “Up to 30% of women with [bacterial vaginosis] may recur within 3 months, and up to 50% after 12 months.”
 

Lifestyle changes and treatments

Recommendations to use condoms, stop smoking, and not douche are important.

In addition, 11 treatment regimens for four drugs – metronidazole, clindamycin, tinidazole, or secnidazole – are available for the treatment of bacterial vaginosis. For recurrent cases, adjusting and switching between the drugs and modes of delivery may help. If a patient started with vaginal gel, they can try an oral medication, or vice versa.

“There’s very little data to guide the optimal therapy for this,” Dr. Birenbaum said. “All of this is worth a try to see if you can beat this before this becomes an ongoing issue.”

As an example of one possible regimen for recurrent bacterial vaginosis, Dr. Birenbaum suggested that a patient could complete a 2- to 4-week course of oral metronidazole instead of the usual 1-week course. The regimen could incorporate boric acid vaginal suppositories 600 mg nightly for 21 days, followed by metronidazole gel 0.75% (one applicator twice per week for 6 months).
 

New therapies may be on the horizon

In a randomized, double-blind, phase 2b trial published in the New England Journal of Medicine that included more than 220 participants, patients who received an investigational product containing Lactobacillus crispatus CTV-05 (Lactin-V) were less likely to have recurrent bacterial vaginosis at 12 weeks, compared with those who received placebo (30% vs. 45%).

A product in development known as TOL-463, a boric acid–based vaginal anti-infective enhanced with ethylenediaminetetraacetic acid, may be safe and effective, a phase 2 study published in Clinical Infectious Diseases suggests.

Investigators in the United Kingdom designed a trial to compare lactic acid gel and metronidazole, and the findings published in the Trials journal may clarify inconsistent results from prior studies.

Furthermore, preclinical research in Pathogens and Disease has identified cationic amphiphiles that might help fight the biofilm that is formed with Gardnerella vaginalis in patients with bacterial vaginosis, Dr. Birenbaum said.

Finally, an exploratory study in Israel published in Nature Medicine evaluated vaginal microbiome transplants in five patients, three of whom required repeat transplantation. Four patients had long-term remission, and one had a reduction in symptoms

Dr. Birenbaum is a reviewer for UpToDate. Dr. Rasmussen had no relevant disclosures.

jremaly@mdedge.com

Limited data are available to guide treatment of recurrent bacterial vaginosis, but behavioral changes and switching between approved medication regimens may help, according to a presenter at the virtual conference on diseases of the vulva and vagina, hosted by the International Society for the Study of Vulvovaginal Disease.

Investigational treatments – such as a live biotherapeutic product delivered vaginally or vaginal microbiome transplantation – could someday be additional options if they prove safe and effective. “The current research is emphasizing biofilm disruption and products that will reestablish normal acidic vaginal pH,” said Debra L. Birenbaum, MD, assistant professor of obstetrics and gynecology at Dartmouth-Hitchcock Medical Center in Lebanon, N.H.

As for home remedies, Dr. Birenbaum and another presenter at the conference, Cynthia Rasmussen, MD, urged caution during a panel discussion.

“I think the vagina knows its business, and the more you mess with it, the more you invite trouble,” said Dr. Rasmussen, director emerita of vulvovaginal services at Atrius Health in Burlington, Mass. For instance, tea tree oil, often cited as a home remedy, can be an allergen and very irritating.

“I want to know what women are using, but I try and dissuade them,” said Dr. Birenbaum. “I have to be careful what I say, because you’ll antagonize patients” if you come out strongly against home treatments. “I try to encourage them not to go by things they read on the Internet, because I think that’s where many people are finding their home remedies.”

When counseling patients, an analogy shared during the meeting – the vagina is a self-cleaning oven – may help get the point across. “I love the comment,” Dr. Birenbaum said. “I’ve never used that before. I’m going to start saying that.”
 

Possible causes and risk factors

Bacterial vaginosis, also known as vaginal dysbiosis, is the most common cause of discharge in women of reproductive age worldwide. Growth of a biofilm may cause the condition, which is characterized by a shift in vaginal flora from a Lactobacilli-dominant environment to one of other bacterial types.

Risk factors include douching, smoking, sex with an uncircumcised partner, and having multiple sexual partners. Bacterial vaginosis may be associated with various complications and infections, including increased risk of preterm delivery, postpartum endometritis, postabortal infection, Trichomonas, chlamydia, and HIV.

Unlike recurrent yeast, which is characterized by four or more episodes per year, recurrent bacterial vaginosis has no official criteria, Dr. Birenbaum said. However, recurrence of bacterial vaginosis “is extremely common,” she said. “Up to 30% of women with [bacterial vaginosis] may recur within 3 months, and up to 50% after 12 months.”
 

Lifestyle changes and treatments

Recommendations to use condoms, stop smoking, and not douche are important.

In addition, 11 treatment regimens for four drugs – metronidazole, clindamycin, tinidazole, or secnidazole – are available for the treatment of bacterial vaginosis. For recurrent cases, adjusting and switching between the drugs and modes of delivery may help. If a patient started with vaginal gel, they can try an oral medication, or vice versa.

“There’s very little data to guide the optimal therapy for this,” Dr. Birenbaum said. “All of this is worth a try to see if you can beat this before this becomes an ongoing issue.”

As an example of one possible regimen for recurrent bacterial vaginosis, Dr. Birenbaum suggested that a patient could complete a 2- to 4-week course of oral metronidazole instead of the usual 1-week course. The regimen could incorporate boric acid vaginal suppositories 600 mg nightly for 21 days, followed by metronidazole gel 0.75% (one applicator twice per week for 6 months).
 

New therapies may be on the horizon

In a randomized, double-blind, phase 2b trial published in the New England Journal of Medicine that included more than 220 participants, patients who received an investigational product containing Lactobacillus crispatus CTV-05 (Lactin-V) were less likely to have recurrent bacterial vaginosis at 12 weeks, compared with those who received placebo (30% vs. 45%).

A product in development known as TOL-463, a boric acid–based vaginal anti-infective enhanced with ethylenediaminetetraacetic acid, may be safe and effective, a phase 2 study published in Clinical Infectious Diseases suggests.

Investigators in the United Kingdom designed a trial to compare lactic acid gel and metronidazole, and the findings published in the Trials journal may clarify inconsistent results from prior studies.

Furthermore, preclinical research in Pathogens and Disease has identified cationic amphiphiles that might help fight the biofilm that is formed with Gardnerella vaginalis in patients with bacterial vaginosis, Dr. Birenbaum said.

Finally, an exploratory study in Israel published in Nature Medicine evaluated vaginal microbiome transplants in five patients, three of whom required repeat transplantation. Four patients had long-term remission, and one had a reduction in symptoms

Dr. Birenbaum is a reviewer for UpToDate. Dr. Rasmussen had no relevant disclosures.

jremaly@mdedge.com

Limited data are available to guide treatment of recurrent bacterial vaginosis, but behavioral changes and switching between approved medication regimens may help, according to a presenter at the virtual conference on diseases of the vulva and vagina, hosted by the International Society for the Study of Vulvovaginal Disease.

Investigational treatments – such as a live biotherapeutic product delivered vaginally or vaginal microbiome transplantation – could someday be additional options if they prove safe and effective. “The current research is emphasizing biofilm disruption and products that will reestablish normal acidic vaginal pH,” said Debra L. Birenbaum, MD, assistant professor of obstetrics and gynecology at Dartmouth-Hitchcock Medical Center in Lebanon, N.H.

As for home remedies, Dr. Birenbaum and another presenter at the conference, Cynthia Rasmussen, MD, urged caution during a panel discussion.

“I think the vagina knows its business, and the more you mess with it, the more you invite trouble,” said Dr. Rasmussen, director emerita of vulvovaginal services at Atrius Health in Burlington, Mass. For instance, tea tree oil, often cited as a home remedy, can be an allergen and very irritating.

“I want to know what women are using, but I try and dissuade them,” said Dr. Birenbaum. “I have to be careful what I say, because you’ll antagonize patients” if you come out strongly against home treatments. “I try to encourage them not to go by things they read on the Internet, because I think that’s where many people are finding their home remedies.”

When counseling patients, an analogy shared during the meeting – the vagina is a self-cleaning oven – may help get the point across. “I love the comment,” Dr. Birenbaum said. “I’ve never used that before. I’m going to start saying that.”
 

Possible causes and risk factors

Bacterial vaginosis, also known as vaginal dysbiosis, is the most common cause of discharge in women of reproductive age worldwide. Growth of a biofilm may cause the condition, which is characterized by a shift in vaginal flora from a Lactobacilli-dominant environment to one of other bacterial types.

Risk factors include douching, smoking, sex with an uncircumcised partner, and having multiple sexual partners. Bacterial vaginosis may be associated with various complications and infections, including increased risk of preterm delivery, postpartum endometritis, postabortal infection, Trichomonas, chlamydia, and HIV.

Unlike recurrent yeast, which is characterized by four or more episodes per year, recurrent bacterial vaginosis has no official criteria, Dr. Birenbaum said. However, recurrence of bacterial vaginosis “is extremely common,” she said. “Up to 30% of women with [bacterial vaginosis] may recur within 3 months, and up to 50% after 12 months.”
 

Lifestyle changes and treatments

Recommendations to use condoms, stop smoking, and not douche are important.

In addition, 11 treatment regimens for four drugs – metronidazole, clindamycin, tinidazole, or secnidazole – are available for the treatment of bacterial vaginosis. For recurrent cases, adjusting and switching between the drugs and modes of delivery may help. If a patient started with vaginal gel, they can try an oral medication, or vice versa.

“There’s very little data to guide the optimal therapy for this,” Dr. Birenbaum said. “All of this is worth a try to see if you can beat this before this becomes an ongoing issue.”

As an example of one possible regimen for recurrent bacterial vaginosis, Dr. Birenbaum suggested that a patient could complete a 2- to 4-week course of oral metronidazole instead of the usual 1-week course. The regimen could incorporate boric acid vaginal suppositories 600 mg nightly for 21 days, followed by metronidazole gel 0.75% (one applicator twice per week for 6 months).
 

New therapies may be on the horizon

In a randomized, double-blind, phase 2b trial published in the New England Journal of Medicine that included more than 220 participants, patients who received an investigational product containing Lactobacillus crispatus CTV-05 (Lactin-V) were less likely to have recurrent bacterial vaginosis at 12 weeks, compared with those who received placebo (30% vs. 45%).

A product in development known as TOL-463, a boric acid–based vaginal anti-infective enhanced with ethylenediaminetetraacetic acid, may be safe and effective, a phase 2 study published in Clinical Infectious Diseases suggests.

Investigators in the United Kingdom designed a trial to compare lactic acid gel and metronidazole, and the findings published in the Trials journal may clarify inconsistent results from prior studies.

Furthermore, preclinical research in Pathogens and Disease has identified cationic amphiphiles that might help fight the biofilm that is formed with Gardnerella vaginalis in patients with bacterial vaginosis, Dr. Birenbaum said.

Finally, an exploratory study in Israel published in Nature Medicine evaluated vaginal microbiome transplants in five patients, three of whom required repeat transplantation. Four patients had long-term remission, and one had a reduction in symptoms

Dr. Birenbaum is a reviewer for UpToDate. Dr. Rasmussen had no relevant disclosures.

jremaly@mdedge.com

A three-step approach may help relieve itch in patients with lichen simplex chronicus, “one of the itchiest conditions that we ever see on the vulva,” an expert advised at the virtual conference on diseases of the vulva and vagina, hosted by the International Society for the Study of Vulvovaginal Disease.

For some patients, such as those with excessive sweating or underlying psoriasis, seeing a dermatologist may be beneficial, physicians at the meeting suggested.

Treatment should aim to optimize epithelial barrier function, reduce inflammation, and stop scratching, Lynette Margesson, MD, said in a lecture at the biennial meeting, which is held by the International Society for the Study of Vulvovaginal Disease (ISSVD). “With this condition, please look always for more than one problem.”

Lichen simplex chronicus is a thick, hyperkeratotic, firm, itchy rash that can develop on top of any dermatitis. “It doesn’t show up out of nowhere,” said Dr. Margesson, an obstetrician and gynecologist at Geisel School of Medicine at Dartmouth in Hanover, N.H. “It is because of chronic rubbing and scratching on top of something else.”

It may develop on top of atopic dermatitis, psoriasis, or contact dermatitis, as well as infection, lichen sclerosus, lichen planus, or neoplasia.

Lichen simplex chronicus is characterized by years of relentless itching, and patients may wake up at night scratching. The skin looks and feels leathery, and the condition can be localized or around the entire vulva. Heat, humidity, stress, and irritants may exacerbate the condition.

Patients often try to wash the rash away with scrubbers and cleansers, which only makes it worse, Dr. Margesson said.

To get patients better, improve barrier function, such as by controlling infections, reducing sweating, avoiding irritants, and stopping excessive hygiene. Immediate therapy may include soaks, cool compresses, and ointments.

A superpotent steroid taper (e.g., clobetasol 0.05% ointment), a prednisone taper, or intramuscular triamcinolone may reduce inflammation. Dr. Margesson usually uses clobetasol, although this treatment or halobetasol can burn if patients have open skin. In such cases, she uses prednisone or intramuscular triamcinolone.

Sedating medications may help patients stop scratching, especially at night. Hydroxyzine, doxepin, or amitriptyline 2-3 hours before bedtime can help. Scratching can be a form of obsessive-compulsive disorder, and a small dose of citalopram may help during the day. Patients with significant psychological factors can be difficult to manage and tend to relapse easily, Dr. Margesson said.

If lichen simplex chronicus recurs, test for infections and allergies. “Maybe they need a mild corticosteroid all the time, like 2.5% hydrocortisone to alternate with your superpotent steroid so you can use it longer without thinning the skin,” she suggested.

Although Dr. Margesson does not often treat hyperhidrosis, addressing excessive sweating can make a big difference for patients, she said.

If a gynecologist identifies a patient who may benefit from treatment of hyperhidrosis but has limited experience with medications for this condition, it might make sense to work with a dermatologist, Aruna Venkatesan, MD, chief of dermatology and director of the genital dermatology clinic at Santa Clara Valley Medical Center in San Jose, Calif., suggested during a panel discussion. Most dermatologists treat hyperhidrosis regularly, she said.

Dermatologists also may help treat patients with psoriasis who need systemic medication, Dr. Margesson said.

“In terms of ... doing the lab monitoring and knowing what side effects to look out for, your colleagues who use these medicines more are going to be more comfortable with that,” Dr. Venkatesan said. They also may have more experience navigating insurance denials to obtain a therapy. “Don’t think you are passing the buck to someone else. Sometimes that is the right thing to do, to get that help from someone else.”

Dr. Margesson is an author for UpToDate. Dr. Venkatesan had no conflicts of interest.

jremaly@mdedge.com

A three-step approach may help relieve itch in patients with lichen simplex chronicus, “one of the itchiest conditions that we ever see on the vulva,” an expert advised at the virtual conference on diseases of the vulva and vagina, hosted by the International Society for the Study of Vulvovaginal Disease.

For some patients, such as those with excessive sweating or underlying psoriasis, seeing a dermatologist may be beneficial, physicians at the meeting suggested.

Treatment should aim to optimize epithelial barrier function, reduce inflammation, and stop scratching, Lynette Margesson, MD, said in a lecture at the biennial meeting, which is held by the International Society for the Study of Vulvovaginal Disease (ISSVD). “With this condition, please look always for more than one problem.”

Lichen simplex chronicus is a thick, hyperkeratotic, firm, itchy rash that can develop on top of any dermatitis. “It doesn’t show up out of nowhere,” said Dr. Margesson, an obstetrician and gynecologist at Geisel School of Medicine at Dartmouth in Hanover, N.H. “It is because of chronic rubbing and scratching on top of something else.”

It may develop on top of atopic dermatitis, psoriasis, or contact dermatitis, as well as infection, lichen sclerosus, lichen planus, or neoplasia.

Lichen simplex chronicus is characterized by years of relentless itching, and patients may wake up at night scratching. The skin looks and feels leathery, and the condition can be localized or around the entire vulva. Heat, humidity, stress, and irritants may exacerbate the condition.

Patients often try to wash the rash away with scrubbers and cleansers, which only makes it worse, Dr. Margesson said.

To get patients better, improve barrier function, such as by controlling infections, reducing sweating, avoiding irritants, and stopping excessive hygiene. Immediate therapy may include soaks, cool compresses, and ointments.

A superpotent steroid taper (e.g., clobetasol 0.05% ointment), a prednisone taper, or intramuscular triamcinolone may reduce inflammation. Dr. Margesson usually uses clobetasol, although this treatment or halobetasol can burn if patients have open skin. In such cases, she uses prednisone or intramuscular triamcinolone.

Sedating medications may help patients stop scratching, especially at night. Hydroxyzine, doxepin, or amitriptyline 2-3 hours before bedtime can help. Scratching can be a form of obsessive-compulsive disorder, and a small dose of citalopram may help during the day. Patients with significant psychological factors can be difficult to manage and tend to relapse easily, Dr. Margesson said.

If lichen simplex chronicus recurs, test for infections and allergies. “Maybe they need a mild corticosteroid all the time, like 2.5% hydrocortisone to alternate with your superpotent steroid so you can use it longer without thinning the skin,” she suggested.

Although Dr. Margesson does not often treat hyperhidrosis, addressing excessive sweating can make a big difference for patients, she said.

If a gynecologist identifies a patient who may benefit from treatment of hyperhidrosis but has limited experience with medications for this condition, it might make sense to work with a dermatologist, Aruna Venkatesan, MD, chief of dermatology and director of the genital dermatology clinic at Santa Clara Valley Medical Center in San Jose, Calif., suggested during a panel discussion. Most dermatologists treat hyperhidrosis regularly, she said.

Dermatologists also may help treat patients with psoriasis who need systemic medication, Dr. Margesson said.

“In terms of ... doing the lab monitoring and knowing what side effects to look out for, your colleagues who use these medicines more are going to be more comfortable with that,” Dr. Venkatesan said. They also may have more experience navigating insurance denials to obtain a therapy. “Don’t think you are passing the buck to someone else. Sometimes that is the right thing to do, to get that help from someone else.”

Dr. Margesson is an author for UpToDate. Dr. Venkatesan had no conflicts of interest.

jremaly@mdedge.com

A three-step approach may help relieve itch in patients with lichen simplex chronicus, “one of the itchiest conditions that we ever see on the vulva,” an expert advised at the virtual conference on diseases of the vulva and vagina, hosted by the International Society for the Study of Vulvovaginal Disease.

For some patients, such as those with excessive sweating or underlying psoriasis, seeing a dermatologist may be beneficial, physicians at the meeting suggested.

Treatment should aim to optimize epithelial barrier function, reduce inflammation, and stop scratching, Lynette Margesson, MD, said in a lecture at the biennial meeting, which is held by the International Society for the Study of Vulvovaginal Disease (ISSVD). “With this condition, please look always for more than one problem.”

Lichen simplex chronicus is a thick, hyperkeratotic, firm, itchy rash that can develop on top of any dermatitis. “It doesn’t show up out of nowhere,” said Dr. Margesson, an obstetrician and gynecologist at Geisel School of Medicine at Dartmouth in Hanover, N.H. “It is because of chronic rubbing and scratching on top of something else.”

It may develop on top of atopic dermatitis, psoriasis, or contact dermatitis, as well as infection, lichen sclerosus, lichen planus, or neoplasia.

Lichen simplex chronicus is characterized by years of relentless itching, and patients may wake up at night scratching. The skin looks and feels leathery, and the condition can be localized or around the entire vulva. Heat, humidity, stress, and irritants may exacerbate the condition.

Patients often try to wash the rash away with scrubbers and cleansers, which only makes it worse, Dr. Margesson said.

To get patients better, improve barrier function, such as by controlling infections, reducing sweating, avoiding irritants, and stopping excessive hygiene. Immediate therapy may include soaks, cool compresses, and ointments.

A superpotent steroid taper (e.g., clobetasol 0.05% ointment), a prednisone taper, or intramuscular triamcinolone may reduce inflammation. Dr. Margesson usually uses clobetasol, although this treatment or halobetasol can burn if patients have open skin. In such cases, she uses prednisone or intramuscular triamcinolone.

Sedating medications may help patients stop scratching, especially at night. Hydroxyzine, doxepin, or amitriptyline 2-3 hours before bedtime can help. Scratching can be a form of obsessive-compulsive disorder, and a small dose of citalopram may help during the day. Patients with significant psychological factors can be difficult to manage and tend to relapse easily, Dr. Margesson said.

If lichen simplex chronicus recurs, test for infections and allergies. “Maybe they need a mild corticosteroid all the time, like 2.5% hydrocortisone to alternate with your superpotent steroid so you can use it longer without thinning the skin,” she suggested.

Although Dr. Margesson does not often treat hyperhidrosis, addressing excessive sweating can make a big difference for patients, she said.

If a gynecologist identifies a patient who may benefit from treatment of hyperhidrosis but has limited experience with medications for this condition, it might make sense to work with a dermatologist, Aruna Venkatesan, MD, chief of dermatology and director of the genital dermatology clinic at Santa Clara Valley Medical Center in San Jose, Calif., suggested during a panel discussion. Most dermatologists treat hyperhidrosis regularly, she said.

Dermatologists also may help treat patients with psoriasis who need systemic medication, Dr. Margesson said.

“In terms of ... doing the lab monitoring and knowing what side effects to look out for, your colleagues who use these medicines more are going to be more comfortable with that,” Dr. Venkatesan said. They also may have more experience navigating insurance denials to obtain a therapy. “Don’t think you are passing the buck to someone else. Sometimes that is the right thing to do, to get that help from someone else.”

Dr. Margesson is an author for UpToDate. Dr. Venkatesan had no conflicts of interest.

jremaly@mdedge.com

Earlier this year, I was honored to serve as the Scientific Program Chair for the 46th Annual Scientific Meeting of the Society of Gynecologic Surgeons (SGS). This year’s meeting was the first ever (and hopefully last) “virtual” scientific meeting, which consisted of a hybrid of prerecorded and live presentations. Although faculty and attendees were not able to be together physically, the essence of the lively SGS meetings came through loud and clear. We still had “discussants” comment on the oral presentations and ask questions of the presenters. These questions and answers were all done live—without a glitch! Many thanks to all who made this meeting possible.

In addition to the outstanding abstract and video presentations, there were 4 superb postgraduate courses:

• Mikio Nihira, MD, chaired “Enhanced recovery after surgery: Overcoming barriers to implementation.”
• Charles Hanes, MD, headed up “It’s all about the apex: The key to successful POP surgery.”
• Cara King, DO, MS, led “Total laparoscopic hysterectomy: Pushing the envelope.”
• Vincent Lucente, MD, chaired “Transvaginal reconstructive pelvic surgery using graft augmentation post-FDA.”

Many special thanks to Dr. Lucente who transformed his course into a wonderful article for this special section of OBG Management. These courses were well attended and quite interactive despite the virtual format.

One of our exceptional keynote speakers was Marc Beer (a serial entrepreneur and cofounder, chairman, and CEO of Renovia, Inc.), whose talk was entitled “A primer on medical device innovation—How to avoid common pitfalls while realizing your vision.” Mr. Beer has turned this topic into a unique article for this special section (see next month’s issue for Part 2).

Our TeLinde Lecture, entitled “Artificial intelligence in surgery,” was delivered by the dynamic Vicente Gracias, MD, professor of surgery at Robert Wood Johnson University Hospital, New Brunswick, New Jersey. We also held 2 live panel discussions that were very popular. The first, “Work-life balance and gynecologic surgery,” featured various perspectives from Drs. Kristie Green, Sally Huber, Catherine Matthews, and Charles Rardin. The second panel discussion, entitled “Understanding, managing, and benefiting from your e-presence,” by experts Heather Schueppert; Chief Marketing Officer at Unified Physician Management, Brad Bowman, MD; and Peter Lotze, MD. Both of these panel discussions are included in this special section as well.

I hope you enjoy the content of this special section of OBG Management highlighting the 2020 SGS meeting. Watch for part 2 in the next issue, and I hope to see you at our 47th Annual Scientific Meeting in Palm Springs, California, in March 2021.

Earlier this year, I was honored to serve as the Scientific Program Chair for the 46th Annual Scientific Meeting of the Society of Gynecologic Surgeons (SGS). This year’s meeting was the first ever (and hopefully last) “virtual” scientific meeting, which consisted of a hybrid of prerecorded and live presentations. Although faculty and attendees were not able to be together physically, the essence of the lively SGS meetings came through loud and clear. We still had “discussants” comment on the oral presentations and ask questions of the presenters. These questions and answers were all done live—without a glitch! Many thanks to all who made this meeting possible.

In addition to the outstanding abstract and video presentations, there were 4 superb postgraduate courses:

• Mikio Nihira, MD, chaired “Enhanced recovery after surgery: Overcoming barriers to implementation.”
• Charles Hanes, MD, headed up “It’s all about the apex: The key to successful POP surgery.”
• Cara King, DO, MS, led “Total laparoscopic hysterectomy: Pushing the envelope.”
• Vincent Lucente, MD, chaired “Transvaginal reconstructive pelvic surgery using graft augmentation post-FDA.”

Many special thanks to Dr. Lucente who transformed his course into a wonderful article for this special section of OBG Management. These courses were well attended and quite interactive despite the virtual format.

One of our exceptional keynote speakers was Marc Beer (a serial entrepreneur and cofounder, chairman, and CEO of Renovia, Inc.), whose talk was entitled “A primer on medical device innovation—How to avoid common pitfalls while realizing your vision.” Mr. Beer has turned this topic into a unique article for this special section (see next month’s issue for Part 2).

Our TeLinde Lecture, entitled “Artificial intelligence in surgery,” was delivered by the dynamic Vicente Gracias, MD, professor of surgery at Robert Wood Johnson University Hospital, New Brunswick, New Jersey. We also held 2 live panel discussions that were very popular. The first, “Work-life balance and gynecologic surgery,” featured various perspectives from Drs. Kristie Green, Sally Huber, Catherine Matthews, and Charles Rardin. The second panel discussion, entitled “Understanding, managing, and benefiting from your e-presence,” by experts Heather Schueppert; Chief Marketing Officer at Unified Physician Management, Brad Bowman, MD; and Peter Lotze, MD. Both of these panel discussions are included in this special section as well.

I hope you enjoy the content of this special section of OBG Management highlighting the 2020 SGS meeting. Watch for part 2 in the next issue, and I hope to see you at our 47th Annual Scientific Meeting in Palm Springs, California, in March 2021.

Earlier this year, I was honored to serve as the Scientific Program Chair for the 46th Annual Scientific Meeting of the Society of Gynecologic Surgeons (SGS). This year’s meeting was the first ever (and hopefully last) “virtual” scientific meeting, which consisted of a hybrid of prerecorded and live presentations. Although faculty and attendees were not able to be together physically, the essence of the lively SGS meetings came through loud and clear. We still had “discussants” comment on the oral presentations and ask questions of the presenters. These questions and answers were all done live—without a glitch! Many thanks to all who made this meeting possible.

In addition to the outstanding abstract and video presentations, there were 4 superb postgraduate courses:

• Mikio Nihira, MD, chaired “Enhanced recovery after surgery: Overcoming barriers to implementation.”
• Charles Hanes, MD, headed up “It’s all about the apex: The key to successful POP surgery.”
• Cara King, DO, MS, led “Total laparoscopic hysterectomy: Pushing the envelope.”
• Vincent Lucente, MD, chaired “Transvaginal reconstructive pelvic surgery using graft augmentation post-FDA.”

Many special thanks to Dr. Lucente who transformed his course into a wonderful article for this special section of OBG Management. These courses were well attended and quite interactive despite the virtual format.

One of our exceptional keynote speakers was Marc Beer (a serial entrepreneur and cofounder, chairman, and CEO of Renovia, Inc.), whose talk was entitled “A primer on medical device innovation—How to avoid common pitfalls while realizing your vision.” Mr. Beer has turned this topic into a unique article for this special section (see next month’s issue for Part 2).

Our TeLinde Lecture, entitled “Artificial intelligence in surgery,” was delivered by the dynamic Vicente Gracias, MD, professor of surgery at Robert Wood Johnson University Hospital, New Brunswick, New Jersey. We also held 2 live panel discussions that were very popular. The first, “Work-life balance and gynecologic surgery,” featured various perspectives from Drs. Kristie Green, Sally Huber, Catherine Matthews, and Charles Rardin. The second panel discussion, entitled “Understanding, managing, and benefiting from your e-presence,” by experts Heather Schueppert; Chief Marketing Officer at Unified Physician Management, Brad Bowman, MD; and Peter Lotze, MD. Both of these panel discussions are included in this special section as well.

I hope you enjoy the content of this special section of OBG Management highlighting the 2020 SGS meeting. Watch for part 2 in the next issue, and I hope to see you at our 47th Annual Scientific Meeting in Palm Springs, California, in March 2021.

Patient outcomes after gender-affirming vaginoplasty may improve as surgeons gain experience with the procedure, research suggests. For one surgeon, certain adverse events, including the need for revision surgery, were less likely after 50 cases.

“As surgical programs evolve, the important question becomes: At what case threshold are cases performed safely, efficiently, and with favorable outcomes?” said Cecile A. Ferrando, MD, MPH, program director of the female pelvic medicine and reconstructive surgery fellowship at Cleveland Clinic and director of the transgender surgery and medicine program in the Cleveland Clinic’s Center for LGBT Care.

The answer could guide training for future surgeons, Dr. Ferrando said at the virtual annual scientific meeting of the Society of Gynecologic Surgeons. Future studies should include patient-centered outcomes and data from multiple centers, other doctors said.

Transgender women who opt to surgically transition may undergo vaginoplasty. Although many reports describe surgical techniques, “there is a paucity of evidence-based data as well as few reports on outcomes,” Dr. Ferrando noted.

To describe perioperative adverse events related to vaginoplasty performed for gender affirmation and determine a minimum number of cases needed to reduce their likelihood, Dr. Ferrando performed a retrospective study of 76 patients. The patients underwent surgery between December 2015 and March 2019 and had 6-month postoperative outcomes available. Dr. Ferrando performed the procedures.

Dr. Ferrando evaluated outcomes after increments of 10 cases. After 50 cases, the median surgical time decreased to approximately 180 minutes, which an informal survey of surgeons suggested was efficient, and the rates of adverse events were similar to those in other studies. Dr. Ferrando compared outcomes from the first 50 cases with outcomes from the 26 cases that followed.

Overall, the patients had a mean age of 41 years. The first 50 patients were older on average (44 years vs. 35 years). About 83% underwent full-depth vaginoplasty. The incidence of intraoperative and immediate postoperative events was low and did not differ between the two groups. Rates of delayed postoperative events – those occurring 30 or more days after surgery – did significantly differ between the two groups, however.

After 50 cases, there was a lower incidence of urinary stream abnormalities (7.7% vs. 16.3%), introital stenosis (3.9% vs. 12%), and revision surgery (that is, elective, cosmetic, or functional revision within 6 months; 19.2% vs. 44%), compared with the first 50 cases.

The study did not include patient-centered outcomes and the results may have limited generalizability, Dr. Ferrando noted. “The incidence of serious adverse events related to vaginoplasty is low while minor events are common,” she said. “A 50-case minimum may be an adequate case number target for postgraduate trainees learning how to do this surgery.”

“I learned that the incidence of serious complications, like injuries during the surgery, or serious events immediately after surgery was quite low, which was reassuring,” Dr. Ferrando said in a later interview. “The cosmetic result and detail that is involved with the surgery – something that is very important to patients – that skill set takes time and experience to refine.”

Subsequent studies should include patient-centered outcomes, which may help surgeons understand potential “sources of consternation for patients,” such as persistent corporal tissue, poor aesthetics, vaginal stenosis, urinary meatus location, and clitoral hooding, Joseph J. Pariser, MD, commented in an interview. Dr. Pariser, a urologist who specializes in gender care at the University of Minnesota in Minneapolis, in 2019 reviewed safety outcomes from published case series.

“In my own practice, precise placement of the urethra, familiarity with landmarks during canal dissection, and rapidity of working through steps of the surgery have all dramatically improved as our experience at University of Minnesota performing primary vaginoplasty has grown,” Dr. Pariser said.

Optimal case thresholds may vary depending on a surgeon’s background, Rachel M. Whynott, MD, a reproductive endocrinology and infertility fellow at the University of Iowa in Iowa City, said in an interview. At the University of Kansas in Kansas City, a multidisciplinary team that includes a gynecologist, a reconstructive urologist, and a plastic surgeon performs the procedure.

Dr. Whynott and colleagues recently published a retrospective study that evaluated surgical aptitude over time in a male-to-female penoscrotal vaginoplasty program . Their analysis of 43 cases identified a learning curve that was reflected in overall time in the operating room and time to neoclitoral sensation.

Investigators are “trying to add to the growing body of literature about this procedure and how we can best go about improving outcomes for our patients and improving this surgery,” Dr. Whynott said. A study that includes data from multiple centers would be useful, she added.

Dr. Ferrando disclosed authorship royalties from UpToDate. Dr. Pariser and Dr. Whynott had no relevant financial disclosures.

jremaly@mdedge.com

SOURCE: Ferrando C. SGS 2020, Abstract 09.

Patient outcomes after gender-affirming vaginoplasty may improve as surgeons gain experience with the procedure, research suggests. For one surgeon, certain adverse events, including the need for revision surgery, were less likely after 50 cases.

“As surgical programs evolve, the important question becomes: At what case threshold are cases performed safely, efficiently, and with favorable outcomes?” said Cecile A. Ferrando, MD, MPH, program director of the female pelvic medicine and reconstructive surgery fellowship at Cleveland Clinic and director of the transgender surgery and medicine program in the Cleveland Clinic’s Center for LGBT Care.

The answer could guide training for future surgeons, Dr. Ferrando said at the virtual annual scientific meeting of the Society of Gynecologic Surgeons. Future studies should include patient-centered outcomes and data from multiple centers, other doctors said.

Transgender women who opt to surgically transition may undergo vaginoplasty. Although many reports describe surgical techniques, “there is a paucity of evidence-based data as well as few reports on outcomes,” Dr. Ferrando noted.

To describe perioperative adverse events related to vaginoplasty performed for gender affirmation and determine a minimum number of cases needed to reduce their likelihood, Dr. Ferrando performed a retrospective study of 76 patients. The patients underwent surgery between December 2015 and March 2019 and had 6-month postoperative outcomes available. Dr. Ferrando performed the procedures.

Dr. Ferrando evaluated outcomes after increments of 10 cases. After 50 cases, the median surgical time decreased to approximately 180 minutes, which an informal survey of surgeons suggested was efficient, and the rates of adverse events were similar to those in other studies. Dr. Ferrando compared outcomes from the first 50 cases with outcomes from the 26 cases that followed.

Overall, the patients had a mean age of 41 years. The first 50 patients were older on average (44 years vs. 35 years). About 83% underwent full-depth vaginoplasty. The incidence of intraoperative and immediate postoperative events was low and did not differ between the two groups. Rates of delayed postoperative events – those occurring 30 or more days after surgery – did significantly differ between the two groups, however.

After 50 cases, there was a lower incidence of urinary stream abnormalities (7.7% vs. 16.3%), introital stenosis (3.9% vs. 12%), and revision surgery (that is, elective, cosmetic, or functional revision within 6 months; 19.2% vs. 44%), compared with the first 50 cases.

The study did not include patient-centered outcomes and the results may have limited generalizability, Dr. Ferrando noted. “The incidence of serious adverse events related to vaginoplasty is low while minor events are common,” she said. “A 50-case minimum may be an adequate case number target for postgraduate trainees learning how to do this surgery.”

“I learned that the incidence of serious complications, like injuries during the surgery, or serious events immediately after surgery was quite low, which was reassuring,” Dr. Ferrando said in a later interview. “The cosmetic result and detail that is involved with the surgery – something that is very important to patients – that skill set takes time and experience to refine.”

Subsequent studies should include patient-centered outcomes, which may help surgeons understand potential “sources of consternation for patients,” such as persistent corporal tissue, poor aesthetics, vaginal stenosis, urinary meatus location, and clitoral hooding, Joseph J. Pariser, MD, commented in an interview. Dr. Pariser, a urologist who specializes in gender care at the University of Minnesota in Minneapolis, in 2019 reviewed safety outcomes from published case series.

“In my own practice, precise placement of the urethra, familiarity with landmarks during canal dissection, and rapidity of working through steps of the surgery have all dramatically improved as our experience at University of Minnesota performing primary vaginoplasty has grown,” Dr. Pariser said.

Optimal case thresholds may vary depending on a surgeon’s background, Rachel M. Whynott, MD, a reproductive endocrinology and infertility fellow at the University of Iowa in Iowa City, said in an interview. At the University of Kansas in Kansas City, a multidisciplinary team that includes a gynecologist, a reconstructive urologist, and a plastic surgeon performs the procedure.

Dr. Whynott and colleagues recently published a retrospective study that evaluated surgical aptitude over time in a male-to-female penoscrotal vaginoplasty program . Their analysis of 43 cases identified a learning curve that was reflected in overall time in the operating room and time to neoclitoral sensation.

Investigators are “trying to add to the growing body of literature about this procedure and how we can best go about improving outcomes for our patients and improving this surgery,” Dr. Whynott said. A study that includes data from multiple centers would be useful, she added.

Dr. Ferrando disclosed authorship royalties from UpToDate. Dr. Pariser and Dr. Whynott had no relevant financial disclosures.

jremaly@mdedge.com

SOURCE: Ferrando C. SGS 2020, Abstract 09.

Patient outcomes after gender-affirming vaginoplasty may improve as surgeons gain experience with the procedure, research suggests. For one surgeon, certain adverse events, including the need for revision surgery, were less likely after 50 cases.

“As surgical programs evolve, the important question becomes: At what case threshold are cases performed safely, efficiently, and with favorable outcomes?” said Cecile A. Ferrando, MD, MPH, program director of the female pelvic medicine and reconstructive surgery fellowship at Cleveland Clinic and director of the transgender surgery and medicine program in the Cleveland Clinic’s Center for LGBT Care.

The answer could guide training for future surgeons, Dr. Ferrando said at the virtual annual scientific meeting of the Society of Gynecologic Surgeons. Future studies should include patient-centered outcomes and data from multiple centers, other doctors said.

Transgender women who opt to surgically transition may undergo vaginoplasty. Although many reports describe surgical techniques, “there is a paucity of evidence-based data as well as few reports on outcomes,” Dr. Ferrando noted.

To describe perioperative adverse events related to vaginoplasty performed for gender affirmation and determine a minimum number of cases needed to reduce their likelihood, Dr. Ferrando performed a retrospective study of 76 patients. The patients underwent surgery between December 2015 and March 2019 and had 6-month postoperative outcomes available. Dr. Ferrando performed the procedures.

Dr. Ferrando evaluated outcomes after increments of 10 cases. After 50 cases, the median surgical time decreased to approximately 180 minutes, which an informal survey of surgeons suggested was efficient, and the rates of adverse events were similar to those in other studies. Dr. Ferrando compared outcomes from the first 50 cases with outcomes from the 26 cases that followed.

Overall, the patients had a mean age of 41 years. The first 50 patients were older on average (44 years vs. 35 years). About 83% underwent full-depth vaginoplasty. The incidence of intraoperative and immediate postoperative events was low and did not differ between the two groups. Rates of delayed postoperative events – those occurring 30 or more days after surgery – did significantly differ between the two groups, however.

After 50 cases, there was a lower incidence of urinary stream abnormalities (7.7% vs. 16.3%), introital stenosis (3.9% vs. 12%), and revision surgery (that is, elective, cosmetic, or functional revision within 6 months; 19.2% vs. 44%), compared with the first 50 cases.

The study did not include patient-centered outcomes and the results may have limited generalizability, Dr. Ferrando noted. “The incidence of serious adverse events related to vaginoplasty is low while minor events are common,” she said. “A 50-case minimum may be an adequate case number target for postgraduate trainees learning how to do this surgery.”

“I learned that the incidence of serious complications, like injuries during the surgery, or serious events immediately after surgery was quite low, which was reassuring,” Dr. Ferrando said in a later interview. “The cosmetic result and detail that is involved with the surgery – something that is very important to patients – that skill set takes time and experience to refine.”

Subsequent studies should include patient-centered outcomes, which may help surgeons understand potential “sources of consternation for patients,” such as persistent corporal tissue, poor aesthetics, vaginal stenosis, urinary meatus location, and clitoral hooding, Joseph J. Pariser, MD, commented in an interview. Dr. Pariser, a urologist who specializes in gender care at the University of Minnesota in Minneapolis, in 2019 reviewed safety outcomes from published case series.

“In my own practice, precise placement of the urethra, familiarity with landmarks during canal dissection, and rapidity of working through steps of the surgery have all dramatically improved as our experience at University of Minnesota performing primary vaginoplasty has grown,” Dr. Pariser said.

Optimal case thresholds may vary depending on a surgeon’s background, Rachel M. Whynott, MD, a reproductive endocrinology and infertility fellow at the University of Iowa in Iowa City, said in an interview. At the University of Kansas in Kansas City, a multidisciplinary team that includes a gynecologist, a reconstructive urologist, and a plastic surgeon performs the procedure.

Dr. Whynott and colleagues recently published a retrospective study that evaluated surgical aptitude over time in a male-to-female penoscrotal vaginoplasty program . Their analysis of 43 cases identified a learning curve that was reflected in overall time in the operating room and time to neoclitoral sensation.

Investigators are “trying to add to the growing body of literature about this procedure and how we can best go about improving outcomes for our patients and improving this surgery,” Dr. Whynott said. A study that includes data from multiple centers would be useful, she added.

Dr. Ferrando disclosed authorship royalties from UpToDate. Dr. Pariser and Dr. Whynott had no relevant financial disclosures.

jremaly@mdedge.com

SOURCE: Ferrando C. SGS 2020, Abstract 09.

To have a thriving business in today’s world, a functioning website is crucial to the overall business health. For a medical practice in general, and for its physicians specifically, it is one of the first steps for maintaining a practice. But to grow that practice, it is crucial to take the steps beyond just having a website. Growth requires website opti­mization for search engines, an expanding referral base, and the knowledge to use web tools and social media at your disposal to promote the practice and its physicians. In this roundtable, several marketing experts and web-savvy physicians discuss using available tools to best position and grow a practice.

Choosing a web upgrade

Patrick J. Culligan, MD: Peter, can you start us off by describing your relationship with Heather, and how your practice benefitted from her expertise?

Peter M. Lotze, MD: Sure. I am a urogynecologist in the competitive market of pelvic reconstructive surgery in Houston, Texas. Within that market, my main approach was to reach out to other physicians to refer patients to my practice. It generally would work, but took increasingly greater amounts of time to call these physicians up, write them letters, and maintain relationships. I felt that the large, national practice group that I am in did not have a significant web presence optimized to promote my practice, which makes it difficult for patients seeking your services to find you in their search for a doctor. It is helpful for patients to be able to understand from your website who you are, what you do, and what their experience may be like.

Glaring to me was that a web search specific for me or things that I do, would not produce our company’s results until page 2 or more on Google. This can be devastating for a practice because most people don’t go past the first page, and you can end up with fewer self-referrals, which should be a significant portion of new patients to your practice. I knew I needed guidance; I knew of Heather’s expertise given her exceptional past work building marketing strategies.

Digital go-tos for marketing

Heather Schueppert: Yes, I was pleased to work with Dr. Lotze, and at the time was a marketing consultant for practices such as his. But gone are the days of printed material—brochures, pamphlets, or even billboards—to effectively promote a business, or in this case, a practice. What still withstands the test of time, however, as the number 1 marketing referral source is word of mouth—from your trusted friend, family member, or coworker.

It is now proven that the number 2 most trusted form of advertising, the most persuasive and the most motivating, is online marketing.¹ It is the “digital word of mouth”—the review. Patients are actively online, and a strong digital presence is critical to provide that direct value to retain and grow your patient base.

Continue to: Foundations of private practice reach out...

Foundations of private practice reach out

There are 3 important areas that I consider the foundation of any private practice marketing strategy (TABLE). First is an updated website that is search engine optimized (SEO). You can’t just set it and forget it, it needs to be an updated website. The algorithms for search engines are changing constantly to try to make it as fair and relevant as possible for patients or consumers to find the businesses they are searching for online.

The second area is review management, and for a physician, or even a care center, to do this on your own is a daunting task. It is a critical component, however, to making sure that your reputation out there, that online word of mouth, is as high a star rating as possible.

The third component is local search, which is basically a form of SEO that helps businesses show up in relevant local searches. We are all familiar with the search, “find a restaurant near me,” anything that pushes those search engines to find something local.

Those are what I call the effective triad: that updated website, the review management, and the local search, and all of these are tied together. I think Dr. Lotze and his practice did these effectively well, and I believe that he achieved his goals for the longer term.

Review/reputation management

Dr. Culligan: Brad, is there something that doctors may not know about Healthgrades, and are there opportunities to take full advantage of this physician-rating site?

Brad Bowman, MD: I agree with everything that Dr. Lotze and Heather have said. Start with yourself—what is it that you want to be, the one thing you want to stand for? Get your own marketing, your website right, then, the point is, once you do all that and you are number 1 in SEO, you are still only going to get about 25% of the people looking for you by name to come to your website. The other 75% are going to look at all the other different sites that are out there to provide information to consumers. So the question becomes what do you do with all these other third-party sites? Healthgrades is the most comprehensive and has the highest traffic of the third-party “find a doctor” sites. In 2020, half of all Americans who go to a doctor will use Healthgrades at some point to help select and connect with that doctor.

Physicians have their focus on the quality of the care they provide. Patients, however, focus on the quality of the entire health care experience. Did I get better? How long did I have to wait? Was the office staff helpful? Scarily enough, we still spend more time shopping for a refrigerator or mattress than we do shopping for a doctor. We still tend to think that all doctors are the same. It is the reality of how we have been trained by our insurance companies and by the health care system. That is why getting your marketing right and getting what is it that you want to be known for out there is important, so that you can get the types of patients you want.

Listings management is very important. Make sure that you are findable everywhere. There are services that will do this: Doctor.com, Reputation.com, and many others. They can help you make sure you get all your basic materials right: addresses, phone numbers, your picture. Because 75% of people are going to end up on third-party websites, if your phone number is wrong there, you could lose that patient.

Then the second piece of working with third-party sites is reputation management. Physician reviews are not a bad thing, they are the new word of mouth, as Heather pointed out. Most (80%) of the reviews are going to be positive. The others will be negative, and that is okay. It is important that you get at least 1 or 2 reviews on all the different sites. We know from Healthgrades.com that going from zero reviews to 1 review will increase your call volume by 60%. If you have the choice between 2 physicians and one practice looks like people have been there before, you will go to that one.

You can learn from reviews as well, consumers provide valid feedback. Best practice is to respond to every positive and negative review. Thank them, indicate that you have listened to them, and address any concerns as necessary.

Continue to: Dr. Lotze...

Dr. Lotze: As an example, one of the paramount things that Heather introduced me to was the third party I use to run my website. That company sends a HIPAA-compliant review out to each patient we have seen that day and gives them the opportunity to rate our services and leave comments. If a patient brings up a concern, we can respond immediately, which is important. Patients appreciate feeling that they have been heard. Typically, communicating with a patient will turn the 3-star review into a 5-star as she follows up with the practice.

Ms. Schueppert: Timeliness is important. And just to mention, there certainly is a time commitment to this (and it is a marathon versus a sprint) and there is some financial investment to get it going, but it could truly be detrimental to a practice if you decide not to do anything at all.

Dr. Bowman: Agencies can really help with the time commitment.

Handling bad reviews

Dr. Culligan: What about that person who seems to have it out for you, perhaps giving you multiple bad reviews?

Dr. Bowman: I have seen this before. At Healthgrades, we recently analyzed 8.4 million patient reviews to see what people wrote about.² The first thing they will talk about is quality of care as they see it. Did I get better or not? You can’t “fix” every patient; there will be some that you cannot help. The next thing patients comment on is bedside manner. With negative reviews, you will see more comments about the office staff.²

A single negative review actually helps make the positive ones look more credible. But if you do believe someone is trolling you, we can flag it and will investigate to the best of our ability. (Different sites likely have different editorial policies.) For example, we look at the IP addresses of all reviews, and if multiple reviews are coming from the same location, we would only let one through, overwriting the previous review from that address.

Patients just want to be heard. We have seen people change their views, based on how their review is handled and responded to.

Dr. Lotze: Is there a response by the physician that you think tends to work better in terms of resolving the issue that can minimize a perceived caustic reaction to a patient’s criticism?

Dr. Bowman: First, just like with any stressful situation, take a deep breath and respond when you feel like you can be constructive. When you do respond, be gracious. Thank them for their feedback. Make sure you reference something about their concern: “I understand that you had to wait longer than you would have liked.” Acknowledge the problem they reference, and then just apologize: “I’m sorry we didn’t meet your expectations.” Then, if they waited too long for example, “We have a new system where no one should have to wait more than 30 minutes….” You can respond privately or publically. Generally, public responses are better as it shows other consumers that you are willing to listen and consider their point of view.

Continue to: The next phase at Healthgrades...

The next phase at Healthgrades

Dr. Culligan: Do you see changes to the way physician-rating sites are working now? Are we going to stay status quo over the next 10 years, or do you see frontiers in how your site is going to develop?

Dr. Bowman: For Healthgrades, we rely on quantitative and objective measures, not just the qualitative. We are investing heavily right now in trying to help consumers understand what are the relative volumes of different procedures or different patient types that each individual doctor sees. Orthopedics is an easy example—if you have a knee problem, you want to go to someone who specializes in knees. Our job is to help consumers easily identify, “This is a shoulder doctor, this is a knee doctor, and this is why that matters.”

In the meantime, as a physician, you can always go into our site and state your care philosophy, identifying what is the sort of patient that you like to treat. Transparency is good for everyone, and especially physicians. It helps the right patient show up for you, and it helps you do a better job providing referrals.

Social media: Avoid pitfalls, and use it to your benefit

Dr. Lotze: Branding was one of the things that I was confused about, and Heather really helped me out. As physicians, we put ourselves out there on our websites, which we try to make professional sources of information for patients. But patients often want to see what else they can find out about us, including Healthgrades and social media. I think the thing that is important to know with social media is that it is a place where people learn about you as a person. Your social media should be another avenue of promotion. Whether it is your personal or professional Facebook page, people are going to see those sites. You have an opportunity to promote yourself as a good physician and a good person with a wholesome practice that you want people to come to. If a physician is posting questionable things about themselves on any kind of social media, it could be perceived as inappropriate by the patient. That can impact how patients think of you as a person, and how they are going to grade you. If people lose sight of who you are due to a questionable social media posting, everything else (SEO, the website) can be for naught.

Dr. Culligan: What are the most important social media tools to invest your time in?

Ms. Schueppert: Before anybody jumps into social media, I firmly recommend that you make sure your local search and your Google 3-pack is set up—which is basically a method Google uses to display the top 3 results on its listings page. Then make sure you have a review management system in place. Make sure you have that updated website. Those are the foundational elements. Once you have that going, social media is the next added layer to that digital presence.

I usually recommend LinkedIn. It is huge because you are staying in contact with your colleagues, that business-to-business type of connection. It remains a way for physicians to set themselves up as experts in their level of specialty.

From there, it’s either Instagram or Facebook. If you are serving more of the younger generations, the millennials and younger, then Instagram is the way to go. If you are focusing on your 40+, 50+, they are going to be far more on Facebook.

Continue to: Dr. Lotze...

Dr. Lotze: For me, a Facebook page was a great place to start. The cost of those Google ads—the first things we see at the top of a Google search in their own separate box—is significant. If a practice has that kind of money to invest, great; it is an instant way to be first on the page during a search. But there are more cost-effective ways of doing that, especially as you are getting your name out. Facebook provides, at a smaller cost, promotion of whatever it is that you are seeking to promote. You can find people within a certain zip code, for instance, and use a Facebook ad campaign that can drive people to your Facebook page—which should have both routinely updated new posts and a link to your website. The posts should be interesting topics relevant to the patients you wish to treat (avoiding personal stories or controversial discussions). You can put a post together, or you can have a third-party service do this. People who follow your page will get reminders of you and your practice with each new post. As your page followers increase, your Facebook rank will improve, and your page will more likely be discovered by Facebook searches for your services. With an added link to your office practice website, those patients go straight to your site without getting lost in the noise of Google search results.

For Instagram, a short video or an interesting picture, along with a brief statement, are the essentials. You can add a single link. Marketing here is by direct messaging or having patients going to your website through a link. Instagram, like Facebook, offers analytics to help show you what your audience likes to read about, improving the quality of your posts and increasing number of followers.

YouTube is the number 2 search engine behind Google. A Google search for your field of medicine may be filled with pages of competitors. However, YouTube has a much lower volume of competing practices, making it easier for patients to find you. The only downside to YouTube is that it will list your video along with other competing videos, which can draw attention away from your practice.

If you want to promote your website or practice with video, using a company such as Vimeo is a better choice compared with YouTube, as YouTube gets credit for video views—which improves YouTube’s SEO and not your own website. Vimeo allows for your website to get credit each time the video is watched. Regardless of where you place your videos, make them short and to the point, with links to your website. Videos only need to be long enough to get your message across and stimulate interest in your practice.

If you can have a blog on your website, it also will help with SEO. What a search engine like Google wants to see is that a patient is on your web page and looking at something for at least 60 seconds. If so, the website is deemed to have information that is relevant, improving your SEO ranking.

Finally, Twitter also can be used for getting messaging out and for branding. The problem with it is that many people go to Twitter to follow a Hollywood celebrity, a sports star, or are looking for mass communication. There is less interest on Twitter for physician outreach.

Continue to: Measuring ROI...

Dr. Culligan: What’s the best way to track your return on investment?

Dr. Lotze: First for me was to find out what didn’t work in the office and fix that before really promoting my practice. It’s about the global experience for a patient, as Brad mentioned. As a marketing expert, Heather met with me to understand my goals. She then called my office as a patient to set up an appointment and went through that entire office experience. We identified issues needing improvement.

The next step was to develop a working relationship with my webmaster—someone who can help manage Internet image and SEO. Together, you will develop goals for what the SEO should promote specific to your practice. Once a good SEO program is in place, your website’s ranking will go up—although it can take a minimum of 6 months to see a significant increase. To help understand your website’s performance, your webmaster should provide you with reports on your site’s analytics.

As you go through this process, it is great to have a marketing expert to be the point person. You will work closely together for a while, but eventually you can back off over time. The time and expense you invest on the front end have huge rewards on the back end. Currently, I still spend a reasonable amount of money every month. I have a high self-referral base because of these efforts, however, which results in more patient surgeries and easily covers my expenses. It is money well invested. My website traffic increased by 268% over 2 years (FIGURE). I’ll propose that currently more than half of my patients are self-referrals due to online marketing.

Ms. Schueppert: The only thing I would add is training your front staff. They are checking people in, taking appointments, checking your patients out. Have them be mindful that there are campaigns going on, whether it is a social media push, or a new video that went on the website. They can ask, “How did you hear about us?” when a new patient calls.

Dr. Bowman: Unless you are a large university hospital, where the analytics get significantly more advanced in terms of measuring return on investment (ROI), I think you should just be looking at your schedule and looking at your monthly billings and seeing how they change over time. You can calculate how much a new patient is worth because you can figure out how many patients you have and how much you bill and what your profits are.

Dr. Culligan: For those of us who are hospital employees, you can try to convince the hospital that you can do a detailed ROI analysis, or you can just look at it like (say it’s $3,000 per month), how many surgeries does this project have to generate before the hospital makes that back? The answer is a fraction of 1 case.

Thank you to all of you for your expertise on this roundtable. 

To have a thriving business in today’s world, a functioning website is crucial to the overall business health. For a medical practice in general, and for its physicians specifically, it is one of the first steps for maintaining a practice. But to grow that practice, it is crucial to take the steps beyond just having a website. Growth requires website opti­mization for search engines, an expanding referral base, and the knowledge to use web tools and social media at your disposal to promote the practice and its physicians. In this roundtable, several marketing experts and web-savvy physicians discuss using available tools to best position and grow a practice.

Choosing a web upgrade

Patrick J. Culligan, MD: Peter, can you start us off by describing your relationship with Heather, and how your practice benefitted from her expertise?

Peter M. Lotze, MD: Sure. I am a urogynecologist in the competitive market of pelvic reconstructive surgery in Houston, Texas. Within that market, my main approach was to reach out to other physicians to refer patients to my practice. It generally would work, but took increasingly greater amounts of time to call these physicians up, write them letters, and maintain relationships. I felt that the large, national practice group that I am in did not have a significant web presence optimized to promote my practice, which makes it difficult for patients seeking your services to find you in their search for a doctor. It is helpful for patients to be able to understand from your website who you are, what you do, and what their experience may be like.

Glaring to me was that a web search specific for me or things that I do, would not produce our company’s results until page 2 or more on Google. This can be devastating for a practice because most people don’t go past the first page, and you can end up with fewer self-referrals, which should be a significant portion of new patients to your practice. I knew I needed guidance; I knew of Heather’s expertise given her exceptional past work building marketing strategies.

Digital go-tos for marketing

Heather Schueppert: Yes, I was pleased to work with Dr. Lotze, and at the time was a marketing consultant for practices such as his. But gone are the days of printed material—brochures, pamphlets, or even billboards—to effectively promote a business, or in this case, a practice. What still withstands the test of time, however, as the number 1 marketing referral source is word of mouth—from your trusted friend, family member, or coworker.

It is now proven that the number 2 most trusted form of advertising, the most persuasive and the most motivating, is online marketing.¹ It is the “digital word of mouth”—the review. Patients are actively online, and a strong digital presence is critical to provide that direct value to retain and grow your patient base.

Continue to: Foundations of private practice reach out...

Foundations of private practice reach out

There are 3 important areas that I consider the foundation of any private practice marketing strategy (TABLE). First is an updated website that is search engine optimized (SEO). You can’t just set it and forget it, it needs to be an updated website. The algorithms for search engines are changing constantly to try to make it as fair and relevant as possible for patients or consumers to find the businesses they are searching for online.

The second area is review management, and for a physician, or even a care center, to do this on your own is a daunting task. It is a critical component, however, to making sure that your reputation out there, that online word of mouth, is as high a star rating as possible.

The third component is local search, which is basically a form of SEO that helps businesses show up in relevant local searches. We are all familiar with the search, “find a restaurant near me,” anything that pushes those search engines to find something local.

Those are what I call the effective triad: that updated website, the review management, and the local search, and all of these are tied together. I think Dr. Lotze and his practice did these effectively well, and I believe that he achieved his goals for the longer term.

Review/reputation management

Dr. Culligan: Brad, is there something that doctors may not know about Healthgrades, and are there opportunities to take full advantage of this physician-rating site?

Brad Bowman, MD: I agree with everything that Dr. Lotze and Heather have said. Start with yourself—what is it that you want to be, the one thing you want to stand for? Get your own marketing, your website right, then, the point is, once you do all that and you are number 1 in SEO, you are still only going to get about 25% of the people looking for you by name to come to your website. The other 75% are going to look at all the other different sites that are out there to provide information to consumers. So the question becomes what do you do with all these other third-party sites? Healthgrades is the most comprehensive and has the highest traffic of the third-party “find a doctor” sites. In 2020, half of all Americans who go to a doctor will use Healthgrades at some point to help select and connect with that doctor.

Physicians have their focus on the quality of the care they provide. Patients, however, focus on the quality of the entire health care experience. Did I get better? How long did I have to wait? Was the office staff helpful? Scarily enough, we still spend more time shopping for a refrigerator or mattress than we do shopping for a doctor. We still tend to think that all doctors are the same. It is the reality of how we have been trained by our insurance companies and by the health care system. That is why getting your marketing right and getting what is it that you want to be known for out there is important, so that you can get the types of patients you want.

Listings management is very important. Make sure that you are findable everywhere. There are services that will do this: Doctor.com, Reputation.com, and many others. They can help you make sure you get all your basic materials right: addresses, phone numbers, your picture. Because 75% of people are going to end up on third-party websites, if your phone number is wrong there, you could lose that patient.

Then the second piece of working with third-party sites is reputation management. Physician reviews are not a bad thing, they are the new word of mouth, as Heather pointed out. Most (80%) of the reviews are going to be positive. The others will be negative, and that is okay. It is important that you get at least 1 or 2 reviews on all the different sites. We know from Healthgrades.com that going from zero reviews to 1 review will increase your call volume by 60%. If you have the choice between 2 physicians and one practice looks like people have been there before, you will go to that one.

You can learn from reviews as well, consumers provide valid feedback. Best practice is to respond to every positive and negative review. Thank them, indicate that you have listened to them, and address any concerns as necessary.

Continue to: Dr. Lotze...

Dr. Lotze: As an example, one of the paramount things that Heather introduced me to was the third party I use to run my website. That company sends a HIPAA-compliant review out to each patient we have seen that day and gives them the opportunity to rate our services and leave comments. If a patient brings up a concern, we can respond immediately, which is important. Patients appreciate feeling that they have been heard. Typically, communicating with a patient will turn the 3-star review into a 5-star as she follows up with the practice.

Ms. Schueppert: Timeliness is important. And just to mention, there certainly is a time commitment to this (and it is a marathon versus a sprint) and there is some financial investment to get it going, but it could truly be detrimental to a practice if you decide not to do anything at all.

Dr. Bowman: Agencies can really help with the time commitment.

Handling bad reviews

Dr. Culligan: What about that person who seems to have it out for you, perhaps giving you multiple bad reviews?

Dr. Bowman: I have seen this before. At Healthgrades, we recently analyzed 8.4 million patient reviews to see what people wrote about.² The first thing they will talk about is quality of care as they see it. Did I get better or not? You can’t “fix” every patient; there will be some that you cannot help. The next thing patients comment on is bedside manner. With negative reviews, you will see more comments about the office staff.²

A single negative review actually helps make the positive ones look more credible. But if you do believe someone is trolling you, we can flag it and will investigate to the best of our ability. (Different sites likely have different editorial policies.) For example, we look at the IP addresses of all reviews, and if multiple reviews are coming from the same location, we would only let one through, overwriting the previous review from that address.

Patients just want to be heard. We have seen people change their views, based on how their review is handled and responded to.

Dr. Lotze: Is there a response by the physician that you think tends to work better in terms of resolving the issue that can minimize a perceived caustic reaction to a patient’s criticism?

Dr. Bowman: First, just like with any stressful situation, take a deep breath and respond when you feel like you can be constructive. When you do respond, be gracious. Thank them for their feedback. Make sure you reference something about their concern: “I understand that you had to wait longer than you would have liked.” Acknowledge the problem they reference, and then just apologize: “I’m sorry we didn’t meet your expectations.” Then, if they waited too long for example, “We have a new system where no one should have to wait more than 30 minutes….” You can respond privately or publically. Generally, public responses are better as it shows other consumers that you are willing to listen and consider their point of view.

Continue to: The next phase at Healthgrades...

The next phase at Healthgrades

Dr. Culligan: Do you see changes to the way physician-rating sites are working now? Are we going to stay status quo over the next 10 years, or do you see frontiers in how your site is going to develop?

Dr. Bowman: For Healthgrades, we rely on quantitative and objective measures, not just the qualitative. We are investing heavily right now in trying to help consumers understand what are the relative volumes of different procedures or different patient types that each individual doctor sees. Orthopedics is an easy example—if you have a knee problem, you want to go to someone who specializes in knees. Our job is to help consumers easily identify, “This is a shoulder doctor, this is a knee doctor, and this is why that matters.”

In the meantime, as a physician, you can always go into our site and state your care philosophy, identifying what is the sort of patient that you like to treat. Transparency is good for everyone, and especially physicians. It helps the right patient show up for you, and it helps you do a better job providing referrals.

Social media: Avoid pitfalls, and use it to your benefit

Dr. Lotze: Branding was one of the things that I was confused about, and Heather really helped me out. As physicians, we put ourselves out there on our websites, which we try to make professional sources of information for patients. But patients often want to see what else they can find out about us, including Healthgrades and social media. I think the thing that is important to know with social media is that it is a place where people learn about you as a person. Your social media should be another avenue of promotion. Whether it is your personal or professional Facebook page, people are going to see those sites. You have an opportunity to promote yourself as a good physician and a good person with a wholesome practice that you want people to come to. If a physician is posting questionable things about themselves on any kind of social media, it could be perceived as inappropriate by the patient. That can impact how patients think of you as a person, and how they are going to grade you. If people lose sight of who you are due to a questionable social media posting, everything else (SEO, the website) can be for naught.

Dr. Culligan: What are the most important social media tools to invest your time in?

Ms. Schueppert: Before anybody jumps into social media, I firmly recommend that you make sure your local search and your Google 3-pack is set up—which is basically a method Google uses to display the top 3 results on its listings page. Then make sure you have a review management system in place. Make sure you have that updated website. Those are the foundational elements. Once you have that going, social media is the next added layer to that digital presence.

I usually recommend LinkedIn. It is huge because you are staying in contact with your colleagues, that business-to-business type of connection. It remains a way for physicians to set themselves up as experts in their level of specialty.

From there, it’s either Instagram or Facebook. If you are serving more of the younger generations, the millennials and younger, then Instagram is the way to go. If you are focusing on your 40+, 50+, they are going to be far more on Facebook.

Continue to: Dr. Lotze...

Dr. Lotze: For me, a Facebook page was a great place to start. The cost of those Google ads—the first things we see at the top of a Google search in their own separate box—is significant. If a practice has that kind of money to invest, great; it is an instant way to be first on the page during a search. But there are more cost-effective ways of doing that, especially as you are getting your name out. Facebook provides, at a smaller cost, promotion of whatever it is that you are seeking to promote. You can find people within a certain zip code, for instance, and use a Facebook ad campaign that can drive people to your Facebook page—which should have both routinely updated new posts and a link to your website. The posts should be interesting topics relevant to the patients you wish to treat (avoiding personal stories or controversial discussions). You can put a post together, or you can have a third-party service do this. People who follow your page will get reminders of you and your practice with each new post. As your page followers increase, your Facebook rank will improve, and your page will more likely be discovered by Facebook searches for your services. With an added link to your office practice website, those patients go straight to your site without getting lost in the noise of Google search results.

For Instagram, a short video or an interesting picture, along with a brief statement, are the essentials. You can add a single link. Marketing here is by direct messaging or having patients going to your website through a link. Instagram, like Facebook, offers analytics to help show you what your audience likes to read about, improving the quality of your posts and increasing number of followers.

YouTube is the number 2 search engine behind Google. A Google search for your field of medicine may be filled with pages of competitors. However, YouTube has a much lower volume of competing practices, making it easier for patients to find you. The only downside to YouTube is that it will list your video along with other competing videos, which can draw attention away from your practice.

If you want to promote your website or practice with video, using a company such as Vimeo is a better choice compared with YouTube, as YouTube gets credit for video views—which improves YouTube’s SEO and not your own website. Vimeo allows for your website to get credit each time the video is watched. Regardless of where you place your videos, make them short and to the point, with links to your website. Videos only need to be long enough to get your message across and stimulate interest in your practice.

If you can have a blog on your website, it also will help with SEO. What a search engine like Google wants to see is that a patient is on your web page and looking at something for at least 60 seconds. If so, the website is deemed to have information that is relevant, improving your SEO ranking.

Finally, Twitter also can be used for getting messaging out and for branding. The problem with it is that many people go to Twitter to follow a Hollywood celebrity, a sports star, or are looking for mass communication. There is less interest on Twitter for physician outreach.

Continue to: Measuring ROI...

Dr. Culligan: What’s the best way to track your return on investment?

Dr. Lotze: First for me was to find out what didn’t work in the office and fix that before really promoting my practice. It’s about the global experience for a patient, as Brad mentioned. As a marketing expert, Heather met with me to understand my goals. She then called my office as a patient to set up an appointment and went through that entire office experience. We identified issues needing improvement.

The next step was to develop a working relationship with my webmaster—someone who can help manage Internet image and SEO. Together, you will develop goals for what the SEO should promote specific to your practice. Once a good SEO program is in place, your website’s ranking will go up—although it can take a minimum of 6 months to see a significant increase. To help understand your website’s performance, your webmaster should provide you with reports on your site’s analytics.

As you go through this process, it is great to have a marketing expert to be the point person. You will work closely together for a while, but eventually you can back off over time. The time and expense you invest on the front end have huge rewards on the back end. Currently, I still spend a reasonable amount of money every month. I have a high self-referral base because of these efforts, however, which results in more patient surgeries and easily covers my expenses. It is money well invested. My website traffic increased by 268% over 2 years (FIGURE). I’ll propose that currently more than half of my patients are self-referrals due to online marketing.

Ms. Schueppert: The only thing I would add is training your front staff. They are checking people in, taking appointments, checking your patients out. Have them be mindful that there are campaigns going on, whether it is a social media push, or a new video that went on the website. They can ask, “How did you hear about us?” when a new patient calls.

Dr. Bowman: Unless you are a large university hospital, where the analytics get significantly more advanced in terms of measuring return on investment (ROI), I think you should just be looking at your schedule and looking at your monthly billings and seeing how they change over time. You can calculate how much a new patient is worth because you can figure out how many patients you have and how much you bill and what your profits are.

Dr. Culligan: For those of us who are hospital employees, you can try to convince the hospital that you can do a detailed ROI analysis, or you can just look at it like (say it’s $3,000 per month), how many surgeries does this project have to generate before the hospital makes that back? The answer is a fraction of 1 case.

Thank you to all of you for your expertise on this roundtable. 

To have a thriving business in today’s world, a functioning website is crucial to the overall business health. For a medical practice in general, and for its physicians specifically, it is one of the first steps for maintaining a practice. But to grow that practice, it is crucial to take the steps beyond just having a website. Growth requires website opti­mization for search engines, an expanding referral base, and the knowledge to use web tools and social media at your disposal to promote the practice and its physicians. In this roundtable, several marketing experts and web-savvy physicians discuss using available tools to best position and grow a practice.

Choosing a web upgrade

Patrick J. Culligan, MD: Peter, can you start us off by describing your relationship with Heather, and how your practice benefitted from her expertise?

Peter M. Lotze, MD: Sure. I am a urogynecologist in the competitive market of pelvic reconstructive surgery in Houston, Texas. Within that market, my main approach was to reach out to other physicians to refer patients to my practice. It generally would work, but took increasingly greater amounts of time to call these physicians up, write them letters, and maintain relationships. I felt that the large, national practice group that I am in did not have a significant web presence optimized to promote my practice, which makes it difficult for patients seeking your services to find you in their search for a doctor. It is helpful for patients to be able to understand from your website who you are, what you do, and what their experience may be like.

Glaring to me was that a web search specific for me or things that I do, would not produce our company’s results until page 2 or more on Google. This can be devastating for a practice because most people don’t go past the first page, and you can end up with fewer self-referrals, which should be a significant portion of new patients to your practice. I knew I needed guidance; I knew of Heather’s expertise given her exceptional past work building marketing strategies.

Digital go-tos for marketing

Heather Schueppert: Yes, I was pleased to work with Dr. Lotze, and at the time was a marketing consultant for practices such as his. But gone are the days of printed material—brochures, pamphlets, or even billboards—to effectively promote a business, or in this case, a practice. What still withstands the test of time, however, as the number 1 marketing referral source is word of mouth—from your trusted friend, family member, or coworker.

It is now proven that the number 2 most trusted form of advertising, the most persuasive and the most motivating, is online marketing.¹ It is the “digital word of mouth”—the review. Patients are actively online, and a strong digital presence is critical to provide that direct value to retain and grow your patient base.

Continue to: Foundations of private practice reach out...

Foundations of private practice reach out

There are 3 important areas that I consider the foundation of any private practice marketing strategy (TABLE). First is an updated website that is search engine optimized (SEO). You can’t just set it and forget it, it needs to be an updated website. The algorithms for search engines are changing constantly to try to make it as fair and relevant as possible for patients or consumers to find the businesses they are searching for online.

The second area is review management, and for a physician, or even a care center, to do this on your own is a daunting task. It is a critical component, however, to making sure that your reputation out there, that online word of mouth, is as high a star rating as possible.

The third component is local search, which is basically a form of SEO that helps businesses show up in relevant local searches. We are all familiar with the search, “find a restaurant near me,” anything that pushes those search engines to find something local.

Those are what I call the effective triad: that updated website, the review management, and the local search, and all of these are tied together. I think Dr. Lotze and his practice did these effectively well, and I believe that he achieved his goals for the longer term.

Review/reputation management

Dr. Culligan: Brad, is there something that doctors may not know about Healthgrades, and are there opportunities to take full advantage of this physician-rating site?

Brad Bowman, MD: I agree with everything that Dr. Lotze and Heather have said. Start with yourself—what is it that you want to be, the one thing you want to stand for? Get your own marketing, your website right, then, the point is, once you do all that and you are number 1 in SEO, you are still only going to get about 25% of the people looking for you by name to come to your website. The other 75% are going to look at all the other different sites that are out there to provide information to consumers. So the question becomes what do you do with all these other third-party sites? Healthgrades is the most comprehensive and has the highest traffic of the third-party “find a doctor” sites. In 2020, half of all Americans who go to a doctor will use Healthgrades at some point to help select and connect with that doctor.

Physicians have their focus on the quality of the care they provide. Patients, however, focus on the quality of the entire health care experience. Did I get better? How long did I have to wait? Was the office staff helpful? Scarily enough, we still spend more time shopping for a refrigerator or mattress than we do shopping for a doctor. We still tend to think that all doctors are the same. It is the reality of how we have been trained by our insurance companies and by the health care system. That is why getting your marketing right and getting what is it that you want to be known for out there is important, so that you can get the types of patients you want.

Listings management is very important. Make sure that you are findable everywhere. There are services that will do this: Doctor.com, Reputation.com, and many others. They can help you make sure you get all your basic materials right: addresses, phone numbers, your picture. Because 75% of people are going to end up on third-party websites, if your phone number is wrong there, you could lose that patient.

Then the second piece of working with third-party sites is reputation management. Physician reviews are not a bad thing, they are the new word of mouth, as Heather pointed out. Most (80%) of the reviews are going to be positive. The others will be negative, and that is okay. It is important that you get at least 1 or 2 reviews on all the different sites. We know from Healthgrades.com that going from zero reviews to 1 review will increase your call volume by 60%. If you have the choice between 2 physicians and one practice looks like people have been there before, you will go to that one.

You can learn from reviews as well, consumers provide valid feedback. Best practice is to respond to every positive and negative review. Thank them, indicate that you have listened to them, and address any concerns as necessary.

Continue to: Dr. Lotze...

Dr. Lotze: As an example, one of the paramount things that Heather introduced me to was the third party I use to run my website. That company sends a HIPAA-compliant review out to each patient we have seen that day and gives them the opportunity to rate our services and leave comments. If a patient brings up a concern, we can respond immediately, which is important. Patients appreciate feeling that they have been heard. Typically, communicating with a patient will turn the 3-star review into a 5-star as she follows up with the practice.

Ms. Schueppert: Timeliness is important. And just to mention, there certainly is a time commitment to this (and it is a marathon versus a sprint) and there is some financial investment to get it going, but it could truly be detrimental to a practice if you decide not to do anything at all.

Dr. Bowman: Agencies can really help with the time commitment.

Handling bad reviews

Dr. Culligan: What about that person who seems to have it out for you, perhaps giving you multiple bad reviews?

Dr. Bowman: I have seen this before. At Healthgrades, we recently analyzed 8.4 million patient reviews to see what people wrote about.² The first thing they will talk about is quality of care as they see it. Did I get better or not? You can’t “fix” every patient; there will be some that you cannot help. The next thing patients comment on is bedside manner. With negative reviews, you will see more comments about the office staff.²

A single negative review actually helps make the positive ones look more credible. But if you do believe someone is trolling you, we can flag it and will investigate to the best of our ability. (Different sites likely have different editorial policies.) For example, we look at the IP addresses of all reviews, and if multiple reviews are coming from the same location, we would only let one through, overwriting the previous review from that address.

Patients just want to be heard. We have seen people change their views, based on how their review is handled and responded to.

Dr. Lotze: Is there a response by the physician that you think tends to work better in terms of resolving the issue that can minimize a perceived caustic reaction to a patient’s criticism?

Dr. Bowman: First, just like with any stressful situation, take a deep breath and respond when you feel like you can be constructive. When you do respond, be gracious. Thank them for their feedback. Make sure you reference something about their concern: “I understand that you had to wait longer than you would have liked.” Acknowledge the problem they reference, and then just apologize: “I’m sorry we didn’t meet your expectations.” Then, if they waited too long for example, “We have a new system where no one should have to wait more than 30 minutes….” You can respond privately or publically. Generally, public responses are better as it shows other consumers that you are willing to listen and consider their point of view.

Continue to: The next phase at Healthgrades...

The next phase at Healthgrades

Dr. Culligan: Do you see changes to the way physician-rating sites are working now? Are we going to stay status quo over the next 10 years, or do you see frontiers in how your site is going to develop?

Dr. Bowman: For Healthgrades, we rely on quantitative and objective measures, not just the qualitative. We are investing heavily right now in trying to help consumers understand what are the relative volumes of different procedures or different patient types that each individual doctor sees. Orthopedics is an easy example—if you have a knee problem, you want to go to someone who specializes in knees. Our job is to help consumers easily identify, “This is a shoulder doctor, this is a knee doctor, and this is why that matters.”

In the meantime, as a physician, you can always go into our site and state your care philosophy, identifying what is the sort of patient that you like to treat. Transparency is good for everyone, and especially physicians. It helps the right patient show up for you, and it helps you do a better job providing referrals.

Social media: Avoid pitfalls, and use it to your benefit

Dr. Lotze: Branding was one of the things that I was confused about, and Heather really helped me out. As physicians, we put ourselves out there on our websites, which we try to make professional sources of information for patients. But patients often want to see what else they can find out about us, including Healthgrades and social media. I think the thing that is important to know with social media is that it is a place where people learn about you as a person. Your social media should be another avenue of promotion. Whether it is your personal or professional Facebook page, people are going to see those sites. You have an opportunity to promote yourself as a good physician and a good person with a wholesome practice that you want people to come to. If a physician is posting questionable things about themselves on any kind of social media, it could be perceived as inappropriate by the patient. That can impact how patients think of you as a person, and how they are going to grade you. If people lose sight of who you are due to a questionable social media posting, everything else (SEO, the website) can be for naught.

Dr. Culligan: What are the most important social media tools to invest your time in?

Ms. Schueppert: Before anybody jumps into social media, I firmly recommend that you make sure your local search and your Google 3-pack is set up—which is basically a method Google uses to display the top 3 results on its listings page. Then make sure you have a review management system in place. Make sure you have that updated website. Those are the foundational elements. Once you have that going, social media is the next added layer to that digital presence.

I usually recommend LinkedIn. It is huge because you are staying in contact with your colleagues, that business-to-business type of connection. It remains a way for physicians to set themselves up as experts in their level of specialty.

From there, it’s either Instagram or Facebook. If you are serving more of the younger generations, the millennials and younger, then Instagram is the way to go. If you are focusing on your 40+, 50+, they are going to be far more on Facebook.

Continue to: Dr. Lotze...

Dr. Lotze: For me, a Facebook page was a great place to start. The cost of those Google ads—the first things we see at the top of a Google search in their own separate box—is significant. If a practice has that kind of money to invest, great; it is an instant way to be first on the page during a search. But there are more cost-effective ways of doing that, especially as you are getting your name out. Facebook provides, at a smaller cost, promotion of whatever it is that you are seeking to promote. You can find people within a certain zip code, for instance, and use a Facebook ad campaign that can drive people to your Facebook page—which should have both routinely updated new posts and a link to your website. The posts should be interesting topics relevant to the patients you wish to treat (avoiding personal stories or controversial discussions). You can put a post together, or you can have a third-party service do this. People who follow your page will get reminders of you and your practice with each new post. As your page followers increase, your Facebook rank will improve, and your page will more likely be discovered by Facebook searches for your services. With an added link to your office practice website, those patients go straight to your site without getting lost in the noise of Google search results.

For Instagram, a short video or an interesting picture, along with a brief statement, are the essentials. You can add a single link. Marketing here is by direct messaging or having patients going to your website through a link. Instagram, like Facebook, offers analytics to help show you what your audience likes to read about, improving the quality of your posts and increasing number of followers.

YouTube is the number 2 search engine behind Google. A Google search for your field of medicine may be filled with pages of competitors. However, YouTube has a much lower volume of competing practices, making it easier for patients to find you. The only downside to YouTube is that it will list your video along with other competing videos, which can draw attention away from your practice.

If you want to promote your website or practice with video, using a company such as Vimeo is a better choice compared with YouTube, as YouTube gets credit for video views—which improves YouTube’s SEO and not your own website. Vimeo allows for your website to get credit each time the video is watched. Regardless of where you place your videos, make them short and to the point, with links to your website. Videos only need to be long enough to get your message across and stimulate interest in your practice.

If you can have a blog on your website, it also will help with SEO. What a search engine like Google wants to see is that a patient is on your web page and looking at something for at least 60 seconds. If so, the website is deemed to have information that is relevant, improving your SEO ranking.

Finally, Twitter also can be used for getting messaging out and for branding. The problem with it is that many people go to Twitter to follow a Hollywood celebrity, a sports star, or are looking for mass communication. There is less interest on Twitter for physician outreach.

Continue to: Measuring ROI...

Dr. Culligan: What’s the best way to track your return on investment?

Dr. Lotze: First for me was to find out what didn’t work in the office and fix that before really promoting my practice. It’s about the global experience for a patient, as Brad mentioned. As a marketing expert, Heather met with me to understand my goals. She then called my office as a patient to set up an appointment and went through that entire office experience. We identified issues needing improvement.

The next step was to develop a working relationship with my webmaster—someone who can help manage Internet image and SEO. Together, you will develop goals for what the SEO should promote specific to your practice. Once a good SEO program is in place, your website’s ranking will go up—although it can take a minimum of 6 months to see a significant increase. To help understand your website’s performance, your webmaster should provide you with reports on your site’s analytics.

As you go through this process, it is great to have a marketing expert to be the point person. You will work closely together for a while, but eventually you can back off over time. The time and expense you invest on the front end have huge rewards on the back end. Currently, I still spend a reasonable amount of money every month. I have a high self-referral base because of these efforts, however, which results in more patient surgeries and easily covers my expenses. It is money well invested. My website traffic increased by 268% over 2 years (FIGURE). I’ll propose that currently more than half of my patients are self-referrals due to online marketing.

Ms. Schueppert: The only thing I would add is training your front staff. They are checking people in, taking appointments, checking your patients out. Have them be mindful that there are campaigns going on, whether it is a social media push, or a new video that went on the website. They can ask, “How did you hear about us?” when a new patient calls.

Dr. Bowman: Unless you are a large university hospital, where the analytics get significantly more advanced in terms of measuring return on investment (ROI), I think you should just be looking at your schedule and looking at your monthly billings and seeing how they change over time. You can calculate how much a new patient is worth because you can figure out how many patients you have and how much you bill and what your profits are.

Dr. Culligan: For those of us who are hospital employees, you can try to convince the hospital that you can do a detailed ROI analysis, or you can just look at it like (say it’s $3,000 per month), how many surgeries does this project have to generate before the hospital makes that back? The answer is a fraction of 1 case.

Thank you to all of you for your expertise on this roundtable. 

The Centers for Medicare and Medicaid Services (CMS) finalized an increase in the relative value of evaluation and management (E/M) service codes effective January 1, 2021, which results in an overall decrease in the payment for procedural services in the Medicare program. (Due to the mandate for budget neutrality, an increase in relative value units [RVUs] for E/M resulted in a large decrease in the conversion factor—the number of dollars per RVU). This has increased payments for endocrinologists, rheumatologists, and family medicine clinicians and decreased payments for radiologists, pathologists, and surgeons.

In a major win for physicians, CMS proposes to simplify documentation requirements for billing and focus on the complexity of the medical decision making (MDM) or the total time needed to care for the patient on the date of the service as the foundation for determining the relative value of the service. Therefore, there is no more counting bullets—ie, we don’t have to perform a comprehensive physical exam or review of systems to achieve a high level code! Prior to this change, time was only available for coding purposes when counseling and coordination of care was the predominant service (>50%), and only face-to-face time with the patient was considered. Effective January 1, for office and other outpatient services, total time on the calendar date of the encounter will be used. This acknowledges the intensity and value of non–face-to-face work.

Acting through CMS, the federal government influences greatly the US health care system. CMS is an agency in the Department of Health and Human Services that administers the Medicare program and partners with state governments to administer the Health Insurance Exchanges, Medicaid, and the Children’s Health Insurance programs (CHIP).¹ In addition, CMS is responsible for enforcing quality care standards in long-term care facilities and clinical laboratories and the implementation of the Health Insurance Portability and Accountability Act.¹

In January, CMS plans the following major changes to coding and documentation^2,3:

1. Selection of the level of E/M service will no longer require documentation of bullet points in the history, physical exam, and MDM. The simplified system allows physicians and qualified health care professionals to code either by total time (both face-to-face and non–face-to-face) on the date of the encounter or by level of MDM.
2. For established office patients, 5 levels of office-based evaluation and management services will be retained. CMS had initially proposed to reduce the number of office-based E/M codes from 5 to 3, combining code levels 2, 3, and 4 into 1 code.⁴ However, after receiving feedback from professional societies and the public, CMS abandoned the plan for radical simplification of coding levels.^2,3 Implementation of their proposal would have resulted in the same payment for treatment of a hang nail as for a complex gyn patient with multiple medical problems. Both patient advocacy groups and professional societies argued that incentives originally were misaligned.
3. For new office patients, since both 99201 and 99202 require straightforward MDM, the level 1 code (99201) has been eliminated, reducing the number of code levels from 5 to 4.
4. History and physical exam will no longer be used to determine code level for office E/M codes. These elements will be required only as medically appropriate. This means that documentation review will no longer focus on “bean counting” the elements in the history and physical exam.
5. Following a reassessment of the actual time required to provide E/M services in real-life practice, CMS plans to markedly increase the relative value of office visits for established patients and modestly increase the relative value of office visits for new patients. CMS operates under the principle of “neutral budgeting,” meaning that an increase of the relative value of E/M codes will result in a decrease in the payment for procedural codes. The actual RVUs for procedural services do not change; however, budget neutrality requires a decrease in the dollar conversion factor. The proposed changes will increase the payment for E/M services and decrease payments for procedural services.

Continue to: Refocusing practice on MDM complexity...

Refocusing practice on MDM complexity

The practice of medicine is a calling with great rewards. Prominent among those rewards are improving the health of women, children, and the community, developing deep and trusting relationships with patients, families, and clinical colleagues. The practice of medicine is also replete with a host of punishing administrative burdens, including prior authorizations, clunky electronic medical records, poorly designed quality metrics that are applied to clinicians, and billing compliance rules that emphasize the repetitive documentation of clinical information with minimal value.

Some of the most irritating aspects of medical practice are the CMS rules governing medical record documentation required for billing ambulatory office visits. Current coding compliance focuses on counting the number of systems reviewed in the review of systems; the documentation of past history, social history, and family history; the number of organs and organ elements examined during the physical examination; and the complexity of MDM.

In January 2021, CMS plans to adopt new Current Procedural Terminology (CPT) code descriptors for the office and other outpatient E/M services that sunset most of the “bean-counting” metrics and emphasize the importance of the complexity of MDM in guiding selection of a correct code.² Beginning in January 2021, clinicians will have the option of selecting an E/M code level based on the total amount of time required to provide the office visit service or the complexity of MDM. When selecting a code level based on MDM the new guidance emphasizes the importance of reviewing notes from other clinicians, reviewing test results, ordering of tests, and discussing and coordinating the care of the patient with other treating physicians. These changes reflect a better understanding of what is most important in good medical practice, promoting better patient care. TABLES 1 and 2 provide the initial guidance from CMS concerning selection of E/M code level based on time and MDM, respectively.² The guidance for using MDM to select an E/M code level is likely to evolve following implementation, so stay tuned. When using MDM to select a code, 2 of the 3 general categories are required to select that level of service.

Increase in the valuation of office-based E/M services

The Medicare Physician Fee Schedule uses a resource-based relative value system to determine time and intensity of the work of clinical practice. This system recognizes 3 major factors that influence the resources required to provide a service:

• work of the clinician
• practice expense for technical components
• cost of professional liability insurance.

Many primary care professional associations have long contended that CMS has undervalued office-based E/M services relative to procedures, resulting in the devaluing of primary care practice. After the CPT code descriptors were updated by the CPT editorial panel, 52 specialty societies surveyed their members to provide inputs to CMS on the time and intensity of the office and other outpatient E/M codes as currently practiced. The American Medical Association’s Specialty Society Resource-Based Relative Value Scale Update Committee (RUC) reviewed the surveys and provided new inputs via open comment to CMS. CMS has responded to this feedback with a review of the intensity of clinical work required to provide an ambulatory visit service. In response to the review, CMS proposes to accept the recommendations of the RUC representing the house of medicine and increase the work and practice expense relative value assigned to new and established office visit codes. Overall, the combination of changes in relative values assigned for the work of the clinician and the expense of practice, increases the total value of office-based E/M codes for new patients by 7% to 14% and for established patients from 28% to 46% (see supplemental table in the sidebar at the end of this article).

Continue to: Decreased payments for procedural services...

Decreased payments for procedural services

Medicare is required to offset increased payment in one arena of health care delivery with decreased payment in other arenas of care, thereby achieving “budget-neutrality.” As detailed above, CMS plans to increase Medicare payments for office-based E/M services. Payment for services is calculated by multiplying the total RVUs for a particular service by a “conversion factor” (ie, number of dollars per RVU). To achieve budget-neutrality, CMS has proposed substantially reducing the conversion factor for 2021 (from $36.09 to $32.26), which will effectively decrease Medicare payments for procedural services since their RVUs have not changed. While the AMA RUC and many specialty societies continue to strongly advocate for the E/M work RVU increases to be included in the E/M components of 10- and 90-day global services, CMS has proposed to implement them only for “stand alone” E/M services.

Organizations are lobbying to delay or prevent the planned decrease in conversion factor, which results in substantial declines in payment for procedural services. (See "What do the Medicare billing changes mean for the Obstetrical Bundled services?" at the end of this article.) Due to the economic and clinical practice challenges caused by the corona­virus disease 2019 (COVID-19) pandemic it would be best if CMS did not reduce payments to physicians who are experts in procedural health care, thereby avoiding the risk of reduced access to these vital services.

If the current CMS changes in payment are implemented, endocrinologists, rheumatologists, and family physicians will have an increase in payment, and radiologists, pathologists, and surgeons will have a decrease in payment (TABLE 3).⁶ Obstetrics and gynecology is projected to have an 8% increase in Medicare payment. However, if an obstetrician-gynecologist derives most of their Medicare payments from surgical procedures, they are likely to have a decrease in payment from Medicare. Other payers will be incorporating the new coding structure for 2021; however, their payment structures and conversion factors are likely to vary. It is important to note that the RVUs for procedures have not changed. The budget neutrality adjustment resulted in a much lower conversion factor and therefore a decrease in payment for those specialties whose RVUs did not increase.

Bottom line

Working through the Medicare, Medicaid, and CHIP programs, CMS can influence greatly the practice of medicine including medical record documentation practices and payment rates for every clinical service. CMS proposes to end the onerous “bean counting” approach to billing compliance and refocus on the complexity of MDM as the foundation for selecting a billing code level. This change is long overdue, valuing the effective management of complex patients in office practice. Hopefully, CMS will reverse the planned reduction in the payment for procedural services, preserving patient access to important health care services. ●

What do the Medicare billing changes mean for the Obstetrical Bundled services?

---

The CY 2020 Medicare Physician Fee Schedule Final Rule was published electronically in the Federal Register on November 1, 2019. This final rule aligns the evaluation and management (E/M) coding and payment with changes recommended by the Current Procedural Terminology (CPT) Editorial Panel and American Medical Association’s (AMA) Specialty Society Resource-Based Relative Value Scale Update Committee (RUC) for office/outpatient E/M visits. Unfortunately, the Centers for Medicare and Medicaid Services (CMS) did not agree with the RUC, AMA, and specialty societies that the E/M payment changes should be applicable across all global services that incorporate E/M visits—despite the fact that the values proposed by the RUC incorporated survey data from 52 specialties, representing most of medicine (including those specialties that predominantly perform procedures). Specifically, CMS expressed the view that the number of E/M visits within the 10- and 90-day global codes, as well as the maternity care bundle, were difficult to validate; therefore, the increased values would not be distributed to those procedural services.

Many professional societies expressed significant concerns about the resulting budget neutrality adjustments that would occur effective January 2021. The great news for ObGyns is that the American College of Obstetricians and Gynecologists (ACOG) was able to respond directly to CMS’s concerns with data to support the number of prenatal visits within the Obstetrical Bundle. Tapping into a de-identified, cloud-based data set of prenatal records—representing more than 1,100 obstetric providers with close to 30,000 recently completed pregnancies—ACOG was able to document both a mean and median number of prenatal visits across a broad geographic, payer, and patient demographic that supported the 13 prenatal visits in the Obstetrical Bundle.

With ACOG’s advocacy and ability to provide data to CMS, the proposed physician fee schedule rule for 2021 has proposed to incorporate the E/M increased reimbursement into the prenatal care codes. Now we urge the CMS to finalize this proposal. Although Medicare pays for a tiny number of pregnancies annually, we hope that all payers, including Medicaid and managed care plans, will agree with this acknowledgement of the increased work of evaluation and management that obstetricians provide during prenatal care. Join ACOG in telling CMS to finalize their proposal to increase the values of the global obstetric codes: https://acog.quorum.us/campaign/28579/.

The Centers for Medicare and Medicaid Services (CMS) finalized an increase in the relative value of evaluation and management (E/M) service codes effective January 1, 2021, which results in an overall decrease in the payment for procedural services in the Medicare program. (Due to the mandate for budget neutrality, an increase in relative value units [RVUs] for E/M resulted in a large decrease in the conversion factor—the number of dollars per RVU). This has increased payments for endocrinologists, rheumatologists, and family medicine clinicians and decreased payments for radiologists, pathologists, and surgeons.

In a major win for physicians, CMS proposes to simplify documentation requirements for billing and focus on the complexity of the medical decision making (MDM) or the total time needed to care for the patient on the date of the service as the foundation for determining the relative value of the service. Therefore, there is no more counting bullets—ie, we don’t have to perform a comprehensive physical exam or review of systems to achieve a high level code! Prior to this change, time was only available for coding purposes when counseling and coordination of care was the predominant service (>50%), and only face-to-face time with the patient was considered. Effective January 1, for office and other outpatient services, total time on the calendar date of the encounter will be used. This acknowledges the intensity and value of non–face-to-face work.

Acting through CMS, the federal government influences greatly the US health care system. CMS is an agency in the Department of Health and Human Services that administers the Medicare program and partners with state governments to administer the Health Insurance Exchanges, Medicaid, and the Children’s Health Insurance programs (CHIP).¹ In addition, CMS is responsible for enforcing quality care standards in long-term care facilities and clinical laboratories and the implementation of the Health Insurance Portability and Accountability Act.¹

In January, CMS plans the following major changes to coding and documentation^2,3:

1. Selection of the level of E/M service will no longer require documentation of bullet points in the history, physical exam, and MDM. The simplified system allows physicians and qualified health care professionals to code either by total time (both face-to-face and non–face-to-face) on the date of the encounter or by level of MDM.
2. For established office patients, 5 levels of office-based evaluation and management services will be retained. CMS had initially proposed to reduce the number of office-based E/M codes from 5 to 3, combining code levels 2, 3, and 4 into 1 code.⁴ However, after receiving feedback from professional societies and the public, CMS abandoned the plan for radical simplification of coding levels.^2,3 Implementation of their proposal would have resulted in the same payment for treatment of a hang nail as for a complex gyn patient with multiple medical problems. Both patient advocacy groups and professional societies argued that incentives originally were misaligned.
3. For new office patients, since both 99201 and 99202 require straightforward MDM, the level 1 code (99201) has been eliminated, reducing the number of code levels from 5 to 4.
4. History and physical exam will no longer be used to determine code level for office E/M codes. These elements will be required only as medically appropriate. This means that documentation review will no longer focus on “bean counting” the elements in the history and physical exam.
5. Following a reassessment of the actual time required to provide E/M services in real-life practice, CMS plans to markedly increase the relative value of office visits for established patients and modestly increase the relative value of office visits for new patients. CMS operates under the principle of “neutral budgeting,” meaning that an increase of the relative value of E/M codes will result in a decrease in the payment for procedural codes. The actual RVUs for procedural services do not change; however, budget neutrality requires a decrease in the dollar conversion factor. The proposed changes will increase the payment for E/M services and decrease payments for procedural services.

Continue to: Refocusing practice on MDM complexity...

Refocusing practice on MDM complexity

The practice of medicine is a calling with great rewards. Prominent among those rewards are improving the health of women, children, and the community, developing deep and trusting relationships with patients, families, and clinical colleagues. The practice of medicine is also replete with a host of punishing administrative burdens, including prior authorizations, clunky electronic medical records, poorly designed quality metrics that are applied to clinicians, and billing compliance rules that emphasize the repetitive documentation of clinical information with minimal value.

Some of the most irritating aspects of medical practice are the CMS rules governing medical record documentation required for billing ambulatory office visits. Current coding compliance focuses on counting the number of systems reviewed in the review of systems; the documentation of past history, social history, and family history; the number of organs and organ elements examined during the physical examination; and the complexity of MDM.

In January 2021, CMS plans to adopt new Current Procedural Terminology (CPT) code descriptors for the office and other outpatient E/M services that sunset most of the “bean-counting” metrics and emphasize the importance of the complexity of MDM in guiding selection of a correct code.² Beginning in January 2021, clinicians will have the option of selecting an E/M code level based on the total amount of time required to provide the office visit service or the complexity of MDM. When selecting a code level based on MDM the new guidance emphasizes the importance of reviewing notes from other clinicians, reviewing test results, ordering of tests, and discussing and coordinating the care of the patient with other treating physicians. These changes reflect a better understanding of what is most important in good medical practice, promoting better patient care. TABLES 1 and 2 provide the initial guidance from CMS concerning selection of E/M code level based on time and MDM, respectively.² The guidance for using MDM to select an E/M code level is likely to evolve following implementation, so stay tuned. When using MDM to select a code, 2 of the 3 general categories are required to select that level of service.

Increase in the valuation of office-based E/M services

The Medicare Physician Fee Schedule uses a resource-based relative value system to determine time and intensity of the work of clinical practice. This system recognizes 3 major factors that influence the resources required to provide a service:

• work of the clinician
• practice expense for technical components
• cost of professional liability insurance.

Many primary care professional associations have long contended that CMS has undervalued office-based E/M services relative to procedures, resulting in the devaluing of primary care practice. After the CPT code descriptors were updated by the CPT editorial panel, 52 specialty societies surveyed their members to provide inputs to CMS on the time and intensity of the office and other outpatient E/M codes as currently practiced. The American Medical Association’s Specialty Society Resource-Based Relative Value Scale Update Committee (RUC) reviewed the surveys and provided new inputs via open comment to CMS. CMS has responded to this feedback with a review of the intensity of clinical work required to provide an ambulatory visit service. In response to the review, CMS proposes to accept the recommendations of the RUC representing the house of medicine and increase the work and practice expense relative value assigned to new and established office visit codes. Overall, the combination of changes in relative values assigned for the work of the clinician and the expense of practice, increases the total value of office-based E/M codes for new patients by 7% to 14% and for established patients from 28% to 46% (see supplemental table in the sidebar at the end of this article).

Continue to: Decreased payments for procedural services...

Decreased payments for procedural services

Medicare is required to offset increased payment in one arena of health care delivery with decreased payment in other arenas of care, thereby achieving “budget-neutrality.” As detailed above, CMS plans to increase Medicare payments for office-based E/M services. Payment for services is calculated by multiplying the total RVUs for a particular service by a “conversion factor” (ie, number of dollars per RVU). To achieve budget-neutrality, CMS has proposed substantially reducing the conversion factor for 2021 (from $36.09 to $32.26), which will effectively decrease Medicare payments for procedural services since their RVUs have not changed. While the AMA RUC and many specialty societies continue to strongly advocate for the E/M work RVU increases to be included in the E/M components of 10- and 90-day global services, CMS has proposed to implement them only for “stand alone” E/M services.

Organizations are lobbying to delay or prevent the planned decrease in conversion factor, which results in substantial declines in payment for procedural services. (See "What do the Medicare billing changes mean for the Obstetrical Bundled services?" at the end of this article.) Due to the economic and clinical practice challenges caused by the corona­virus disease 2019 (COVID-19) pandemic it would be best if CMS did not reduce payments to physicians who are experts in procedural health care, thereby avoiding the risk of reduced access to these vital services.

If the current CMS changes in payment are implemented, endocrinologists, rheumatologists, and family physicians will have an increase in payment, and radiologists, pathologists, and surgeons will have a decrease in payment (TABLE 3).⁶ Obstetrics and gynecology is projected to have an 8% increase in Medicare payment. However, if an obstetrician-gynecologist derives most of their Medicare payments from surgical procedures, they are likely to have a decrease in payment from Medicare. Other payers will be incorporating the new coding structure for 2021; however, their payment structures and conversion factors are likely to vary. It is important to note that the RVUs for procedures have not changed. The budget neutrality adjustment resulted in a much lower conversion factor and therefore a decrease in payment for those specialties whose RVUs did not increase.

Bottom line

Working through the Medicare, Medicaid, and CHIP programs, CMS can influence greatly the practice of medicine including medical record documentation practices and payment rates for every clinical service. CMS proposes to end the onerous “bean counting” approach to billing compliance and refocus on the complexity of MDM as the foundation for selecting a billing code level. This change is long overdue, valuing the effective management of complex patients in office practice. Hopefully, CMS will reverse the planned reduction in the payment for procedural services, preserving patient access to important health care services. ●

What do the Medicare billing changes mean for the Obstetrical Bundled services?

---

The CY 2020 Medicare Physician Fee Schedule Final Rule was published electronically in the Federal Register on November 1, 2019. This final rule aligns the evaluation and management (E/M) coding and payment with changes recommended by the Current Procedural Terminology (CPT) Editorial Panel and American Medical Association’s (AMA) Specialty Society Resource-Based Relative Value Scale Update Committee (RUC) for office/outpatient E/M visits. Unfortunately, the Centers for Medicare and Medicaid Services (CMS) did not agree with the RUC, AMA, and specialty societies that the E/M payment changes should be applicable across all global services that incorporate E/M visits—despite the fact that the values proposed by the RUC incorporated survey data from 52 specialties, representing most of medicine (including those specialties that predominantly perform procedures). Specifically, CMS expressed the view that the number of E/M visits within the 10- and 90-day global codes, as well as the maternity care bundle, were difficult to validate; therefore, the increased values would not be distributed to those procedural services.

Many professional societies expressed significant concerns about the resulting budget neutrality adjustments that would occur effective January 2021. The great news for ObGyns is that the American College of Obstetricians and Gynecologists (ACOG) was able to respond directly to CMS’s concerns with data to support the number of prenatal visits within the Obstetrical Bundle. Tapping into a de-identified, cloud-based data set of prenatal records—representing more than 1,100 obstetric providers with close to 30,000 recently completed pregnancies—ACOG was able to document both a mean and median number of prenatal visits across a broad geographic, payer, and patient demographic that supported the 13 prenatal visits in the Obstetrical Bundle.

With ACOG’s advocacy and ability to provide data to CMS, the proposed physician fee schedule rule for 2021 has proposed to incorporate the E/M increased reimbursement into the prenatal care codes. Now we urge the CMS to finalize this proposal. Although Medicare pays for a tiny number of pregnancies annually, we hope that all payers, including Medicaid and managed care plans, will agree with this acknowledgement of the increased work of evaluation and management that obstetricians provide during prenatal care. Join ACOG in telling CMS to finalize their proposal to increase the values of the global obstetric codes: https://acog.quorum.us/campaign/28579/.

The Centers for Medicare and Medicaid Services (CMS) finalized an increase in the relative value of evaluation and management (E/M) service codes effective January 1, 2021, which results in an overall decrease in the payment for procedural services in the Medicare program. (Due to the mandate for budget neutrality, an increase in relative value units [RVUs] for E/M resulted in a large decrease in the conversion factor—the number of dollars per RVU). This has increased payments for endocrinologists, rheumatologists, and family medicine clinicians and decreased payments for radiologists, pathologists, and surgeons.

In a major win for physicians, CMS proposes to simplify documentation requirements for billing and focus on the complexity of the medical decision making (MDM) or the total time needed to care for the patient on the date of the service as the foundation for determining the relative value of the service. Therefore, there is no more counting bullets—ie, we don’t have to perform a comprehensive physical exam or review of systems to achieve a high level code! Prior to this change, time was only available for coding purposes when counseling and coordination of care was the predominant service (>50%), and only face-to-face time with the patient was considered. Effective January 1, for office and other outpatient services, total time on the calendar date of the encounter will be used. This acknowledges the intensity and value of non–face-to-face work.

Acting through CMS, the federal government influences greatly the US health care system. CMS is an agency in the Department of Health and Human Services that administers the Medicare program and partners with state governments to administer the Health Insurance Exchanges, Medicaid, and the Children’s Health Insurance programs (CHIP).¹ In addition, CMS is responsible for enforcing quality care standards in long-term care facilities and clinical laboratories and the implementation of the Health Insurance Portability and Accountability Act.¹

In January, CMS plans the following major changes to coding and documentation^2,3:

1. Selection of the level of E/M service will no longer require documentation of bullet points in the history, physical exam, and MDM. The simplified system allows physicians and qualified health care professionals to code either by total time (both face-to-face and non–face-to-face) on the date of the encounter or by level of MDM.
2. For established office patients, 5 levels of office-based evaluation and management services will be retained. CMS had initially proposed to reduce the number of office-based E/M codes from 5 to 3, combining code levels 2, 3, and 4 into 1 code.⁴ However, after receiving feedback from professional societies and the public, CMS abandoned the plan for radical simplification of coding levels.^2,3 Implementation of their proposal would have resulted in the same payment for treatment of a hang nail as for a complex gyn patient with multiple medical problems. Both patient advocacy groups and professional societies argued that incentives originally were misaligned.
3. For new office patients, since both 99201 and 99202 require straightforward MDM, the level 1 code (99201) has been eliminated, reducing the number of code levels from 5 to 4.
4. History and physical exam will no longer be used to determine code level for office E/M codes. These elements will be required only as medically appropriate. This means that documentation review will no longer focus on “bean counting” the elements in the history and physical exam.
5. Following a reassessment of the actual time required to provide E/M services in real-life practice, CMS plans to markedly increase the relative value of office visits for established patients and modestly increase the relative value of office visits for new patients. CMS operates under the principle of “neutral budgeting,” meaning that an increase of the relative value of E/M codes will result in a decrease in the payment for procedural codes. The actual RVUs for procedural services do not change; however, budget neutrality requires a decrease in the dollar conversion factor. The proposed changes will increase the payment for E/M services and decrease payments for procedural services.

Continue to: Refocusing practice on MDM complexity...

Refocusing practice on MDM complexity

The practice of medicine is a calling with great rewards. Prominent among those rewards are improving the health of women, children, and the community, developing deep and trusting relationships with patients, families, and clinical colleagues. The practice of medicine is also replete with a host of punishing administrative burdens, including prior authorizations, clunky electronic medical records, poorly designed quality metrics that are applied to clinicians, and billing compliance rules that emphasize the repetitive documentation of clinical information with minimal value.

Some of the most irritating aspects of medical practice are the CMS rules governing medical record documentation required for billing ambulatory office visits. Current coding compliance focuses on counting the number of systems reviewed in the review of systems; the documentation of past history, social history, and family history; the number of organs and organ elements examined during the physical examination; and the complexity of MDM.

In January 2021, CMS plans to adopt new Current Procedural Terminology (CPT) code descriptors for the office and other outpatient E/M services that sunset most of the “bean-counting” metrics and emphasize the importance of the complexity of MDM in guiding selection of a correct code.² Beginning in January 2021, clinicians will have the option of selecting an E/M code level based on the total amount of time required to provide the office visit service or the complexity of MDM. When selecting a code level based on MDM the new guidance emphasizes the importance of reviewing notes from other clinicians, reviewing test results, ordering of tests, and discussing and coordinating the care of the patient with other treating physicians. These changes reflect a better understanding of what is most important in good medical practice, promoting better patient care. TABLES 1 and 2 provide the initial guidance from CMS concerning selection of E/M code level based on time and MDM, respectively.² The guidance for using MDM to select an E/M code level is likely to evolve following implementation, so stay tuned. When using MDM to select a code, 2 of the 3 general categories are required to select that level of service.

Increase in the valuation of office-based E/M services

The Medicare Physician Fee Schedule uses a resource-based relative value system to determine time and intensity of the work of clinical practice. This system recognizes 3 major factors that influence the resources required to provide a service:

• work of the clinician
• practice expense for technical components
• cost of professional liability insurance.

Many primary care professional associations have long contended that CMS has undervalued office-based E/M services relative to procedures, resulting in the devaluing of primary care practice. After the CPT code descriptors were updated by the CPT editorial panel, 52 specialty societies surveyed their members to provide inputs to CMS on the time and intensity of the office and other outpatient E/M codes as currently practiced. The American Medical Association’s Specialty Society Resource-Based Relative Value Scale Update Committee (RUC) reviewed the surveys and provided new inputs via open comment to CMS. CMS has responded to this feedback with a review of the intensity of clinical work required to provide an ambulatory visit service. In response to the review, CMS proposes to accept the recommendations of the RUC representing the house of medicine and increase the work and practice expense relative value assigned to new and established office visit codes. Overall, the combination of changes in relative values assigned for the work of the clinician and the expense of practice, increases the total value of office-based E/M codes for new patients by 7% to 14% and for established patients from 28% to 46% (see supplemental table in the sidebar at the end of this article).

Continue to: Decreased payments for procedural services...

Decreased payments for procedural services

Medicare is required to offset increased payment in one arena of health care delivery with decreased payment in other arenas of care, thereby achieving “budget-neutrality.” As detailed above, CMS plans to increase Medicare payments for office-based E/M services. Payment for services is calculated by multiplying the total RVUs for a particular service by a “conversion factor” (ie, number of dollars per RVU). To achieve budget-neutrality, CMS has proposed substantially reducing the conversion factor for 2021 (from $36.09 to $32.26), which will effectively decrease Medicare payments for procedural services since their RVUs have not changed. While the AMA RUC and many specialty societies continue to strongly advocate for the E/M work RVU increases to be included in the E/M components of 10- and 90-day global services, CMS has proposed to implement them only for “stand alone” E/M services.

Organizations are lobbying to delay or prevent the planned decrease in conversion factor, which results in substantial declines in payment for procedural services. (See "What do the Medicare billing changes mean for the Obstetrical Bundled services?" at the end of this article.) Due to the economic and clinical practice challenges caused by the corona­virus disease 2019 (COVID-19) pandemic it would be best if CMS did not reduce payments to physicians who are experts in procedural health care, thereby avoiding the risk of reduced access to these vital services.

If the current CMS changes in payment are implemented, endocrinologists, rheumatologists, and family physicians will have an increase in payment, and radiologists, pathologists, and surgeons will have a decrease in payment (TABLE 3).⁶ Obstetrics and gynecology is projected to have an 8% increase in Medicare payment. However, if an obstetrician-gynecologist derives most of their Medicare payments from surgical procedures, they are likely to have a decrease in payment from Medicare. Other payers will be incorporating the new coding structure for 2021; however, their payment structures and conversion factors are likely to vary. It is important to note that the RVUs for procedures have not changed. The budget neutrality adjustment resulted in a much lower conversion factor and therefore a decrease in payment for those specialties whose RVUs did not increase.

Bottom line

Working through the Medicare, Medicaid, and CHIP programs, CMS can influence greatly the practice of medicine including medical record documentation practices and payment rates for every clinical service. CMS proposes to end the onerous “bean counting” approach to billing compliance and refocus on the complexity of MDM as the foundation for selecting a billing code level. This change is long overdue, valuing the effective management of complex patients in office practice. Hopefully, CMS will reverse the planned reduction in the payment for procedural services, preserving patient access to important health care services. ●

What do the Medicare billing changes mean for the Obstetrical Bundled services?

---

The CY 2020 Medicare Physician Fee Schedule Final Rule was published electronically in the Federal Register on November 1, 2019. This final rule aligns the evaluation and management (E/M) coding and payment with changes recommended by the Current Procedural Terminology (CPT) Editorial Panel and American Medical Association’s (AMA) Specialty Society Resource-Based Relative Value Scale Update Committee (RUC) for office/outpatient E/M visits. Unfortunately, the Centers for Medicare and Medicaid Services (CMS) did not agree with the RUC, AMA, and specialty societies that the E/M payment changes should be applicable across all global services that incorporate E/M visits—despite the fact that the values proposed by the RUC incorporated survey data from 52 specialties, representing most of medicine (including those specialties that predominantly perform procedures). Specifically, CMS expressed the view that the number of E/M visits within the 10- and 90-day global codes, as well as the maternity care bundle, were difficult to validate; therefore, the increased values would not be distributed to those procedural services.

Many professional societies expressed significant concerns about the resulting budget neutrality adjustments that would occur effective January 2021. The great news for ObGyns is that the American College of Obstetricians and Gynecologists (ACOG) was able to respond directly to CMS’s concerns with data to support the number of prenatal visits within the Obstetrical Bundle. Tapping into a de-identified, cloud-based data set of prenatal records—representing more than 1,100 obstetric providers with close to 30,000 recently completed pregnancies—ACOG was able to document both a mean and median number of prenatal visits across a broad geographic, payer, and patient demographic that supported the 13 prenatal visits in the Obstetrical Bundle.

With ACOG’s advocacy and ability to provide data to CMS, the proposed physician fee schedule rule for 2021 has proposed to incorporate the E/M increased reimbursement into the prenatal care codes. Now we urge the CMS to finalize this proposal. Although Medicare pays for a tiny number of pregnancies annually, we hope that all payers, including Medicaid and managed care plans, will agree with this acknowledgement of the increased work of evaluation and management that obstetricians provide during prenatal care. Join ACOG in telling CMS to finalize their proposal to increase the values of the global obstetric codes: https://acog.quorum.us/campaign/28579/.