Gynecology

Abnormal uterine bleeding (AUB) continues to be a top reason that women present for gynecologic care. In general, our approach to the management of AUB is to diagnose causes before we prescribe therapy and to offer conservative therapies initially and progress to more invasive measures if indicated.

In this Update, we highlight several new studies that provide evidence for preferential use of certain medical and surgical therapies. In considering conservative therapy for the treatment of AUB, we take a closer look at the efficacy of cyclic progestogens. Another important issue, as more types of endometrial ablation (EA) are being developed and are coming into the market, is the need for additional guidance regarding decisions about EA versus progestin-releasing intrauterine devices (IUDs). Lastly, an unintended consequence of an increased cesarean delivery rate is the development of isthmocele, also known as cesarean scar defect or uterine niche. These defects, which can be bothersome and cause abnormal bleeding, are treated with various techniques. Within the last year, 2 systematic reviews that compare the efficacy of several different approaches and provide guidance have been published.

Is it time to retire cyclic progestogens for the treatment of heavy menstrual bleeding?

Bofill Rodriguez M, Lethaby A, Low C, et al. Cyclical progestogens for heavy menstrual bleeding. Cochrane Database Syst Rev. 2019;(8):CD001016.

In a recent Cochrane Database Systematic Review, Bofill Rodriguez and colleagues looked at the efficacy, safety, and tolerability of oral progestogen therapy for heavy menstrual bleeding.¹ They considered progestogen (medroxyprogesterone acetate or norethisterone) in short-cycle use (7 to 10 days in the luteal phase) and long-cycle use (21 days per cycle) in a review of 15 randomized clinical trials (RCTs) that included a total of 1,071 women. As this topic had not been updated in 12 years, this review was essential in demonstrating changes that occurred over the past decade.

The primary outcomes of the analysis were menstrual blood loss and treatment satisfaction. Secondary outcomes included the number of days of bleeding, quality of life, adherence and acceptability of treatment, adverse events, and costs.

Classic progestogens fall short compared with newer approaches

Analysis of the data revealed that short-cycle progestogen was inferior to treatment with tranexamic acid, danazol, and the 65-µg progesterone-releasing IUD (Pg-IUD). Of note, the 65-µg Pg-IUD has been off the market since 2001, and danazol is rarely used in current practice. Furthermore, based on 2 trials, cyclic progestogens demonstrated no clear benefit over nonsteroidal anti-inflammatory drugs. Additionally, long-cycle progestogen therapy was found to be inferior to the 52-mg levonorgestrel-releasing IUD (LNG-IUD), tranexamic acid, and ormeloxifene.

It should be noted that the quality of evidence is still lacking for progestogen therapy, and this study's main limitation is bias, as the women and the researchers were aware of the treatments that were given. This review is helpful, however, for emphasizing the advantage of tranexamic acid and LNG-IUD use in clinical care.

The takeaway. Although it may not necessarily be time to retire the use of cyclic oral progestogens, the 52-mg LNG-IUD or tranexamic acid may be more successful for treating AUB in women who are appropriate candidates.

Continue to: Endometrial ablation...

Endometrial ablation: New evidence informs when it could (and could not) be the best option

Bergeron C, Laberge PY, Boutin A, et al. Endometrial ablation or resection versus levonorgestrel intra-uterine system for the treatment of women with heavy menstrual bleeding and a normal uterine cavity: a systematic review with meta-analysis. Hum Reprod Update. 2020;26:302-311.

Vitale SG, Ferrero S, Ciebiera M, et al. Hysteroscopic endometrial resection vs hysterectomy for abnormal uterine bleeding: impact on quality of life and sexuality. Evidence from a systematic review of randomized controlled trials. Curr Opin Obstet Gynecol. 2020;32:159-165.

Two systematic reviews evaluated the efficacy of EA in women with abnormal uterine bleeding. One compared EA with the LNG-IUD and reported on safety and efficacy, while the other compared EA with hysterectomy and reported on quality of life.

Bergeron and colleagues reviewed 13 studies that included 884 women to compare the efficacy and safety of EA or resection with the LNG-IUD for the treatment of premenopausal women with AUB.³ They found no significant differences between EA and the LNG-IUD in terms of subsequent hysterectomy (risk ratio [RR] = 1.3; 95% confidence interval [CI], 0.60-2.11). It was not surprising that, when looking at age, EA was associated with a higher risk for hysterectomy in women younger than age 42 (RR = 5.26; 95% CI, 1.21-22.91). Conversely, subsequent hysterectomy was less likely with EA compared to LNG-IUD use in women older than 42 years. However, statistical significance was not reached in the older group (RR = 0.51; 95% CI, 0.21-1.24).

In the systematic review by Vitale and colleagues, 9 studies met inclusion criteria for a comparison of EA and hysterectomy, with the objective of ascertaining improvement in quality of life and several other measures.⁴

Although there was significant heterogeneity between assessment tools, both treatment groups experienced similar improvements in quality of life during the first year. However, hysterectomy was more advantageous in terms of improving uterine bleeding and satisfaction in the long term when compared with EA.⁴

Continue to: Laparoscopy is best approach for isthomocele management, with caveats...

He Y, Zhong J, Zhou W, et al. Four surgical strategies for the treatment of cesarean scar defect: a systematic review and network meta-analysis. J Minim Invasive Gynecol. 2020;27:593-602.

Vitale SG, Ludwin A, Vilos GA, et al. From hysteroscopy to laparoendoscopic surgery: what is the best surgical approach for symptomatic isthmocele? A systematic review and meta-analysis. Arch Gynecol Obstet. 2020;301:33-52.

The isthmocele (cesarean scar defect, uterine niche), a known complication of cesarean delivery, represents a myometrial defect in the anterior uterine wall that often presents as abnormal uterine bleeding. It also can be a site for pregnancy-related complications, such as invasive placentation, placenta previa, and uterine rupture.

Two systematic reviews compared surgical strategies for treating isthmocele, including laparoscopy, hysteroscopy, combined laparoscopy and hysteroscopy, laparotomy, and vaginal repair.

Laparoscopy reduced isthmocele-associated AUB better than other techniques

A review by He and colleagues analyzed data from 10 pertinent studies (4 RCTs and 6 observational studies) that included 858 patients in total.⁵ Treatments compared were laparoscopy, hysteroscopy, combined laparoscopy with hysteroscopy, and vaginal repair for reduction of AUB and isthmocele and diverticulum depth.

The authors found no difference in intraoperative bleeding between the 4 surgical methods (laparotomy was not included in this review). Hysteroscopic surgery was associated with the shortest operative time, while laparoscopy was the longest surgery. In terms of reducing intermittent abnormal bleeding and scar depth, laparoscopic surgery performed better than the other 3 methods.

Approach considerations in isthmocele repair

Vitale and colleagues conducted a systematic review that included 33 publications (28 focused on a single surgical technique, 5 compared different techniques) to examine the effectiveness and risks of various surgical approaches for isthmocele in women with AUB, infertility, or for prevention of obstetric complications.⁶

Results of their analysis in general favored a laparoscopic approach for patients who desired future fertility, with an improvement rate of 92.7%. Hysteroscopic correction had an 85% improvement rate, and vaginal correction had an 82.5% improvement rate.

Although there were no high-level data to suggest a threshold for myometrial thickness in recommending a surgical approach, the authors provided a helpful algorithm for choosing a route based on a patient's fertility desires. For the asymptomatic patient, they suggest no treatment. In symptomatic patients, the laparoscopic approach is the gold standard but requires significant laparoscopic surgical skill, and a hysteroscopic approach may be considered as an alternative route if the residual myometrial defect is greater than 2.5 to 3.5 mm. For patients who are not considering future reproduction, hysteroscopy is the gold standard as long as the residual myometrial thickness is greater than 2.5 to 3.5 mm.

The takeaway. Of the several methods used for surgical isthmocele management, the laparoscopic approach reduced intermittent abnormal bleeding and scar depth better than other methods. It also was associated with the longest surgical duration. Hysteroscopic surgery was the quickest procedure to perform and is effective in removing the upper valve to promote the elimination of the hematocele and symptoms of abnormal bleeding; however, it does not change the anatomic aspects of the isthmocele in terms of myometrial thickness. Some authors suggested that deciding on the surgical route should be based on fertility desires and the residual thickness of the myometrium. ●

Abnormal uterine bleeding (AUB) continues to be a top reason that women present for gynecologic care. In general, our approach to the management of AUB is to diagnose causes before we prescribe therapy and to offer conservative therapies initially and progress to more invasive measures if indicated.

In this Update, we highlight several new studies that provide evidence for preferential use of certain medical and surgical therapies. In considering conservative therapy for the treatment of AUB, we take a closer look at the efficacy of cyclic progestogens. Another important issue, as more types of endometrial ablation (EA) are being developed and are coming into the market, is the need for additional guidance regarding decisions about EA versus progestin-releasing intrauterine devices (IUDs). Lastly, an unintended consequence of an increased cesarean delivery rate is the development of isthmocele, also known as cesarean scar defect or uterine niche. These defects, which can be bothersome and cause abnormal bleeding, are treated with various techniques. Within the last year, 2 systematic reviews that compare the efficacy of several different approaches and provide guidance have been published.

Is it time to retire cyclic progestogens for the treatment of heavy menstrual bleeding?

Bofill Rodriguez M, Lethaby A, Low C, et al. Cyclical progestogens for heavy menstrual bleeding. Cochrane Database Syst Rev. 2019;(8):CD001016.

In a recent Cochrane Database Systematic Review, Bofill Rodriguez and colleagues looked at the efficacy, safety, and tolerability of oral progestogen therapy for heavy menstrual bleeding.¹ They considered progestogen (medroxyprogesterone acetate or norethisterone) in short-cycle use (7 to 10 days in the luteal phase) and long-cycle use (21 days per cycle) in a review of 15 randomized clinical trials (RCTs) that included a total of 1,071 women. As this topic had not been updated in 12 years, this review was essential in demonstrating changes that occurred over the past decade.

The primary outcomes of the analysis were menstrual blood loss and treatment satisfaction. Secondary outcomes included the number of days of bleeding, quality of life, adherence and acceptability of treatment, adverse events, and costs.

Classic progestogens fall short compared with newer approaches

Analysis of the data revealed that short-cycle progestogen was inferior to treatment with tranexamic acid, danazol, and the 65-µg progesterone-releasing IUD (Pg-IUD). Of note, the 65-µg Pg-IUD has been off the market since 2001, and danazol is rarely used in current practice. Furthermore, based on 2 trials, cyclic progestogens demonstrated no clear benefit over nonsteroidal anti-inflammatory drugs. Additionally, long-cycle progestogen therapy was found to be inferior to the 52-mg levonorgestrel-releasing IUD (LNG-IUD), tranexamic acid, and ormeloxifene.

It should be noted that the quality of evidence is still lacking for progestogen therapy, and this study's main limitation is bias, as the women and the researchers were aware of the treatments that were given. This review is helpful, however, for emphasizing the advantage of tranexamic acid and LNG-IUD use in clinical care.

The takeaway. Although it may not necessarily be time to retire the use of cyclic oral progestogens, the 52-mg LNG-IUD or tranexamic acid may be more successful for treating AUB in women who are appropriate candidates.

Continue to: Endometrial ablation...

Endometrial ablation: New evidence informs when it could (and could not) be the best option

Bergeron C, Laberge PY, Boutin A, et al. Endometrial ablation or resection versus levonorgestrel intra-uterine system for the treatment of women with heavy menstrual bleeding and a normal uterine cavity: a systematic review with meta-analysis. Hum Reprod Update. 2020;26:302-311.

Vitale SG, Ferrero S, Ciebiera M, et al. Hysteroscopic endometrial resection vs hysterectomy for abnormal uterine bleeding: impact on quality of life and sexuality. Evidence from a systematic review of randomized controlled trials. Curr Opin Obstet Gynecol. 2020;32:159-165.

Two systematic reviews evaluated the efficacy of EA in women with abnormal uterine bleeding. One compared EA with the LNG-IUD and reported on safety and efficacy, while the other compared EA with hysterectomy and reported on quality of life.

Bergeron and colleagues reviewed 13 studies that included 884 women to compare the efficacy and safety of EA or resection with the LNG-IUD for the treatment of premenopausal women with AUB.³ They found no significant differences between EA and the LNG-IUD in terms of subsequent hysterectomy (risk ratio [RR] = 1.3; 95% confidence interval [CI], 0.60-2.11). It was not surprising that, when looking at age, EA was associated with a higher risk for hysterectomy in women younger than age 42 (RR = 5.26; 95% CI, 1.21-22.91). Conversely, subsequent hysterectomy was less likely with EA compared to LNG-IUD use in women older than 42 years. However, statistical significance was not reached in the older group (RR = 0.51; 95% CI, 0.21-1.24).

In the systematic review by Vitale and colleagues, 9 studies met inclusion criteria for a comparison of EA and hysterectomy, with the objective of ascertaining improvement in quality of life and several other measures.⁴

Although there was significant heterogeneity between assessment tools, both treatment groups experienced similar improvements in quality of life during the first year. However, hysterectomy was more advantageous in terms of improving uterine bleeding and satisfaction in the long term when compared with EA.⁴

Continue to: Laparoscopy is best approach for isthomocele management, with caveats...

He Y, Zhong J, Zhou W, et al. Four surgical strategies for the treatment of cesarean scar defect: a systematic review and network meta-analysis. J Minim Invasive Gynecol. 2020;27:593-602.

Vitale SG, Ludwin A, Vilos GA, et al. From hysteroscopy to laparoendoscopic surgery: what is the best surgical approach for symptomatic isthmocele? A systematic review and meta-analysis. Arch Gynecol Obstet. 2020;301:33-52.

The isthmocele (cesarean scar defect, uterine niche), a known complication of cesarean delivery, represents a myometrial defect in the anterior uterine wall that often presents as abnormal uterine bleeding. It also can be a site for pregnancy-related complications, such as invasive placentation, placenta previa, and uterine rupture.

Two systematic reviews compared surgical strategies for treating isthmocele, including laparoscopy, hysteroscopy, combined laparoscopy and hysteroscopy, laparotomy, and vaginal repair.

Laparoscopy reduced isthmocele-associated AUB better than other techniques

A review by He and colleagues analyzed data from 10 pertinent studies (4 RCTs and 6 observational studies) that included 858 patients in total.⁵ Treatments compared were laparoscopy, hysteroscopy, combined laparoscopy with hysteroscopy, and vaginal repair for reduction of AUB and isthmocele and diverticulum depth.

The authors found no difference in intraoperative bleeding between the 4 surgical methods (laparotomy was not included in this review). Hysteroscopic surgery was associated with the shortest operative time, while laparoscopy was the longest surgery. In terms of reducing intermittent abnormal bleeding and scar depth, laparoscopic surgery performed better than the other 3 methods.

Approach considerations in isthmocele repair

Vitale and colleagues conducted a systematic review that included 33 publications (28 focused on a single surgical technique, 5 compared different techniques) to examine the effectiveness and risks of various surgical approaches for isthmocele in women with AUB, infertility, or for prevention of obstetric complications.⁶

Results of their analysis in general favored a laparoscopic approach for patients who desired future fertility, with an improvement rate of 92.7%. Hysteroscopic correction had an 85% improvement rate, and vaginal correction had an 82.5% improvement rate.

Although there were no high-level data to suggest a threshold for myometrial thickness in recommending a surgical approach, the authors provided a helpful algorithm for choosing a route based on a patient's fertility desires. For the asymptomatic patient, they suggest no treatment. In symptomatic patients, the laparoscopic approach is the gold standard but requires significant laparoscopic surgical skill, and a hysteroscopic approach may be considered as an alternative route if the residual myometrial defect is greater than 2.5 to 3.5 mm. For patients who are not considering future reproduction, hysteroscopy is the gold standard as long as the residual myometrial thickness is greater than 2.5 to 3.5 mm.

The takeaway. Of the several methods used for surgical isthmocele management, the laparoscopic approach reduced intermittent abnormal bleeding and scar depth better than other methods. It also was associated with the longest surgical duration. Hysteroscopic surgery was the quickest procedure to perform and is effective in removing the upper valve to promote the elimination of the hematocele and symptoms of abnormal bleeding; however, it does not change the anatomic aspects of the isthmocele in terms of myometrial thickness. Some authors suggested that deciding on the surgical route should be based on fertility desires and the residual thickness of the myometrium. ●

Abnormal uterine bleeding (AUB) continues to be a top reason that women present for gynecologic care. In general, our approach to the management of AUB is to diagnose causes before we prescribe therapy and to offer conservative therapies initially and progress to more invasive measures if indicated.

In this Update, we highlight several new studies that provide evidence for preferential use of certain medical and surgical therapies. In considering conservative therapy for the treatment of AUB, we take a closer look at the efficacy of cyclic progestogens. Another important issue, as more types of endometrial ablation (EA) are being developed and are coming into the market, is the need for additional guidance regarding decisions about EA versus progestin-releasing intrauterine devices (IUDs). Lastly, an unintended consequence of an increased cesarean delivery rate is the development of isthmocele, also known as cesarean scar defect or uterine niche. These defects, which can be bothersome and cause abnormal bleeding, are treated with various techniques. Within the last year, 2 systematic reviews that compare the efficacy of several different approaches and provide guidance have been published.

Is it time to retire cyclic progestogens for the treatment of heavy menstrual bleeding?

Bofill Rodriguez M, Lethaby A, Low C, et al. Cyclical progestogens for heavy menstrual bleeding. Cochrane Database Syst Rev. 2019;(8):CD001016.

In a recent Cochrane Database Systematic Review, Bofill Rodriguez and colleagues looked at the efficacy, safety, and tolerability of oral progestogen therapy for heavy menstrual bleeding.¹ They considered progestogen (medroxyprogesterone acetate or norethisterone) in short-cycle use (7 to 10 days in the luteal phase) and long-cycle use (21 days per cycle) in a review of 15 randomized clinical trials (RCTs) that included a total of 1,071 women. As this topic had not been updated in 12 years, this review was essential in demonstrating changes that occurred over the past decade.

The primary outcomes of the analysis were menstrual blood loss and treatment satisfaction. Secondary outcomes included the number of days of bleeding, quality of life, adherence and acceptability of treatment, adverse events, and costs.

Classic progestogens fall short compared with newer approaches

Analysis of the data revealed that short-cycle progestogen was inferior to treatment with tranexamic acid, danazol, and the 65-µg progesterone-releasing IUD (Pg-IUD). Of note, the 65-µg Pg-IUD has been off the market since 2001, and danazol is rarely used in current practice. Furthermore, based on 2 trials, cyclic progestogens demonstrated no clear benefit over nonsteroidal anti-inflammatory drugs. Additionally, long-cycle progestogen therapy was found to be inferior to the 52-mg levonorgestrel-releasing IUD (LNG-IUD), tranexamic acid, and ormeloxifene.

It should be noted that the quality of evidence is still lacking for progestogen therapy, and this study's main limitation is bias, as the women and the researchers were aware of the treatments that were given. This review is helpful, however, for emphasizing the advantage of tranexamic acid and LNG-IUD use in clinical care.

The takeaway. Although it may not necessarily be time to retire the use of cyclic oral progestogens, the 52-mg LNG-IUD or tranexamic acid may be more successful for treating AUB in women who are appropriate candidates.

Continue to: Endometrial ablation...

Endometrial ablation: New evidence informs when it could (and could not) be the best option

Bergeron C, Laberge PY, Boutin A, et al. Endometrial ablation or resection versus levonorgestrel intra-uterine system for the treatment of women with heavy menstrual bleeding and a normal uterine cavity: a systematic review with meta-analysis. Hum Reprod Update. 2020;26:302-311.

Vitale SG, Ferrero S, Ciebiera M, et al. Hysteroscopic endometrial resection vs hysterectomy for abnormal uterine bleeding: impact on quality of life and sexuality. Evidence from a systematic review of randomized controlled trials. Curr Opin Obstet Gynecol. 2020;32:159-165.

Two systematic reviews evaluated the efficacy of EA in women with abnormal uterine bleeding. One compared EA with the LNG-IUD and reported on safety and efficacy, while the other compared EA with hysterectomy and reported on quality of life.

Bergeron and colleagues reviewed 13 studies that included 884 women to compare the efficacy and safety of EA or resection with the LNG-IUD for the treatment of premenopausal women with AUB.³ They found no significant differences between EA and the LNG-IUD in terms of subsequent hysterectomy (risk ratio [RR] = 1.3; 95% confidence interval [CI], 0.60-2.11). It was not surprising that, when looking at age, EA was associated with a higher risk for hysterectomy in women younger than age 42 (RR = 5.26; 95% CI, 1.21-22.91). Conversely, subsequent hysterectomy was less likely with EA compared to LNG-IUD use in women older than 42 years. However, statistical significance was not reached in the older group (RR = 0.51; 95% CI, 0.21-1.24).

In the systematic review by Vitale and colleagues, 9 studies met inclusion criteria for a comparison of EA and hysterectomy, with the objective of ascertaining improvement in quality of life and several other measures.⁴

Although there was significant heterogeneity between assessment tools, both treatment groups experienced similar improvements in quality of life during the first year. However, hysterectomy was more advantageous in terms of improving uterine bleeding and satisfaction in the long term when compared with EA.⁴

Continue to: Laparoscopy is best approach for isthomocele management, with caveats...

He Y, Zhong J, Zhou W, et al. Four surgical strategies for the treatment of cesarean scar defect: a systematic review and network meta-analysis. J Minim Invasive Gynecol. 2020;27:593-602.

Vitale SG, Ludwin A, Vilos GA, et al. From hysteroscopy to laparoendoscopic surgery: what is the best surgical approach for symptomatic isthmocele? A systematic review and meta-analysis. Arch Gynecol Obstet. 2020;301:33-52.

The isthmocele (cesarean scar defect, uterine niche), a known complication of cesarean delivery, represents a myometrial defect in the anterior uterine wall that often presents as abnormal uterine bleeding. It also can be a site for pregnancy-related complications, such as invasive placentation, placenta previa, and uterine rupture.

Two systematic reviews compared surgical strategies for treating isthmocele, including laparoscopy, hysteroscopy, combined laparoscopy and hysteroscopy, laparotomy, and vaginal repair.

Laparoscopy reduced isthmocele-associated AUB better than other techniques

A review by He and colleagues analyzed data from 10 pertinent studies (4 RCTs and 6 observational studies) that included 858 patients in total.⁵ Treatments compared were laparoscopy, hysteroscopy, combined laparoscopy with hysteroscopy, and vaginal repair for reduction of AUB and isthmocele and diverticulum depth.

The authors found no difference in intraoperative bleeding between the 4 surgical methods (laparotomy was not included in this review). Hysteroscopic surgery was associated with the shortest operative time, while laparoscopy was the longest surgery. In terms of reducing intermittent abnormal bleeding and scar depth, laparoscopic surgery performed better than the other 3 methods.

Approach considerations in isthmocele repair

Vitale and colleagues conducted a systematic review that included 33 publications (28 focused on a single surgical technique, 5 compared different techniques) to examine the effectiveness and risks of various surgical approaches for isthmocele in women with AUB, infertility, or for prevention of obstetric complications.⁶

Results of their analysis in general favored a laparoscopic approach for patients who desired future fertility, with an improvement rate of 92.7%. Hysteroscopic correction had an 85% improvement rate, and vaginal correction had an 82.5% improvement rate.

Although there were no high-level data to suggest a threshold for myometrial thickness in recommending a surgical approach, the authors provided a helpful algorithm for choosing a route based on a patient's fertility desires. For the asymptomatic patient, they suggest no treatment. In symptomatic patients, the laparoscopic approach is the gold standard but requires significant laparoscopic surgical skill, and a hysteroscopic approach may be considered as an alternative route if the residual myometrial defect is greater than 2.5 to 3.5 mm. For patients who are not considering future reproduction, hysteroscopy is the gold standard as long as the residual myometrial thickness is greater than 2.5 to 3.5 mm.

The takeaway. Of the several methods used for surgical isthmocele management, the laparoscopic approach reduced intermittent abnormal bleeding and scar depth better than other methods. It also was associated with the longest surgical duration. Hysteroscopic surgery was the quickest procedure to perform and is effective in removing the upper valve to promote the elimination of the hematocele and symptoms of abnormal bleeding; however, it does not change the anatomic aspects of the isthmocele in terms of myometrial thickness. Some authors suggested that deciding on the surgical route should be based on fertility desires and the residual thickness of the myometrium. ●

Simon JA, Al-Hendy A, Archer DF, et al. Elagolix treatment for up to 12 months in women with heavy menstrual bleeding and uterine leiomyomas. Obstet Gynecol. 2020;135:1313-1326.

Expert Commentary

Uterine fibroids are common (occurring in up to 80% of reproductive-age women),^1,2 and often associated with heavy menstrual bleeding (HMB). There are surgical and medical options, but typically medical options are used for short periods of time. Elagolix with hormonal add-back therapy was recently approved (May 29, 2020) by the US Food and Drug Administration (FDA) for treatment of HMB in women with uterine fibroids for up to 24 months.

Elagolix is an oral, nonpeptide gonadotropin-releasing hormone antagonist that results in a dose-dependent reduction of gonadotropins and ovarian sex hormones. There are now 2 approved products containing elagolix, with different indications:

• Orilissa. Elagolix was approved in 2018 by the FDA for moderate to severe pain associated with endometriosis. For that indication there are 2 dose options of elagolix (150 mg for up to 2 years and 200 mg for up to 6 months) and there is no hormonal add-back therapy.
• Oriahnn. Elagolix and hormonal add-back therapy was approved in 2020 for HMB associated with uterine fibroids for up to 24 months. The total daily dose of elagolix is 600 mg (elagolix 300 mg in the morning with estradiol 1 mg/norethindrone acetate 0.5 mg and then in the evening elagolix 300 mg and no hormonal add-back).

This new class of drug, GnRH antagonist, is an important one for women’s health, and emerging science will continue to expand its potential uses, such as in reproductive health, as well as long-term efficacy and safety. The difference in daily dose of elagolix for endometriosis (150 mg for 24 months) compared with HMB associated with fibroids (600 mg for 24 months) is why the hormonal add-back therapy is important and allows for protection of bone density.

This is an important manuscript because it highlights a medical option for women with HMB associated with fibroids, which can be used for a long period of time. Further, the improvement in bleeding is both impressive and maintained in the extension study. Approximately 90% of women show improvement in their menstrual bleeding associated with fibroids.

The question of what to do after 24 months of therapy with elagolix and hormonal add-back therapy is an important one, but providers should recognize that the limiting factor with this elagolix and hormonal add-back therapy is bone mineral density (BMD). We will only learn more and more moving forward if this is a clinically meaningful reason for stopping treatment at 24 months. The FDA takes a strict view of safety, and providers must weigh this with the benefit of therapy.

One other highlight between the 2 approved medications is that Orilissa does not have a black box warning, given that there is no hormonal add-back therapy. Oriahnn does have a warning, regarding thromboembolic disorders and vascular events:

• Estrogen and progestin combinations, including Oriahnn, increase the risk of thrombotic or thromboembolic disorders, especially in women at increased risk for these events.
• Oriahnn is contraindicated in women with current or a history of thrombotic or thromboembolic disorders and in women at increased risk for these events, including women over 35 years of age who smoke or women with uncontrolled hypertension.

Continue to: Details about the study...

Details about the study

The study by Simon et al is an extension study (UF-EXTEND), in that women could participate if they had completed 1 of the 2 pivotal studies on elagolix. The pivotal studies (Elaris UF1 and UF2) were both randomized, double-blinded, placebo-controlled studies with up to 6 months of therapy; for UF-EXTEND, however, participants were randomly assigned to either combined elagolix and hormone replacement therapy or elagolix alone for an additional 6 months of therapy. Although it was known that all participants would receive elagolix in UF-EXTEND, those who received hormonal add-back therapy were blinded. All women were then followed up for an additional 12 months after treatment ended.

The efficacy of elagolix was measured by the objective alkaline hematin method for menstrual blood loss with the a priori coprimary endpoints. The elagolix and hormonal add-back therapy group showed objective improvement in menstrual blood loss at 12 months in 87.9% of women in the extension study (89.4% in the elagolix alone group). This compares with 72.2% improvement at 6 months of treatment in the UF1 and UF2 studies for those taking elagolix and hormonal add-back therapy. These findings illustrate maintenance of the efficacy seen within the 6-month pivotal studies using elagolix over an extended amount of time.

The safety of elagolix also was demonstrated in UF-EXTEND. The 3 most common adverse events were similar to those found in Elaris UF1 and UF2 and included hot flushes, headache, and nausea. In the elagolix and hormonal add-back therapy group during the extension study, the percentage with hot flushes was 7%, headache 6%, and nausea 4%. These are small percentages, which is encouraging for providers and women with HMB associated with fibroids.

Effects on bone density

Bone density was evaluated at baseline in the UF1 and UF2 studies, through treatment, and then 12 months after the extended treatment was stopped. The hormonal add-back therapy of estradiol 1 mg/norethindrone acetate 0.5 mg significantly protected bone density. Some women did not have a decrease in bone density, but for those who did the average was less than 5% for the lumbar spine. The lumbar spine is considered the most reactive, so this illustrates the safety that combined therapy offers women with HMB and fibroids.

The lumbar spine is considered the most reactive, so this site is often used as the main focus with BMD studies. As Simon et al show, the lumbar spine mean BMD percent change from baseline for the elagolix with add-back therapy was -1.5% (95% confidence interval [CI], -1.9 to -1.0) in women who received up to 12 months of treatment at month 6 in the extension study. After stopping elagolix with add-back therapy, at 6 months the elagolix with add-back therapy had a Z-score of -0.6% (95% CI, -1.1 to -0.1). This shows a trend toward baseline, or a recovery within a short time from stopping medication.

Continue to: Study strengths and limitations...

Study strengths and limitations

Strengths of this study include its overall design; efficacy endpoints, which were all established a priori; the fact that measurement of menstrual blood loss was done with the objective alkaline hematin method; and the statistical analysis, which is thorough and well presented. This extension study allowed further evaluation of efficacy and safety for elagolix. Although the authors point out that there may be some selection bias in an extension study, the fact that so many women elected to continue into the extended study is a positive reflection of the treatment.

As providers learn of new therapies for management of HMB associated with fibroids, it is important to consider who will benefit the most. In my opinion, any woman with heavy periods associated with fibroids could be a candidate for elagolix with add-back therapy. This treatment is highly effective, well tolerated, and safe. My approach to management includes educating a woman on all potential therapies and this new option of elagolix and add-back therapy is an important one. The decision for an individual woman on how to manage heavy periods associated with fibroids should consider her contraceptive needs, medical issues, and the risk and benefit of individual therapies. ●

Simon JA, Al-Hendy A, Archer DF, et al. Elagolix treatment for up to 12 months in women with heavy menstrual bleeding and uterine leiomyomas. Obstet Gynecol. 2020;135:1313-1326.

Expert Commentary

Uterine fibroids are common (occurring in up to 80% of reproductive-age women),^1,2 and often associated with heavy menstrual bleeding (HMB). There are surgical and medical options, but typically medical options are used for short periods of time. Elagolix with hormonal add-back therapy was recently approved (May 29, 2020) by the US Food and Drug Administration (FDA) for treatment of HMB in women with uterine fibroids for up to 24 months.

Elagolix is an oral, nonpeptide gonadotropin-releasing hormone antagonist that results in a dose-dependent reduction of gonadotropins and ovarian sex hormones. There are now 2 approved products containing elagolix, with different indications:

• Orilissa. Elagolix was approved in 2018 by the FDA for moderate to severe pain associated with endometriosis. For that indication there are 2 dose options of elagolix (150 mg for up to 2 years and 200 mg for up to 6 months) and there is no hormonal add-back therapy.
• Oriahnn. Elagolix and hormonal add-back therapy was approved in 2020 for HMB associated with uterine fibroids for up to 24 months. The total daily dose of elagolix is 600 mg (elagolix 300 mg in the morning with estradiol 1 mg/norethindrone acetate 0.5 mg and then in the evening elagolix 300 mg and no hormonal add-back).

This new class of drug, GnRH antagonist, is an important one for women’s health, and emerging science will continue to expand its potential uses, such as in reproductive health, as well as long-term efficacy and safety. The difference in daily dose of elagolix for endometriosis (150 mg for 24 months) compared with HMB associated with fibroids (600 mg for 24 months) is why the hormonal add-back therapy is important and allows for protection of bone density.

This is an important manuscript because it highlights a medical option for women with HMB associated with fibroids, which can be used for a long period of time. Further, the improvement in bleeding is both impressive and maintained in the extension study. Approximately 90% of women show improvement in their menstrual bleeding associated with fibroids.

The question of what to do after 24 months of therapy with elagolix and hormonal add-back therapy is an important one, but providers should recognize that the limiting factor with this elagolix and hormonal add-back therapy is bone mineral density (BMD). We will only learn more and more moving forward if this is a clinically meaningful reason for stopping treatment at 24 months. The FDA takes a strict view of safety, and providers must weigh this with the benefit of therapy.

One other highlight between the 2 approved medications is that Orilissa does not have a black box warning, given that there is no hormonal add-back therapy. Oriahnn does have a warning, regarding thromboembolic disorders and vascular events:

• Estrogen and progestin combinations, including Oriahnn, increase the risk of thrombotic or thromboembolic disorders, especially in women at increased risk for these events.
• Oriahnn is contraindicated in women with current or a history of thrombotic or thromboembolic disorders and in women at increased risk for these events, including women over 35 years of age who smoke or women with uncontrolled hypertension.

Continue to: Details about the study...

Details about the study

The study by Simon et al is an extension study (UF-EXTEND), in that women could participate if they had completed 1 of the 2 pivotal studies on elagolix. The pivotal studies (Elaris UF1 and UF2) were both randomized, double-blinded, placebo-controlled studies with up to 6 months of therapy; for UF-EXTEND, however, participants were randomly assigned to either combined elagolix and hormone replacement therapy or elagolix alone for an additional 6 months of therapy. Although it was known that all participants would receive elagolix in UF-EXTEND, those who received hormonal add-back therapy were blinded. All women were then followed up for an additional 12 months after treatment ended.

The efficacy of elagolix was measured by the objective alkaline hematin method for menstrual blood loss with the a priori coprimary endpoints. The elagolix and hormonal add-back therapy group showed objective improvement in menstrual blood loss at 12 months in 87.9% of women in the extension study (89.4% in the elagolix alone group). This compares with 72.2% improvement at 6 months of treatment in the UF1 and UF2 studies for those taking elagolix and hormonal add-back therapy. These findings illustrate maintenance of the efficacy seen within the 6-month pivotal studies using elagolix over an extended amount of time.

The safety of elagolix also was demonstrated in UF-EXTEND. The 3 most common adverse events were similar to those found in Elaris UF1 and UF2 and included hot flushes, headache, and nausea. In the elagolix and hormonal add-back therapy group during the extension study, the percentage with hot flushes was 7%, headache 6%, and nausea 4%. These are small percentages, which is encouraging for providers and women with HMB associated with fibroids.

Effects on bone density

Bone density was evaluated at baseline in the UF1 and UF2 studies, through treatment, and then 12 months after the extended treatment was stopped. The hormonal add-back therapy of estradiol 1 mg/norethindrone acetate 0.5 mg significantly protected bone density. Some women did not have a decrease in bone density, but for those who did the average was less than 5% for the lumbar spine. The lumbar spine is considered the most reactive, so this illustrates the safety that combined therapy offers women with HMB and fibroids.

The lumbar spine is considered the most reactive, so this site is often used as the main focus with BMD studies. As Simon et al show, the lumbar spine mean BMD percent change from baseline for the elagolix with add-back therapy was -1.5% (95% confidence interval [CI], -1.9 to -1.0) in women who received up to 12 months of treatment at month 6 in the extension study. After stopping elagolix with add-back therapy, at 6 months the elagolix with add-back therapy had a Z-score of -0.6% (95% CI, -1.1 to -0.1). This shows a trend toward baseline, or a recovery within a short time from stopping medication.

Continue to: Study strengths and limitations...

Study strengths and limitations

Strengths of this study include its overall design; efficacy endpoints, which were all established a priori; the fact that measurement of menstrual blood loss was done with the objective alkaline hematin method; and the statistical analysis, which is thorough and well presented. This extension study allowed further evaluation of efficacy and safety for elagolix. Although the authors point out that there may be some selection bias in an extension study, the fact that so many women elected to continue into the extended study is a positive reflection of the treatment.

As providers learn of new therapies for management of HMB associated with fibroids, it is important to consider who will benefit the most. In my opinion, any woman with heavy periods associated with fibroids could be a candidate for elagolix with add-back therapy. This treatment is highly effective, well tolerated, and safe. My approach to management includes educating a woman on all potential therapies and this new option of elagolix and add-back therapy is an important one. The decision for an individual woman on how to manage heavy periods associated with fibroids should consider her contraceptive needs, medical issues, and the risk and benefit of individual therapies. ●

Simon JA, Al-Hendy A, Archer DF, et al. Elagolix treatment for up to 12 months in women with heavy menstrual bleeding and uterine leiomyomas. Obstet Gynecol. 2020;135:1313-1326.

Expert Commentary

Uterine fibroids are common (occurring in up to 80% of reproductive-age women),^1,2 and often associated with heavy menstrual bleeding (HMB). There are surgical and medical options, but typically medical options are used for short periods of time. Elagolix with hormonal add-back therapy was recently approved (May 29, 2020) by the US Food and Drug Administration (FDA) for treatment of HMB in women with uterine fibroids for up to 24 months.

Elagolix is an oral, nonpeptide gonadotropin-releasing hormone antagonist that results in a dose-dependent reduction of gonadotropins and ovarian sex hormones. There are now 2 approved products containing elagolix, with different indications:

• Orilissa. Elagolix was approved in 2018 by the FDA for moderate to severe pain associated with endometriosis. For that indication there are 2 dose options of elagolix (150 mg for up to 2 years and 200 mg for up to 6 months) and there is no hormonal add-back therapy.
• Oriahnn. Elagolix and hormonal add-back therapy was approved in 2020 for HMB associated with uterine fibroids for up to 24 months. The total daily dose of elagolix is 600 mg (elagolix 300 mg in the morning with estradiol 1 mg/norethindrone acetate 0.5 mg and then in the evening elagolix 300 mg and no hormonal add-back).

This new class of drug, GnRH antagonist, is an important one for women’s health, and emerging science will continue to expand its potential uses, such as in reproductive health, as well as long-term efficacy and safety. The difference in daily dose of elagolix for endometriosis (150 mg for 24 months) compared with HMB associated with fibroids (600 mg for 24 months) is why the hormonal add-back therapy is important and allows for protection of bone density.

This is an important manuscript because it highlights a medical option for women with HMB associated with fibroids, which can be used for a long period of time. Further, the improvement in bleeding is both impressive and maintained in the extension study. Approximately 90% of women show improvement in their menstrual bleeding associated with fibroids.

The question of what to do after 24 months of therapy with elagolix and hormonal add-back therapy is an important one, but providers should recognize that the limiting factor with this elagolix and hormonal add-back therapy is bone mineral density (BMD). We will only learn more and more moving forward if this is a clinically meaningful reason for stopping treatment at 24 months. The FDA takes a strict view of safety, and providers must weigh this with the benefit of therapy.

One other highlight between the 2 approved medications is that Orilissa does not have a black box warning, given that there is no hormonal add-back therapy. Oriahnn does have a warning, regarding thromboembolic disorders and vascular events:

• Estrogen and progestin combinations, including Oriahnn, increase the risk of thrombotic or thromboembolic disorders, especially in women at increased risk for these events.
• Oriahnn is contraindicated in women with current or a history of thrombotic or thromboembolic disorders and in women at increased risk for these events, including women over 35 years of age who smoke or women with uncontrolled hypertension.

Continue to: Details about the study...

Details about the study

The study by Simon et al is an extension study (UF-EXTEND), in that women could participate if they had completed 1 of the 2 pivotal studies on elagolix. The pivotal studies (Elaris UF1 and UF2) were both randomized, double-blinded, placebo-controlled studies with up to 6 months of therapy; for UF-EXTEND, however, participants were randomly assigned to either combined elagolix and hormone replacement therapy or elagolix alone for an additional 6 months of therapy. Although it was known that all participants would receive elagolix in UF-EXTEND, those who received hormonal add-back therapy were blinded. All women were then followed up for an additional 12 months after treatment ended.

The efficacy of elagolix was measured by the objective alkaline hematin method for menstrual blood loss with the a priori coprimary endpoints. The elagolix and hormonal add-back therapy group showed objective improvement in menstrual blood loss at 12 months in 87.9% of women in the extension study (89.4% in the elagolix alone group). This compares with 72.2% improvement at 6 months of treatment in the UF1 and UF2 studies for those taking elagolix and hormonal add-back therapy. These findings illustrate maintenance of the efficacy seen within the 6-month pivotal studies using elagolix over an extended amount of time.

The safety of elagolix also was demonstrated in UF-EXTEND. The 3 most common adverse events were similar to those found in Elaris UF1 and UF2 and included hot flushes, headache, and nausea. In the elagolix and hormonal add-back therapy group during the extension study, the percentage with hot flushes was 7%, headache 6%, and nausea 4%. These are small percentages, which is encouraging for providers and women with HMB associated with fibroids.

Effects on bone density

Bone density was evaluated at baseline in the UF1 and UF2 studies, through treatment, and then 12 months after the extended treatment was stopped. The hormonal add-back therapy of estradiol 1 mg/norethindrone acetate 0.5 mg significantly protected bone density. Some women did not have a decrease in bone density, but for those who did the average was less than 5% for the lumbar spine. The lumbar spine is considered the most reactive, so this illustrates the safety that combined therapy offers women with HMB and fibroids.

The lumbar spine is considered the most reactive, so this site is often used as the main focus with BMD studies. As Simon et al show, the lumbar spine mean BMD percent change from baseline for the elagolix with add-back therapy was -1.5% (95% confidence interval [CI], -1.9 to -1.0) in women who received up to 12 months of treatment at month 6 in the extension study. After stopping elagolix with add-back therapy, at 6 months the elagolix with add-back therapy had a Z-score of -0.6% (95% CI, -1.1 to -0.1). This shows a trend toward baseline, or a recovery within a short time from stopping medication.

Continue to: Study strengths and limitations...

Study strengths and limitations

Strengths of this study include its overall design; efficacy endpoints, which were all established a priori; the fact that measurement of menstrual blood loss was done with the objective alkaline hematin method; and the statistical analysis, which is thorough and well presented. This extension study allowed further evaluation of efficacy and safety for elagolix. Although the authors point out that there may be some selection bias in an extension study, the fact that so many women elected to continue into the extended study is a positive reflection of the treatment.

As providers learn of new therapies for management of HMB associated with fibroids, it is important to consider who will benefit the most. In my opinion, any woman with heavy periods associated with fibroids could be a candidate for elagolix with add-back therapy. This treatment is highly effective, well tolerated, and safe. My approach to management includes educating a woman on all potential therapies and this new option of elagolix and add-back therapy is an important one. The decision for an individual woman on how to manage heavy periods associated with fibroids should consider her contraceptive needs, medical issues, and the risk and benefit of individual therapies. ●

In the first 2 articles of this series, “Telemedicine: A primer for today’s ObGyn” and “Telemedicine: Common hurdles and proper coding for ObGyns,” which appeared in the May and June issues of OBG Management, we discussed caring for patients without face-to-face visits and that virtual visits are an opportunity to provide good care in a world such as that created by COVID-19. We also discussed which patients are the most appropriate candidates for telemedicine, as well as how to properly code virtual visits so that you are paid for your time and service. This third article addresses the legal concerns and caveats of using telemedicine and makes a prediction for the future of virtual health care.

Legal issues surrounding telemedicine

There are numerous legal, regulatory, and compliance issues that existed before the pandemic that likely will continue to be of concern postpandemic. Although the recent 1135 waiver (allowing Medicare to pay for office, hospital, and other visits furnished via telehealth)¹ and other regulations are now in place for almost every aspect of telemedicine, virtual medicine is not a free-for-all (even though it may seem like it). Practicing ethical telemedicine entails abiding by numerous federal and state-specific laws and requirements. It is important to be aware of the laws in each state in which your patients are located and to practice according to the requirements of these laws. This often requires consultation with an experienced health care attorney who is knowledgeable about the use of telemedicine and who can help you with issues surrounding:

• Malpractice insurance. It is an important first step to contact your practice’s malpractice insurance carrier and confirm coverage for telemedicine visits. Telemedicine visits are considered the same as in-person visits when determining scope of practice and malpractice liability. Nevertheless, a best practice is to have written verification from your malpractice carrier about the types of telemedicine services and claims for which your ObGyn practice is covered. Additionally, if you care for patients virtually who live in a state in which you are not licensed, check with your carrier to determine if potential claims will be covered.
• Corporate practice laws. These laws require that your practice be governed by a health care professional and not someone with a nonmedical background. This becomes important if you are looking to create a virtual practice in another state. States that prohibit the corporate practice of medicine have state-specific mandates that require strict adherence. Consult with a health care attorney before entering into a business arrangement with a nonphysician or corporate entity.
• Delegation agreement requirements. These laws require physician collaboration and/or supervision of allied health care workers such as nurse practitioners (NPs) and physician assistants (PAs) and may limit the number of allied health care providers that a physician may supervise. Many states are allowing allied health care workers to practice at the top of their license, but this is still state specific. Thus, it is an important issue to consider, especially for practices that rely heavily on the services of advanced practice registered nurses (APRNs), for example, who have a broad scope of practice and who may be qualified to care for many common ObGyn problems.
• Informed consent requirements. Some states have no requirements regarding consent for a virtual visit. Others require either written or verbal consent. In states that do not require informed consent, it is best practice to nevertheless obtain either written or oral consent and to document in the patient’s record that consent was obtained before initiating a virtual visit. The consent should follow state-mandated disclosures, as well as the practice’s policies regarding billing, scheduling, and cancellations of telemedicine visits.
• Interstate licensing laws. Because of the COVID-19 pandemic, federal and state licensure waivers are in place to allow physicians to care for patients outside the physician’s home state, but these waivers likely will be lifted postpandemic. Once waivers are lifted, physicians will need to be licensed not only in the state in which they practice but also in the state where the patient is located at the time of treatment. Even physicians who practice in states that belong to the Interstate Medical Licensure Compact² must apply for and obtain a license to practice within Compact member states. Membership in the Interstate Medical Licensure Compact expedites the licensure process, but does not alleviate the need to obtain a license to practice in each member state. To ensure compliance with interstate licensure laws, seek advice from a health care attorney specializing in telemedicine.
• Drug monitoring laws. The Ryan Haight Online Pharmacy Consumer Protection Act of 2008³ implemented a requirement that physicians have at least one in-person, face-to-face visit with patients before prescribing a controlled substance for the first time. Because state laws may vary, we suggest consulting with a health care attorney to understand your state’s requirements for prescribing controlled substances to new patients and when using telemedicine (see “Prescription drugs” at https://www.cdc.gov/phlp/publications/topic/prescription.html for more information).
• Data privacy and security. From a content perspective, health care data and personally identifiable information are extremely rich, which makes electronic health records (EHRs), or the digital form of patients’ medical histories and other data, particularly tempting targets for hackers and cyber criminals. We caution that services such as Facetime and Skype are not encrypted; they have been granted waivers for telemedicine use, but these waivers are probably not going to be permanent once the COVID-19 crisis passes.
• HIPAA compliance. Generally—and certainly under normal circumstances—telemedicine is subject to the same rules governing protected health information (PHI) as any other technology and process used in physician practices. The Health Insurance Portability and Accountability Act (HIPAA) Security Rule includes guidelines on telemedicine and stipulates that only authorized users should have access to ePHI, that a system of secure communication must be established to protect the security of ePHI, and that a system to monitor communications must be maintained, among other requirements.⁴ Third parties that provide telemedicine, data storage, and other services, with a few exceptions, must have a business associate agreement (BAA) with a covered entity. Covered entities include health care providers, health plans, and health and health care clearinghouses. Such an agreement should include specific language that ensures that HIPAA requirements will be met and that governs permitted and required uses of PHI, strictly limits other uses of PHI, and establishes appropriate safeguards and steps that must be taken in the event of a breach or disallowed disclosure of PHI. Best practice requires that providers establish robust protocols, policies, and processes for handling sensitive information.

During the COVID-19 pandemic, however, certain HIPAA restrictions relating to telemedicine have been temporarily waived by the US Department of Health and Human Services (HHS). More specifically, HHS Secretary Alex Azar has exercised his authority to waive sanctions against covered hospitals for noncompliance with requirements: to obtain a patient’s consent to speak with family members or friends involved in the patient’s care, to distribute a notice of privacy practices, to request privacy restrictions, to request confidential communications, and the use of nonpublic facing audio and video communications products, among others.⁵ These are temporary measures only; once the national public health emergency has passed or at the HHS Secretary’s discretion based on new developments, this position on discretionary nonenforcement may end.

Continue to: Crisis creates opportunity: The future of telemedicine...

Crisis creates opportunity: The future of telemedicine

It was just a few years ago when the use of telemedicine was relegated to treating patients in only rural areas or those located a great distance from brick and mortar practices. But the pandemic, along with the coincident relaxation of the Centers for Medicare and Medicaid Services’ (CMS) requirements for conducting telemedicine visits has made the technology highly attractive to ObGyns who can now treat many patients 24/7 from their homes using laptops and even mobile devices. In addition, the pandemic has prompted an expansion of current procedural terminology (CPT) codes that makes it possible to bill patients for telemedicine services and be appropriately compensated.

Thus, as awful as COVID-19 is, we can conclude that it has provided us with opportunities. We predict that when the crisis has abated, although the current relaxation of HIPAA guidelines will probably be rescinded, restrictions will not likely return to precoronavirus status; changes will certainly be made, and telemedicine will likely become part and parcel of caring for ObGyn patients.

Telemedicine has been used successfully for years to improve patient access to medical care while reducing health care costs. In 2016, an estimated 61% of US health care institutions and 40% to 50% of US hospitals used telemedicine.⁶ And according to the results of a survey of America’s physicians conducted in April 2020, almost half (48%) are treating patients through telemedicine, which is up from just 18% 2 years ago.⁷

Letting loose the genie in the bottle

Widespread use of telemedicine traditionally has been limited by low reimbursement rates and interstate licensing and practice issues, but we predict that the use of telemedicine is going to significantly increase in the future. Here’s why:⁸ Disruptive innovation was defined by Professor Clayton Christensen of the Harvard Business School in 1997.⁹ Disruptive innovation explains the process by which a disruptive force spurs the development of simple, convenient, and affordable solutions that then replace processes that are expensive and complicated. According to Christensen, a critical element of the process is a technology that makes a product or service more accessible to a larger number of people while reducing cost and increasing ease of use. For example, innovations making equipment for dialysis cheaper and simpler helped make it possible to administer the treatment in neighborhood clinics, rather than in centralized hospitals, thus disrupting the hospital’s share of the dialysis business.

The concept of telemedicine and the technology for its implementation have been available for more than 15 years. However, it was the coronavirus that released the genie from the bottle, serving as the disruptive force to release the innovation. Telemedicine has demonstrated that the technology offers solutions that address patients’ urgent, unmet needs for access to care at an affordable price and that enhances the productivity of the ObGyn. The result is simple, convenient, and affordable; patients can readily access the medical care they need to effectively maintain their health or manage conditions that arise.

Telemedicine has reached a level of critical mass. Data suggest that patients, especially younger ones, have accepted and appreciate the use of this technology.¹⁰ It gives patients more opportunities to receive health care in their homes or at work where they feel more comfortable and less anxious than they do in physicians’ offices.

Several other health care issues may be altered by telemedicine.

The physician shortage. If the data are to be believed, there will be a significant shortage of physicians—and perhaps ObGyns—in the near future.¹¹ Telemedicine can help the problem by making it possible to provide medical care not only in rural areas where there are no ObGyns but also in urban areas where a shortage may be looming.

Continuing medical education (CME). CME is moving from large, expensive, in-person conferences to virtual conferences and online learning.

The American health care budget is bloated with expenses exceeding $3 trillion.¹² Telemedicine can help reduce health care costs by facilitating patient appointments that do not require office staff or many of the overhead expenses associated with brick and mortar operations. Telemedicine reduces the financial impact of patient no-shows. Because patients are keen on participating, the use of telemedicine likely will improve patient engagement and clinical outcomes. Telemedicine already has a reputation of reducing unnecessary office and emergency room visits and hospital admissions.¹³

Clinical trials. One of the obstacles to overcome in the early stages of a clinical trial is finding participants. Telemedicine will make patient recruitment more straightforward. And because telemedicine makes distance from the office a nonissue, recruiters will be less restricted by geographic boundaries.

In addition, telemedicine allows for the participants of the trial to stay in their homes most of the time while wearing remote monitoring devices. Such devices would enable trial researchers to spot deviations from patients’ baseline readings.

The bottom line

COVID-19 has provided the opportunity for us to see how telemedicine can contribute to reducing the spread of infectious diseases by protecting physicians, their staff, and patients themselves. Once the COVID-19 crisis has passed, it is likely that telemedicine will continue to move health care delivery from the hospital or clinic into the home. The growth and integration of information and communication technologies into health care delivery holds great potential for patients, providers, and payers in health systems of the future. ●

In the first 2 articles of this series, “Telemedicine: A primer for today’s ObGyn” and “Telemedicine: Common hurdles and proper coding for ObGyns,” which appeared in the May and June issues of OBG Management, we discussed caring for patients without face-to-face visits and that virtual visits are an opportunity to provide good care in a world such as that created by COVID-19. We also discussed which patients are the most appropriate candidates for telemedicine, as well as how to properly code virtual visits so that you are paid for your time and service. This third article addresses the legal concerns and caveats of using telemedicine and makes a prediction for the future of virtual health care.

Legal issues surrounding telemedicine

There are numerous legal, regulatory, and compliance issues that existed before the pandemic that likely will continue to be of concern postpandemic. Although the recent 1135 waiver (allowing Medicare to pay for office, hospital, and other visits furnished via telehealth)¹ and other regulations are now in place for almost every aspect of telemedicine, virtual medicine is not a free-for-all (even though it may seem like it). Practicing ethical telemedicine entails abiding by numerous federal and state-specific laws and requirements. It is important to be aware of the laws in each state in which your patients are located and to practice according to the requirements of these laws. This often requires consultation with an experienced health care attorney who is knowledgeable about the use of telemedicine and who can help you with issues surrounding:

• Malpractice insurance. It is an important first step to contact your practice’s malpractice insurance carrier and confirm coverage for telemedicine visits. Telemedicine visits are considered the same as in-person visits when determining scope of practice and malpractice liability. Nevertheless, a best practice is to have written verification from your malpractice carrier about the types of telemedicine services and claims for which your ObGyn practice is covered. Additionally, if you care for patients virtually who live in a state in which you are not licensed, check with your carrier to determine if potential claims will be covered.
• Corporate practice laws. These laws require that your practice be governed by a health care professional and not someone with a nonmedical background. This becomes important if you are looking to create a virtual practice in another state. States that prohibit the corporate practice of medicine have state-specific mandates that require strict adherence. Consult with a health care attorney before entering into a business arrangement with a nonphysician or corporate entity.
• Delegation agreement requirements. These laws require physician collaboration and/or supervision of allied health care workers such as nurse practitioners (NPs) and physician assistants (PAs) and may limit the number of allied health care providers that a physician may supervise. Many states are allowing allied health care workers to practice at the top of their license, but this is still state specific. Thus, it is an important issue to consider, especially for practices that rely heavily on the services of advanced practice registered nurses (APRNs), for example, who have a broad scope of practice and who may be qualified to care for many common ObGyn problems.
• Informed consent requirements. Some states have no requirements regarding consent for a virtual visit. Others require either written or verbal consent. In states that do not require informed consent, it is best practice to nevertheless obtain either written or oral consent and to document in the patient’s record that consent was obtained before initiating a virtual visit. The consent should follow state-mandated disclosures, as well as the practice’s policies regarding billing, scheduling, and cancellations of telemedicine visits.
• Interstate licensing laws. Because of the COVID-19 pandemic, federal and state licensure waivers are in place to allow physicians to care for patients outside the physician’s home state, but these waivers likely will be lifted postpandemic. Once waivers are lifted, physicians will need to be licensed not only in the state in which they practice but also in the state where the patient is located at the time of treatment. Even physicians who practice in states that belong to the Interstate Medical Licensure Compact² must apply for and obtain a license to practice within Compact member states. Membership in the Interstate Medical Licensure Compact expedites the licensure process, but does not alleviate the need to obtain a license to practice in each member state. To ensure compliance with interstate licensure laws, seek advice from a health care attorney specializing in telemedicine.
• Drug monitoring laws. The Ryan Haight Online Pharmacy Consumer Protection Act of 2008³ implemented a requirement that physicians have at least one in-person, face-to-face visit with patients before prescribing a controlled substance for the first time. Because state laws may vary, we suggest consulting with a health care attorney to understand your state’s requirements for prescribing controlled substances to new patients and when using telemedicine (see “Prescription drugs” at https://www.cdc.gov/phlp/publications/topic/prescription.html for more information).
• Data privacy and security. From a content perspective, health care data and personally identifiable information are extremely rich, which makes electronic health records (EHRs), or the digital form of patients’ medical histories and other data, particularly tempting targets for hackers and cyber criminals. We caution that services such as Facetime and Skype are not encrypted; they have been granted waivers for telemedicine use, but these waivers are probably not going to be permanent once the COVID-19 crisis passes.
• HIPAA compliance. Generally—and certainly under normal circumstances—telemedicine is subject to the same rules governing protected health information (PHI) as any other technology and process used in physician practices. The Health Insurance Portability and Accountability Act (HIPAA) Security Rule includes guidelines on telemedicine and stipulates that only authorized users should have access to ePHI, that a system of secure communication must be established to protect the security of ePHI, and that a system to monitor communications must be maintained, among other requirements.⁴ Third parties that provide telemedicine, data storage, and other services, with a few exceptions, must have a business associate agreement (BAA) with a covered entity. Covered entities include health care providers, health plans, and health and health care clearinghouses. Such an agreement should include specific language that ensures that HIPAA requirements will be met and that governs permitted and required uses of PHI, strictly limits other uses of PHI, and establishes appropriate safeguards and steps that must be taken in the event of a breach or disallowed disclosure of PHI. Best practice requires that providers establish robust protocols, policies, and processes for handling sensitive information.

During the COVID-19 pandemic, however, certain HIPAA restrictions relating to telemedicine have been temporarily waived by the US Department of Health and Human Services (HHS). More specifically, HHS Secretary Alex Azar has exercised his authority to waive sanctions against covered hospitals for noncompliance with requirements: to obtain a patient’s consent to speak with family members or friends involved in the patient’s care, to distribute a notice of privacy practices, to request privacy restrictions, to request confidential communications, and the use of nonpublic facing audio and video communications products, among others.⁵ These are temporary measures only; once the national public health emergency has passed or at the HHS Secretary’s discretion based on new developments, this position on discretionary nonenforcement may end.

Continue to: Crisis creates opportunity: The future of telemedicine...

Crisis creates opportunity: The future of telemedicine

It was just a few years ago when the use of telemedicine was relegated to treating patients in only rural areas or those located a great distance from brick and mortar practices. But the pandemic, along with the coincident relaxation of the Centers for Medicare and Medicaid Services’ (CMS) requirements for conducting telemedicine visits has made the technology highly attractive to ObGyns who can now treat many patients 24/7 from their homes using laptops and even mobile devices. In addition, the pandemic has prompted an expansion of current procedural terminology (CPT) codes that makes it possible to bill patients for telemedicine services and be appropriately compensated.

Thus, as awful as COVID-19 is, we can conclude that it has provided us with opportunities. We predict that when the crisis has abated, although the current relaxation of HIPAA guidelines will probably be rescinded, restrictions will not likely return to precoronavirus status; changes will certainly be made, and telemedicine will likely become part and parcel of caring for ObGyn patients.

Telemedicine has been used successfully for years to improve patient access to medical care while reducing health care costs. In 2016, an estimated 61% of US health care institutions and 40% to 50% of US hospitals used telemedicine.⁶ And according to the results of a survey of America’s physicians conducted in April 2020, almost half (48%) are treating patients through telemedicine, which is up from just 18% 2 years ago.⁷

Letting loose the genie in the bottle

Widespread use of telemedicine traditionally has been limited by low reimbursement rates and interstate licensing and practice issues, but we predict that the use of telemedicine is going to significantly increase in the future. Here’s why:⁸ Disruptive innovation was defined by Professor Clayton Christensen of the Harvard Business School in 1997.⁹ Disruptive innovation explains the process by which a disruptive force spurs the development of simple, convenient, and affordable solutions that then replace processes that are expensive and complicated. According to Christensen, a critical element of the process is a technology that makes a product or service more accessible to a larger number of people while reducing cost and increasing ease of use. For example, innovations making equipment for dialysis cheaper and simpler helped make it possible to administer the treatment in neighborhood clinics, rather than in centralized hospitals, thus disrupting the hospital’s share of the dialysis business.

The concept of telemedicine and the technology for its implementation have been available for more than 15 years. However, it was the coronavirus that released the genie from the bottle, serving as the disruptive force to release the innovation. Telemedicine has demonstrated that the technology offers solutions that address patients’ urgent, unmet needs for access to care at an affordable price and that enhances the productivity of the ObGyn. The result is simple, convenient, and affordable; patients can readily access the medical care they need to effectively maintain their health or manage conditions that arise.

Telemedicine has reached a level of critical mass. Data suggest that patients, especially younger ones, have accepted and appreciate the use of this technology.¹⁰ It gives patients more opportunities to receive health care in their homes or at work where they feel more comfortable and less anxious than they do in physicians’ offices.

Several other health care issues may be altered by telemedicine.

The physician shortage. If the data are to be believed, there will be a significant shortage of physicians—and perhaps ObGyns—in the near future.¹¹ Telemedicine can help the problem by making it possible to provide medical care not only in rural areas where there are no ObGyns but also in urban areas where a shortage may be looming.

Continuing medical education (CME). CME is moving from large, expensive, in-person conferences to virtual conferences and online learning.

The American health care budget is bloated with expenses exceeding $3 trillion.¹² Telemedicine can help reduce health care costs by facilitating patient appointments that do not require office staff or many of the overhead expenses associated with brick and mortar operations. Telemedicine reduces the financial impact of patient no-shows. Because patients are keen on participating, the use of telemedicine likely will improve patient engagement and clinical outcomes. Telemedicine already has a reputation of reducing unnecessary office and emergency room visits and hospital admissions.¹³

Clinical trials. One of the obstacles to overcome in the early stages of a clinical trial is finding participants. Telemedicine will make patient recruitment more straightforward. And because telemedicine makes distance from the office a nonissue, recruiters will be less restricted by geographic boundaries.

In addition, telemedicine allows for the participants of the trial to stay in their homes most of the time while wearing remote monitoring devices. Such devices would enable trial researchers to spot deviations from patients’ baseline readings.

The bottom line

COVID-19 has provided the opportunity for us to see how telemedicine can contribute to reducing the spread of infectious diseases by protecting physicians, their staff, and patients themselves. Once the COVID-19 crisis has passed, it is likely that telemedicine will continue to move health care delivery from the hospital or clinic into the home. The growth and integration of information and communication technologies into health care delivery holds great potential for patients, providers, and payers in health systems of the future. ●

In the first 2 articles of this series, “Telemedicine: A primer for today’s ObGyn” and “Telemedicine: Common hurdles and proper coding for ObGyns,” which appeared in the May and June issues of OBG Management, we discussed caring for patients without face-to-face visits and that virtual visits are an opportunity to provide good care in a world such as that created by COVID-19. We also discussed which patients are the most appropriate candidates for telemedicine, as well as how to properly code virtual visits so that you are paid for your time and service. This third article addresses the legal concerns and caveats of using telemedicine and makes a prediction for the future of virtual health care.

Legal issues surrounding telemedicine

There are numerous legal, regulatory, and compliance issues that existed before the pandemic that likely will continue to be of concern postpandemic. Although the recent 1135 waiver (allowing Medicare to pay for office, hospital, and other visits furnished via telehealth)¹ and other regulations are now in place for almost every aspect of telemedicine, virtual medicine is not a free-for-all (even though it may seem like it). Practicing ethical telemedicine entails abiding by numerous federal and state-specific laws and requirements. It is important to be aware of the laws in each state in which your patients are located and to practice according to the requirements of these laws. This often requires consultation with an experienced health care attorney who is knowledgeable about the use of telemedicine and who can help you with issues surrounding:

• Malpractice insurance. It is an important first step to contact your practice’s malpractice insurance carrier and confirm coverage for telemedicine visits. Telemedicine visits are considered the same as in-person visits when determining scope of practice and malpractice liability. Nevertheless, a best practice is to have written verification from your malpractice carrier about the types of telemedicine services and claims for which your ObGyn practice is covered. Additionally, if you care for patients virtually who live in a state in which you are not licensed, check with your carrier to determine if potential claims will be covered.
• Corporate practice laws. These laws require that your practice be governed by a health care professional and not someone with a nonmedical background. This becomes important if you are looking to create a virtual practice in another state. States that prohibit the corporate practice of medicine have state-specific mandates that require strict adherence. Consult with a health care attorney before entering into a business arrangement with a nonphysician or corporate entity.
• Delegation agreement requirements. These laws require physician collaboration and/or supervision of allied health care workers such as nurse practitioners (NPs) and physician assistants (PAs) and may limit the number of allied health care providers that a physician may supervise. Many states are allowing allied health care workers to practice at the top of their license, but this is still state specific. Thus, it is an important issue to consider, especially for practices that rely heavily on the services of advanced practice registered nurses (APRNs), for example, who have a broad scope of practice and who may be qualified to care for many common ObGyn problems.
• Informed consent requirements. Some states have no requirements regarding consent for a virtual visit. Others require either written or verbal consent. In states that do not require informed consent, it is best practice to nevertheless obtain either written or oral consent and to document in the patient’s record that consent was obtained before initiating a virtual visit. The consent should follow state-mandated disclosures, as well as the practice’s policies regarding billing, scheduling, and cancellations of telemedicine visits.
• Interstate licensing laws. Because of the COVID-19 pandemic, federal and state licensure waivers are in place to allow physicians to care for patients outside the physician’s home state, but these waivers likely will be lifted postpandemic. Once waivers are lifted, physicians will need to be licensed not only in the state in which they practice but also in the state where the patient is located at the time of treatment. Even physicians who practice in states that belong to the Interstate Medical Licensure Compact² must apply for and obtain a license to practice within Compact member states. Membership in the Interstate Medical Licensure Compact expedites the licensure process, but does not alleviate the need to obtain a license to practice in each member state. To ensure compliance with interstate licensure laws, seek advice from a health care attorney specializing in telemedicine.
• Drug monitoring laws. The Ryan Haight Online Pharmacy Consumer Protection Act of 2008³ implemented a requirement that physicians have at least one in-person, face-to-face visit with patients before prescribing a controlled substance for the first time. Because state laws may vary, we suggest consulting with a health care attorney to understand your state’s requirements for prescribing controlled substances to new patients and when using telemedicine (see “Prescription drugs” at https://www.cdc.gov/phlp/publications/topic/prescription.html for more information).
• Data privacy and security. From a content perspective, health care data and personally identifiable information are extremely rich, which makes electronic health records (EHRs), or the digital form of patients’ medical histories and other data, particularly tempting targets for hackers and cyber criminals. We caution that services such as Facetime and Skype are not encrypted; they have been granted waivers for telemedicine use, but these waivers are probably not going to be permanent once the COVID-19 crisis passes.
• HIPAA compliance. Generally—and certainly under normal circumstances—telemedicine is subject to the same rules governing protected health information (PHI) as any other technology and process used in physician practices. The Health Insurance Portability and Accountability Act (HIPAA) Security Rule includes guidelines on telemedicine and stipulates that only authorized users should have access to ePHI, that a system of secure communication must be established to protect the security of ePHI, and that a system to monitor communications must be maintained, among other requirements.⁴ Third parties that provide telemedicine, data storage, and other services, with a few exceptions, must have a business associate agreement (BAA) with a covered entity. Covered entities include health care providers, health plans, and health and health care clearinghouses. Such an agreement should include specific language that ensures that HIPAA requirements will be met and that governs permitted and required uses of PHI, strictly limits other uses of PHI, and establishes appropriate safeguards and steps that must be taken in the event of a breach or disallowed disclosure of PHI. Best practice requires that providers establish robust protocols, policies, and processes for handling sensitive information.

During the COVID-19 pandemic, however, certain HIPAA restrictions relating to telemedicine have been temporarily waived by the US Department of Health and Human Services (HHS). More specifically, HHS Secretary Alex Azar has exercised his authority to waive sanctions against covered hospitals for noncompliance with requirements: to obtain a patient’s consent to speak with family members or friends involved in the patient’s care, to distribute a notice of privacy practices, to request privacy restrictions, to request confidential communications, and the use of nonpublic facing audio and video communications products, among others.⁵ These are temporary measures only; once the national public health emergency has passed or at the HHS Secretary’s discretion based on new developments, this position on discretionary nonenforcement may end.

Continue to: Crisis creates opportunity: The future of telemedicine...

Crisis creates opportunity: The future of telemedicine

It was just a few years ago when the use of telemedicine was relegated to treating patients in only rural areas or those located a great distance from brick and mortar practices. But the pandemic, along with the coincident relaxation of the Centers for Medicare and Medicaid Services’ (CMS) requirements for conducting telemedicine visits has made the technology highly attractive to ObGyns who can now treat many patients 24/7 from their homes using laptops and even mobile devices. In addition, the pandemic has prompted an expansion of current procedural terminology (CPT) codes that makes it possible to bill patients for telemedicine services and be appropriately compensated.

Thus, as awful as COVID-19 is, we can conclude that it has provided us with opportunities. We predict that when the crisis has abated, although the current relaxation of HIPAA guidelines will probably be rescinded, restrictions will not likely return to precoronavirus status; changes will certainly be made, and telemedicine will likely become part and parcel of caring for ObGyn patients.

Telemedicine has been used successfully for years to improve patient access to medical care while reducing health care costs. In 2016, an estimated 61% of US health care institutions and 40% to 50% of US hospitals used telemedicine.⁶ And according to the results of a survey of America’s physicians conducted in April 2020, almost half (48%) are treating patients through telemedicine, which is up from just 18% 2 years ago.⁷

Letting loose the genie in the bottle

Widespread use of telemedicine traditionally has been limited by low reimbursement rates and interstate licensing and practice issues, but we predict that the use of telemedicine is going to significantly increase in the future. Here’s why:⁸ Disruptive innovation was defined by Professor Clayton Christensen of the Harvard Business School in 1997.⁹ Disruptive innovation explains the process by which a disruptive force spurs the development of simple, convenient, and affordable solutions that then replace processes that are expensive and complicated. According to Christensen, a critical element of the process is a technology that makes a product or service more accessible to a larger number of people while reducing cost and increasing ease of use. For example, innovations making equipment for dialysis cheaper and simpler helped make it possible to administer the treatment in neighborhood clinics, rather than in centralized hospitals, thus disrupting the hospital’s share of the dialysis business.

The concept of telemedicine and the technology for its implementation have been available for more than 15 years. However, it was the coronavirus that released the genie from the bottle, serving as the disruptive force to release the innovation. Telemedicine has demonstrated that the technology offers solutions that address patients’ urgent, unmet needs for access to care at an affordable price and that enhances the productivity of the ObGyn. The result is simple, convenient, and affordable; patients can readily access the medical care they need to effectively maintain their health or manage conditions that arise.

Telemedicine has reached a level of critical mass. Data suggest that patients, especially younger ones, have accepted and appreciate the use of this technology.¹⁰ It gives patients more opportunities to receive health care in their homes or at work where they feel more comfortable and less anxious than they do in physicians’ offices.

Several other health care issues may be altered by telemedicine.

The physician shortage. If the data are to be believed, there will be a significant shortage of physicians—and perhaps ObGyns—in the near future.¹¹ Telemedicine can help the problem by making it possible to provide medical care not only in rural areas where there are no ObGyns but also in urban areas where a shortage may be looming.

Continuing medical education (CME). CME is moving from large, expensive, in-person conferences to virtual conferences and online learning.

The American health care budget is bloated with expenses exceeding $3 trillion.¹² Telemedicine can help reduce health care costs by facilitating patient appointments that do not require office staff or many of the overhead expenses associated with brick and mortar operations. Telemedicine reduces the financial impact of patient no-shows. Because patients are keen on participating, the use of telemedicine likely will improve patient engagement and clinical outcomes. Telemedicine already has a reputation of reducing unnecessary office and emergency room visits and hospital admissions.¹³

Clinical trials. One of the obstacles to overcome in the early stages of a clinical trial is finding participants. Telemedicine will make patient recruitment more straightforward. And because telemedicine makes distance from the office a nonissue, recruiters will be less restricted by geographic boundaries.

In addition, telemedicine allows for the participants of the trial to stay in their homes most of the time while wearing remote monitoring devices. Such devices would enable trial researchers to spot deviations from patients’ baseline readings.

The bottom line

COVID-19 has provided the opportunity for us to see how telemedicine can contribute to reducing the spread of infectious diseases by protecting physicians, their staff, and patients themselves. Once the COVID-19 crisis has passed, it is likely that telemedicine will continue to move health care delivery from the hospital or clinic into the home. The growth and integration of information and communication technologies into health care delivery holds great potential for patients, providers, and payers in health systems of the future. ●

For women undergoing urethral diverticulectomy, adding a pubovaginal sling at the time of surgery resolved stress urinary incontinence 79% of the time, a large retrospective cohort study has found.

Alexander Raths/Fotolia

However, in 66% of cases in which the diverticulectomy alone was performed, women also saw their stress urinary incontinence (SUI) resolve.

For a study published online in the American Journal of Obstetrics and Gynecology, Sarah E. Bradley, MD, of Georgetown University in Washington and colleagues analyzed records for 485 urethral diverticulectomies performed at 11 institutions over a 16-year period. One-fifth of patients had an autologous fascial pubovaginal sling (PVS) placed at the time of surgery.

The concomitant sling was associated with a significantly greater reduction of SUI after adjustment for prior diverticulectomy, prior incontinence surgery, age, race, and parity (adjusted odds ratio, 2.27; 95% confidence interval, 1.02-5.03; P = .043).

However, 10% of women in the sling-treated group had recurrent UTI from 6 weeks after surgery, compared with 3% of those in the diverticulectomy-only group (P = .001). Even after adjustment for higher rates of UTI before surgery in the sling group, the odds of recurrent UTI still were higher with the concomitant sling. Women within the sling group also were more likely to experience urinary retention at more than 6 weeks after surgery (8% vs. 1%; P equal to .0001).

Dr. Bradley and her colleagues noted that theirs was the largest study to date evaluating postoperative SUI in patients undergoing diverticulectomy with and without a PVS, noting that many surgeons do not routinely offer the sling at the time of diverticulectomy.

They also acknowledged a selection bias in their study. “With the previously thought theoretical increased risk of the addition of PVS, it is likely that most providers would prefer only to offer this concomitant procedure to those with significantly bothersome SUI. Additionally, the majority of women that underwent PVS (83%) came from two of the 11 participating institutions,” the researchers wrote.

In an interview, Catherine A. Mathews, MD, of Wake Forest University in Winston Salem, N.C., argued for a different interpretation of the study’s results.

“The study was beautifully done and it’s an ideal subject for a review, but in some respect the authors missed the opportunity to highlight that there was a spontaneous resolution of stress incontinence symptoms in 66% of women who received diverticulectomy alone,” Dr. Matthews said, adding that this has important implications for medical decision-making and patient choice.

“Morbidity associated with the pubovaginal sling was very low in this study, probably because it was being done by very proficient surgeons, but in many centers it is higher,” Dr. Matthews said. Even with the overall low morbidity seen in the study, “there was still a significant price to pay” for some women in the pubovaginal sling–treated group. “Recurrent UTI can be challenging to manage in the long term, with antibiotic morbidity and significant symptom bother. For the patients with urinary retention, having to manage it with a catheter is a really awful.”

Dr. Matthews said that the study made a case for interval, rather than concomitant, sling placement in women undergoing urethral diverticulectomy. “If you have a patient who insists on addressing symptoms concomitantly, this study provides good information about the long-term likelihood of two complications: urinary retention and recurrent UTI,” she said. “The vast majority of patients that I’m counseling would choose not to have the sling because of these complications.” And while avoiding reoperation may seem a good reason to opt for the PVS during diverticulectomy, the sling was not associated with a decrease in reoperations, compared with diverticulectomy alone, she noted.

“As we can see in the study, diverticulectomy itself has a high impact on stress incontinence,” Dr. Matthews continued. “If you restore the urethral anatomy and wait for the urethra to heal, you have a very good chance that the incontinence resolves.” For those women who do not see resolution and whose symptoms are still severe enough to bother them, “you’d have the flexibility postoperatively to offer not only a pubovaginal sling, but a synthetic mesh sling or a urethral bulking procedure.”

Dr. Bradley and her colleagues reported no relevant financial disclosures. Dr. Matthews disclosed financial support from Boston Scientific and serving as an expert witness for Johnson & Johnson.

SOURCE: Bradley SE et al. Am J Obstet Gynecol. 2020. doi: 10.1016/j.ajog.2020.06.002.

For women undergoing urethral diverticulectomy, adding a pubovaginal sling at the time of surgery resolved stress urinary incontinence 79% of the time, a large retrospective cohort study has found.

Alexander Raths/Fotolia

However, in 66% of cases in which the diverticulectomy alone was performed, women also saw their stress urinary incontinence (SUI) resolve.

For a study published online in the American Journal of Obstetrics and Gynecology, Sarah E. Bradley, MD, of Georgetown University in Washington and colleagues analyzed records for 485 urethral diverticulectomies performed at 11 institutions over a 16-year period. One-fifth of patients had an autologous fascial pubovaginal sling (PVS) placed at the time of surgery.

The concomitant sling was associated with a significantly greater reduction of SUI after adjustment for prior diverticulectomy, prior incontinence surgery, age, race, and parity (adjusted odds ratio, 2.27; 95% confidence interval, 1.02-5.03; P = .043).

However, 10% of women in the sling-treated group had recurrent UTI from 6 weeks after surgery, compared with 3% of those in the diverticulectomy-only group (P = .001). Even after adjustment for higher rates of UTI before surgery in the sling group, the odds of recurrent UTI still were higher with the concomitant sling. Women within the sling group also were more likely to experience urinary retention at more than 6 weeks after surgery (8% vs. 1%; P equal to .0001).

Dr. Bradley and her colleagues noted that theirs was the largest study to date evaluating postoperative SUI in patients undergoing diverticulectomy with and without a PVS, noting that many surgeons do not routinely offer the sling at the time of diverticulectomy.

They also acknowledged a selection bias in their study. “With the previously thought theoretical increased risk of the addition of PVS, it is likely that most providers would prefer only to offer this concomitant procedure to those with significantly bothersome SUI. Additionally, the majority of women that underwent PVS (83%) came from two of the 11 participating institutions,” the researchers wrote.

In an interview, Catherine A. Mathews, MD, of Wake Forest University in Winston Salem, N.C., argued for a different interpretation of the study’s results.

“The study was beautifully done and it’s an ideal subject for a review, but in some respect the authors missed the opportunity to highlight that there was a spontaneous resolution of stress incontinence symptoms in 66% of women who received diverticulectomy alone,” Dr. Matthews said, adding that this has important implications for medical decision-making and patient choice.

“Morbidity associated with the pubovaginal sling was very low in this study, probably because it was being done by very proficient surgeons, but in many centers it is higher,” Dr. Matthews said. Even with the overall low morbidity seen in the study, “there was still a significant price to pay” for some women in the pubovaginal sling–treated group. “Recurrent UTI can be challenging to manage in the long term, with antibiotic morbidity and significant symptom bother. For the patients with urinary retention, having to manage it with a catheter is a really awful.”

Dr. Matthews said that the study made a case for interval, rather than concomitant, sling placement in women undergoing urethral diverticulectomy. “If you have a patient who insists on addressing symptoms concomitantly, this study provides good information about the long-term likelihood of two complications: urinary retention and recurrent UTI,” she said. “The vast majority of patients that I’m counseling would choose not to have the sling because of these complications.” And while avoiding reoperation may seem a good reason to opt for the PVS during diverticulectomy, the sling was not associated with a decrease in reoperations, compared with diverticulectomy alone, she noted.

“As we can see in the study, diverticulectomy itself has a high impact on stress incontinence,” Dr. Matthews continued. “If you restore the urethral anatomy and wait for the urethra to heal, you have a very good chance that the incontinence resolves.” For those women who do not see resolution and whose symptoms are still severe enough to bother them, “you’d have the flexibility postoperatively to offer not only a pubovaginal sling, but a synthetic mesh sling or a urethral bulking procedure.”

Dr. Bradley and her colleagues reported no relevant financial disclosures. Dr. Matthews disclosed financial support from Boston Scientific and serving as an expert witness for Johnson & Johnson.

SOURCE: Bradley SE et al. Am J Obstet Gynecol. 2020. doi: 10.1016/j.ajog.2020.06.002.

For women undergoing urethral diverticulectomy, adding a pubovaginal sling at the time of surgery resolved stress urinary incontinence 79% of the time, a large retrospective cohort study has found.

Alexander Raths/Fotolia

However, in 66% of cases in which the diverticulectomy alone was performed, women also saw their stress urinary incontinence (SUI) resolve.

For a study published online in the American Journal of Obstetrics and Gynecology, Sarah E. Bradley, MD, of Georgetown University in Washington and colleagues analyzed records for 485 urethral diverticulectomies performed at 11 institutions over a 16-year period. One-fifth of patients had an autologous fascial pubovaginal sling (PVS) placed at the time of surgery.

The concomitant sling was associated with a significantly greater reduction of SUI after adjustment for prior diverticulectomy, prior incontinence surgery, age, race, and parity (adjusted odds ratio, 2.27; 95% confidence interval, 1.02-5.03; P = .043).

However, 10% of women in the sling-treated group had recurrent UTI from 6 weeks after surgery, compared with 3% of those in the diverticulectomy-only group (P = .001). Even after adjustment for higher rates of UTI before surgery in the sling group, the odds of recurrent UTI still were higher with the concomitant sling. Women within the sling group also were more likely to experience urinary retention at more than 6 weeks after surgery (8% vs. 1%; P equal to .0001).

Dr. Bradley and her colleagues noted that theirs was the largest study to date evaluating postoperative SUI in patients undergoing diverticulectomy with and without a PVS, noting that many surgeons do not routinely offer the sling at the time of diverticulectomy.

They also acknowledged a selection bias in their study. “With the previously thought theoretical increased risk of the addition of PVS, it is likely that most providers would prefer only to offer this concomitant procedure to those with significantly bothersome SUI. Additionally, the majority of women that underwent PVS (83%) came from two of the 11 participating institutions,” the researchers wrote.

In an interview, Catherine A. Mathews, MD, of Wake Forest University in Winston Salem, N.C., argued for a different interpretation of the study’s results.

“The study was beautifully done and it’s an ideal subject for a review, but in some respect the authors missed the opportunity to highlight that there was a spontaneous resolution of stress incontinence symptoms in 66% of women who received diverticulectomy alone,” Dr. Matthews said, adding that this has important implications for medical decision-making and patient choice.

“Morbidity associated with the pubovaginal sling was very low in this study, probably because it was being done by very proficient surgeons, but in many centers it is higher,” Dr. Matthews said. Even with the overall low morbidity seen in the study, “there was still a significant price to pay” for some women in the pubovaginal sling–treated group. “Recurrent UTI can be challenging to manage in the long term, with antibiotic morbidity and significant symptom bother. For the patients with urinary retention, having to manage it with a catheter is a really awful.”

Dr. Matthews said that the study made a case for interval, rather than concomitant, sling placement in women undergoing urethral diverticulectomy. “If you have a patient who insists on addressing symptoms concomitantly, this study provides good information about the long-term likelihood of two complications: urinary retention and recurrent UTI,” she said. “The vast majority of patients that I’m counseling would choose not to have the sling because of these complications.” And while avoiding reoperation may seem a good reason to opt for the PVS during diverticulectomy, the sling was not associated with a decrease in reoperations, compared with diverticulectomy alone, she noted.

“As we can see in the study, diverticulectomy itself has a high impact on stress incontinence,” Dr. Matthews continued. “If you restore the urethral anatomy and wait for the urethra to heal, you have a very good chance that the incontinence resolves.” For those women who do not see resolution and whose symptoms are still severe enough to bother them, “you’d have the flexibility postoperatively to offer not only a pubovaginal sling, but a synthetic mesh sling or a urethral bulking procedure.”

Dr. Bradley and her colleagues reported no relevant financial disclosures. Dr. Matthews disclosed financial support from Boston Scientific and serving as an expert witness for Johnson & Johnson.

SOURCE: Bradley SE et al. Am J Obstet Gynecol. 2020. doi: 10.1016/j.ajog.2020.06.002.

Since the COVID-19 pandemic began, many significant changes have occurred that have made the implementation of telemedicine easier and more attractive for gynecologic practices. In the first article in this series, we discussed the benefits of telemedicine to physicians and patients, how to get started using telemedicine, and implementing a workflow. This article will discuss the common hurdles in the process and the proper coding to use to insure reimbursement for services rendered.

Barriers to implementing telemedicine

Incorrect assumptions

Latecomers to telemedicine often assume that patients prefer face-to-face visits when, in fact, many may prefer the convenience of virtual visits. More than 50% of patients who are surveyed about their experience with telemedicine say that online tools have helped improve their relationship with their providers.¹ Telemedicine has grown astronomically during the COVID-19 pandemic to the point where many patients now expect their health care providers to be able to conduct virtual visits. Practices that do not offer telemedicine may find their patients seeking services elsewhere. Nearly two-thirds of health care professionals expect their commitment to telemedicine to increase significantly in the next 3 years.² Of those providers who have not yet adopted the practice, nearly 85% expect to implement telemedicine in the near future.³ COVID-19 has motivated the increased use of telemedicine to enhance the communication with patients, making it possible for patients to have enhanced access to health care during this pandemic while minimizing infectious transmission of COVID-19 to physicians and their staff.⁴

Admittedly, telemedicine is not appropriate for all patients. In general, situations that do not lend themselves to telemedicine are those for which an in-person visit is required to evaluate the patient via a physical examination, to perform a protocol-driven procedure, or provide an aggressive intervention. Additional patients for whom telemedicine may be inappropriate include those with cognitive disorders, those with language barriers, those with emergency situations that warrant an office visit or a visit to the emergency department, and patients who do not have access to the technology to conduct a virtual visit.

Cost and complexity

The process of implementing electronic health records (EHRs) left a bitter taste in the mouths of many health care professionals. But EHRs are complicated and expensive. Implementation often resulted in lost productivity. Because the learning curve was so steep, many physicians had to decrease the number of patients they saw before becoming comfortable with the conversion from paper charts to an EHR.

Telemedicine implementation is much less onerous and expensive. Telemedicine is available as a cloud-based platform, which requires less information technology (IT) support and less hardware and software. The technology required for patients to participate in telemedicine is nearly ubiquitous. According to the Pew Research Center, 96% of Americans own a cell phone (81% have a smart phone), and more than half (52%) own a tablet, so the basic equipment to connect patients to providers is already in place.⁵

On the provider side, the basic equipment required for a telemedicine program is a computer with video and audio capabilities and a broadband connection that is fast enough to show video in real time and to provide high-quality viewing of any images to be reviewed.

The growth in telemedicine means that telemedicine options are now more diverse, with many more affordable solutions. However, most telemedicine programs do require the purchase and set-up of new technology and equipment and the training of staff—some of which may be outside the budgets of health care providers in smaller independent practices. Many gynecologists have technology budgets that are already stretched thin. And for patients who do not have access to a smartphone or computer with Internet access, real-time telemedicine may be out of reach.

But with new guidelines put forth by the Centers for Medicare and Medicaid Services (CMS) in March 2020, connectivity can take place inexpensively using free platforms such as Google Hangouts, Skype, Facetime, and Facebook Messenger. If a non‒HIPAA-compliant platform is used initially, conversion to a HIPAA-compliant platform is recommended.⁶ These platforms do not require the purchase of, or subscription to, any expensive hardware or software. The disadvantages of these programs are the lack of documentation, the failure to be Health Insurance Portability and Accountability Act (HIPAA)-compliant, and the lack of encryption; however, these disadvantages are no longer an issue after the new CMS guidelines.

Depending on the magnitude of the program, IT assistance may be needed to get started. It is imperative that the telemedicine program is interoperable with the EHR and the billing program. Otherwise, double and triple entry will erase the efficiency provided by conducting a virtual visit.

Continue to: Licensing...

Licensing

Another concern or barrier is a license to participate in telemedicine. The March 15, 2020, approval of telemedicine states that physicians who are licensed in the state where the patient is located do not require any additional license or permission to conduct virtual visits.⁷ CMS has temporarily waived the requirement that out-of-state providers be licensed in the state where they are providing services when they are licensed in another state. For questions regarding licensure, contact your State Board of Medicine or Department of Health for information on requirements for licenses across state lines (see “Resources,” at the end of the article).

Informed consent

Just like with any other aspect of providing care for patients, obtaining informed consent is paramount. Not only is getting informed patient consent a recommended best practice of the American Telemedicine Association (ATA), but it is actually a legal requirement in many states and could be a condition of getting paid, depending on the payer. To check the requirements regarding patient consent in your state, look at The National Telehealth Policy Resource Center’s state map (see “Resources.")

Some states do not have any requirements regarding consent for a virtual visit. Others require verbal consent. Even if it is not a legal requirement in your state, consider making it a part of your practice’s policy to obtain written or verbal consent and to document in the patient’s record that consent was obtained prior to the virtual visit so that you are protected when using this new technology.

Because telemedicine is a new way of receiving care for many patients, it is important to let them know how it works including how patient confidentiality and privacy are handled, what technical equipment is required, and what they should expect in terms of scheduling, cancellations, and billing policies. A sample consent form for telemedicine use is shown in FIGURE 1.

Liability insurance

Another hurdle that must be considered is liability insurance for conducting virtual visits with patients. Gynecologists who are going to offer telemedicine care to patients should request proof in writing that their liability insurance policy covers telemedicine malpractice and that the coverage extends to other states should the patient be in another state from the state in which the gynecologist holds a license. Additionally, gynecologists who provide telemedicine care should check with liability insurers regarding any requirements or limitations to conducting a virtual visit with their patients and should document them. For example, the policy may require that the physician keep a written or recorded record of the visit in the EHR. If that is the case, then using Skype, Facebook, or Google for the virtual visit, which do not include documentation, would be less desirable.

Privacy

Certainly, there is concern about privacy, and HIPAA compliance is critical to telemedicine success. Because of the COVID-19 emergency, as of March 1, 2020, physicians may now communicate with patients, and provide telehealth services, through remote communications without penalties.⁸ With these changes in the HIPAA requirements, physicians may use applications that allow for video chats, including Apple FaceTime, Facebook Messenger video chat, Google Hangouts video, and Skype, to provide telehealth without risk that the Office for Civil Rights will impose a penalty for noncompliance with HIPAA rules. The consent for patients should mention that these “public” applications potentially introduce privacy risks. This is a motivation for gynecologists to consider one of the programs that promises encryption, privacy, and HIPAA compliance, such as Updox, Doxy.me, and Amazon Chime. It is also important to recognize that a virtual visit could result in colleagues (if the patient is in an office setting) or family members (if the patient is in the home environment) overhearing conversations between the health care professional and the patient. Therefore, we suggest that patients conduct virtual visits in locations in which they feel assured of some semblance of privacy.

Continue to: Compensation for telemedicine...

Compensation for telemedicine

Perhaps the biggest barrier to virtual health adoption has been compensation for telemedicine visits. Both commercial payers and CMS have been slow to enact formal policies for telemedicine reimbursement. Because of this, the common misconceptions (that providers cannot be reimbursed for telemedicine appointments or that compensation occurs at a reduced rate) have persisted, making telemedicine economically unappealing.

The good news is that this is changing; legislation in most states is quickly embracing virtual health visits as a result of the COVID-19 pandemic.⁹ In fact, as of January 1, 2020, telemedicine services are no longer considered “optional” coverage in Medicare Advantage plans.¹⁰ Nor are they required to have an additional fee. Instead, CMS now allows telemedicine as a standard, covered benefit in all plans, enabling beneficiaries to seek care from their homes rather than requiring them to go to a health care facility.¹¹ In the past, telemedicine was restricted for use in rural areas or when patients resided a great distance from their health care providers. Starting March 6, 2020, and for the duration of the COVID-19 public health emergency, Medicare will make payment for professional services furnished to beneficiaries in all areas of the country in all settings regardless of location or distance between the patient and the health care provider.¹²

In addition, since March 15, 2020, CMS has expanded access to telemedicine services for all Medicare beneficiaries—not just those who have been diagnosed with COVID-19.¹³ The expanded access also applies to pre-COVID-19 coverage from physician offices, skilled nursing facilities, and hospitals. This means that Medicare will now make payments to physicians for telemedicine services provided in any health care facility or in a patient’s home, so that patients do not need to go to the physician’s office.

The facts are that there are parity laws and that commercial payers and CMS are required by state law to reimburse for telemedicine—often at the same rate as that for a comparable in-person visit. On the commercial side, there has been an increase in commercial parity legislation that requires health plans to cover virtual visits in the same way they cover face-to-face services. With the new guidelines for reimbursement, every state and Washington DC has parity laws in place. (To stay abreast of state-by-state changes in virtual health reimbursement, the Center for Connected Health Policy and the Advisory Board Primer are valuable resources. See “Resources.”) As long as the provider performs and documents the elements of history and decision-making, including the time spent counseling, and documents the visit as if a face-to-face visit occurred, then clinicians have a billable evaluation and management (E&M) visit.

Continue to: Virtual services for Medicare patients...

Virtual services for Medicare patients

There are 3 main types of virtual services gynecologists can provide to Medicare patients: Medicare telehealth visits, virtual check-ins, and e-visits.

Medicare telehealth visits. Largely because of the COVID-19 pandemic, Medicare patients may now use telecommunication technology for any services that previously occurred in an in-person communication. The gynecologist must use an interactive audio and video telecommunications system that permits real-time communication between the physician and the patient, and the patient should have a prior established relationship with the gynecologist with whom the telemedicine visit is taking place. The new guidelines indicate that the US Department of Health and Human Services (HHS) will not conduct audits to ensure that such a prior relationship exists for claims submitted during this public health emergency.¹⁴

The Current Procedural Terminology (CPT) codes for virtual visits using synchronous audio/visual communication are:

• 99201-99295, Office visit for a new patient
• 99211-99215, Office visit for an established patient.

Important modifiers for telemedicine visits include:

• modifier 02 for POS (place of service) for telehealth Medicare
• modifier 95 for commercial payers.

(A list of all available CPT codes for telehealth services from CMS can be found in “Resources.”)

Virtual check-ins. Established Medicare patients may have a brief communication with gynecologists the traditional way using a telephone or via live video. These brief virtual services, usually 5 to 10 minutes in duration, are initiated by the patient. The purpose of the virtual check-in is to determine if an office visit or a test or procedure is indicated.

Medicare pays for these “virtual check-ins” (or brief communication technology-based services) for patients to communicate with their physicians and avoid unnecessary trips to the office. These brief virtual check-ins are only for established patients. If an existing patient contacts the gynecologist’s office to ask a question or determine if an office visit is necessary, the gynecologist may bill for it using code G2012.

E-visits. Established Medicare patients may have non–face-to-face patient-initiated communications with their gynecologists without going to the physician’s office. These services can be billed only when the physician has an established relationship with the patient. The services may be billed using CPT codes 99421 to 99423. Coding for these visits is determined by the length of time the gynecologist spends online with the patient:

• 99421: Online digital evaluation and management service, for an established patient 5 to 10 minutes spent on the virtual visit
• 99422: 11 to 20 minutes
• 99423: ≥ 21 minutes.

Many clinicians want to immediately start the communication process with their patients. Many will avail themselves of the free video communication offered by Google Hangouts, Skype, Facetime, and Facebook Messenger. Since the March 15, 2020, relaxation of the HIPAA restrictions for telemedicine, it is now possible to have a virtual visit with a patient using one of the free, non–HIPAA-compliant connections. This type of visit is no different than a telephone call but with an added video component. Using these free technologies, a gynecologist can have an asynchronous visit with a patient (referred to as the store and forward method of sending information or medical images), which means that the service takes place in one direction with no opportunity for interaction with the patient. Asynchronous visits are akin to video text messages left for the patient. By contrast, a synchronous or real-time video visit with a patient is a 2-way communication that provides medical care without examining the patient.

Using triangulation

There are some downsides to telemedicine visits. First, virtual visits on Skype, FaceTime, and other non–HIPAA-compliant methods are not conducted on an encrypted website. Second, no documentation is created for the doctor-patient encounter. Finally, unless the physician keeps a record of these virtual visits and submits the interactions to the practice coders, there will be no billing and no reimbursement for the visits. In this scenario, physicians are legally responsible for their decision-making, prescription writing, and medical advice, but do not receive compensation for their efforts.

This can be remedied by using “triangulation,” which involves: 1. the physician, 2. the patient, and 3. a scribe or medical assistant who will record the visit. Before initiating the virtual visit using triangulation, it is imperative to ask the patient for permission if your medical assistant (or any other person in the office who functions as a scribe) will be listening to the conversation. It is important to explain that the person is there to take accurate notes and ascertain that the notes are entered into the EHR. Also, the scribe or assistant will record the time, date, and duration of the visit, which is a requirement for billing purposes. The scribe may also ascertain that the visit is properly coded and entered into the practice management system, and that a bill is submitted to the insurance company. By using triangulation, you have documentation that consent was obtained, that the visit took place, that notes were taken, and that the patient’s insurance company will be billed for the visit (see FIGURE 2 for a sample documentation form).

Continue to: Which CPT codes should I use?...

Which CPT codes should I use?

The answer depends on a number of factors, but a good rule of thumb is to use the same codes that you would use for an in-person appointment (CPT codes 99211-99215 for an established patient visit and 99201-99205 for a new patient visit). These are the most common CPT codes for outpatient gynecologic office visits whether they take place face-to-face or as a synchronous virtual visit (via a real-time interactive audio and video telecommunications system).

For example, the reimbursement for code 99213 has a range from $73 to $100. You may wonder how you can achieve the complexity requirements for a level-3 office visit without a physical examination. Whether as a face-to-face or virtual visit, documentation for these encounters requires 2 of 3 of the following components:

• expanded problem-focused history
• expanded problem-focused exam (not accomplished with telemedicine)
• low-complexity medical decision-making OR
• at least 15 minutes spent face to face with the patient if coding is based on time.

If a gynecologist reviews the results of a recent lab test for an estrogen-deficient patient and adjusts the estrogen dosage, writes a prescription, and spends 15 minutes communicating with the patient, he/she has met the complexity requirements for a code 99213. Because Level 3 and 4 visits (99214 and 99215) require a comprehensive physical examination, it is necessary to document the time spent with the patient (code 99214 requires 25 to 39 minutes of consultation and code 99215 requires ≥ 40 minutes).

Some final billing and coding advice

Always confirm telemedicine billing guidelines before beginning to conduct telemedicine visits. Consider starting a phone call to a payer armed with the fact that the payer is required by law to offer parity between telemedicine and face-to-face visits. Then ask which specific billing codes should be used.

Until you and your practice become comfortable with the process of, and the coding and billing for, telemedicine, consider using a telemedicine platform that has a built-in rules engine that offers recommendations for each telemedicine visit based on past claims data. These systems help gynecologists determine which CPT code to use and which modifiers are appropriate for the various insurance companies. In other words, the rules engine helps you submit a clean claim that is less likely to be denied and very likely to be paid. There are some vendors who are so confident that their rules engine will match the service with the proper CPT code and modifier that they guarantee full private payer reimbursement for telemedicine visits, or the vendor will reimburse the claim.

Watch for the third and final installment in this series, which was written with the assistance of 2 attorneys. It will review the legal guidelines for implementing telemedicine in a gynecologic practice and discuss the future of the technology. ●

Since the COVID-19 pandemic began, many significant changes have occurred that have made the implementation of telemedicine easier and more attractive for gynecologic practices. In the first article in this series, we discussed the benefits of telemedicine to physicians and patients, how to get started using telemedicine, and implementing a workflow. This article will discuss the common hurdles in the process and the proper coding to use to insure reimbursement for services rendered.

Barriers to implementing telemedicine

Incorrect assumptions

Latecomers to telemedicine often assume that patients prefer face-to-face visits when, in fact, many may prefer the convenience of virtual visits. More than 50% of patients who are surveyed about their experience with telemedicine say that online tools have helped improve their relationship with their providers.¹ Telemedicine has grown astronomically during the COVID-19 pandemic to the point where many patients now expect their health care providers to be able to conduct virtual visits. Practices that do not offer telemedicine may find their patients seeking services elsewhere. Nearly two-thirds of health care professionals expect their commitment to telemedicine to increase significantly in the next 3 years.² Of those providers who have not yet adopted the practice, nearly 85% expect to implement telemedicine in the near future.³ COVID-19 has motivated the increased use of telemedicine to enhance the communication with patients, making it possible for patients to have enhanced access to health care during this pandemic while minimizing infectious transmission of COVID-19 to physicians and their staff.⁴

Admittedly, telemedicine is not appropriate for all patients. In general, situations that do not lend themselves to telemedicine are those for which an in-person visit is required to evaluate the patient via a physical examination, to perform a protocol-driven procedure, or provide an aggressive intervention. Additional patients for whom telemedicine may be inappropriate include those with cognitive disorders, those with language barriers, those with emergency situations that warrant an office visit or a visit to the emergency department, and patients who do not have access to the technology to conduct a virtual visit.

Cost and complexity

The process of implementing electronic health records (EHRs) left a bitter taste in the mouths of many health care professionals. But EHRs are complicated and expensive. Implementation often resulted in lost productivity. Because the learning curve was so steep, many physicians had to decrease the number of patients they saw before becoming comfortable with the conversion from paper charts to an EHR.

Telemedicine implementation is much less onerous and expensive. Telemedicine is available as a cloud-based platform, which requires less information technology (IT) support and less hardware and software. The technology required for patients to participate in telemedicine is nearly ubiquitous. According to the Pew Research Center, 96% of Americans own a cell phone (81% have a smart phone), and more than half (52%) own a tablet, so the basic equipment to connect patients to providers is already in place.⁵

On the provider side, the basic equipment required for a telemedicine program is a computer with video and audio capabilities and a broadband connection that is fast enough to show video in real time and to provide high-quality viewing of any images to be reviewed.

The growth in telemedicine means that telemedicine options are now more diverse, with many more affordable solutions. However, most telemedicine programs do require the purchase and set-up of new technology and equipment and the training of staff—some of which may be outside the budgets of health care providers in smaller independent practices. Many gynecologists have technology budgets that are already stretched thin. And for patients who do not have access to a smartphone or computer with Internet access, real-time telemedicine may be out of reach.

But with new guidelines put forth by the Centers for Medicare and Medicaid Services (CMS) in March 2020, connectivity can take place inexpensively using free platforms such as Google Hangouts, Skype, Facetime, and Facebook Messenger. If a non‒HIPAA-compliant platform is used initially, conversion to a HIPAA-compliant platform is recommended.⁶ These platforms do not require the purchase of, or subscription to, any expensive hardware or software. The disadvantages of these programs are the lack of documentation, the failure to be Health Insurance Portability and Accountability Act (HIPAA)-compliant, and the lack of encryption; however, these disadvantages are no longer an issue after the new CMS guidelines.

Depending on the magnitude of the program, IT assistance may be needed to get started. It is imperative that the telemedicine program is interoperable with the EHR and the billing program. Otherwise, double and triple entry will erase the efficiency provided by conducting a virtual visit.

Continue to: Licensing...

Licensing

Another concern or barrier is a license to participate in telemedicine. The March 15, 2020, approval of telemedicine states that physicians who are licensed in the state where the patient is located do not require any additional license or permission to conduct virtual visits.⁷ CMS has temporarily waived the requirement that out-of-state providers be licensed in the state where they are providing services when they are licensed in another state. For questions regarding licensure, contact your State Board of Medicine or Department of Health for information on requirements for licenses across state lines (see “Resources,” at the end of the article).

Informed consent

Just like with any other aspect of providing care for patients, obtaining informed consent is paramount. Not only is getting informed patient consent a recommended best practice of the American Telemedicine Association (ATA), but it is actually a legal requirement in many states and could be a condition of getting paid, depending on the payer. To check the requirements regarding patient consent in your state, look at The National Telehealth Policy Resource Center’s state map (see “Resources.")

Some states do not have any requirements regarding consent for a virtual visit. Others require verbal consent. Even if it is not a legal requirement in your state, consider making it a part of your practice’s policy to obtain written or verbal consent and to document in the patient’s record that consent was obtained prior to the virtual visit so that you are protected when using this new technology.

Because telemedicine is a new way of receiving care for many patients, it is important to let them know how it works including how patient confidentiality and privacy are handled, what technical equipment is required, and what they should expect in terms of scheduling, cancellations, and billing policies. A sample consent form for telemedicine use is shown in FIGURE 1.

Liability insurance

Another hurdle that must be considered is liability insurance for conducting virtual visits with patients. Gynecologists who are going to offer telemedicine care to patients should request proof in writing that their liability insurance policy covers telemedicine malpractice and that the coverage extends to other states should the patient be in another state from the state in which the gynecologist holds a license. Additionally, gynecologists who provide telemedicine care should check with liability insurers regarding any requirements or limitations to conducting a virtual visit with their patients and should document them. For example, the policy may require that the physician keep a written or recorded record of the visit in the EHR. If that is the case, then using Skype, Facebook, or Google for the virtual visit, which do not include documentation, would be less desirable.

Privacy

Certainly, there is concern about privacy, and HIPAA compliance is critical to telemedicine success. Because of the COVID-19 emergency, as of March 1, 2020, physicians may now communicate with patients, and provide telehealth services, through remote communications without penalties.⁸ With these changes in the HIPAA requirements, physicians may use applications that allow for video chats, including Apple FaceTime, Facebook Messenger video chat, Google Hangouts video, and Skype, to provide telehealth without risk that the Office for Civil Rights will impose a penalty for noncompliance with HIPAA rules. The consent for patients should mention that these “public” applications potentially introduce privacy risks. This is a motivation for gynecologists to consider one of the programs that promises encryption, privacy, and HIPAA compliance, such as Updox, Doxy.me, and Amazon Chime. It is also important to recognize that a virtual visit could result in colleagues (if the patient is in an office setting) or family members (if the patient is in the home environment) overhearing conversations between the health care professional and the patient. Therefore, we suggest that patients conduct virtual visits in locations in which they feel assured of some semblance of privacy.

Continue to: Compensation for telemedicine...

Compensation for telemedicine

Perhaps the biggest barrier to virtual health adoption has been compensation for telemedicine visits. Both commercial payers and CMS have been slow to enact formal policies for telemedicine reimbursement. Because of this, the common misconceptions (that providers cannot be reimbursed for telemedicine appointments or that compensation occurs at a reduced rate) have persisted, making telemedicine economically unappealing.

The good news is that this is changing; legislation in most states is quickly embracing virtual health visits as a result of the COVID-19 pandemic.⁹ In fact, as of January 1, 2020, telemedicine services are no longer considered “optional” coverage in Medicare Advantage plans.¹⁰ Nor are they required to have an additional fee. Instead, CMS now allows telemedicine as a standard, covered benefit in all plans, enabling beneficiaries to seek care from their homes rather than requiring them to go to a health care facility.¹¹ In the past, telemedicine was restricted for use in rural areas or when patients resided a great distance from their health care providers. Starting March 6, 2020, and for the duration of the COVID-19 public health emergency, Medicare will make payment for professional services furnished to beneficiaries in all areas of the country in all settings regardless of location or distance between the patient and the health care provider.¹²

In addition, since March 15, 2020, CMS has expanded access to telemedicine services for all Medicare beneficiaries—not just those who have been diagnosed with COVID-19.¹³ The expanded access also applies to pre-COVID-19 coverage from physician offices, skilled nursing facilities, and hospitals. This means that Medicare will now make payments to physicians for telemedicine services provided in any health care facility or in a patient’s home, so that patients do not need to go to the physician’s office.

The facts are that there are parity laws and that commercial payers and CMS are required by state law to reimburse for telemedicine—often at the same rate as that for a comparable in-person visit. On the commercial side, there has been an increase in commercial parity legislation that requires health plans to cover virtual visits in the same way they cover face-to-face services. With the new guidelines for reimbursement, every state and Washington DC has parity laws in place. (To stay abreast of state-by-state changes in virtual health reimbursement, the Center for Connected Health Policy and the Advisory Board Primer are valuable resources. See “Resources.”) As long as the provider performs and documents the elements of history and decision-making, including the time spent counseling, and documents the visit as if a face-to-face visit occurred, then clinicians have a billable evaluation and management (E&M) visit.

Continue to: Virtual services for Medicare patients...

Virtual services for Medicare patients

There are 3 main types of virtual services gynecologists can provide to Medicare patients: Medicare telehealth visits, virtual check-ins, and e-visits.

Medicare telehealth visits. Largely because of the COVID-19 pandemic, Medicare patients may now use telecommunication technology for any services that previously occurred in an in-person communication. The gynecologist must use an interactive audio and video telecommunications system that permits real-time communication between the physician and the patient, and the patient should have a prior established relationship with the gynecologist with whom the telemedicine visit is taking place. The new guidelines indicate that the US Department of Health and Human Services (HHS) will not conduct audits to ensure that such a prior relationship exists for claims submitted during this public health emergency.¹⁴

The Current Procedural Terminology (CPT) codes for virtual visits using synchronous audio/visual communication are:

• 99201-99295, Office visit for a new patient
• 99211-99215, Office visit for an established patient.

Important modifiers for telemedicine visits include:

• modifier 02 for POS (place of service) for telehealth Medicare
• modifier 95 for commercial payers.

(A list of all available CPT codes for telehealth services from CMS can be found in “Resources.”)

Virtual check-ins. Established Medicare patients may have a brief communication with gynecologists the traditional way using a telephone or via live video. These brief virtual services, usually 5 to 10 minutes in duration, are initiated by the patient. The purpose of the virtual check-in is to determine if an office visit or a test or procedure is indicated.

Medicare pays for these “virtual check-ins” (or brief communication technology-based services) for patients to communicate with their physicians and avoid unnecessary trips to the office. These brief virtual check-ins are only for established patients. If an existing patient contacts the gynecologist’s office to ask a question or determine if an office visit is necessary, the gynecologist may bill for it using code G2012.

E-visits. Established Medicare patients may have non–face-to-face patient-initiated communications with their gynecologists without going to the physician’s office. These services can be billed only when the physician has an established relationship with the patient. The services may be billed using CPT codes 99421 to 99423. Coding for these visits is determined by the length of time the gynecologist spends online with the patient:

• 99421: Online digital evaluation and management service, for an established patient 5 to 10 minutes spent on the virtual visit
• 99422: 11 to 20 minutes
• 99423: ≥ 21 minutes.

Many clinicians want to immediately start the communication process with their patients. Many will avail themselves of the free video communication offered by Google Hangouts, Skype, Facetime, and Facebook Messenger. Since the March 15, 2020, relaxation of the HIPAA restrictions for telemedicine, it is now possible to have a virtual visit with a patient using one of the free, non–HIPAA-compliant connections. This type of visit is no different than a telephone call but with an added video component. Using these free technologies, a gynecologist can have an asynchronous visit with a patient (referred to as the store and forward method of sending information or medical images), which means that the service takes place in one direction with no opportunity for interaction with the patient. Asynchronous visits are akin to video text messages left for the patient. By contrast, a synchronous or real-time video visit with a patient is a 2-way communication that provides medical care without examining the patient.

Using triangulation

There are some downsides to telemedicine visits. First, virtual visits on Skype, FaceTime, and other non–HIPAA-compliant methods are not conducted on an encrypted website. Second, no documentation is created for the doctor-patient encounter. Finally, unless the physician keeps a record of these virtual visits and submits the interactions to the practice coders, there will be no billing and no reimbursement for the visits. In this scenario, physicians are legally responsible for their decision-making, prescription writing, and medical advice, but do not receive compensation for their efforts.

This can be remedied by using “triangulation,” which involves: 1. the physician, 2. the patient, and 3. a scribe or medical assistant who will record the visit. Before initiating the virtual visit using triangulation, it is imperative to ask the patient for permission if your medical assistant (or any other person in the office who functions as a scribe) will be listening to the conversation. It is important to explain that the person is there to take accurate notes and ascertain that the notes are entered into the EHR. Also, the scribe or assistant will record the time, date, and duration of the visit, which is a requirement for billing purposes. The scribe may also ascertain that the visit is properly coded and entered into the practice management system, and that a bill is submitted to the insurance company. By using triangulation, you have documentation that consent was obtained, that the visit took place, that notes were taken, and that the patient’s insurance company will be billed for the visit (see FIGURE 2 for a sample documentation form).

Continue to: Which CPT codes should I use?...

Which CPT codes should I use?

The answer depends on a number of factors, but a good rule of thumb is to use the same codes that you would use for an in-person appointment (CPT codes 99211-99215 for an established patient visit and 99201-99205 for a new patient visit). These are the most common CPT codes for outpatient gynecologic office visits whether they take place face-to-face or as a synchronous virtual visit (via a real-time interactive audio and video telecommunications system).

For example, the reimbursement for code 99213 has a range from $73 to $100. You may wonder how you can achieve the complexity requirements for a level-3 office visit without a physical examination. Whether as a face-to-face or virtual visit, documentation for these encounters requires 2 of 3 of the following components:

• expanded problem-focused history
• expanded problem-focused exam (not accomplished with telemedicine)
• low-complexity medical decision-making OR
• at least 15 minutes spent face to face with the patient if coding is based on time.

If a gynecologist reviews the results of a recent lab test for an estrogen-deficient patient and adjusts the estrogen dosage, writes a prescription, and spends 15 minutes communicating with the patient, he/she has met the complexity requirements for a code 99213. Because Level 3 and 4 visits (99214 and 99215) require a comprehensive physical examination, it is necessary to document the time spent with the patient (code 99214 requires 25 to 39 minutes of consultation and code 99215 requires ≥ 40 minutes).

Some final billing and coding advice

Always confirm telemedicine billing guidelines before beginning to conduct telemedicine visits. Consider starting a phone call to a payer armed with the fact that the payer is required by law to offer parity between telemedicine and face-to-face visits. Then ask which specific billing codes should be used.

Until you and your practice become comfortable with the process of, and the coding and billing for, telemedicine, consider using a telemedicine platform that has a built-in rules engine that offers recommendations for each telemedicine visit based on past claims data. These systems help gynecologists determine which CPT code to use and which modifiers are appropriate for the various insurance companies. In other words, the rules engine helps you submit a clean claim that is less likely to be denied and very likely to be paid. There are some vendors who are so confident that their rules engine will match the service with the proper CPT code and modifier that they guarantee full private payer reimbursement for telemedicine visits, or the vendor will reimburse the claim.

Watch for the third and final installment in this series, which was written with the assistance of 2 attorneys. It will review the legal guidelines for implementing telemedicine in a gynecologic practice and discuss the future of the technology. ●

Since the COVID-19 pandemic began, many significant changes have occurred that have made the implementation of telemedicine easier and more attractive for gynecologic practices. In the first article in this series, we discussed the benefits of telemedicine to physicians and patients, how to get started using telemedicine, and implementing a workflow. This article will discuss the common hurdles in the process and the proper coding to use to insure reimbursement for services rendered.

Barriers to implementing telemedicine

Incorrect assumptions

Latecomers to telemedicine often assume that patients prefer face-to-face visits when, in fact, many may prefer the convenience of virtual visits. More than 50% of patients who are surveyed about their experience with telemedicine say that online tools have helped improve their relationship with their providers.¹ Telemedicine has grown astronomically during the COVID-19 pandemic to the point where many patients now expect their health care providers to be able to conduct virtual visits. Practices that do not offer telemedicine may find their patients seeking services elsewhere. Nearly two-thirds of health care professionals expect their commitment to telemedicine to increase significantly in the next 3 years.² Of those providers who have not yet adopted the practice, nearly 85% expect to implement telemedicine in the near future.³ COVID-19 has motivated the increased use of telemedicine to enhance the communication with patients, making it possible for patients to have enhanced access to health care during this pandemic while minimizing infectious transmission of COVID-19 to physicians and their staff.⁴

Admittedly, telemedicine is not appropriate for all patients. In general, situations that do not lend themselves to telemedicine are those for which an in-person visit is required to evaluate the patient via a physical examination, to perform a protocol-driven procedure, or provide an aggressive intervention. Additional patients for whom telemedicine may be inappropriate include those with cognitive disorders, those with language barriers, those with emergency situations that warrant an office visit or a visit to the emergency department, and patients who do not have access to the technology to conduct a virtual visit.

Cost and complexity

The process of implementing electronic health records (EHRs) left a bitter taste in the mouths of many health care professionals. But EHRs are complicated and expensive. Implementation often resulted in lost productivity. Because the learning curve was so steep, many physicians had to decrease the number of patients they saw before becoming comfortable with the conversion from paper charts to an EHR.

Telemedicine implementation is much less onerous and expensive. Telemedicine is available as a cloud-based platform, which requires less information technology (IT) support and less hardware and software. The technology required for patients to participate in telemedicine is nearly ubiquitous. According to the Pew Research Center, 96% of Americans own a cell phone (81% have a smart phone), and more than half (52%) own a tablet, so the basic equipment to connect patients to providers is already in place.⁵

On the provider side, the basic equipment required for a telemedicine program is a computer with video and audio capabilities and a broadband connection that is fast enough to show video in real time and to provide high-quality viewing of any images to be reviewed.

The growth in telemedicine means that telemedicine options are now more diverse, with many more affordable solutions. However, most telemedicine programs do require the purchase and set-up of new technology and equipment and the training of staff—some of which may be outside the budgets of health care providers in smaller independent practices. Many gynecologists have technology budgets that are already stretched thin. And for patients who do not have access to a smartphone or computer with Internet access, real-time telemedicine may be out of reach.

But with new guidelines put forth by the Centers for Medicare and Medicaid Services (CMS) in March 2020, connectivity can take place inexpensively using free platforms such as Google Hangouts, Skype, Facetime, and Facebook Messenger. If a non‒HIPAA-compliant platform is used initially, conversion to a HIPAA-compliant platform is recommended.⁶ These platforms do not require the purchase of, or subscription to, any expensive hardware or software. The disadvantages of these programs are the lack of documentation, the failure to be Health Insurance Portability and Accountability Act (HIPAA)-compliant, and the lack of encryption; however, these disadvantages are no longer an issue after the new CMS guidelines.

Depending on the magnitude of the program, IT assistance may be needed to get started. It is imperative that the telemedicine program is interoperable with the EHR and the billing program. Otherwise, double and triple entry will erase the efficiency provided by conducting a virtual visit.

Continue to: Licensing...

Licensing

Another concern or barrier is a license to participate in telemedicine. The March 15, 2020, approval of telemedicine states that physicians who are licensed in the state where the patient is located do not require any additional license or permission to conduct virtual visits.⁷ CMS has temporarily waived the requirement that out-of-state providers be licensed in the state where they are providing services when they are licensed in another state. For questions regarding licensure, contact your State Board of Medicine or Department of Health for information on requirements for licenses across state lines (see “Resources,” at the end of the article).

Informed consent

Just like with any other aspect of providing care for patients, obtaining informed consent is paramount. Not only is getting informed patient consent a recommended best practice of the American Telemedicine Association (ATA), but it is actually a legal requirement in many states and could be a condition of getting paid, depending on the payer. To check the requirements regarding patient consent in your state, look at The National Telehealth Policy Resource Center’s state map (see “Resources.")

Some states do not have any requirements regarding consent for a virtual visit. Others require verbal consent. Even if it is not a legal requirement in your state, consider making it a part of your practice’s policy to obtain written or verbal consent and to document in the patient’s record that consent was obtained prior to the virtual visit so that you are protected when using this new technology.

Because telemedicine is a new way of receiving care for many patients, it is important to let them know how it works including how patient confidentiality and privacy are handled, what technical equipment is required, and what they should expect in terms of scheduling, cancellations, and billing policies. A sample consent form for telemedicine use is shown in FIGURE 1.

Liability insurance

Another hurdle that must be considered is liability insurance for conducting virtual visits with patients. Gynecologists who are going to offer telemedicine care to patients should request proof in writing that their liability insurance policy covers telemedicine malpractice and that the coverage extends to other states should the patient be in another state from the state in which the gynecologist holds a license. Additionally, gynecologists who provide telemedicine care should check with liability insurers regarding any requirements or limitations to conducting a virtual visit with their patients and should document them. For example, the policy may require that the physician keep a written or recorded record of the visit in the EHR. If that is the case, then using Skype, Facebook, or Google for the virtual visit, which do not include documentation, would be less desirable.

Privacy

Certainly, there is concern about privacy, and HIPAA compliance is critical to telemedicine success. Because of the COVID-19 emergency, as of March 1, 2020, physicians may now communicate with patients, and provide telehealth services, through remote communications without penalties.⁸ With these changes in the HIPAA requirements, physicians may use applications that allow for video chats, including Apple FaceTime, Facebook Messenger video chat, Google Hangouts video, and Skype, to provide telehealth without risk that the Office for Civil Rights will impose a penalty for noncompliance with HIPAA rules. The consent for patients should mention that these “public” applications potentially introduce privacy risks. This is a motivation for gynecologists to consider one of the programs that promises encryption, privacy, and HIPAA compliance, such as Updox, Doxy.me, and Amazon Chime. It is also important to recognize that a virtual visit could result in colleagues (if the patient is in an office setting) or family members (if the patient is in the home environment) overhearing conversations between the health care professional and the patient. Therefore, we suggest that patients conduct virtual visits in locations in which they feel assured of some semblance of privacy.

Continue to: Compensation for telemedicine...

Compensation for telemedicine

Perhaps the biggest barrier to virtual health adoption has been compensation for telemedicine visits. Both commercial payers and CMS have been slow to enact formal policies for telemedicine reimbursement. Because of this, the common misconceptions (that providers cannot be reimbursed for telemedicine appointments or that compensation occurs at a reduced rate) have persisted, making telemedicine economically unappealing.

The good news is that this is changing; legislation in most states is quickly embracing virtual health visits as a result of the COVID-19 pandemic.⁹ In fact, as of January 1, 2020, telemedicine services are no longer considered “optional” coverage in Medicare Advantage plans.¹⁰ Nor are they required to have an additional fee. Instead, CMS now allows telemedicine as a standard, covered benefit in all plans, enabling beneficiaries to seek care from their homes rather than requiring them to go to a health care facility.¹¹ In the past, telemedicine was restricted for use in rural areas or when patients resided a great distance from their health care providers. Starting March 6, 2020, and for the duration of the COVID-19 public health emergency, Medicare will make payment for professional services furnished to beneficiaries in all areas of the country in all settings regardless of location or distance between the patient and the health care provider.¹²

In addition, since March 15, 2020, CMS has expanded access to telemedicine services for all Medicare beneficiaries—not just those who have been diagnosed with COVID-19.¹³ The expanded access also applies to pre-COVID-19 coverage from physician offices, skilled nursing facilities, and hospitals. This means that Medicare will now make payments to physicians for telemedicine services provided in any health care facility or in a patient’s home, so that patients do not need to go to the physician’s office.

The facts are that there are parity laws and that commercial payers and CMS are required by state law to reimburse for telemedicine—often at the same rate as that for a comparable in-person visit. On the commercial side, there has been an increase in commercial parity legislation that requires health plans to cover virtual visits in the same way they cover face-to-face services. With the new guidelines for reimbursement, every state and Washington DC has parity laws in place. (To stay abreast of state-by-state changes in virtual health reimbursement, the Center for Connected Health Policy and the Advisory Board Primer are valuable resources. See “Resources.”) As long as the provider performs and documents the elements of history and decision-making, including the time spent counseling, and documents the visit as if a face-to-face visit occurred, then clinicians have a billable evaluation and management (E&M) visit.

Continue to: Virtual services for Medicare patients...

Virtual services for Medicare patients

There are 3 main types of virtual services gynecologists can provide to Medicare patients: Medicare telehealth visits, virtual check-ins, and e-visits.

Medicare telehealth visits. Largely because of the COVID-19 pandemic, Medicare patients may now use telecommunication technology for any services that previously occurred in an in-person communication. The gynecologist must use an interactive audio and video telecommunications system that permits real-time communication between the physician and the patient, and the patient should have a prior established relationship with the gynecologist with whom the telemedicine visit is taking place. The new guidelines indicate that the US Department of Health and Human Services (HHS) will not conduct audits to ensure that such a prior relationship exists for claims submitted during this public health emergency.¹⁴

The Current Procedural Terminology (CPT) codes for virtual visits using synchronous audio/visual communication are:

• 99201-99295, Office visit for a new patient
• 99211-99215, Office visit for an established patient.

Important modifiers for telemedicine visits include:

• modifier 02 for POS (place of service) for telehealth Medicare
• modifier 95 for commercial payers.

(A list of all available CPT codes for telehealth services from CMS can be found in “Resources.”)

Virtual check-ins. Established Medicare patients may have a brief communication with gynecologists the traditional way using a telephone or via live video. These brief virtual services, usually 5 to 10 minutes in duration, are initiated by the patient. The purpose of the virtual check-in is to determine if an office visit or a test or procedure is indicated.

Medicare pays for these “virtual check-ins” (or brief communication technology-based services) for patients to communicate with their physicians and avoid unnecessary trips to the office. These brief virtual check-ins are only for established patients. If an existing patient contacts the gynecologist’s office to ask a question or determine if an office visit is necessary, the gynecologist may bill for it using code G2012.

E-visits. Established Medicare patients may have non–face-to-face patient-initiated communications with their gynecologists without going to the physician’s office. These services can be billed only when the physician has an established relationship with the patient. The services may be billed using CPT codes 99421 to 99423. Coding for these visits is determined by the length of time the gynecologist spends online with the patient:

• 99421: Online digital evaluation and management service, for an established patient 5 to 10 minutes spent on the virtual visit
• 99422: 11 to 20 minutes
• 99423: ≥ 21 minutes.

Many clinicians want to immediately start the communication process with their patients. Many will avail themselves of the free video communication offered by Google Hangouts, Skype, Facetime, and Facebook Messenger. Since the March 15, 2020, relaxation of the HIPAA restrictions for telemedicine, it is now possible to have a virtual visit with a patient using one of the free, non–HIPAA-compliant connections. This type of visit is no different than a telephone call but with an added video component. Using these free technologies, a gynecologist can have an asynchronous visit with a patient (referred to as the store and forward method of sending information or medical images), which means that the service takes place in one direction with no opportunity for interaction with the patient. Asynchronous visits are akin to video text messages left for the patient. By contrast, a synchronous or real-time video visit with a patient is a 2-way communication that provides medical care without examining the patient.

Using triangulation

There are some downsides to telemedicine visits. First, virtual visits on Skype, FaceTime, and other non–HIPAA-compliant methods are not conducted on an encrypted website. Second, no documentation is created for the doctor-patient encounter. Finally, unless the physician keeps a record of these virtual visits and submits the interactions to the practice coders, there will be no billing and no reimbursement for the visits. In this scenario, physicians are legally responsible for their decision-making, prescription writing, and medical advice, but do not receive compensation for their efforts.

This can be remedied by using “triangulation,” which involves: 1. the physician, 2. the patient, and 3. a scribe or medical assistant who will record the visit. Before initiating the virtual visit using triangulation, it is imperative to ask the patient for permission if your medical assistant (or any other person in the office who functions as a scribe) will be listening to the conversation. It is important to explain that the person is there to take accurate notes and ascertain that the notes are entered into the EHR. Also, the scribe or assistant will record the time, date, and duration of the visit, which is a requirement for billing purposes. The scribe may also ascertain that the visit is properly coded and entered into the practice management system, and that a bill is submitted to the insurance company. By using triangulation, you have documentation that consent was obtained, that the visit took place, that notes were taken, and that the patient’s insurance company will be billed for the visit (see FIGURE 2 for a sample documentation form).

Continue to: Which CPT codes should I use?...

Which CPT codes should I use?

The answer depends on a number of factors, but a good rule of thumb is to use the same codes that you would use for an in-person appointment (CPT codes 99211-99215 for an established patient visit and 99201-99205 for a new patient visit). These are the most common CPT codes for outpatient gynecologic office visits whether they take place face-to-face or as a synchronous virtual visit (via a real-time interactive audio and video telecommunications system).

For example, the reimbursement for code 99213 has a range from $73 to $100. You may wonder how you can achieve the complexity requirements for a level-3 office visit without a physical examination. Whether as a face-to-face or virtual visit, documentation for these encounters requires 2 of 3 of the following components:

• expanded problem-focused history
• expanded problem-focused exam (not accomplished with telemedicine)
• low-complexity medical decision-making OR
• at least 15 minutes spent face to face with the patient if coding is based on time.

If a gynecologist reviews the results of a recent lab test for an estrogen-deficient patient and adjusts the estrogen dosage, writes a prescription, and spends 15 minutes communicating with the patient, he/she has met the complexity requirements for a code 99213. Because Level 3 and 4 visits (99214 and 99215) require a comprehensive physical examination, it is necessary to document the time spent with the patient (code 99214 requires 25 to 39 minutes of consultation and code 99215 requires ≥ 40 minutes).

Some final billing and coding advice

Always confirm telemedicine billing guidelines before beginning to conduct telemedicine visits. Consider starting a phone call to a payer armed with the fact that the payer is required by law to offer parity between telemedicine and face-to-face visits. Then ask which specific billing codes should be used.

Until you and your practice become comfortable with the process of, and the coding and billing for, telemedicine, consider using a telemedicine platform that has a built-in rules engine that offers recommendations for each telemedicine visit based on past claims data. These systems help gynecologists determine which CPT code to use and which modifiers are appropriate for the various insurance companies. In other words, the rules engine helps you submit a clean claim that is less likely to be denied and very likely to be paid. There are some vendors who are so confident that their rules engine will match the service with the proper CPT code and modifier that they guarantee full private payer reimbursement for telemedicine visits, or the vendor will reimburse the claim.

Watch for the third and final installment in this series, which was written with the assistance of 2 attorneys. It will review the legal guidelines for implementing telemedicine in a gynecologic practice and discuss the future of the technology. ●

Many benign, premalignant, and malignant lesions can occur on the vulva. These can be challenging to differentiate by examination alone. A vulvar biopsy often is needed to appropriately diagnose—and ultimately treat—these various conditions.

In this article, we review vulvar biopsy procedures, describe how to prepare tissue specimens for the pathologist, and provide some brief case examples in which biopsy established the diagnosis.

Ask questions first

Prior to examining a patient with a vulvar lesion, obtain a detailed history. Asking specific questions may aid in making the correct diagnosis, such as:

• How long has the lesion been present? Has it changed? What color is it?
• Was any trigger, or trauma, associated with onset of the lesion?
• Does the lesion itch, burn, or cause pain? Is there any associated bleeding or discharge?
• Are other lesions present in the vagina, anus, or mouth, or are other skin lesions present?
• Are any systemic symptoms present, such as fever, lymphadenopathy, weight loss, or joint pain?
• What is the patient’s previous treatment history, including over-the-counter medications and prescribed medications?
• Has there been any incontinence of urine or stool? Does the patient use a pad?
• Is the patient scratching? Is there any nighttime scratching? It also can be useful to ask her partner, if she has one, about nighttime scratching.
• Is there a family history of vulvar conditions?
• Has there been any change in her use of products like soap, lotions, cleansing wipes, sprays, lubricants, or laundry detergent?
• Has the patient had any new partners or significant travel history?

Preprocedure counseling points

Prior to proceeding with a vulvar biopsy, review with the patient the risks, benefits, and alternatives and obtain patient consent for the procedure. Vulvar biopsy risks include pain, bleeding, infection, injury to surrounding tissue, and the need for further surgery. Make patients aware that some biopsies are nondiagnostic. We recommend that clinicians perform a time-out verification to ensure that the patient’s identity and planned procedure are correct.

Assess the biopsy site

A wide variety of lesions may require a biopsy for diagnosis. While it can be challenging to know where to biopsy, taking the time to determine the proper biopsy site may enhance pathology results.

When considering colored lesions, depth is the important factor, and a punch biopsy often is sufficient. A tumor should be biopsied in the thickest area. Lesions that are concerning for malignancy may require multiple biopsies. An erosion or ulcer is best biopsied on the edge, including a small amount of surrounding tissue. For most patients, biopsy of normal-appearing tissue is of low diagnostic yield. Lastly, we try to avoid biopsies directly on the midline to facilitate better healing.¹

A photograph of the vulva prior to biopsy may be helpful for the pathologist to see the tissue. Some electronic medical records have the capability to include photographs. Due to the sensitive nature of these photographs, we prefer that a separate written patient consent be obtained prior to taking photographs. We find also that photos are a useful reference for progression of disease at follow-up in a shared care team.

Continue to: Anesthesia procedure and instrument kit...

Anesthesia procedure and instrument kit

Some patients may benefit from the application of topical lidocaine 4% cream (L.M.X.4) prior to the injection of a local anesthetic for tissue biopsy. Ideally, topical lidocaine should be placed on the vulva and covered with a dressing such as Tegaderm or cellophane up to 30 minutes before the anticipated biopsy procedure. The anesthetic effect generally lasts for about 60 minutes. Many patients report stinging for several seconds upon application. Due to clinic time restrictions, we tend to reserve this method for a limited subset of patients. If planning a return visit for a biopsy, the patient can place the topical anesthetic herself.

For the anesthetic injection, we recommend lidocaine 1% or 2% with epinephrine in all areas of the vulva except for the glans clitoris. For a punch biopsy, we draw up 1 to 3 mL in a 3-mL syringe and inject with a 21- to 30-gauge needle, using a lower gauge for thicker tissue. We have not found buffering the anesthetic with sodium bicarbonate to be of particular use. For the glans clitoris, lidocaine without epinephrine should be utilized.

Equipment. Depending on your office setting, having a premade instrument kit may be preferred to peel-pack equipment. We prefer a premade tray that contains sterile gauze, a hemostat, iris scissors, a needle driver, a scalpel handle, and Adson forceps (FIGURE 1).

Types of biopsy procedures

Punch biopsy. We recommend a 4-mm Keyes biopsy punch. As mentioned, we use a biopsy kit to facilitate the procedure. After the tissue is properly anesthetized and prepped, we test the area via gentle touch to the skin with the hemostat or Adson forceps. To perform the punch biopsy, gentle, consistent pressure in a clockwise-counterclockwise fashion yields the best results. The goal is to obtain a 5-mm depth for hair-bearing skin and a 3-mm depth for all other tissue.² The tissue should then be excised at the base with scissors, taking care not to crush the specimen with forceps.

Punch biopsy permits sampling of the epidermis, dermis, and subcutaneous tissue. Hemostasis is maintained with either silver nitrate, Monsel’s solution (ferric sulfate), or a dissolvable suture such as 4-0 Monocryl (poliglecaprone 25) or Vicryl Rapide (polyglactin 910).

Stitch biopsy. We find the stitch biopsy to be very useful given the architecture of the vulva. A modification of the shave biopsy, the stitch biopsy is depicted in FIGURE 2. A 3-0 or 4-0 dissolvable suture is placed through the intended area of biopsy. Iris scissors are used to undermine the tissue while the suture is held on tension. The goal is to remove the suture with the specimen. Separate sutures are used for hemostasis. The stitch does not cause the crushing artifacts on prepared specimens. Depending on the proceduralist’s comfort, a relatively large sample can be obtained in this fashion. If the suture held on tension is inadvertently cut, a second pass can be made with suture; alternatively, care can be used to remove remaining tissue with forceps and scissors, again avoiding crush injury to the tissue.

When planning an excisional biopsy, place a stitch on the excised tissue to mark orientation or pin out the entire specimen to a foam board to help your pathologist interpret tissue orientation.

The box "Vulvar biopsy established the diagnosis" at the end of this discussion provides 6 case examples of vulvar lesions and the respective diagnoses confirmed by biopsy.

Continue to: Preparing tissue for the pathologist...

Preparing tissue for the pathologist

Here are 5 tips for preparing the biopsied specimen for pathology:

• Include a question for the pathologist, such as “rule out lichen sclerosus or lichen simplex chronicus.” The majority of specimens should be sent in formalin. At times, frozen sections are done in the operating room.
• Double-check that the proper paperwork is included with every specimen and be very specific regarding the exact location of the lesion on the vulva. Include photographs whenever possible.
• Request that a dermatopathologist or a gynecologic pathologist with a special interest in vulvar dermatology, when feasible, review the tissue.
• Check your laboratory’s protocol for sending biopsies from areas around ulcerated tissue. Often, special medium is required for immunohistochemistry stains.
• Call your pathologist with questions about results; he or she often is happy to clarify, and together you may be able to arrive at a diagnosis to better serve your patient.³

Complications and how to avoid them

Bleeding. Any procedure has bleeding risks. To avoid bleeding, review the patient’s medication list and medical history prior to biopsy, as certain medications, such as blood thinners, increase risk for bleeding. Counseling a patient on applying direct pressure to the biopsy site for 2 minutes is generally sufficient for any bleeding that may occur once she is discharged from the clinic.

Infection. With aseptic technique, infection of a biopsy site is rare. We use nonsterile gloves for biopsy procedures. This does not increase the risk of infection.⁴ If a patient has iodine allergy, dilute chlorhexidine is a reasonable alternative for skin cleansing. Instruct the patient to keep the site clean and dry; if the biopsy proximity is close to the urethra or anus, use of a peri-bottle may be preferred after toileting. Instruct patients not to pull sutures. While instructions are specific for each patient, we generally advise that patients wait 4 to 7 days before resuming use of topical medications.

Scarring or tattooing. Avoid using dyed suture on skin surfaces and counsel the patient that silver nitrate can permanently stain tissue. Usually, small biopsies heal well but a small scar is possible.

Key points to keep in mind

• Counsel patients on biopsy risks, benefits, and alternatives. Counsel regarding possible inconclusive results.
• Take time in choosing the biopsy site and consider multiple biopsies.
• Have all anticipated equipment available; consider using premade biopsy kits.
• Consider performing a stitch biopsy to avoid crush injury.
• Take photographs of the area to be biopsied and communicate with your pathologist to facilitate diagnosis.

Vulvar biopsy established the diagnosis in these cases

---

Case 1

A 62-year-old woman with a history of vulvar lichen sclerosus presents for examination reporting symptoms of perianal irritation. Vulvar examination is consistent with lichen sclerosus, with an area of erosion on the right labium majus. In addition, thickened tissue firm to the touch raises concern. The clinician recommends a vulvar biopsy to evaluate for lichen sclerosus, differentiated vulvar intraepithelial neoplasia (dVIN), and vulvar cancer.

Biopsies were obtained of the areas highlighted in the photo. Pathology shows dVIN.

Image courtesy of Hope Haefner, MD.

 

Case 2

A 22-year-old woman presents with concerns of raised bumps on the vulva. The bumps can be itchy and irritating but are not painful. They seem to have grown and spread since she first noticed them.

The examination is consistent with condylomata acuminata and biopsy is recommended with a 4-mm punch. Biopsy results are consistent with condylomata acuminata.

Image courtesy of Hope Haefner, MD.

 

Case 3

A 30-year-old woman presents with concern of a raised area on the vulva. It is itchy and sometimes painful. Acetic acid is applied to the vulva and acetowhite changes are noted. 4-mm punch biopsies are obtained in multiple areas.

 

The final pathology shows high-grade squamous intraepithelial lesions (HSIL) of the vulva.

Image courtesy of Hope Haefner, MD.

 

Case 4

A 19-year-old woman presents with concerns of a pigmented, darkened area on the vulva. She is not sure how long the lesion has been present. It is not itchy and does not cause pain or irritation.

This presentation is an excellent opportunity for an excisional biopsy of the vulva. A marking pen is used to draw margins. A No. 15 blade is used to outline and then undermine the lesion, removing it in its entirety.

 

Final pathology shows a compound nevus of the vulva.

Image courtesy of Hope Haefner, MD.

 

Case 5

A 56-year-old woman presents with a 2-year history of vulvar irritation, burning, and itching. Examination reveals vulvar paleness in an hourglass configuration. There is loss of the labia minora and phimosis of the prepuce overlying the clitoris.

 

A 4-mm punch biopsy result is consistent with a diagnosis of lichen sclerosus.

Image courtesy of Hope Haefner, MD.

 

Case 6

A 65-year-old woman with a long history of lichen sclerosus presents with painful bleeding and a raised lesion on the vulva. Examination reveals a firm raised area that is friable to touch.

 

A 4-mm punch biopsy result reveals that the pathology is significant for squamous cell carcinoma.

Image courtesy of Hope Haefner, MD.

Many benign, premalignant, and malignant lesions can occur on the vulva. These can be challenging to differentiate by examination alone. A vulvar biopsy often is needed to appropriately diagnose—and ultimately treat—these various conditions.

In this article, we review vulvar biopsy procedures, describe how to prepare tissue specimens for the pathologist, and provide some brief case examples in which biopsy established the diagnosis.

Ask questions first

Prior to examining a patient with a vulvar lesion, obtain a detailed history. Asking specific questions may aid in making the correct diagnosis, such as:

• How long has the lesion been present? Has it changed? What color is it?
• Was any trigger, or trauma, associated with onset of the lesion?
• Does the lesion itch, burn, or cause pain? Is there any associated bleeding or discharge?
• Are other lesions present in the vagina, anus, or mouth, or are other skin lesions present?
• Are any systemic symptoms present, such as fever, lymphadenopathy, weight loss, or joint pain?
• What is the patient’s previous treatment history, including over-the-counter medications and prescribed medications?
• Has there been any incontinence of urine or stool? Does the patient use a pad?
• Is the patient scratching? Is there any nighttime scratching? It also can be useful to ask her partner, if she has one, about nighttime scratching.
• Is there a family history of vulvar conditions?
• Has there been any change in her use of products like soap, lotions, cleansing wipes, sprays, lubricants, or laundry detergent?
• Has the patient had any new partners or significant travel history?

Preprocedure counseling points

Prior to proceeding with a vulvar biopsy, review with the patient the risks, benefits, and alternatives and obtain patient consent for the procedure. Vulvar biopsy risks include pain, bleeding, infection, injury to surrounding tissue, and the need for further surgery. Make patients aware that some biopsies are nondiagnostic. We recommend that clinicians perform a time-out verification to ensure that the patient’s identity and planned procedure are correct.

Assess the biopsy site

A wide variety of lesions may require a biopsy for diagnosis. While it can be challenging to know where to biopsy, taking the time to determine the proper biopsy site may enhance pathology results.

When considering colored lesions, depth is the important factor, and a punch biopsy often is sufficient. A tumor should be biopsied in the thickest area. Lesions that are concerning for malignancy may require multiple biopsies. An erosion or ulcer is best biopsied on the edge, including a small amount of surrounding tissue. For most patients, biopsy of normal-appearing tissue is of low diagnostic yield. Lastly, we try to avoid biopsies directly on the midline to facilitate better healing.¹

A photograph of the vulva prior to biopsy may be helpful for the pathologist to see the tissue. Some electronic medical records have the capability to include photographs. Due to the sensitive nature of these photographs, we prefer that a separate written patient consent be obtained prior to taking photographs. We find also that photos are a useful reference for progression of disease at follow-up in a shared care team.

Continue to: Anesthesia procedure and instrument kit...

Anesthesia procedure and instrument kit

Some patients may benefit from the application of topical lidocaine 4% cream (L.M.X.4) prior to the injection of a local anesthetic for tissue biopsy. Ideally, topical lidocaine should be placed on the vulva and covered with a dressing such as Tegaderm or cellophane up to 30 minutes before the anticipated biopsy procedure. The anesthetic effect generally lasts for about 60 minutes. Many patients report stinging for several seconds upon application. Due to clinic time restrictions, we tend to reserve this method for a limited subset of patients. If planning a return visit for a biopsy, the patient can place the topical anesthetic herself.

For the anesthetic injection, we recommend lidocaine 1% or 2% with epinephrine in all areas of the vulva except for the glans clitoris. For a punch biopsy, we draw up 1 to 3 mL in a 3-mL syringe and inject with a 21- to 30-gauge needle, using a lower gauge for thicker tissue. We have not found buffering the anesthetic with sodium bicarbonate to be of particular use. For the glans clitoris, lidocaine without epinephrine should be utilized.

Equipment. Depending on your office setting, having a premade instrument kit may be preferred to peel-pack equipment. We prefer a premade tray that contains sterile gauze, a hemostat, iris scissors, a needle driver, a scalpel handle, and Adson forceps (FIGURE 1).

Types of biopsy procedures

Punch biopsy. We recommend a 4-mm Keyes biopsy punch. As mentioned, we use a biopsy kit to facilitate the procedure. After the tissue is properly anesthetized and prepped, we test the area via gentle touch to the skin with the hemostat or Adson forceps. To perform the punch biopsy, gentle, consistent pressure in a clockwise-counterclockwise fashion yields the best results. The goal is to obtain a 5-mm depth for hair-bearing skin and a 3-mm depth for all other tissue.² The tissue should then be excised at the base with scissors, taking care not to crush the specimen with forceps.

Punch biopsy permits sampling of the epidermis, dermis, and subcutaneous tissue. Hemostasis is maintained with either silver nitrate, Monsel’s solution (ferric sulfate), or a dissolvable suture such as 4-0 Monocryl (poliglecaprone 25) or Vicryl Rapide (polyglactin 910).

Stitch biopsy. We find the stitch biopsy to be very useful given the architecture of the vulva. A modification of the shave biopsy, the stitch biopsy is depicted in FIGURE 2. A 3-0 or 4-0 dissolvable suture is placed through the intended area of biopsy. Iris scissors are used to undermine the tissue while the suture is held on tension. The goal is to remove the suture with the specimen. Separate sutures are used for hemostasis. The stitch does not cause the crushing artifacts on prepared specimens. Depending on the proceduralist’s comfort, a relatively large sample can be obtained in this fashion. If the suture held on tension is inadvertently cut, a second pass can be made with suture; alternatively, care can be used to remove remaining tissue with forceps and scissors, again avoiding crush injury to the tissue.

When planning an excisional biopsy, place a stitch on the excised tissue to mark orientation or pin out the entire specimen to a foam board to help your pathologist interpret tissue orientation.

The box "Vulvar biopsy established the diagnosis" at the end of this discussion provides 6 case examples of vulvar lesions and the respective diagnoses confirmed by biopsy.

Continue to: Preparing tissue for the pathologist...

Preparing tissue for the pathologist

Here are 5 tips for preparing the biopsied specimen for pathology:

• Include a question for the pathologist, such as “rule out lichen sclerosus or lichen simplex chronicus.” The majority of specimens should be sent in formalin. At times, frozen sections are done in the operating room.
• Double-check that the proper paperwork is included with every specimen and be very specific regarding the exact location of the lesion on the vulva. Include photographs whenever possible.
• Request that a dermatopathologist or a gynecologic pathologist with a special interest in vulvar dermatology, when feasible, review the tissue.
• Check your laboratory’s protocol for sending biopsies from areas around ulcerated tissue. Often, special medium is required for immunohistochemistry stains.
• Call your pathologist with questions about results; he or she often is happy to clarify, and together you may be able to arrive at a diagnosis to better serve your patient.³

Complications and how to avoid them

Bleeding. Any procedure has bleeding risks. To avoid bleeding, review the patient’s medication list and medical history prior to biopsy, as certain medications, such as blood thinners, increase risk for bleeding. Counseling a patient on applying direct pressure to the biopsy site for 2 minutes is generally sufficient for any bleeding that may occur once she is discharged from the clinic.

Infection. With aseptic technique, infection of a biopsy site is rare. We use nonsterile gloves for biopsy procedures. This does not increase the risk of infection.⁴ If a patient has iodine allergy, dilute chlorhexidine is a reasonable alternative for skin cleansing. Instruct the patient to keep the site clean and dry; if the biopsy proximity is close to the urethra or anus, use of a peri-bottle may be preferred after toileting. Instruct patients not to pull sutures. While instructions are specific for each patient, we generally advise that patients wait 4 to 7 days before resuming use of topical medications.

Scarring or tattooing. Avoid using dyed suture on skin surfaces and counsel the patient that silver nitrate can permanently stain tissue. Usually, small biopsies heal well but a small scar is possible.

Key points to keep in mind

• Counsel patients on biopsy risks, benefits, and alternatives. Counsel regarding possible inconclusive results.
• Take time in choosing the biopsy site and consider multiple biopsies.
• Have all anticipated equipment available; consider using premade biopsy kits.
• Consider performing a stitch biopsy to avoid crush injury.
• Take photographs of the area to be biopsied and communicate with your pathologist to facilitate diagnosis.

Vulvar biopsy established the diagnosis in these cases

---

Case 1

A 62-year-old woman with a history of vulvar lichen sclerosus presents for examination reporting symptoms of perianal irritation. Vulvar examination is consistent with lichen sclerosus, with an area of erosion on the right labium majus. In addition, thickened tissue firm to the touch raises concern. The clinician recommends a vulvar biopsy to evaluate for lichen sclerosus, differentiated vulvar intraepithelial neoplasia (dVIN), and vulvar cancer.

Biopsies were obtained of the areas highlighted in the photo. Pathology shows dVIN.

Image courtesy of Hope Haefner, MD.

 

Case 2

A 22-year-old woman presents with concerns of raised bumps on the vulva. The bumps can be itchy and irritating but are not painful. They seem to have grown and spread since she first noticed them.

The examination is consistent with condylomata acuminata and biopsy is recommended with a 4-mm punch. Biopsy results are consistent with condylomata acuminata.

Image courtesy of Hope Haefner, MD.

 

Case 3

A 30-year-old woman presents with concern of a raised area on the vulva. It is itchy and sometimes painful. Acetic acid is applied to the vulva and acetowhite changes are noted. 4-mm punch biopsies are obtained in multiple areas.

 

The final pathology shows high-grade squamous intraepithelial lesions (HSIL) of the vulva.

Image courtesy of Hope Haefner, MD.

 

Case 4

A 19-year-old woman presents with concerns of a pigmented, darkened area on the vulva. She is not sure how long the lesion has been present. It is not itchy and does not cause pain or irritation.

This presentation is an excellent opportunity for an excisional biopsy of the vulva. A marking pen is used to draw margins. A No. 15 blade is used to outline and then undermine the lesion, removing it in its entirety.

 

Final pathology shows a compound nevus of the vulva.

Image courtesy of Hope Haefner, MD.

 

Case 5

A 56-year-old woman presents with a 2-year history of vulvar irritation, burning, and itching. Examination reveals vulvar paleness in an hourglass configuration. There is loss of the labia minora and phimosis of the prepuce overlying the clitoris.

 

A 4-mm punch biopsy result is consistent with a diagnosis of lichen sclerosus.

Image courtesy of Hope Haefner, MD.

 

Case 6

A 65-year-old woman with a long history of lichen sclerosus presents with painful bleeding and a raised lesion on the vulva. Examination reveals a firm raised area that is friable to touch.

 

A 4-mm punch biopsy result reveals that the pathology is significant for squamous cell carcinoma.

Image courtesy of Hope Haefner, MD.

Many benign, premalignant, and malignant lesions can occur on the vulva. These can be challenging to differentiate by examination alone. A vulvar biopsy often is needed to appropriately diagnose—and ultimately treat—these various conditions.

In this article, we review vulvar biopsy procedures, describe how to prepare tissue specimens for the pathologist, and provide some brief case examples in which biopsy established the diagnosis.

Ask questions first

Prior to examining a patient with a vulvar lesion, obtain a detailed history. Asking specific questions may aid in making the correct diagnosis, such as:

• How long has the lesion been present? Has it changed? What color is it?
• Was any trigger, or trauma, associated with onset of the lesion?
• Does the lesion itch, burn, or cause pain? Is there any associated bleeding or discharge?
• Are other lesions present in the vagina, anus, or mouth, or are other skin lesions present?
• Are any systemic symptoms present, such as fever, lymphadenopathy, weight loss, or joint pain?
• What is the patient’s previous treatment history, including over-the-counter medications and prescribed medications?
• Has there been any incontinence of urine or stool? Does the patient use a pad?
• Is the patient scratching? Is there any nighttime scratching? It also can be useful to ask her partner, if she has one, about nighttime scratching.
• Is there a family history of vulvar conditions?
• Has there been any change in her use of products like soap, lotions, cleansing wipes, sprays, lubricants, or laundry detergent?
• Has the patient had any new partners or significant travel history?

Preprocedure counseling points

Prior to proceeding with a vulvar biopsy, review with the patient the risks, benefits, and alternatives and obtain patient consent for the procedure. Vulvar biopsy risks include pain, bleeding, infection, injury to surrounding tissue, and the need for further surgery. Make patients aware that some biopsies are nondiagnostic. We recommend that clinicians perform a time-out verification to ensure that the patient’s identity and planned procedure are correct.

Assess the biopsy site

A wide variety of lesions may require a biopsy for diagnosis. While it can be challenging to know where to biopsy, taking the time to determine the proper biopsy site may enhance pathology results.

When considering colored lesions, depth is the important factor, and a punch biopsy often is sufficient. A tumor should be biopsied in the thickest area. Lesions that are concerning for malignancy may require multiple biopsies. An erosion or ulcer is best biopsied on the edge, including a small amount of surrounding tissue. For most patients, biopsy of normal-appearing tissue is of low diagnostic yield. Lastly, we try to avoid biopsies directly on the midline to facilitate better healing.¹

A photograph of the vulva prior to biopsy may be helpful for the pathologist to see the tissue. Some electronic medical records have the capability to include photographs. Due to the sensitive nature of these photographs, we prefer that a separate written patient consent be obtained prior to taking photographs. We find also that photos are a useful reference for progression of disease at follow-up in a shared care team.

Continue to: Anesthesia procedure and instrument kit...

Anesthesia procedure and instrument kit

Some patients may benefit from the application of topical lidocaine 4% cream (L.M.X.4) prior to the injection of a local anesthetic for tissue biopsy. Ideally, topical lidocaine should be placed on the vulva and covered with a dressing such as Tegaderm or cellophane up to 30 minutes before the anticipated biopsy procedure. The anesthetic effect generally lasts for about 60 minutes. Many patients report stinging for several seconds upon application. Due to clinic time restrictions, we tend to reserve this method for a limited subset of patients. If planning a return visit for a biopsy, the patient can place the topical anesthetic herself.

For the anesthetic injection, we recommend lidocaine 1% or 2% with epinephrine in all areas of the vulva except for the glans clitoris. For a punch biopsy, we draw up 1 to 3 mL in a 3-mL syringe and inject with a 21- to 30-gauge needle, using a lower gauge for thicker tissue. We have not found buffering the anesthetic with sodium bicarbonate to be of particular use. For the glans clitoris, lidocaine without epinephrine should be utilized.

Equipment. Depending on your office setting, having a premade instrument kit may be preferred to peel-pack equipment. We prefer a premade tray that contains sterile gauze, a hemostat, iris scissors, a needle driver, a scalpel handle, and Adson forceps (FIGURE 1).

Types of biopsy procedures

Punch biopsy. We recommend a 4-mm Keyes biopsy punch. As mentioned, we use a biopsy kit to facilitate the procedure. After the tissue is properly anesthetized and prepped, we test the area via gentle touch to the skin with the hemostat or Adson forceps. To perform the punch biopsy, gentle, consistent pressure in a clockwise-counterclockwise fashion yields the best results. The goal is to obtain a 5-mm depth for hair-bearing skin and a 3-mm depth for all other tissue.² The tissue should then be excised at the base with scissors, taking care not to crush the specimen with forceps.

Punch biopsy permits sampling of the epidermis, dermis, and subcutaneous tissue. Hemostasis is maintained with either silver nitrate, Monsel’s solution (ferric sulfate), or a dissolvable suture such as 4-0 Monocryl (poliglecaprone 25) or Vicryl Rapide (polyglactin 910).

Stitch biopsy. We find the stitch biopsy to be very useful given the architecture of the vulva. A modification of the shave biopsy, the stitch biopsy is depicted in FIGURE 2. A 3-0 or 4-0 dissolvable suture is placed through the intended area of biopsy. Iris scissors are used to undermine the tissue while the suture is held on tension. The goal is to remove the suture with the specimen. Separate sutures are used for hemostasis. The stitch does not cause the crushing artifacts on prepared specimens. Depending on the proceduralist’s comfort, a relatively large sample can be obtained in this fashion. If the suture held on tension is inadvertently cut, a second pass can be made with suture; alternatively, care can be used to remove remaining tissue with forceps and scissors, again avoiding crush injury to the tissue.

When planning an excisional biopsy, place a stitch on the excised tissue to mark orientation or pin out the entire specimen to a foam board to help your pathologist interpret tissue orientation.

The box "Vulvar biopsy established the diagnosis" at the end of this discussion provides 6 case examples of vulvar lesions and the respective diagnoses confirmed by biopsy.

Continue to: Preparing tissue for the pathologist...

Preparing tissue for the pathologist

Here are 5 tips for preparing the biopsied specimen for pathology:

• Include a question for the pathologist, such as “rule out lichen sclerosus or lichen simplex chronicus.” The majority of specimens should be sent in formalin. At times, frozen sections are done in the operating room.
• Double-check that the proper paperwork is included with every specimen and be very specific regarding the exact location of the lesion on the vulva. Include photographs whenever possible.
• Request that a dermatopathologist or a gynecologic pathologist with a special interest in vulvar dermatology, when feasible, review the tissue.
• Check your laboratory’s protocol for sending biopsies from areas around ulcerated tissue. Often, special medium is required for immunohistochemistry stains.
• Call your pathologist with questions about results; he or she often is happy to clarify, and together you may be able to arrive at a diagnosis to better serve your patient.³

Complications and how to avoid them

Bleeding. Any procedure has bleeding risks. To avoid bleeding, review the patient’s medication list and medical history prior to biopsy, as certain medications, such as blood thinners, increase risk for bleeding. Counseling a patient on applying direct pressure to the biopsy site for 2 minutes is generally sufficient for any bleeding that may occur once she is discharged from the clinic.

Infection. With aseptic technique, infection of a biopsy site is rare. We use nonsterile gloves for biopsy procedures. This does not increase the risk of infection.⁴ If a patient has iodine allergy, dilute chlorhexidine is a reasonable alternative for skin cleansing. Instruct the patient to keep the site clean and dry; if the biopsy proximity is close to the urethra or anus, use of a peri-bottle may be preferred after toileting. Instruct patients not to pull sutures. While instructions are specific for each patient, we generally advise that patients wait 4 to 7 days before resuming use of topical medications.

Scarring or tattooing. Avoid using dyed suture on skin surfaces and counsel the patient that silver nitrate can permanently stain tissue. Usually, small biopsies heal well but a small scar is possible.

Key points to keep in mind

• Counsel patients on biopsy risks, benefits, and alternatives. Counsel regarding possible inconclusive results.
• Take time in choosing the biopsy site and consider multiple biopsies.
• Have all anticipated equipment available; consider using premade biopsy kits.
• Consider performing a stitch biopsy to avoid crush injury.
• Take photographs of the area to be biopsied and communicate with your pathologist to facilitate diagnosis.

Vulvar biopsy established the diagnosis in these cases

---

Case 1

A 62-year-old woman with a history of vulvar lichen sclerosus presents for examination reporting symptoms of perianal irritation. Vulvar examination is consistent with lichen sclerosus, with an area of erosion on the right labium majus. In addition, thickened tissue firm to the touch raises concern. The clinician recommends a vulvar biopsy to evaluate for lichen sclerosus, differentiated vulvar intraepithelial neoplasia (dVIN), and vulvar cancer.

Biopsies were obtained of the areas highlighted in the photo. Pathology shows dVIN.

Image courtesy of Hope Haefner, MD.

 

Case 2

A 22-year-old woman presents with concerns of raised bumps on the vulva. The bumps can be itchy and irritating but are not painful. They seem to have grown and spread since she first noticed them.

The examination is consistent with condylomata acuminata and biopsy is recommended with a 4-mm punch. Biopsy results are consistent with condylomata acuminata.

Image courtesy of Hope Haefner, MD.

 

Case 3

A 30-year-old woman presents with concern of a raised area on the vulva. It is itchy and sometimes painful. Acetic acid is applied to the vulva and acetowhite changes are noted. 4-mm punch biopsies are obtained in multiple areas.

 

The final pathology shows high-grade squamous intraepithelial lesions (HSIL) of the vulva.

Image courtesy of Hope Haefner, MD.

 

Case 4

A 19-year-old woman presents with concerns of a pigmented, darkened area on the vulva. She is not sure how long the lesion has been present. It is not itchy and does not cause pain or irritation.

This presentation is an excellent opportunity for an excisional biopsy of the vulva. A marking pen is used to draw margins. A No. 15 blade is used to outline and then undermine the lesion, removing it in its entirety.

 

Final pathology shows a compound nevus of the vulva.

Image courtesy of Hope Haefner, MD.

 

Case 5

A 56-year-old woman presents with a 2-year history of vulvar irritation, burning, and itching. Examination reveals vulvar paleness in an hourglass configuration. There is loss of the labia minora and phimosis of the prepuce overlying the clitoris.

 

A 4-mm punch biopsy result is consistent with a diagnosis of lichen sclerosus.

Image courtesy of Hope Haefner, MD.

 

Case 6

A 65-year-old woman with a long history of lichen sclerosus presents with painful bleeding and a raised lesion on the vulva. Examination reveals a firm raised area that is friable to touch.

 

A 4-mm punch biopsy result reveals that the pathology is significant for squamous cell carcinoma.

Image courtesy of Hope Haefner, MD.

The 2019 ASCCP Risk-Based Management Consensus Guidelines for Abnormal Cervical Cancer Screening Tests and Cancer Precursors Consensus Guidelines, which represent a consensus of nearly 20 professional organizations and patient advocates, are a culmination of almost 10 years of research.¹ With the last version issued in 2012,² these latest guidelines offer the most recent recommendations regarding safely triaging women with abnormal cervical cancer screening results.

According to the consensus, research has shown that risk-based management allows clinicians to better discriminate women who will likely develop precancer from those who can safely continue with routine screening. As you will hear from guidelines coauthor Dr. Warner Huh, one of the most important differences between these guidelines and the 2012 version is a new emphasis on the principle of “equal management for equal risk.” Essentially, this insures that all women who have the same amount of risk for progression to precancer or cancer are managed the same.

The guidelines were once again published in the Journal of Lower Genital Tract Disease, and the tables they reference are publicly available. Additionally, ASCCP is developing a new management guidelines app to facilitate the use of the guidelines on smartphones and computers. With the publicly available risk tables, and the ASCCP navigation app, the guidelines will more easily accommodate updates as new information and technology become available.

OBG Management: The latest ASCCP guidelines, published in April, represent a “paradigm shift” from results to risk-based guidelines. Can you explain what this means and why the shift was undertaken?

Warner K. Huh, MD: Yes, the shift occurred because we needed to focus less on algorithms and more on risk. We started promulgating a concept of “equal management for equal risk” back in 2012. What this means is that if we have a method to look up a risk score based on relevant test results and other pieces of information, then all patients with that score should be managed in the same manner. We wanted that to be the underlying principle.

Focusing on risk tables also makes it easier to incorporate any future technologies used for risk estimation without having to rebuild algorithms from scratch. ASCCP is developing a new management guidelines app to streamline navigation of the guidelines. This app makes them easier for clinicians to use; they simply plug in certain variables from the patient’s history and receive 1 of 5 outputs: treatment, colposcopy, or surveillance at 1, 3, or 5 years.

The only drawbacks, if you view them as such, are that the clinician must plug in all the variables, and then must sit back and trust in what we have done. Clinicians have to trust that the system works and will simplify the clinical decision making.

We spent a lot of time determining what the risk thresholds should be. Some may argue they are arbitrary, but the decisions were data-driven, and carefully, thoughtfully vetted; we deliberated about whether the cut points actually made sense clinically to a practicing clinician base. The clinical action thresholds refer to a specific percentage below which a woman falls into one bucket and above which she falls into another bucket.

The other element that is unique about the guidelines is that instead of looking at the patient’s current screening result in isolation, the user sees it along with the prior one because prior history dictates subsequent risk.

It’s important that clinicians understand why this system is so markedly different from what we have done previously, and why risk-based guidelines make infinitely more sense than algorithmic ones. It’s because: 1) they can be easier to use; 2) they incorporate new data more efficiently and effectively than algorithm-based guidelines; and 3) they can incorporate future technologies seamlessly rather than having to create yet another algorithm.

Continue to: OBG Management : What do clinicians need in order to execute the guidelines?...

OBG Management: What do clinicians need in order to execute the guidelines?

Dr. Huh: Nothing. All of the information needed—the guidelines article and risk tables—are publicly available. However, to make navigation of the guidelines easier, the plan is for the app that I mentioned. I have the app on my phone and am actively beta testing it now. We’re planning on creating a web-based application as well, that will allow users to access the Internet and their electronic health record system so that they can plug in information directly from patient charts. The web-based app will be similar to the web-based Breast Cancer Surveillance Consortium’s Risk Calculator (https://tools.bcsc-scc.org/BC5yearRisk/calculator.htm). You will pull it up, plug in the requested information, including the patient’s age; their Pap smear and genotyping results; and their previous screening history.

OBG Management: When will the app be available for users?

Dr. Huh: It will be available for release on June 8.

OBG Management: Were HPV vaccination levels incorporated into the new guidelines?

OBG Management: Have recommendations regarding colposcopy changed?

Dr. Huh: Not really. About 3 years ago, we created basic colposcopy guidelines—the ASCCP Colposcopy Standards—so everything about colposcopy references back to those guidelines. Those colposcopy standards covered terminology and risk-based colposcopy, which actually aligns beautifully with these guidelines.

OBG Management: To narrow in on some changes from the prior guidelines, can colposcopy be deferred in certain patients?

Dr. Huh: Yes. Not everyone who has an abnormal screening test needs to come back for colposcopy.

OBG Management: How has guidance for expedited treatment or treatment without colposcopic biopsy changed?

Dr. Huh: This was heavily debated within not only the treatment group that I co-chaired with Richard Guido, MD, but also within the entire steering committee. The recommendation is that if the patient has an immediate risk of CIN 3 that is >60%, the patient should go straight to treatment without a colposcopic biopsy. The main reason for this is that you do not want to biopsy a patient and then lose them to follow-up.

When a woman has >60% immediate risk of CIN 3, we are fairly certain that colposcopy is not going to change management ultimately, so we recommend that patients receive treatment right away. We have already been doing this for 15 to 20 years, so this is not a new concept. It is just more formally codified here by assigning a percentage to the risk. Those who have between 25% and 60% immediate risk of CIN 3 should receive immediate colposcopy. We realize that not all clinicians have the ability to do this, so if clinicians can’t treat immediately, we recommend they do whatever they can to prevent losing the patient to follow-up.

OBG Management: How should a positive primary HPV screening test be managed?

Dr. Huh: If a woman has a positive primary HPV screening test, genotyping should be performed. If genotyping reveals HPV 16 or 18, then the patient should proceed to colposcopy. If genotyping reveals other forms of HPV, reflex cytology or a Pap smear should follow. ●

The 2019 ASCCP Risk-Based Management Consensus Guidelines for Abnormal Cervical Cancer Screening Tests and Cancer Precursors Consensus Guidelines, which represent a consensus of nearly 20 professional organizations and patient advocates, are a culmination of almost 10 years of research.¹ With the last version issued in 2012,² these latest guidelines offer the most recent recommendations regarding safely triaging women with abnormal cervical cancer screening results.

According to the consensus, research has shown that risk-based management allows clinicians to better discriminate women who will likely develop precancer from those who can safely continue with routine screening. As you will hear from guidelines coauthor Dr. Warner Huh, one of the most important differences between these guidelines and the 2012 version is a new emphasis on the principle of “equal management for equal risk.” Essentially, this insures that all women who have the same amount of risk for progression to precancer or cancer are managed the same.

The guidelines were once again published in the Journal of Lower Genital Tract Disease, and the tables they reference are publicly available. Additionally, ASCCP is developing a new management guidelines app to facilitate the use of the guidelines on smartphones and computers. With the publicly available risk tables, and the ASCCP navigation app, the guidelines will more easily accommodate updates as new information and technology become available.

OBG Management: The latest ASCCP guidelines, published in April, represent a “paradigm shift” from results to risk-based guidelines. Can you explain what this means and why the shift was undertaken?

Warner K. Huh, MD: Yes, the shift occurred because we needed to focus less on algorithms and more on risk. We started promulgating a concept of “equal management for equal risk” back in 2012. What this means is that if we have a method to look up a risk score based on relevant test results and other pieces of information, then all patients with that score should be managed in the same manner. We wanted that to be the underlying principle.

Focusing on risk tables also makes it easier to incorporate any future technologies used for risk estimation without having to rebuild algorithms from scratch. ASCCP is developing a new management guidelines app to streamline navigation of the guidelines. This app makes them easier for clinicians to use; they simply plug in certain variables from the patient’s history and receive 1 of 5 outputs: treatment, colposcopy, or surveillance at 1, 3, or 5 years.

The only drawbacks, if you view them as such, are that the clinician must plug in all the variables, and then must sit back and trust in what we have done. Clinicians have to trust that the system works and will simplify the clinical decision making.

We spent a lot of time determining what the risk thresholds should be. Some may argue they are arbitrary, but the decisions were data-driven, and carefully, thoughtfully vetted; we deliberated about whether the cut points actually made sense clinically to a practicing clinician base. The clinical action thresholds refer to a specific percentage below which a woman falls into one bucket and above which she falls into another bucket.

The other element that is unique about the guidelines is that instead of looking at the patient’s current screening result in isolation, the user sees it along with the prior one because prior history dictates subsequent risk.

It’s important that clinicians understand why this system is so markedly different from what we have done previously, and why risk-based guidelines make infinitely more sense than algorithmic ones. It’s because: 1) they can be easier to use; 2) they incorporate new data more efficiently and effectively than algorithm-based guidelines; and 3) they can incorporate future technologies seamlessly rather than having to create yet another algorithm.

Continue to: OBG Management : What do clinicians need in order to execute the guidelines?...

OBG Management: What do clinicians need in order to execute the guidelines?

Dr. Huh: Nothing. All of the information needed—the guidelines article and risk tables—are publicly available. However, to make navigation of the guidelines easier, the plan is for the app that I mentioned. I have the app on my phone and am actively beta testing it now. We’re planning on creating a web-based application as well, that will allow users to access the Internet and their electronic health record system so that they can plug in information directly from patient charts. The web-based app will be similar to the web-based Breast Cancer Surveillance Consortium’s Risk Calculator (https://tools.bcsc-scc.org/BC5yearRisk/calculator.htm). You will pull it up, plug in the requested information, including the patient’s age; their Pap smear and genotyping results; and their previous screening history.

OBG Management: When will the app be available for users?

Dr. Huh: It will be available for release on June 8.

OBG Management: Were HPV vaccination levels incorporated into the new guidelines?

OBG Management: Have recommendations regarding colposcopy changed?

Dr. Huh: Not really. About 3 years ago, we created basic colposcopy guidelines—the ASCCP Colposcopy Standards—so everything about colposcopy references back to those guidelines. Those colposcopy standards covered terminology and risk-based colposcopy, which actually aligns beautifully with these guidelines.

OBG Management: To narrow in on some changes from the prior guidelines, can colposcopy be deferred in certain patients?

Dr. Huh: Yes. Not everyone who has an abnormal screening test needs to come back for colposcopy.

OBG Management: How has guidance for expedited treatment or treatment without colposcopic biopsy changed?

Dr. Huh: This was heavily debated within not only the treatment group that I co-chaired with Richard Guido, MD, but also within the entire steering committee. The recommendation is that if the patient has an immediate risk of CIN 3 that is >60%, the patient should go straight to treatment without a colposcopic biopsy. The main reason for this is that you do not want to biopsy a patient and then lose them to follow-up.

When a woman has >60% immediate risk of CIN 3, we are fairly certain that colposcopy is not going to change management ultimately, so we recommend that patients receive treatment right away. We have already been doing this for 15 to 20 years, so this is not a new concept. It is just more formally codified here by assigning a percentage to the risk. Those who have between 25% and 60% immediate risk of CIN 3 should receive immediate colposcopy. We realize that not all clinicians have the ability to do this, so if clinicians can’t treat immediately, we recommend they do whatever they can to prevent losing the patient to follow-up.

OBG Management: How should a positive primary HPV screening test be managed?

Dr. Huh: If a woman has a positive primary HPV screening test, genotyping should be performed. If genotyping reveals HPV 16 or 18, then the patient should proceed to colposcopy. If genotyping reveals other forms of HPV, reflex cytology or a Pap smear should follow. ●

The 2019 ASCCP Risk-Based Management Consensus Guidelines for Abnormal Cervical Cancer Screening Tests and Cancer Precursors Consensus Guidelines, which represent a consensus of nearly 20 professional organizations and patient advocates, are a culmination of almost 10 years of research.¹ With the last version issued in 2012,² these latest guidelines offer the most recent recommendations regarding safely triaging women with abnormal cervical cancer screening results.

According to the consensus, research has shown that risk-based management allows clinicians to better discriminate women who will likely develop precancer from those who can safely continue with routine screening. As you will hear from guidelines coauthor Dr. Warner Huh, one of the most important differences between these guidelines and the 2012 version is a new emphasis on the principle of “equal management for equal risk.” Essentially, this insures that all women who have the same amount of risk for progression to precancer or cancer are managed the same.

The guidelines were once again published in the Journal of Lower Genital Tract Disease, and the tables they reference are publicly available. Additionally, ASCCP is developing a new management guidelines app to facilitate the use of the guidelines on smartphones and computers. With the publicly available risk tables, and the ASCCP navigation app, the guidelines will more easily accommodate updates as new information and technology become available.

OBG Management: The latest ASCCP guidelines, published in April, represent a “paradigm shift” from results to risk-based guidelines. Can you explain what this means and why the shift was undertaken?

Warner K. Huh, MD: Yes, the shift occurred because we needed to focus less on algorithms and more on risk. We started promulgating a concept of “equal management for equal risk” back in 2012. What this means is that if we have a method to look up a risk score based on relevant test results and other pieces of information, then all patients with that score should be managed in the same manner. We wanted that to be the underlying principle.

Focusing on risk tables also makes it easier to incorporate any future technologies used for risk estimation without having to rebuild algorithms from scratch. ASCCP is developing a new management guidelines app to streamline navigation of the guidelines. This app makes them easier for clinicians to use; they simply plug in certain variables from the patient’s history and receive 1 of 5 outputs: treatment, colposcopy, or surveillance at 1, 3, or 5 years.

The only drawbacks, if you view them as such, are that the clinician must plug in all the variables, and then must sit back and trust in what we have done. Clinicians have to trust that the system works and will simplify the clinical decision making.

We spent a lot of time determining what the risk thresholds should be. Some may argue they are arbitrary, but the decisions were data-driven, and carefully, thoughtfully vetted; we deliberated about whether the cut points actually made sense clinically to a practicing clinician base. The clinical action thresholds refer to a specific percentage below which a woman falls into one bucket and above which she falls into another bucket.

The other element that is unique about the guidelines is that instead of looking at the patient’s current screening result in isolation, the user sees it along with the prior one because prior history dictates subsequent risk.

It’s important that clinicians understand why this system is so markedly different from what we have done previously, and why risk-based guidelines make infinitely more sense than algorithmic ones. It’s because: 1) they can be easier to use; 2) they incorporate new data more efficiently and effectively than algorithm-based guidelines; and 3) they can incorporate future technologies seamlessly rather than having to create yet another algorithm.

Continue to: OBG Management : What do clinicians need in order to execute the guidelines?...

OBG Management: What do clinicians need in order to execute the guidelines?

Dr. Huh: Nothing. All of the information needed—the guidelines article and risk tables—are publicly available. However, to make navigation of the guidelines easier, the plan is for the app that I mentioned. I have the app on my phone and am actively beta testing it now. We’re planning on creating a web-based application as well, that will allow users to access the Internet and their electronic health record system so that they can plug in information directly from patient charts. The web-based app will be similar to the web-based Breast Cancer Surveillance Consortium’s Risk Calculator (https://tools.bcsc-scc.org/BC5yearRisk/calculator.htm). You will pull it up, plug in the requested information, including the patient’s age; their Pap smear and genotyping results; and their previous screening history.

OBG Management: When will the app be available for users?

Dr. Huh: It will be available for release on June 8.

OBG Management: Were HPV vaccination levels incorporated into the new guidelines?

OBG Management: Have recommendations regarding colposcopy changed?

Dr. Huh: Not really. About 3 years ago, we created basic colposcopy guidelines—the ASCCP Colposcopy Standards—so everything about colposcopy references back to those guidelines. Those colposcopy standards covered terminology and risk-based colposcopy, which actually aligns beautifully with these guidelines.

OBG Management: To narrow in on some changes from the prior guidelines, can colposcopy be deferred in certain patients?

Dr. Huh: Yes. Not everyone who has an abnormal screening test needs to come back for colposcopy.

OBG Management: How has guidance for expedited treatment or treatment without colposcopic biopsy changed?

Dr. Huh: This was heavily debated within not only the treatment group that I co-chaired with Richard Guido, MD, but also within the entire steering committee. The recommendation is that if the patient has an immediate risk of CIN 3 that is >60%, the patient should go straight to treatment without a colposcopic biopsy. The main reason for this is that you do not want to biopsy a patient and then lose them to follow-up.

When a woman has >60% immediate risk of CIN 3, we are fairly certain that colposcopy is not going to change management ultimately, so we recommend that patients receive treatment right away. We have already been doing this for 15 to 20 years, so this is not a new concept. It is just more formally codified here by assigning a percentage to the risk. Those who have between 25% and 60% immediate risk of CIN 3 should receive immediate colposcopy. We realize that not all clinicians have the ability to do this, so if clinicians can’t treat immediately, we recommend they do whatever they can to prevent losing the patient to follow-up.

OBG Management: How should a positive primary HPV screening test be managed?

Dr. Huh: If a woman has a positive primary HPV screening test, genotyping should be performed. If genotyping reveals HPV 16 or 18, then the patient should proceed to colposcopy. If genotyping reveals other forms of HPV, reflex cytology or a Pap smear should follow. ●

Although pelvic examinations may only last a few minutes, the examination is scary and uncomfortable for many patients. To help minimize fear and discomfort, the exam should take place in a comfortable and professional environment. The clinician should provide appropriate gowns, private facilities for undressing, sensitively use draping, and clearly explain the components of the examination. Trained professional chaperones play an important role in intimate physical examinations, including:

• providing reassurance to the patient of the professional integrity of the intimate examination
• supporting and educating the patient during the examination
• increasing the efficiency of the clinician during a procedure
• acting as a witness should a misunderstanding with the patient arise.

Major medical professional societies have issued guidance to clinicians on the use of a chaperone during intimate physical examinations. Professional society guidance ranges from endorsing joint decision-making between physician and patient on the presence of a chaperone to more proscriptive guidance that emphasizes the importance of a chaperone at every intimate physical examination.

Examples of professional societies’ guidance that supports joint decision-making between physician and patient about the presence of a chaperone include:

• American Medical Association: “Adopt a policy that patients are free to request a chaperone and ensure that the policy is communicated to patients. Always honor a patient’s request to have a chaperone.”¹
• Society of Obstetricians and Gynaecologists of Canada: “It is a reasonable and acceptable practice to perform a physical examination, including breast and pelvic examination without the presence of a third person in the room unless the woman or health care provider indicates a desire for a third party to be present.” “If the health care provider chooses to have a third person present during all examinations, the health care provider should explain this policy to the woman.”²
• American College of Physicians: “Care and respect should guide the performance of the physical examination. The location and degree of privacy should be appropriate for the examination being performed, with chaperone services as an option. An appropriate setting and sufficient time should be allocated to encourage exploration of aspects of the patient’s life pertinent to health, including habits, relationships, sexuality, vocation, culture, religion, and spirituality.”³

By contrast, the following professional society guidance strongly recommends the presence of a chaperone for every intimate physical examination:

• United States Veterans Administration: “A female chaperone must be in the examination room during breast and pelvic exams…this includes procedures such as urodynamic testing or treatments such as pelvic floor physical therapy.”⁴
• Royal College of Obstetricians and Gynaecologists: “The presence of a chaperone is considered essential for every pelvic examination. Verbal consent should be obtained in the presence of the chaperone who is to be present during the examination and recorded in the notes. If the patient declines the presence of a chaperone, the doctor should explain that a chaperone is also required to help in many cases and then attempt to arrange for the chaperone to be standing nearby within earshot. The reasons for declining a chaperone and alternative arrangements offered should be documented. Consent should also be specific to whether the intended examination is vaginal, rectal or both. Communication skills are essential in conducting intimate examinations.”⁵
• American College Health Association (ACHA): “It is ACHA’s recommendation that, as part of institutional policy, a chaperone be provided for every sensitive medical examination and procedure.”⁶

Continue to: New guidance from ACOG on trained chaperones...

New guidance from ACOG on trained chaperones

The American College of Obstetricians and Gynecologists (ACOG) recently issued a committee opinion recommending “that a chaperone be present for all breast, genital, and rectal examinations. The need for a chaperone is irrespective of the sex or gender of the person performing the examination and applies to examinations performed in the outpatient and inpatient settings, including labor and delivery, as well as during diagnostic studies such as transvaginal ultrasonography and urodynamic testing.”⁷

This new proscriptive guidance will significantly change practice for the many obstetrician-gynecologists who do not routinely have a chaperone present during intimate examinations. The policy provides exceptions to the presence of a chaperone in cases of medical emergencies and if the patient declines a chaperone. ACOG recommends that when a patient declines a chaperone the clinician should educate the patient that a “chaperone is an integral part of the clinical team whose role includes assisting with the examination and protecting the patient and the physician. Any concerns the patient has regarding the presence of a chaperone should be elicited and addressed if feasible. If, after counseling, the patient refuses the chaperone, this decision should be respected and documented in the medical record.”⁷ ACOG discourages the use of family members, medical students, and residents as chaperones.

Training of chaperones

Chaperones are health care professionals who should be trained for their specific role. Chaperones need to protect patient privacy and the confidentiality of health information. Chaperones should be trained to recognize the components of a professional intimate examination and to identify variances from standard practice. In many ambulatory practices, medical assistants perform the role of chaperone. The American Association of Medical Assistants (AAMA) offers national certification for medical assistants through an examination developed by the National Board of Medical Examiners. To be eligible for AAMA certification an individual must complete at least two semesters of medical assisting education that includes courses in anatomy, physiology, pharmacology, and relevant mathematics.

Reporting variances that occur during an intimate examination

Best practices are evolving on how to deal with the rare event of a chaperone witnessing a physician perform an intimate examination that is outside of standard professional practice. Chaperones may be reluctant to report a variance because physicians are in a powerful position, and the accuracy of their report will be challenged, threatening the chaperone’s employment. Processes for encouraging all team members to report concerns must be clearly explained to the chaperone and other members of the health care team. Clinicians should be aware that deviations from standard practice will be reported and investigated. Medical practices must develop a reporting system that ensures the reporting individual will be protected from retaliation.

In addition, the chaperone needs to know to whom they should report a variance. In large multispecialty medical practices, chaperones often can report concerns to nursing leaders or human resources. In small ambulatory practices, chaperones may be advised to report concerns about a physician to the practice manager or medical director. Regardless, every practice should have the best process for reporting a concern. In turn, the practice leaders who are responsible for investigating reports of concerning behavior should have a defined process for confidentially interviewing the chaperone, clinician, and patient.

Even when a chaperone is present for intimate examinations, problems can arise if the chaperone is not trained to recognize variances from standard practice or does not have a clear means for reporting variances and when the practice does not have a process for investigating reported variances.

Sadly, misconduct has been documented among priests, ministers, sports coaches, professors, scout masters, and clinicians. Trusted professionals are in positions of power in relation to their clients, patients, and students. Physicians and nurses are held in high esteem and trust by patients. To preserve the trust of the public we must treat all people with dignity and respect their autonomy. The presence of a chaperone during intimate examinations may help us fulfill Hippocrates’ edict, “First, do no harm.” ●

Although pelvic examinations may only last a few minutes, the examination is scary and uncomfortable for many patients. To help minimize fear and discomfort, the exam should take place in a comfortable and professional environment. The clinician should provide appropriate gowns, private facilities for undressing, sensitively use draping, and clearly explain the components of the examination. Trained professional chaperones play an important role in intimate physical examinations, including:

• providing reassurance to the patient of the professional integrity of the intimate examination
• supporting and educating the patient during the examination
• increasing the efficiency of the clinician during a procedure
• acting as a witness should a misunderstanding with the patient arise.

Major medical professional societies have issued guidance to clinicians on the use of a chaperone during intimate physical examinations. Professional society guidance ranges from endorsing joint decision-making between physician and patient on the presence of a chaperone to more proscriptive guidance that emphasizes the importance of a chaperone at every intimate physical examination.

Examples of professional societies’ guidance that supports joint decision-making between physician and patient about the presence of a chaperone include:

• American Medical Association: “Adopt a policy that patients are free to request a chaperone and ensure that the policy is communicated to patients. Always honor a patient’s request to have a chaperone.”¹
• Society of Obstetricians and Gynaecologists of Canada: “It is a reasonable and acceptable practice to perform a physical examination, including breast and pelvic examination without the presence of a third person in the room unless the woman or health care provider indicates a desire for a third party to be present.” “If the health care provider chooses to have a third person present during all examinations, the health care provider should explain this policy to the woman.”²
• American College of Physicians: “Care and respect should guide the performance of the physical examination. The location and degree of privacy should be appropriate for the examination being performed, with chaperone services as an option. An appropriate setting and sufficient time should be allocated to encourage exploration of aspects of the patient’s life pertinent to health, including habits, relationships, sexuality, vocation, culture, religion, and spirituality.”³

By contrast, the following professional society guidance strongly recommends the presence of a chaperone for every intimate physical examination:

• United States Veterans Administration: “A female chaperone must be in the examination room during breast and pelvic exams…this includes procedures such as urodynamic testing or treatments such as pelvic floor physical therapy.”⁴
• Royal College of Obstetricians and Gynaecologists: “The presence of a chaperone is considered essential for every pelvic examination. Verbal consent should be obtained in the presence of the chaperone who is to be present during the examination and recorded in the notes. If the patient declines the presence of a chaperone, the doctor should explain that a chaperone is also required to help in many cases and then attempt to arrange for the chaperone to be standing nearby within earshot. The reasons for declining a chaperone and alternative arrangements offered should be documented. Consent should also be specific to whether the intended examination is vaginal, rectal or both. Communication skills are essential in conducting intimate examinations.”⁵
• American College Health Association (ACHA): “It is ACHA’s recommendation that, as part of institutional policy, a chaperone be provided for every sensitive medical examination and procedure.”⁶

Continue to: New guidance from ACOG on trained chaperones...

New guidance from ACOG on trained chaperones

The American College of Obstetricians and Gynecologists (ACOG) recently issued a committee opinion recommending “that a chaperone be present for all breast, genital, and rectal examinations. The need for a chaperone is irrespective of the sex or gender of the person performing the examination and applies to examinations performed in the outpatient and inpatient settings, including labor and delivery, as well as during diagnostic studies such as transvaginal ultrasonography and urodynamic testing.”⁷

This new proscriptive guidance will significantly change practice for the many obstetrician-gynecologists who do not routinely have a chaperone present during intimate examinations. The policy provides exceptions to the presence of a chaperone in cases of medical emergencies and if the patient declines a chaperone. ACOG recommends that when a patient declines a chaperone the clinician should educate the patient that a “chaperone is an integral part of the clinical team whose role includes assisting with the examination and protecting the patient and the physician. Any concerns the patient has regarding the presence of a chaperone should be elicited and addressed if feasible. If, after counseling, the patient refuses the chaperone, this decision should be respected and documented in the medical record.”⁷ ACOG discourages the use of family members, medical students, and residents as chaperones.

Training of chaperones

Chaperones are health care professionals who should be trained for their specific role. Chaperones need to protect patient privacy and the confidentiality of health information. Chaperones should be trained to recognize the components of a professional intimate examination and to identify variances from standard practice. In many ambulatory practices, medical assistants perform the role of chaperone. The American Association of Medical Assistants (AAMA) offers national certification for medical assistants through an examination developed by the National Board of Medical Examiners. To be eligible for AAMA certification an individual must complete at least two semesters of medical assisting education that includes courses in anatomy, physiology, pharmacology, and relevant mathematics.

Reporting variances that occur during an intimate examination

Best practices are evolving on how to deal with the rare event of a chaperone witnessing a physician perform an intimate examination that is outside of standard professional practice. Chaperones may be reluctant to report a variance because physicians are in a powerful position, and the accuracy of their report will be challenged, threatening the chaperone’s employment. Processes for encouraging all team members to report concerns must be clearly explained to the chaperone and other members of the health care team. Clinicians should be aware that deviations from standard practice will be reported and investigated. Medical practices must develop a reporting system that ensures the reporting individual will be protected from retaliation.

In addition, the chaperone needs to know to whom they should report a variance. In large multispecialty medical practices, chaperones often can report concerns to nursing leaders or human resources. In small ambulatory practices, chaperones may be advised to report concerns about a physician to the practice manager or medical director. Regardless, every practice should have the best process for reporting a concern. In turn, the practice leaders who are responsible for investigating reports of concerning behavior should have a defined process for confidentially interviewing the chaperone, clinician, and patient.

Even when a chaperone is present for intimate examinations, problems can arise if the chaperone is not trained to recognize variances from standard practice or does not have a clear means for reporting variances and when the practice does not have a process for investigating reported variances.

Sadly, misconduct has been documented among priests, ministers, sports coaches, professors, scout masters, and clinicians. Trusted professionals are in positions of power in relation to their clients, patients, and students. Physicians and nurses are held in high esteem and trust by patients. To preserve the trust of the public we must treat all people with dignity and respect their autonomy. The presence of a chaperone during intimate examinations may help us fulfill Hippocrates’ edict, “First, do no harm.” ●

Although pelvic examinations may only last a few minutes, the examination is scary and uncomfortable for many patients. To help minimize fear and discomfort, the exam should take place in a comfortable and professional environment. The clinician should provide appropriate gowns, private facilities for undressing, sensitively use draping, and clearly explain the components of the examination. Trained professional chaperones play an important role in intimate physical examinations, including:

• providing reassurance to the patient of the professional integrity of the intimate examination
• supporting and educating the patient during the examination
• increasing the efficiency of the clinician during a procedure
• acting as a witness should a misunderstanding with the patient arise.

Major medical professional societies have issued guidance to clinicians on the use of a chaperone during intimate physical examinations. Professional society guidance ranges from endorsing joint decision-making between physician and patient on the presence of a chaperone to more proscriptive guidance that emphasizes the importance of a chaperone at every intimate physical examination.

Examples of professional societies’ guidance that supports joint decision-making between physician and patient about the presence of a chaperone include:

• American Medical Association: “Adopt a policy that patients are free to request a chaperone and ensure that the policy is communicated to patients. Always honor a patient’s request to have a chaperone.”¹
• Society of Obstetricians and Gynaecologists of Canada: “It is a reasonable and acceptable practice to perform a physical examination, including breast and pelvic examination without the presence of a third person in the room unless the woman or health care provider indicates a desire for a third party to be present.” “If the health care provider chooses to have a third person present during all examinations, the health care provider should explain this policy to the woman.”²
• American College of Physicians: “Care and respect should guide the performance of the physical examination. The location and degree of privacy should be appropriate for the examination being performed, with chaperone services as an option. An appropriate setting and sufficient time should be allocated to encourage exploration of aspects of the patient’s life pertinent to health, including habits, relationships, sexuality, vocation, culture, religion, and spirituality.”³

By contrast, the following professional society guidance strongly recommends the presence of a chaperone for every intimate physical examination:

• United States Veterans Administration: “A female chaperone must be in the examination room during breast and pelvic exams…this includes procedures such as urodynamic testing or treatments such as pelvic floor physical therapy.”⁴
• Royal College of Obstetricians and Gynaecologists: “The presence of a chaperone is considered essential for every pelvic examination. Verbal consent should be obtained in the presence of the chaperone who is to be present during the examination and recorded in the notes. If the patient declines the presence of a chaperone, the doctor should explain that a chaperone is also required to help in many cases and then attempt to arrange for the chaperone to be standing nearby within earshot. The reasons for declining a chaperone and alternative arrangements offered should be documented. Consent should also be specific to whether the intended examination is vaginal, rectal or both. Communication skills are essential in conducting intimate examinations.”⁵
• American College Health Association (ACHA): “It is ACHA’s recommendation that, as part of institutional policy, a chaperone be provided for every sensitive medical examination and procedure.”⁶

Continue to: New guidance from ACOG on trained chaperones...

New guidance from ACOG on trained chaperones

The American College of Obstetricians and Gynecologists (ACOG) recently issued a committee opinion recommending “that a chaperone be present for all breast, genital, and rectal examinations. The need for a chaperone is irrespective of the sex or gender of the person performing the examination and applies to examinations performed in the outpatient and inpatient settings, including labor and delivery, as well as during diagnostic studies such as transvaginal ultrasonography and urodynamic testing.”⁷

This new proscriptive guidance will significantly change practice for the many obstetrician-gynecologists who do not routinely have a chaperone present during intimate examinations. The policy provides exceptions to the presence of a chaperone in cases of medical emergencies and if the patient declines a chaperone. ACOG recommends that when a patient declines a chaperone the clinician should educate the patient that a “chaperone is an integral part of the clinical team whose role includes assisting with the examination and protecting the patient and the physician. Any concerns the patient has regarding the presence of a chaperone should be elicited and addressed if feasible. If, after counseling, the patient refuses the chaperone, this decision should be respected and documented in the medical record.”⁷ ACOG discourages the use of family members, medical students, and residents as chaperones.

Training of chaperones

Chaperones are health care professionals who should be trained for their specific role. Chaperones need to protect patient privacy and the confidentiality of health information. Chaperones should be trained to recognize the components of a professional intimate examination and to identify variances from standard practice. In many ambulatory practices, medical assistants perform the role of chaperone. The American Association of Medical Assistants (AAMA) offers national certification for medical assistants through an examination developed by the National Board of Medical Examiners. To be eligible for AAMA certification an individual must complete at least two semesters of medical assisting education that includes courses in anatomy, physiology, pharmacology, and relevant mathematics.

Reporting variances that occur during an intimate examination

Best practices are evolving on how to deal with the rare event of a chaperone witnessing a physician perform an intimate examination that is outside of standard professional practice. Chaperones may be reluctant to report a variance because physicians are in a powerful position, and the accuracy of their report will be challenged, threatening the chaperone’s employment. Processes for encouraging all team members to report concerns must be clearly explained to the chaperone and other members of the health care team. Clinicians should be aware that deviations from standard practice will be reported and investigated. Medical practices must develop a reporting system that ensures the reporting individual will be protected from retaliation.

In addition, the chaperone needs to know to whom they should report a variance. In large multispecialty medical practices, chaperones often can report concerns to nursing leaders or human resources. In small ambulatory practices, chaperones may be advised to report concerns about a physician to the practice manager or medical director. Regardless, every practice should have the best process for reporting a concern. In turn, the practice leaders who are responsible for investigating reports of concerning behavior should have a defined process for confidentially interviewing the chaperone, clinician, and patient.

Even when a chaperone is present for intimate examinations, problems can arise if the chaperone is not trained to recognize variances from standard practice or does not have a clear means for reporting variances and when the practice does not have a process for investigating reported variances.

Sadly, misconduct has been documented among priests, ministers, sports coaches, professors, scout masters, and clinicians. Trusted professionals are in positions of power in relation to their clients, patients, and students. Physicians and nurses are held in high esteem and trust by patients. To preserve the trust of the public we must treat all people with dignity and respect their autonomy. The presence of a chaperone during intimate examinations may help us fulfill Hippocrates’ edict, “First, do no harm.” ●

The Food and Drug Administration approved a medication for the management of heavy menstrual bleeding associated with uterine fibroids in premenopausal women. The medication, marketed as Oriahnn, is an estrogen and progestin combination product that consists of elagolix, estradiol, and norethindrone acetate capsules packaged together for oral use, according to an FDA announcement.

Wikimedia Commons/FitzColinGerald/ Creative Commons License

“Uterine fibroids are the most common benign tumors affecting premenopausal women, and one of the most common symptoms from fibroids is heavy menstrual bleeding,” Christine P. Nguyen, MD, acting director of the division of urology, obstetrics, and gynecology in the FDA’s Center for Drug Evaluation and Research, said in a news release. “Although surgical treatments, such as hysterectomy, are available, patients may not qualify for surgery or want the procedure. Various nonsurgical therapies are used to treat fibroid-related heavy menstrual bleeding, but none have been FDA approved specifically for this use. Today’s approval provides an FDA-approved medical treatment option for these patients.”

Fibroids, which occur most commonly in women aged 35-49 years, typically resolve after menopause but are a leading reason for hysterectomy in the United States, according to the release.

Researchers established the efficacy of the treatment in two clinical trials that included 591 premenopausal women with heavy menstrual bleeding. Participants received the drug or placebo for 6 months. The investigators defined heavy menstrual bleeding as at least two menstrual cycles with greater than 80 mL of menstrual blood loss. The primary endpoint was the proportion of women who achieved menstrual blood loss less than 80 mL at the final month and 50% or greater reduction in menstrual blood loss volume from baseline to the final month. In one trial, 69% of patients who received Oriahnn met this endpoint, compared with 9% of patients who received placebo. In the second study, 77% of patients who received the drug achieved this endpoint, compared with 11% of patients who received placebo.

Oriahnn may cause bone loss that may not be completely recovered after stopping treatment, so women should not take the medication for more than 24 months, according to the FDA announcement. Health care professionals may recommend bone density scans before and during treatment.

The most common side effects included hot flushes, headache, fatigue, and irregular vaginal bleeding. The drug’s label includes a boxed warning about a risk of strokes and blood clots, especially in women at increased risk for these events. Contraindications include osteoporosis, a history of breast cancer or other hormonally sensitive cancer, liver disease, and abnormal uterine bleeding. Oriahnn does not prevent pregnancy and may increase blood pressure, according to the press release. AbbVie markets the drug.

[email protected]

The Food and Drug Administration approved a medication for the management of heavy menstrual bleeding associated with uterine fibroids in premenopausal women. The medication, marketed as Oriahnn, is an estrogen and progestin combination product that consists of elagolix, estradiol, and norethindrone acetate capsules packaged together for oral use, according to an FDA announcement.

Wikimedia Commons/FitzColinGerald/ Creative Commons License

“Uterine fibroids are the most common benign tumors affecting premenopausal women, and one of the most common symptoms from fibroids is heavy menstrual bleeding,” Christine P. Nguyen, MD, acting director of the division of urology, obstetrics, and gynecology in the FDA’s Center for Drug Evaluation and Research, said in a news release. “Although surgical treatments, such as hysterectomy, are available, patients may not qualify for surgery or want the procedure. Various nonsurgical therapies are used to treat fibroid-related heavy menstrual bleeding, but none have been FDA approved specifically for this use. Today’s approval provides an FDA-approved medical treatment option for these patients.”

Fibroids, which occur most commonly in women aged 35-49 years, typically resolve after menopause but are a leading reason for hysterectomy in the United States, according to the release.

Researchers established the efficacy of the treatment in two clinical trials that included 591 premenopausal women with heavy menstrual bleeding. Participants received the drug or placebo for 6 months. The investigators defined heavy menstrual bleeding as at least two menstrual cycles with greater than 80 mL of menstrual blood loss. The primary endpoint was the proportion of women who achieved menstrual blood loss less than 80 mL at the final month and 50% or greater reduction in menstrual blood loss volume from baseline to the final month. In one trial, 69% of patients who received Oriahnn met this endpoint, compared with 9% of patients who received placebo. In the second study, 77% of patients who received the drug achieved this endpoint, compared with 11% of patients who received placebo.

Oriahnn may cause bone loss that may not be completely recovered after stopping treatment, so women should not take the medication for more than 24 months, according to the FDA announcement. Health care professionals may recommend bone density scans before and during treatment.

The most common side effects included hot flushes, headache, fatigue, and irregular vaginal bleeding. The drug’s label includes a boxed warning about a risk of strokes and blood clots, especially in women at increased risk for these events. Contraindications include osteoporosis, a history of breast cancer or other hormonally sensitive cancer, liver disease, and abnormal uterine bleeding. Oriahnn does not prevent pregnancy and may increase blood pressure, according to the press release. AbbVie markets the drug.

[email protected]

The Food and Drug Administration approved a medication for the management of heavy menstrual bleeding associated with uterine fibroids in premenopausal women. The medication, marketed as Oriahnn, is an estrogen and progestin combination product that consists of elagolix, estradiol, and norethindrone acetate capsules packaged together for oral use, according to an FDA announcement.

Wikimedia Commons/FitzColinGerald/ Creative Commons License

“Uterine fibroids are the most common benign tumors affecting premenopausal women, and one of the most common symptoms from fibroids is heavy menstrual bleeding,” Christine P. Nguyen, MD, acting director of the division of urology, obstetrics, and gynecology in the FDA’s Center for Drug Evaluation and Research, said in a news release. “Although surgical treatments, such as hysterectomy, are available, patients may not qualify for surgery or want the procedure. Various nonsurgical therapies are used to treat fibroid-related heavy menstrual bleeding, but none have been FDA approved specifically for this use. Today’s approval provides an FDA-approved medical treatment option for these patients.”

Fibroids, which occur most commonly in women aged 35-49 years, typically resolve after menopause but are a leading reason for hysterectomy in the United States, according to the release.

Researchers established the efficacy of the treatment in two clinical trials that included 591 premenopausal women with heavy menstrual bleeding. Participants received the drug or placebo for 6 months. The investigators defined heavy menstrual bleeding as at least two menstrual cycles with greater than 80 mL of menstrual blood loss. The primary endpoint was the proportion of women who achieved menstrual blood loss less than 80 mL at the final month and 50% or greater reduction in menstrual blood loss volume from baseline to the final month. In one trial, 69% of patients who received Oriahnn met this endpoint, compared with 9% of patients who received placebo. In the second study, 77% of patients who received the drug achieved this endpoint, compared with 11% of patients who received placebo.

Oriahnn may cause bone loss that may not be completely recovered after stopping treatment, so women should not take the medication for more than 24 months, according to the FDA announcement. Health care professionals may recommend bone density scans before and during treatment.

The most common side effects included hot flushes, headache, fatigue, and irregular vaginal bleeding. The drug’s label includes a boxed warning about a risk of strokes and blood clots, especially in women at increased risk for these events. Contraindications include osteoporosis, a history of breast cancer or other hormonally sensitive cancer, liver disease, and abnormal uterine bleeding. Oriahnn does not prevent pregnancy and may increase blood pressure, according to the press release. AbbVie markets the drug.

[email protected]

The current standard frontline therapy for advanced epithelial ovarian, fallopian tube, and primary peritoneal cancer includes a combination of surgical cytoreduction and at least six cycles of platinum-based chemotherapy. While this achieves a complete clinical response (“remission”) in most, 85% of patients will recur and eventually succumb to the disease. This suggests that treatments are good at inducing remission, but poor at eradicating the disease altogether. This has motivated the consideration of maintenance therapy: extended treatment beyond completion of chemotherapy during the period of time when patients are clinically disease free.

Maintenance therapy is an appealing concept for clinicians who desperately want to “hold” their patients in a disease-free state for longer periods. It is also a profitable way to administer therapy as there is more compensation to the pharmaceutical industry from chronic, long-term drug administration rather than episodic treatment courses. However, the following question must be asked: Is this extended therapy worthwhile for all patients, and is it good value?

In the past 12 months, three major industry-sponsored clinical trials have been published (PRIMA, PAOLA-1, and VELIA)which suggest a benefit for all patients with advanced epithelial ovarian cancer in receiving prolonged poly (ADP-ribose) polymerase inhibitor (PARPi) therapy after primary chemotherapy.^1-3 This has resulted in Food and Drug Administration approval for some of these agents as maintenance therapy. Despite differences in the drugs tested and the timing of therapy, these studies observed that treatment of advanced ovarian cancer with the addition of a PARPi during and/or after carboplatin and paclitaxel chemotherapy for up to an additional 3 years resulted in a longer progression-free survival (PFS) of approximately 6 months. PFS is defined as the time to measurable recurrence or death. However, this positive effect was not equally distributed across the whole population; rather, it appeared to be created by a substantial response in a smaller subgroup.

PARP inhibitor therapies such as olaparib, niraparib, veliparib, and rucaparib target a family of enzymes that repair DNA and stabilize the human genome through the repair of single-stranded DNA breaks. Inhibiting these enzymes facilitates the accumulation of single-stranded breaks, allowing the development of double-strand breaks, which in turn cannot be repaired if the cell has deficient homologous recombination (HRD) such as through a germline or somatic BRCA mutation, or alternative relevant mutation that confers a similar effect. The opportunistic pairing of a drug interaction with a pathway specific to the cancer is an example of a targeted therapy.

In order to improve the value of cancer drug therapy, there has been emphasis by cooperative research groups, such as the Gynecologic Oncology Group, to study the efficacy of targeted therapies, such as PARPi, in patients identified by biomarkers such as tumors that possess germline or somatic HRD in whom they are most likely to work. This approach makes good common sense and promises to deliver a large magnitude of clinical benefit in a smaller focused population. Therefore, even if drug costs are high, the treatment may still have value. Consistent with that principle, the recently published VELIA, PRIMA, and PAOLA-1 trials all showed impressive benefit in PFS (on average 11-12 months) for the subgroup of patients with HRD. However, these studies were designed and funded by the pharmaceutical industry, and abandoned the principle of biomarker-driven targeted therapy. They did not limit their studies to the HRD-positive population most likely to benefit, but instead included and reported on the impact on all-comers (patients with both HRD and HR-proficient tumors). Subsequently their final conclusions could be extrapolated to the general population of ovarian cancer patients, and in doing so, a larger share of the marketplace.

Only 30% of the general population of ovarian, fallopian tube and primary peritoneal cancer patients carry a germline or somatic BRCA mutation and less than half carry this or alternative mutations which confer HRD. The remaining majority are HR-proficient tumors. However, the three study populations in the aforementioned trials were enriched for HRD tumors with 50%-60% subjects carrying germline or somatic HRD. Therefore, it is likely that the observed benefits in the “intent-to-treat” group were larger than what a clinician would observe in their patient population. Additionally, the large (11-12 month) gains in the HRD-positive group may have been so significant that they compensated for the subtle impact in the HR-proficient population (less than 3 months), resulting in an average total effect that, while being statistically significant for “all comers,” was actually only clinically significant for the HRD group. The positive impact for HRD tumors effectively boosted the results for the group as a whole.

The use of PFS as a primary endpoint raises another significant concern with the design of these PARPi maintenance trials. Much has been written about the importance of PFS as an endpoint for ovarian cancer because of confounding effects of subsequent therapy and to minimize the costs and duration of clinical trials.⁴ PFS is a quicker, less expensive endpoint to capture than overall survival. It usually correlates with overall survival, but typically only when there is a large magnitude of benefit in PFS. These arguments are fair when considering episodic drug therapies in the setting of measurable, active disease. However, maintenance therapy is given during a period of what patients think of as remission. Remission is valued by patients because it is a gateway to cure, and also because it is a time devoid of symptoms of disease, toxicity (therapeutic and financial), and the burden of frequent medical visits and interventions. While PFS is a measure of the length of remission, it is not a measure of cure. We should ask: What does it mean to a patient if she has a longer remission but needs to be on drug therapy (with its associated burdens and toxicities) in order to maintain that remission? We know that an increase in PFS with maintenance therapy does not always result in a commensurate increase in survival. One does not always precede the other. An example of this is the use of maintenance bevacizumab following upfront chemotherapy which improves PFS by 4 months, but is not associated with an increase in survival.⁵

When considering the value and ethics of maintenance therapy, it should be associated with a proven survival benefit or an improvement in quality of life. With respect to PARPi maintenance, we lack the data regarding the former, and have contrary evidence regarding the latter. In these three trials, PARPi maintenance was associated with significantly more toxicity than placebo including the commonly observed nausea and fatigue. Most of us would not like to be on a drug therapy for 3 years that made us feel nauseated or fatigued if it didn’t also increase our chance of cure or a longer life. While the significant PFS benefit of maintenance PARPi that is consistently observed in HRD-positive ovarian cancers suggests there will also likely be a clinically significant improvement in survival and cure in that specific subpopulation, this is less likely true for the majority of women with HR-proficient ovarian cancers. Time will tell this story, but as yet, we don’t know.

The use of maintenance PARPi therapy during and/or after primary cytotoxic chemotherapy for advanced epithelial ovarian, primary peritoneal, and fallopian tube cancer is associated with a substantial benefit in time to recurrence in a population with HRD tumors and a small benefit among the majority who don’t. However, it comes at the cost of toxicity at a time when patients would otherwise be free of disease and treatment. I propose that, until a survival benefit for all women has been observed, we should consider a targeted and biomarker-driven approach to maintenance PARPi prescription, favoring prescription for those with germline or somatic HRD mutations.

Dr. Rossi is assistant professor in the division of gynecologic oncology at the University of North Carolina at Chapel Hill. She said she had no relevant financial disclosures. Email Dr. Rossi at [email protected].

References

1. González-Martín A et al. N Engl J Med. 2019 Dec 19;381(25):2391-402.

2. Ray-Coquard I et al. N Engl J Med. 2019 Dec 19;381(25):2416-28.

3. Coleman RL et al. N Engl J Med. 2019 Dec 19;381(25):2403-15.

4. Herzog TJ et al. Gynecol Oncol. 2014 Jan;132(1):8-17.

5. Tewari KS et al. J Clin Oncol. 2019 Sep 10;37(26):2317-28.

The current standard frontline therapy for advanced epithelial ovarian, fallopian tube, and primary peritoneal cancer includes a combination of surgical cytoreduction and at least six cycles of platinum-based chemotherapy. While this achieves a complete clinical response (“remission”) in most, 85% of patients will recur and eventually succumb to the disease. This suggests that treatments are good at inducing remission, but poor at eradicating the disease altogether. This has motivated the consideration of maintenance therapy: extended treatment beyond completion of chemotherapy during the period of time when patients are clinically disease free.

Maintenance therapy is an appealing concept for clinicians who desperately want to “hold” their patients in a disease-free state for longer periods. It is also a profitable way to administer therapy as there is more compensation to the pharmaceutical industry from chronic, long-term drug administration rather than episodic treatment courses. However, the following question must be asked: Is this extended therapy worthwhile for all patients, and is it good value?

In the past 12 months, three major industry-sponsored clinical trials have been published (PRIMA, PAOLA-1, and VELIA)which suggest a benefit for all patients with advanced epithelial ovarian cancer in receiving prolonged poly (ADP-ribose) polymerase inhibitor (PARPi) therapy after primary chemotherapy.^1-3 This has resulted in Food and Drug Administration approval for some of these agents as maintenance therapy. Despite differences in the drugs tested and the timing of therapy, these studies observed that treatment of advanced ovarian cancer with the addition of a PARPi during and/or after carboplatin and paclitaxel chemotherapy for up to an additional 3 years resulted in a longer progression-free survival (PFS) of approximately 6 months. PFS is defined as the time to measurable recurrence or death. However, this positive effect was not equally distributed across the whole population; rather, it appeared to be created by a substantial response in a smaller subgroup.

PARP inhibitor therapies such as olaparib, niraparib, veliparib, and rucaparib target a family of enzymes that repair DNA and stabilize the human genome through the repair of single-stranded DNA breaks. Inhibiting these enzymes facilitates the accumulation of single-stranded breaks, allowing the development of double-strand breaks, which in turn cannot be repaired if the cell has deficient homologous recombination (HRD) such as through a germline or somatic BRCA mutation, or alternative relevant mutation that confers a similar effect. The opportunistic pairing of a drug interaction with a pathway specific to the cancer is an example of a targeted therapy.

In order to improve the value of cancer drug therapy, there has been emphasis by cooperative research groups, such as the Gynecologic Oncology Group, to study the efficacy of targeted therapies, such as PARPi, in patients identified by biomarkers such as tumors that possess germline or somatic HRD in whom they are most likely to work. This approach makes good common sense and promises to deliver a large magnitude of clinical benefit in a smaller focused population. Therefore, even if drug costs are high, the treatment may still have value. Consistent with that principle, the recently published VELIA, PRIMA, and PAOLA-1 trials all showed impressive benefit in PFS (on average 11-12 months) for the subgroup of patients with HRD. However, these studies were designed and funded by the pharmaceutical industry, and abandoned the principle of biomarker-driven targeted therapy. They did not limit their studies to the HRD-positive population most likely to benefit, but instead included and reported on the impact on all-comers (patients with both HRD and HR-proficient tumors). Subsequently their final conclusions could be extrapolated to the general population of ovarian cancer patients, and in doing so, a larger share of the marketplace.

Only 30% of the general population of ovarian, fallopian tube and primary peritoneal cancer patients carry a germline or somatic BRCA mutation and less than half carry this or alternative mutations which confer HRD. The remaining majority are HR-proficient tumors. However, the three study populations in the aforementioned trials were enriched for HRD tumors with 50%-60% subjects carrying germline or somatic HRD. Therefore, it is likely that the observed benefits in the “intent-to-treat” group were larger than what a clinician would observe in their patient population. Additionally, the large (11-12 month) gains in the HRD-positive group may have been so significant that they compensated for the subtle impact in the HR-proficient population (less than 3 months), resulting in an average total effect that, while being statistically significant for “all comers,” was actually only clinically significant for the HRD group. The positive impact for HRD tumors effectively boosted the results for the group as a whole.

The use of PFS as a primary endpoint raises another significant concern with the design of these PARPi maintenance trials. Much has been written about the importance of PFS as an endpoint for ovarian cancer because of confounding effects of subsequent therapy and to minimize the costs and duration of clinical trials.⁴ PFS is a quicker, less expensive endpoint to capture than overall survival. It usually correlates with overall survival, but typically only when there is a large magnitude of benefit in PFS. These arguments are fair when considering episodic drug therapies in the setting of measurable, active disease. However, maintenance therapy is given during a period of what patients think of as remission. Remission is valued by patients because it is a gateway to cure, and also because it is a time devoid of symptoms of disease, toxicity (therapeutic and financial), and the burden of frequent medical visits and interventions. While PFS is a measure of the length of remission, it is not a measure of cure. We should ask: What does it mean to a patient if she has a longer remission but needs to be on drug therapy (with its associated burdens and toxicities) in order to maintain that remission? We know that an increase in PFS with maintenance therapy does not always result in a commensurate increase in survival. One does not always precede the other. An example of this is the use of maintenance bevacizumab following upfront chemotherapy which improves PFS by 4 months, but is not associated with an increase in survival.⁵

When considering the value and ethics of maintenance therapy, it should be associated with a proven survival benefit or an improvement in quality of life. With respect to PARPi maintenance, we lack the data regarding the former, and have contrary evidence regarding the latter. In these three trials, PARPi maintenance was associated with significantly more toxicity than placebo including the commonly observed nausea and fatigue. Most of us would not like to be on a drug therapy for 3 years that made us feel nauseated or fatigued if it didn’t also increase our chance of cure or a longer life. While the significant PFS benefit of maintenance PARPi that is consistently observed in HRD-positive ovarian cancers suggests there will also likely be a clinically significant improvement in survival and cure in that specific subpopulation, this is less likely true for the majority of women with HR-proficient ovarian cancers. Time will tell this story, but as yet, we don’t know.

The use of maintenance PARPi therapy during and/or after primary cytotoxic chemotherapy for advanced epithelial ovarian, primary peritoneal, and fallopian tube cancer is associated with a substantial benefit in time to recurrence in a population with HRD tumors and a small benefit among the majority who don’t. However, it comes at the cost of toxicity at a time when patients would otherwise be free of disease and treatment. I propose that, until a survival benefit for all women has been observed, we should consider a targeted and biomarker-driven approach to maintenance PARPi prescription, favoring prescription for those with germline or somatic HRD mutations.

Dr. Rossi is assistant professor in the division of gynecologic oncology at the University of North Carolina at Chapel Hill. She said she had no relevant financial disclosures. Email Dr. Rossi at [email protected].

References

1. González-Martín A et al. N Engl J Med. 2019 Dec 19;381(25):2391-402.

2. Ray-Coquard I et al. N Engl J Med. 2019 Dec 19;381(25):2416-28.

3. Coleman RL et al. N Engl J Med. 2019 Dec 19;381(25):2403-15.

4. Herzog TJ et al. Gynecol Oncol. 2014 Jan;132(1):8-17.

5. Tewari KS et al. J Clin Oncol. 2019 Sep 10;37(26):2317-28.

The current standard frontline therapy for advanced epithelial ovarian, fallopian tube, and primary peritoneal cancer includes a combination of surgical cytoreduction and at least six cycles of platinum-based chemotherapy. While this achieves a complete clinical response (“remission”) in most, 85% of patients will recur and eventually succumb to the disease. This suggests that treatments are good at inducing remission, but poor at eradicating the disease altogether. This has motivated the consideration of maintenance therapy: extended treatment beyond completion of chemotherapy during the period of time when patients are clinically disease free.

Maintenance therapy is an appealing concept for clinicians who desperately want to “hold” their patients in a disease-free state for longer periods. It is also a profitable way to administer therapy as there is more compensation to the pharmaceutical industry from chronic, long-term drug administration rather than episodic treatment courses. However, the following question must be asked: Is this extended therapy worthwhile for all patients, and is it good value?

In the past 12 months, three major industry-sponsored clinical trials have been published (PRIMA, PAOLA-1, and VELIA)which suggest a benefit for all patients with advanced epithelial ovarian cancer in receiving prolonged poly (ADP-ribose) polymerase inhibitor (PARPi) therapy after primary chemotherapy.^1-3 This has resulted in Food and Drug Administration approval for some of these agents as maintenance therapy. Despite differences in the drugs tested and the timing of therapy, these studies observed that treatment of advanced ovarian cancer with the addition of a PARPi during and/or after carboplatin and paclitaxel chemotherapy for up to an additional 3 years resulted in a longer progression-free survival (PFS) of approximately 6 months. PFS is defined as the time to measurable recurrence or death. However, this positive effect was not equally distributed across the whole population; rather, it appeared to be created by a substantial response in a smaller subgroup.

PARP inhibitor therapies such as olaparib, niraparib, veliparib, and rucaparib target a family of enzymes that repair DNA and stabilize the human genome through the repair of single-stranded DNA breaks. Inhibiting these enzymes facilitates the accumulation of single-stranded breaks, allowing the development of double-strand breaks, which in turn cannot be repaired if the cell has deficient homologous recombination (HRD) such as through a germline or somatic BRCA mutation, or alternative relevant mutation that confers a similar effect. The opportunistic pairing of a drug interaction with a pathway specific to the cancer is an example of a targeted therapy.

In order to improve the value of cancer drug therapy, there has been emphasis by cooperative research groups, such as the Gynecologic Oncology Group, to study the efficacy of targeted therapies, such as PARPi, in patients identified by biomarkers such as tumors that possess germline or somatic HRD in whom they are most likely to work. This approach makes good common sense and promises to deliver a large magnitude of clinical benefit in a smaller focused population. Therefore, even if drug costs are high, the treatment may still have value. Consistent with that principle, the recently published VELIA, PRIMA, and PAOLA-1 trials all showed impressive benefit in PFS (on average 11-12 months) for the subgroup of patients with HRD. However, these studies were designed and funded by the pharmaceutical industry, and abandoned the principle of biomarker-driven targeted therapy. They did not limit their studies to the HRD-positive population most likely to benefit, but instead included and reported on the impact on all-comers (patients with both HRD and HR-proficient tumors). Subsequently their final conclusions could be extrapolated to the general population of ovarian cancer patients, and in doing so, a larger share of the marketplace.

Only 30% of the general population of ovarian, fallopian tube and primary peritoneal cancer patients carry a germline or somatic BRCA mutation and less than half carry this or alternative mutations which confer HRD. The remaining majority are HR-proficient tumors. However, the three study populations in the aforementioned trials were enriched for HRD tumors with 50%-60% subjects carrying germline or somatic HRD. Therefore, it is likely that the observed benefits in the “intent-to-treat” group were larger than what a clinician would observe in their patient population. Additionally, the large (11-12 month) gains in the HRD-positive group may have been so significant that they compensated for the subtle impact in the HR-proficient population (less than 3 months), resulting in an average total effect that, while being statistically significant for “all comers,” was actually only clinically significant for the HRD group. The positive impact for HRD tumors effectively boosted the results for the group as a whole.

The use of PFS as a primary endpoint raises another significant concern with the design of these PARPi maintenance trials. Much has been written about the importance of PFS as an endpoint for ovarian cancer because of confounding effects of subsequent therapy and to minimize the costs and duration of clinical trials.⁴ PFS is a quicker, less expensive endpoint to capture than overall survival. It usually correlates with overall survival, but typically only when there is a large magnitude of benefit in PFS. These arguments are fair when considering episodic drug therapies in the setting of measurable, active disease. However, maintenance therapy is given during a period of what patients think of as remission. Remission is valued by patients because it is a gateway to cure, and also because it is a time devoid of symptoms of disease, toxicity (therapeutic and financial), and the burden of frequent medical visits and interventions. While PFS is a measure of the length of remission, it is not a measure of cure. We should ask: What does it mean to a patient if she has a longer remission but needs to be on drug therapy (with its associated burdens and toxicities) in order to maintain that remission? We know that an increase in PFS with maintenance therapy does not always result in a commensurate increase in survival. One does not always precede the other. An example of this is the use of maintenance bevacizumab following upfront chemotherapy which improves PFS by 4 months, but is not associated with an increase in survival.⁵

When considering the value and ethics of maintenance therapy, it should be associated with a proven survival benefit or an improvement in quality of life. With respect to PARPi maintenance, we lack the data regarding the former, and have contrary evidence regarding the latter. In these three trials, PARPi maintenance was associated with significantly more toxicity than placebo including the commonly observed nausea and fatigue. Most of us would not like to be on a drug therapy for 3 years that made us feel nauseated or fatigued if it didn’t also increase our chance of cure or a longer life. While the significant PFS benefit of maintenance PARPi that is consistently observed in HRD-positive ovarian cancers suggests there will also likely be a clinically significant improvement in survival and cure in that specific subpopulation, this is less likely true for the majority of women with HR-proficient ovarian cancers. Time will tell this story, but as yet, we don’t know.

The use of maintenance PARPi therapy during and/or after primary cytotoxic chemotherapy for advanced epithelial ovarian, primary peritoneal, and fallopian tube cancer is associated with a substantial benefit in time to recurrence in a population with HRD tumors and a small benefit among the majority who don’t. However, it comes at the cost of toxicity at a time when patients would otherwise be free of disease and treatment. I propose that, until a survival benefit for all women has been observed, we should consider a targeted and biomarker-driven approach to maintenance PARPi prescription, favoring prescription for those with germline or somatic HRD mutations.

Dr. Rossi is assistant professor in the division of gynecologic oncology at the University of North Carolina at Chapel Hill. She said she had no relevant financial disclosures. Email Dr. Rossi at [email protected].

References

1. González-Martín A et al. N Engl J Med. 2019 Dec 19;381(25):2391-402.

2. Ray-Coquard I et al. N Engl J Med. 2019 Dec 19;381(25):2416-28.

3. Coleman RL et al. N Engl J Med. 2019 Dec 19;381(25):2403-15.

4. Herzog TJ et al. Gynecol Oncol. 2014 Jan;132(1):8-17.

5. Tewari KS et al. J Clin Oncol. 2019 Sep 10;37(26):2317-28.