Contraception

Pharmacists in Oregon with the authority to prescribe hormonal contraceptive therapy have improved access to and continuation of contraceptive therapy, based on two retrospective studies of Medicaid patients published in Obstetrics & Gynecology.

Additionally, the safety profile associated with pharmacist prescribing of hormonal contraceptive therapy was on par with that of other prescribing clinicians.

“In the first 2 years of program implementation, we found evidence that pharmacists were safely reaching new contraceptive users and [helping to meet national goals in reducing unwanted pregnancy],” Lorinda Anderson, PharmD, and colleagues, the authors of one of the studies, wrote.

In 2016, Oregon became the first state to grant pharmacists authority to prescribe hormonal contraception without requiring consultation. The findings suggest that expanding prescribing authority for contraceptive therapy to pharmacists in other states could limit barriers to access, as 90% of United States residents live within 5 miles of a pharmacy.

In one of the two studies, Maria I. Rodriguez, MD, MPH, and colleagues conducted a claims-based review of the primary outcomes of pharmacist-initiated and non-pharmacist-initiated prescriptions on unintended pregnancies in Oregon’s Medicaid program. They also evaluated secondary outcomes, such as costs and quality-adjusted life years (QALYs).

In the first 2 years after the Oregon law went into effect, 248 pharmacists wrote 1,313, or 10%, of all hormonal contraception prescriptions for women who were Medicaid recipients and were prescribed hormonal contraception by any legally allowed healthcare provider. Pharmacists prescribed hormonal contraception for 367 of the 3,614 women studied.

Based on an economic model, pharmacist-initiated hormonal contraceptive therapy prevented an estimated 51 unintended pregnancies and saved $1.6 million in the first two years following the program’s inception in Oregon. Quality of life improved with 158 QALYs per 198,100 women.

Additionally, pharmacist-provided services cost less per patient than non pharmacist health care provider-services, $28 vs. $81.

“We believe our findings to be conservative given that our model was based on use 24 months after implementation. We expect over time that knowledge of and use of contraceptive access from pharmacists will increase,” Dr. Rodriguez, of Oregon Health & Science University, Portland, and colleagues wrote.

In the second study, Dr. Anderson, of the Oregon State University, Corvallis, and colleagues pooled Oregon Medicaid pharmacy claims, eligibility, medical, diagnostic, and demographic data over the 2-year period for the 3,614 patients who received new prescriptions for transdermal and oral contraception, and the 1,313 claims filed for 367 women prescribed contraception by 162 pharmacists.

Within the first 4 months following the program’s inception in Oregon, pharmacists averaged 40 contraceptive claims per month. Over the next 7 months, claims increased to 61 and peaked at 80 claims after 18 months. Chain community pharmacies accounted for 94% of the claims; 71% of claims were in metropolitan areas.

Based on demographics, 73.8% of the women who were prescribed contraception by a pharmacist were first-time recipients. Combined oral contraception was prescribed for 90.5% of the women, and 82% of the women were 18-35 years of age. In the 180-day period prior to receiving pharmacist-prescribed contraception, 61.5% of patients were not using contraception but were attempting to engage in pharmacy-provided hormonal contraceptive care.

The researchers also examined contraceptive safety by looking at whether patients with medical contraindications (Medical Eligibility Criteria Category 3 or 4) were receiving contraindicated methods. “We found that overall adherence to the clinical algorithm for prescribing pharmacists was high. Only 12 (5%) patients were identified as having Medical Eligibility Criteria Category 3 or 4 medical conditions, and two (less than 1%) patients with medications contraindicating OC use received a prescription,” Dr. Anderson and her colleagues wrote.

They noted that the initial legislation passed in Oregon only included oral and transdermal hormonal contraception as methods pharmacists could prescribe. In 2017, with implementation in 2018, this was amended to include the vaginal ring and injection. “As the program matures, and contracts with additional insurers are implemented at pharmacies, we expect the number of pharmacist prescriptions to increase,” the authors wrote.

Dr. Rodriguez reported financial compensation from Merck, the World Health Organization, CooperSurgical, and a previous relationship with Merck. Dr. Anderson reports no conflicts of interest.

SOURCES: Rodriguez M et al. Obstet Gynecol. 2019 Jun;133(6):1238-46; Anderson A et al. Obstet Gynecol. 2019 Jun;133(6):1231-7.


 

Pharmacists in Oregon with the authority to prescribe hormonal contraceptive therapy have improved access to and continuation of contraceptive therapy, based on two retrospective studies of Medicaid patients published in Obstetrics & Gynecology.

Additionally, the safety profile associated with pharmacist prescribing of hormonal contraceptive therapy was on par with that of other prescribing clinicians.

“In the first 2 years of program implementation, we found evidence that pharmacists were safely reaching new contraceptive users and [helping to meet national goals in reducing unwanted pregnancy],” Lorinda Anderson, PharmD, and colleagues, the authors of one of the studies, wrote.

In 2016, Oregon became the first state to grant pharmacists authority to prescribe hormonal contraception without requiring consultation. The findings suggest that expanding prescribing authority for contraceptive therapy to pharmacists in other states could limit barriers to access, as 90% of United States residents live within 5 miles of a pharmacy.

In one of the two studies, Maria I. Rodriguez, MD, MPH, and colleagues conducted a claims-based review of the primary outcomes of pharmacist-initiated and non-pharmacist-initiated prescriptions on unintended pregnancies in Oregon’s Medicaid program. They also evaluated secondary outcomes, such as costs and quality-adjusted life years (QALYs).

In the first 2 years after the Oregon law went into effect, 248 pharmacists wrote 1,313, or 10%, of all hormonal contraception prescriptions for women who were Medicaid recipients and were prescribed hormonal contraception by any legally allowed healthcare provider. Pharmacists prescribed hormonal contraception for 367 of the 3,614 women studied.

Based on an economic model, pharmacist-initiated hormonal contraceptive therapy prevented an estimated 51 unintended pregnancies and saved $1.6 million in the first two years following the program’s inception in Oregon. Quality of life improved with 158 QALYs per 198,100 women.

Additionally, pharmacist-provided services cost less per patient than non pharmacist health care provider-services, $28 vs. $81.

“We believe our findings to be conservative given that our model was based on use 24 months after implementation. We expect over time that knowledge of and use of contraceptive access from pharmacists will increase,” Dr. Rodriguez, of Oregon Health & Science University, Portland, and colleagues wrote.

In the second study, Dr. Anderson, of the Oregon State University, Corvallis, and colleagues pooled Oregon Medicaid pharmacy claims, eligibility, medical, diagnostic, and demographic data over the 2-year period for the 3,614 patients who received new prescriptions for transdermal and oral contraception, and the 1,313 claims filed for 367 women prescribed contraception by 162 pharmacists.

Within the first 4 months following the program’s inception in Oregon, pharmacists averaged 40 contraceptive claims per month. Over the next 7 months, claims increased to 61 and peaked at 80 claims after 18 months. Chain community pharmacies accounted for 94% of the claims; 71% of claims were in metropolitan areas.

Based on demographics, 73.8% of the women who were prescribed contraception by a pharmacist were first-time recipients. Combined oral contraception was prescribed for 90.5% of the women, and 82% of the women were 18-35 years of age. In the 180-day period prior to receiving pharmacist-prescribed contraception, 61.5% of patients were not using contraception but were attempting to engage in pharmacy-provided hormonal contraceptive care.

The researchers also examined contraceptive safety by looking at whether patients with medical contraindications (Medical Eligibility Criteria Category 3 or 4) were receiving contraindicated methods. “We found that overall adherence to the clinical algorithm for prescribing pharmacists was high. Only 12 (5%) patients were identified as having Medical Eligibility Criteria Category 3 or 4 medical conditions, and two (less than 1%) patients with medications contraindicating OC use received a prescription,” Dr. Anderson and her colleagues wrote.

They noted that the initial legislation passed in Oregon only included oral and transdermal hormonal contraception as methods pharmacists could prescribe. In 2017, with implementation in 2018, this was amended to include the vaginal ring and injection. “As the program matures, and contracts with additional insurers are implemented at pharmacies, we expect the number of pharmacist prescriptions to increase,” the authors wrote.

Dr. Rodriguez reported financial compensation from Merck, the World Health Organization, CooperSurgical, and a previous relationship with Merck. Dr. Anderson reports no conflicts of interest.

SOURCES: Rodriguez M et al. Obstet Gynecol. 2019 Jun;133(6):1238-46; Anderson A et al. Obstet Gynecol. 2019 Jun;133(6):1231-7.


 

Pharmacists in Oregon with the authority to prescribe hormonal contraceptive therapy have improved access to and continuation of contraceptive therapy, based on two retrospective studies of Medicaid patients published in Obstetrics & Gynecology.

Additionally, the safety profile associated with pharmacist prescribing of hormonal contraceptive therapy was on par with that of other prescribing clinicians.

“In the first 2 years of program implementation, we found evidence that pharmacists were safely reaching new contraceptive users and [helping to meet national goals in reducing unwanted pregnancy],” Lorinda Anderson, PharmD, and colleagues, the authors of one of the studies, wrote.

In 2016, Oregon became the first state to grant pharmacists authority to prescribe hormonal contraception without requiring consultation. The findings suggest that expanding prescribing authority for contraceptive therapy to pharmacists in other states could limit barriers to access, as 90% of United States residents live within 5 miles of a pharmacy.

In one of the two studies, Maria I. Rodriguez, MD, MPH, and colleagues conducted a claims-based review of the primary outcomes of pharmacist-initiated and non-pharmacist-initiated prescriptions on unintended pregnancies in Oregon’s Medicaid program. They also evaluated secondary outcomes, such as costs and quality-adjusted life years (QALYs).

In the first 2 years after the Oregon law went into effect, 248 pharmacists wrote 1,313, or 10%, of all hormonal contraception prescriptions for women who were Medicaid recipients and were prescribed hormonal contraception by any legally allowed healthcare provider. Pharmacists prescribed hormonal contraception for 367 of the 3,614 women studied.

Based on an economic model, pharmacist-initiated hormonal contraceptive therapy prevented an estimated 51 unintended pregnancies and saved $1.6 million in the first two years following the program’s inception in Oregon. Quality of life improved with 158 QALYs per 198,100 women.

Additionally, pharmacist-provided services cost less per patient than non pharmacist health care provider-services, $28 vs. $81.

“We believe our findings to be conservative given that our model was based on use 24 months after implementation. We expect over time that knowledge of and use of contraceptive access from pharmacists will increase,” Dr. Rodriguez, of Oregon Health & Science University, Portland, and colleagues wrote.

In the second study, Dr. Anderson, of the Oregon State University, Corvallis, and colleagues pooled Oregon Medicaid pharmacy claims, eligibility, medical, diagnostic, and demographic data over the 2-year period for the 3,614 patients who received new prescriptions for transdermal and oral contraception, and the 1,313 claims filed for 367 women prescribed contraception by 162 pharmacists.

Within the first 4 months following the program’s inception in Oregon, pharmacists averaged 40 contraceptive claims per month. Over the next 7 months, claims increased to 61 and peaked at 80 claims after 18 months. Chain community pharmacies accounted for 94% of the claims; 71% of claims were in metropolitan areas.

Based on demographics, 73.8% of the women who were prescribed contraception by a pharmacist were first-time recipients. Combined oral contraception was prescribed for 90.5% of the women, and 82% of the women were 18-35 years of age. In the 180-day period prior to receiving pharmacist-prescribed contraception, 61.5% of patients were not using contraception but were attempting to engage in pharmacy-provided hormonal contraceptive care.

The researchers also examined contraceptive safety by looking at whether patients with medical contraindications (Medical Eligibility Criteria Category 3 or 4) were receiving contraindicated methods. “We found that overall adherence to the clinical algorithm for prescribing pharmacists was high. Only 12 (5%) patients were identified as having Medical Eligibility Criteria Category 3 or 4 medical conditions, and two (less than 1%) patients with medications contraindicating OC use received a prescription,” Dr. Anderson and her colleagues wrote.

They noted that the initial legislation passed in Oregon only included oral and transdermal hormonal contraception as methods pharmacists could prescribe. In 2017, with implementation in 2018, this was amended to include the vaginal ring and injection. “As the program matures, and contracts with additional insurers are implemented at pharmacies, we expect the number of pharmacist prescriptions to increase,” the authors wrote.

Dr. Rodriguez reported financial compensation from Merck, the World Health Organization, CooperSurgical, and a previous relationship with Merck. Dr. Anderson reports no conflicts of interest.

SOURCES: Rodriguez M et al. Obstet Gynecol. 2019 Jun;133(6):1238-46; Anderson A et al. Obstet Gynecol. 2019 Jun;133(6):1231-7.


 

Grouping the term “transgender” in the abbreviation LGBT (lesbian, gay, bisexual, transgender) has historically been empowering for trans and gender nonconforming (GNC) persons. However, it also has contributed to the misunderstanding that gender identity is interchangeable with sexual identity. This common misconception can be a barrier to trans and GNC patients seeking care from ob.gyns. for their reproductive health needs.

Rawpixel/Thinkstock

By definition, gender identity refers to an internal experience of one’s gender, of one’s self.¹ While gender identity has social implications, it ultimately is something that a person experiences independently of interactions with others. By contrast, sexual orientation has an explicitly relational underpinning because sexual orientation involves attraction to others. The distinction between gender identity and sexual orientation is similar to an internal-versus-external, or a self-versus-other dichotomy. A further nuance to add is that sexual behavior does not always reflect sexual orientation, and sexual behavior can vary along a wide spectrum when gender identity is added to the equation.

Overall, health care providers should be careful not make assumptions about a patient’s sexual orientation based on a patient’s gender identity. When approaching a sexual history with any patient, but especially a transgender or GNC patient, providers should think deeply about what information is medically relevant.² The purpose of a sexual history is to identify behaviors that contribute to health risk, including pregnancy, sexually transmitted infection, and social problems such as sex-trafficking or intimate partner violence. The health care provider’s job is to ask questions that will uncover these risk factors.

With the advent of a more inclusive attitude toward gay and lesbian partnership, many providers already have learned to collect the sexual history without assuming the gender of a person’s sexual contacts. Still, when a provider is taking the sexual history, gender often is inappropriately used as proxy for the type of sex that a patient may be having. For example, a provider asking a cisgender woman about her sexual activity may ask, “how many sexual partners have you had in the last year?” But then, the provider may follow-up her response of “three sexual partners in the last year” by asking “men, women, or both?” By asking a patient if the patient’s sexual partners are “men, women, or both,” providers fail to accurately elucidate the risk factors that they are actually seeking when taking a sexual history. The cisgender woman from the above scenario may reply that she has been sleeping only with women for the last year, but if the sexual partners are transgender women, aka a woman who was assigned male at birth and therefore still may use her penis/testes for sexual purposes, then the patient actually may be at risk for pregnancy and may also have a different risk factor profile for sexually transmitted infections than if the patient were sexually active with cisgender women.

A different approach to using gender in taking the sexual history is to speak plainly about which sex organs come into contact during sexual activity. When patients identify as transgender or GNC, a provider first should start by asking them what language they would like providers to use when discussing sex organs.³ One example is that many trans men, both those who have undergone mastectomy as well as those who have not, may not use the word “breasts” to describe their “chests.” This distinction may make the difference between gaining and losing the trust of a trans/GNC patient in your clinic. After identifying how a patient would like to refer to sex organs, a provider can continue by asking which of the patient’s sex partners’ organs come into contact with the patient’s organs during sexual activity. Alternatively, starting with an even more broad line of questioning may be best for some patients, such as “how do you like to have sex?”

Carefully identifying the type of sex and what sex organs are involved has concrete medical implications. Patients assigned female at birth who are on hormone therapy with testosterone may need supportive care if they continue to use their vaginas in sexual encounters because testosterone can lead to a relatively hypoestrogenic state. Patients assigned male at birth who have undergone vaginoplasty procedures may need counseling about how to use and support their neovaginas as well as adjusted testing for dysplasia. Patients assigned female at birth who want to avoid pregnancy may need a nuanced consultation regarding contraception. These are just a few examples of how obstetrician-gynecologists can better support the sexual health of their trans/GNC patients by having an accurate understanding of how a trans/GNC person has sex.
 

Dr. Joyner is an assistant professor at Emory University, Atlanta, and is the director of gynecologic services in the Gender Center at Grady Memorial Hospital in Atlanta. Dr. Joyner identifies as a cisgender female and uses she/hers/her as her personal pronouns. Dr. Joey Bahng is a PGY-1 resident physician in Emory University’s gynecology & obstetrics residency program. Dr. Bahng identifies as nonbinary and uses they/them/their as their personal pronouns. Dr. Bahng and Dr. Joyner reported no relevant financial disclosures

References

1. Sexual orientation and gender identity definitions. Human Rights Campaign.

2. Taking a sexual history from transgender people. Transforming Health at the Centers for Disease Control and Prevention.

3. Sexual health history: Talking sex with gender non-conforming and trans patients. National LGBT Health Education Center at The Fenway Institute.

Grouping the term “transgender” in the abbreviation LGBT (lesbian, gay, bisexual, transgender) has historically been empowering for trans and gender nonconforming (GNC) persons. However, it also has contributed to the misunderstanding that gender identity is interchangeable with sexual identity. This common misconception can be a barrier to trans and GNC patients seeking care from ob.gyns. for their reproductive health needs.

Rawpixel/Thinkstock

By definition, gender identity refers to an internal experience of one’s gender, of one’s self.¹ While gender identity has social implications, it ultimately is something that a person experiences independently of interactions with others. By contrast, sexual orientation has an explicitly relational underpinning because sexual orientation involves attraction to others. The distinction between gender identity and sexual orientation is similar to an internal-versus-external, or a self-versus-other dichotomy. A further nuance to add is that sexual behavior does not always reflect sexual orientation, and sexual behavior can vary along a wide spectrum when gender identity is added to the equation.

Overall, health care providers should be careful not make assumptions about a patient’s sexual orientation based on a patient’s gender identity. When approaching a sexual history with any patient, but especially a transgender or GNC patient, providers should think deeply about what information is medically relevant.² The purpose of a sexual history is to identify behaviors that contribute to health risk, including pregnancy, sexually transmitted infection, and social problems such as sex-trafficking or intimate partner violence. The health care provider’s job is to ask questions that will uncover these risk factors.

With the advent of a more inclusive attitude toward gay and lesbian partnership, many providers already have learned to collect the sexual history without assuming the gender of a person’s sexual contacts. Still, when a provider is taking the sexual history, gender often is inappropriately used as proxy for the type of sex that a patient may be having. For example, a provider asking a cisgender woman about her sexual activity may ask, “how many sexual partners have you had in the last year?” But then, the provider may follow-up her response of “three sexual partners in the last year” by asking “men, women, or both?” By asking a patient if the patient’s sexual partners are “men, women, or both,” providers fail to accurately elucidate the risk factors that they are actually seeking when taking a sexual history. The cisgender woman from the above scenario may reply that she has been sleeping only with women for the last year, but if the sexual partners are transgender women, aka a woman who was assigned male at birth and therefore still may use her penis/testes for sexual purposes, then the patient actually may be at risk for pregnancy and may also have a different risk factor profile for sexually transmitted infections than if the patient were sexually active with cisgender women.

A different approach to using gender in taking the sexual history is to speak plainly about which sex organs come into contact during sexual activity. When patients identify as transgender or GNC, a provider first should start by asking them what language they would like providers to use when discussing sex organs.³ One example is that many trans men, both those who have undergone mastectomy as well as those who have not, may not use the word “breasts” to describe their “chests.” This distinction may make the difference between gaining and losing the trust of a trans/GNC patient in your clinic. After identifying how a patient would like to refer to sex organs, a provider can continue by asking which of the patient’s sex partners’ organs come into contact with the patient’s organs during sexual activity. Alternatively, starting with an even more broad line of questioning may be best for some patients, such as “how do you like to have sex?”

Carefully identifying the type of sex and what sex organs are involved has concrete medical implications. Patients assigned female at birth who are on hormone therapy with testosterone may need supportive care if they continue to use their vaginas in sexual encounters because testosterone can lead to a relatively hypoestrogenic state. Patients assigned male at birth who have undergone vaginoplasty procedures may need counseling about how to use and support their neovaginas as well as adjusted testing for dysplasia. Patients assigned female at birth who want to avoid pregnancy may need a nuanced consultation regarding contraception. These are just a few examples of how obstetrician-gynecologists can better support the sexual health of their trans/GNC patients by having an accurate understanding of how a trans/GNC person has sex.
 

Dr. Joyner is an assistant professor at Emory University, Atlanta, and is the director of gynecologic services in the Gender Center at Grady Memorial Hospital in Atlanta. Dr. Joyner identifies as a cisgender female and uses she/hers/her as her personal pronouns. Dr. Joey Bahng is a PGY-1 resident physician in Emory University’s gynecology & obstetrics residency program. Dr. Bahng identifies as nonbinary and uses they/them/their as their personal pronouns. Dr. Bahng and Dr. Joyner reported no relevant financial disclosures

References

1. Sexual orientation and gender identity definitions. Human Rights Campaign.

2. Taking a sexual history from transgender people. Transforming Health at the Centers for Disease Control and Prevention.

3. Sexual health history: Talking sex with gender non-conforming and trans patients. National LGBT Health Education Center at The Fenway Institute.

Grouping the term “transgender” in the abbreviation LGBT (lesbian, gay, bisexual, transgender) has historically been empowering for trans and gender nonconforming (GNC) persons. However, it also has contributed to the misunderstanding that gender identity is interchangeable with sexual identity. This common misconception can be a barrier to trans and GNC patients seeking care from ob.gyns. for their reproductive health needs.

Rawpixel/Thinkstock

By definition, gender identity refers to an internal experience of one’s gender, of one’s self.¹ While gender identity has social implications, it ultimately is something that a person experiences independently of interactions with others. By contrast, sexual orientation has an explicitly relational underpinning because sexual orientation involves attraction to others. The distinction between gender identity and sexual orientation is similar to an internal-versus-external, or a self-versus-other dichotomy. A further nuance to add is that sexual behavior does not always reflect sexual orientation, and sexual behavior can vary along a wide spectrum when gender identity is added to the equation.

Overall, health care providers should be careful not make assumptions about a patient’s sexual orientation based on a patient’s gender identity. When approaching a sexual history with any patient, but especially a transgender or GNC patient, providers should think deeply about what information is medically relevant.² The purpose of a sexual history is to identify behaviors that contribute to health risk, including pregnancy, sexually transmitted infection, and social problems such as sex-trafficking or intimate partner violence. The health care provider’s job is to ask questions that will uncover these risk factors.

With the advent of a more inclusive attitude toward gay and lesbian partnership, many providers already have learned to collect the sexual history without assuming the gender of a person’s sexual contacts. Still, when a provider is taking the sexual history, gender often is inappropriately used as proxy for the type of sex that a patient may be having. For example, a provider asking a cisgender woman about her sexual activity may ask, “how many sexual partners have you had in the last year?” But then, the provider may follow-up her response of “three sexual partners in the last year” by asking “men, women, or both?” By asking a patient if the patient’s sexual partners are “men, women, or both,” providers fail to accurately elucidate the risk factors that they are actually seeking when taking a sexual history. The cisgender woman from the above scenario may reply that she has been sleeping only with women for the last year, but if the sexual partners are transgender women, aka a woman who was assigned male at birth and therefore still may use her penis/testes for sexual purposes, then the patient actually may be at risk for pregnancy and may also have a different risk factor profile for sexually transmitted infections than if the patient were sexually active with cisgender women.

A different approach to using gender in taking the sexual history is to speak plainly about which sex organs come into contact during sexual activity. When patients identify as transgender or GNC, a provider first should start by asking them what language they would like providers to use when discussing sex organs.³ One example is that many trans men, both those who have undergone mastectomy as well as those who have not, may not use the word “breasts” to describe their “chests.” This distinction may make the difference between gaining and losing the trust of a trans/GNC patient in your clinic. After identifying how a patient would like to refer to sex organs, a provider can continue by asking which of the patient’s sex partners’ organs come into contact with the patient’s organs during sexual activity. Alternatively, starting with an even more broad line of questioning may be best for some patients, such as “how do you like to have sex?”

Carefully identifying the type of sex and what sex organs are involved has concrete medical implications. Patients assigned female at birth who are on hormone therapy with testosterone may need supportive care if they continue to use their vaginas in sexual encounters because testosterone can lead to a relatively hypoestrogenic state. Patients assigned male at birth who have undergone vaginoplasty procedures may need counseling about how to use and support their neovaginas as well as adjusted testing for dysplasia. Patients assigned female at birth who want to avoid pregnancy may need a nuanced consultation regarding contraception. These are just a few examples of how obstetrician-gynecologists can better support the sexual health of their trans/GNC patients by having an accurate understanding of how a trans/GNC person has sex.
 

Dr. Joyner is an assistant professor at Emory University, Atlanta, and is the director of gynecologic services in the Gender Center at Grady Memorial Hospital in Atlanta. Dr. Joyner identifies as a cisgender female and uses she/hers/her as her personal pronouns. Dr. Joey Bahng is a PGY-1 resident physician in Emory University’s gynecology & obstetrics residency program. Dr. Bahng identifies as nonbinary and uses they/them/their as their personal pronouns. Dr. Bahng and Dr. Joyner reported no relevant financial disclosures

References

1. Sexual orientation and gender identity definitions. Human Rights Campaign.

2. Taking a sexual history from transgender people. Transforming Health at the Centers for Disease Control and Prevention.

3. Sexual health history: Talking sex with gender non-conforming and trans patients. National LGBT Health Education Center at The Fenway Institute.

NASHVILLE, TENN. – Immediate postpartum insertion of an intrauterine device (IUD) is highly cost effective despite an expulsion rate of 10%-30%, according to Eve Espey, MD.

“I think [the rate] is going to settle out at around 15%-20%, but good cost-effectiveness studies show that, even if it were that high, it is still highly cost effective,” she said during an update on contraceptives at the annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists.

Immediate postpartum long-acting reversible contraception (LARC), including an IUD or implant, may reduce rapid-repeat pregnancy, she added, noting, however, that while Medicaid is covering it in many states, “it turns out that payment models are very cumbersome; they actually don’t work very well.”

At the University of New Mexico (UNM) in Albuquerque, where Dr .Espey is a professor and chair of the department of obstetrics and gynecology and director of the family planning fellowship, immediate postpartum LARC is offered to women with Medicaid coverage, and payment is received in about 97% of cases.

It took about 4 years of persistent effort to make that happen, she said, adding that the UNM Hospital still is the only one in the state offering the service, although efforts are underway to help other hospitals “troubleshoot the issues.”

Another challenge is the lack of private insurance coverage for immediate postpartum LARC, she said.

“I was super enthusiastic about this a few years ago, and I remain super enthusiastic about it, but I think it’s going to take another 5 years or so [for better coverage], and honestly I think what we really need is an inpatient LARC CPT code to make this happen.”

In this video interview, Dr. Espey discusses the “agony and ecstasy” of immediate postpartum LARC, summarizing the main points regarding its benefits and challenges as presented during an “EdTalk” she gave at the meeting.

Dr. Espey reported having no relevant financial disclosures.

[email protected]

NASHVILLE, TENN. – Immediate postpartum insertion of an intrauterine device (IUD) is highly cost effective despite an expulsion rate of 10%-30%, according to Eve Espey, MD.

“I think [the rate] is going to settle out at around 15%-20%, but good cost-effectiveness studies show that, even if it were that high, it is still highly cost effective,” she said during an update on contraceptives at the annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists.

Immediate postpartum long-acting reversible contraception (LARC), including an IUD or implant, may reduce rapid-repeat pregnancy, she added, noting, however, that while Medicaid is covering it in many states, “it turns out that payment models are very cumbersome; they actually don’t work very well.”

At the University of New Mexico (UNM) in Albuquerque, where Dr .Espey is a professor and chair of the department of obstetrics and gynecology and director of the family planning fellowship, immediate postpartum LARC is offered to women with Medicaid coverage, and payment is received in about 97% of cases.

It took about 4 years of persistent effort to make that happen, she said, adding that the UNM Hospital still is the only one in the state offering the service, although efforts are underway to help other hospitals “troubleshoot the issues.”

Another challenge is the lack of private insurance coverage for immediate postpartum LARC, she said.

“I was super enthusiastic about this a few years ago, and I remain super enthusiastic about it, but I think it’s going to take another 5 years or so [for better coverage], and honestly I think what we really need is an inpatient LARC CPT code to make this happen.”

In this video interview, Dr. Espey discusses the “agony and ecstasy” of immediate postpartum LARC, summarizing the main points regarding its benefits and challenges as presented during an “EdTalk” she gave at the meeting.

Dr. Espey reported having no relevant financial disclosures.

[email protected]

NASHVILLE, TENN. – Immediate postpartum insertion of an intrauterine device (IUD) is highly cost effective despite an expulsion rate of 10%-30%, according to Eve Espey, MD.

“I think [the rate] is going to settle out at around 15%-20%, but good cost-effectiveness studies show that, even if it were that high, it is still highly cost effective,” she said during an update on contraceptives at the annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists.

Immediate postpartum long-acting reversible contraception (LARC), including an IUD or implant, may reduce rapid-repeat pregnancy, she added, noting, however, that while Medicaid is covering it in many states, “it turns out that payment models are very cumbersome; they actually don’t work very well.”

At the University of New Mexico (UNM) in Albuquerque, where Dr .Espey is a professor and chair of the department of obstetrics and gynecology and director of the family planning fellowship, immediate postpartum LARC is offered to women with Medicaid coverage, and payment is received in about 97% of cases.

It took about 4 years of persistent effort to make that happen, she said, adding that the UNM Hospital still is the only one in the state offering the service, although efforts are underway to help other hospitals “troubleshoot the issues.”

Another challenge is the lack of private insurance coverage for immediate postpartum LARC, she said.

“I was super enthusiastic about this a few years ago, and I remain super enthusiastic about it, but I think it’s going to take another 5 years or so [for better coverage], and honestly I think what we really need is an inpatient LARC CPT code to make this happen.”

In this video interview, Dr. Espey discusses the “agony and ecstasy” of immediate postpartum LARC, summarizing the main points regarding its benefits and challenges as presented during an “EdTalk” she gave at the meeting.

Dr. Espey reported having no relevant financial disclosures.

[email protected]

NASHVILLE, TENN. – The unintended pregnancy rate is declining after years of hovering at close to 50%.

While the rates among women of color remain high – currently at 58 and 79 per 1,000 women aged 15-44 years for Hispanic and black women, respectively – they have declined from 79 and 92 per 1,000 Hispanic and black women in that age group in 2008, and the overall rate is now at about 45%, Eve Espey, MD, said at the annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists.

“Considering the scope and number of women affected by unplanned pregnancy, this is actually a huge public health achievement,” said Dr. Espey, professor and chair of the department of obstetrics & gynecology at the University of New Mexico, Albuquerque.

The declines in unintended pregnancies are largely attributable to “better and more consistent use of contraceptives, and, interestingly, increased abstinence,” she noted, adding that “another enormous determinant of this decrease in unintended pregnancy is the use of long-acting reversible contraception [LARC].” About 2% of women used contraceptives in 2002, and now, based on the latest cycle of data from 2015-2017, 16% of women use contraceptives.

In this video interview, Dr. Espey discusses the main points of her talk entitled “Contraceptives: What you need to know in 2019,” including:

• The importance of “following reproductive justice–based principles and counseling” when it comes to prescribing contraceptives.
• The latest data showing that certain LARC methods remain safe and effective beyond their approved duration of use.
• Trends with respect to tubal ligation and salpingectomy.
• The value of the Centers for Disease Control and Prevention’s U.S. Medical Eligibility Criteria (MEC) for evidence-based guidance on selecting contraceptives based on patients’ individual needs.

“[MEC] is something every ob.gyn. should consider using,” she said, noting that access is available through a free app. “As our patients are more complex and have more comorbidities, it’s particularly helpful for matching up patients and their conditions with recommendations for specific contraceptive methods.”

Dr. Espey reported having no financial disclosures.

[email protected]

NASHVILLE, TENN. – The unintended pregnancy rate is declining after years of hovering at close to 50%.

While the rates among women of color remain high – currently at 58 and 79 per 1,000 women aged 15-44 years for Hispanic and black women, respectively – they have declined from 79 and 92 per 1,000 Hispanic and black women in that age group in 2008, and the overall rate is now at about 45%, Eve Espey, MD, said at the annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists.

“Considering the scope and number of women affected by unplanned pregnancy, this is actually a huge public health achievement,” said Dr. Espey, professor and chair of the department of obstetrics & gynecology at the University of New Mexico, Albuquerque.

The declines in unintended pregnancies are largely attributable to “better and more consistent use of contraceptives, and, interestingly, increased abstinence,” she noted, adding that “another enormous determinant of this decrease in unintended pregnancy is the use of long-acting reversible contraception [LARC].” About 2% of women used contraceptives in 2002, and now, based on the latest cycle of data from 2015-2017, 16% of women use contraceptives.

In this video interview, Dr. Espey discusses the main points of her talk entitled “Contraceptives: What you need to know in 2019,” including:

• The importance of “following reproductive justice–based principles and counseling” when it comes to prescribing contraceptives.
• The latest data showing that certain LARC methods remain safe and effective beyond their approved duration of use.
• Trends with respect to tubal ligation and salpingectomy.
• The value of the Centers for Disease Control and Prevention’s U.S. Medical Eligibility Criteria (MEC) for evidence-based guidance on selecting contraceptives based on patients’ individual needs.

“[MEC] is something every ob.gyn. should consider using,” she said, noting that access is available through a free app. “As our patients are more complex and have more comorbidities, it’s particularly helpful for matching up patients and their conditions with recommendations for specific contraceptive methods.”

Dr. Espey reported having no financial disclosures.

[email protected]

NASHVILLE, TENN. – The unintended pregnancy rate is declining after years of hovering at close to 50%.

While the rates among women of color remain high – currently at 58 and 79 per 1,000 women aged 15-44 years for Hispanic and black women, respectively – they have declined from 79 and 92 per 1,000 Hispanic and black women in that age group in 2008, and the overall rate is now at about 45%, Eve Espey, MD, said at the annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists.

“Considering the scope and number of women affected by unplanned pregnancy, this is actually a huge public health achievement,” said Dr. Espey, professor and chair of the department of obstetrics & gynecology at the University of New Mexico, Albuquerque.

The declines in unintended pregnancies are largely attributable to “better and more consistent use of contraceptives, and, interestingly, increased abstinence,” she noted, adding that “another enormous determinant of this decrease in unintended pregnancy is the use of long-acting reversible contraception [LARC].” About 2% of women used contraceptives in 2002, and now, based on the latest cycle of data from 2015-2017, 16% of women use contraceptives.

In this video interview, Dr. Espey discusses the main points of her talk entitled “Contraceptives: What you need to know in 2019,” including:

• The importance of “following reproductive justice–based principles and counseling” when it comes to prescribing contraceptives.
• The latest data showing that certain LARC methods remain safe and effective beyond their approved duration of use.
• Trends with respect to tubal ligation and salpingectomy.
• The value of the Centers for Disease Control and Prevention’s U.S. Medical Eligibility Criteria (MEC) for evidence-based guidance on selecting contraceptives based on patients’ individual needs.

“[MEC] is something every ob.gyn. should consider using,” she said, noting that access is available through a free app. “As our patients are more complex and have more comorbidities, it’s particularly helpful for matching up patients and their conditions with recommendations for specific contraceptive methods.”

Dr. Espey reported having no financial disclosures.

[email protected]

NASHVILLE, TENN. – The 52 mg levonorgestrel intrauterine system Liletta, which is currently approved as a contraceptive for up to 5 years of use, remains highly effective and safe for an additional year of use, according to findings from an ongoing 10-year trial.

Sharon Worcester/MDedge News

Of 1,714 women enrolled in the multicenter phase 3 trial and for whom demographic information is available, 379 have completed 6 years of use. Nine pregnancies have occurred to date, including 2 in year 1, 4 in year 2, and 1 each in years 3-5, for a cumulative life-table pregnancy rate through year 6 of 0.87, Carolyn L. Westhoff, MD, MSc, reported during a poster session at the annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists.

Six (67%) of the pregnancies were ectopic, noted Dr. Westhoff of Columbia University, N.Y.

Study subjects include 1,568 women aged 16-35 years at enrollment (986 were nulliparous and 433 were obese) and 146 aged 36 to 45 years. All were followed after device placement, with 138 having completed 8 years of use.

Two perforations occurred following device placement–both within the first year, and none have occurred since, Dr. Westhoff noted.

Other adverse events included expulsion in 68 women (4.0%), with 50 of those (73.5%) occurring in the first year of use, and pelvic infection in 15 women (0.9%), with 11 (73.3%) of those occurring after 6 or more months of use.


Only 40 women (2.3%) discontinued the study due to bleeding, and 30 of those (75%) did so in the first 2 years.

The findings show that Liletta is highly effective and safe over 6 years of use in both nulliparous and parous women, and in both non-obese and obese women, Dr. Westhoff concluded. She added that “there were no additional pregnancies in 6 years, and this study will be continuing to look all the way to 10-year effectiveness.”

This study is funded by Medicines360, a non-profit pharmaceutical company. Dr. Westhoff is a consultant or advisory board member for Agile and Cooper Surgical, and a Data and Safety Monitoring Board member for phase 4 studies for Bayer and Merck.

[email protected]

SOURCE: Westhoff C et al., ACOG 2019: Abstract 13M.

NASHVILLE, TENN. – The 52 mg levonorgestrel intrauterine system Liletta, which is currently approved as a contraceptive for up to 5 years of use, remains highly effective and safe for an additional year of use, according to findings from an ongoing 10-year trial.

Sharon Worcester/MDedge News

Of 1,714 women enrolled in the multicenter phase 3 trial and for whom demographic information is available, 379 have completed 6 years of use. Nine pregnancies have occurred to date, including 2 in year 1, 4 in year 2, and 1 each in years 3-5, for a cumulative life-table pregnancy rate through year 6 of 0.87, Carolyn L. Westhoff, MD, MSc, reported during a poster session at the annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists.

Six (67%) of the pregnancies were ectopic, noted Dr. Westhoff of Columbia University, N.Y.

Study subjects include 1,568 women aged 16-35 years at enrollment (986 were nulliparous and 433 were obese) and 146 aged 36 to 45 years. All were followed after device placement, with 138 having completed 8 years of use.

Two perforations occurred following device placement–both within the first year, and none have occurred since, Dr. Westhoff noted.

Other adverse events included expulsion in 68 women (4.0%), with 50 of those (73.5%) occurring in the first year of use, and pelvic infection in 15 women (0.9%), with 11 (73.3%) of those occurring after 6 or more months of use.


Only 40 women (2.3%) discontinued the study due to bleeding, and 30 of those (75%) did so in the first 2 years.

The findings show that Liletta is highly effective and safe over 6 years of use in both nulliparous and parous women, and in both non-obese and obese women, Dr. Westhoff concluded. She added that “there were no additional pregnancies in 6 years, and this study will be continuing to look all the way to 10-year effectiveness.”

This study is funded by Medicines360, a non-profit pharmaceutical company. Dr. Westhoff is a consultant or advisory board member for Agile and Cooper Surgical, and a Data and Safety Monitoring Board member for phase 4 studies for Bayer and Merck.

[email protected]

SOURCE: Westhoff C et al., ACOG 2019: Abstract 13M.

NASHVILLE, TENN. – The 52 mg levonorgestrel intrauterine system Liletta, which is currently approved as a contraceptive for up to 5 years of use, remains highly effective and safe for an additional year of use, according to findings from an ongoing 10-year trial.

Sharon Worcester/MDedge News

Of 1,714 women enrolled in the multicenter phase 3 trial and for whom demographic information is available, 379 have completed 6 years of use. Nine pregnancies have occurred to date, including 2 in year 1, 4 in year 2, and 1 each in years 3-5, for a cumulative life-table pregnancy rate through year 6 of 0.87, Carolyn L. Westhoff, MD, MSc, reported during a poster session at the annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists.

Six (67%) of the pregnancies were ectopic, noted Dr. Westhoff of Columbia University, N.Y.

Study subjects include 1,568 women aged 16-35 years at enrollment (986 were nulliparous and 433 were obese) and 146 aged 36 to 45 years. All were followed after device placement, with 138 having completed 8 years of use.

Two perforations occurred following device placement–both within the first year, and none have occurred since, Dr. Westhoff noted.

Other adverse events included expulsion in 68 women (4.0%), with 50 of those (73.5%) occurring in the first year of use, and pelvic infection in 15 women (0.9%), with 11 (73.3%) of those occurring after 6 or more months of use.


Only 40 women (2.3%) discontinued the study due to bleeding, and 30 of those (75%) did so in the first 2 years.

The findings show that Liletta is highly effective and safe over 6 years of use in both nulliparous and parous women, and in both non-obese and obese women, Dr. Westhoff concluded. She added that “there were no additional pregnancies in 6 years, and this study will be continuing to look all the way to 10-year effectiveness.”

This study is funded by Medicines360, a non-profit pharmaceutical company. Dr. Westhoff is a consultant or advisory board member for Agile and Cooper Surgical, and a Data and Safety Monitoring Board member for phase 4 studies for Bayer and Merck.

[email protected]

SOURCE: Westhoff C et al., ACOG 2019: Abstract 13M.

Two federal judges have temporarily barred the Trump administration from making changes to the Title X program that would restrict funding from clinics that provide abortion counseling or that refer patients for abortion services.

jsmith/iStockphoto

U.S. District Judge Stanley Bastian for the District of Eastern Washington on April 25 approved a temporary nationwide ban against the program changes in response to legal a challenge by Washington state. The same day, U.S. District Judge for the District of Oregon Michael J. McShane also preliminarily barred the restrictions from taking effect in response to a legal challenge by the American Medical Association and the Planned Parenthood Federation of America.

Judge McShane called the program restrictions “arbitrary and capricious,” and wrote that the rules ignore comprehensive, ethical, and evidence-based health care, and impermissibly interfere with the patient-doctor relationship. Judge Bastian agreed, writing in his order that the plaintiffs have demonstrated that the restrictions violate the central purpose of Title X, which is to equalize access to comprehensive, evidence-based, and voluntary family planning.

“Plaintiffs have demonstrated they are likely to suffer irreparable harm in the absence of a preliminary injunction by presenting facts and argument that the final rule may or likely will: seriously disrupt or destroy the existing network of Title X providers in both the State of Washington and throughout the entire nation,” Judge Bastian wrote in his order.

Changes to the Title X program – scheduled to take effect May 3 – would have made health clinics ineligible for Title X funding if they offer, promote, or support abortion as a method of family planning. Title X grants generally go to health centers that provide reproductive health care – such as STD-testing, cancer screenings, and contraception – to low-income families. Under the rule, the government would withdraw financial assistance to clinics if they allow counseling or referrals associated with abortion, regardless of whether the money is used for other health care services.

HHS officials said that the final rule will provide for clear financial and physical separation between Title X and non–Title X activities, reduce confusion on the part of Title X clinics and the public about permissible Title X activities, and improve program transparency by requiring more complete reporting by grantees about their partnerships with referral agencies.

Two federal judges have temporarily barred the Trump administration from making changes to the Title X program that would restrict funding from clinics that provide abortion counseling or that refer patients for abortion services.

jsmith/iStockphoto

U.S. District Judge Stanley Bastian for the District of Eastern Washington on April 25 approved a temporary nationwide ban against the program changes in response to legal a challenge by Washington state. The same day, U.S. District Judge for the District of Oregon Michael J. McShane also preliminarily barred the restrictions from taking effect in response to a legal challenge by the American Medical Association and the Planned Parenthood Federation of America.

Judge McShane called the program restrictions “arbitrary and capricious,” and wrote that the rules ignore comprehensive, ethical, and evidence-based health care, and impermissibly interfere with the patient-doctor relationship. Judge Bastian agreed, writing in his order that the plaintiffs have demonstrated that the restrictions violate the central purpose of Title X, which is to equalize access to comprehensive, evidence-based, and voluntary family planning.

“Plaintiffs have demonstrated they are likely to suffer irreparable harm in the absence of a preliminary injunction by presenting facts and argument that the final rule may or likely will: seriously disrupt or destroy the existing network of Title X providers in both the State of Washington and throughout the entire nation,” Judge Bastian wrote in his order.

Changes to the Title X program – scheduled to take effect May 3 – would have made health clinics ineligible for Title X funding if they offer, promote, or support abortion as a method of family planning. Title X grants generally go to health centers that provide reproductive health care – such as STD-testing, cancer screenings, and contraception – to low-income families. Under the rule, the government would withdraw financial assistance to clinics if they allow counseling or referrals associated with abortion, regardless of whether the money is used for other health care services.

HHS officials said that the final rule will provide for clear financial and physical separation between Title X and non–Title X activities, reduce confusion on the part of Title X clinics and the public about permissible Title X activities, and improve program transparency by requiring more complete reporting by grantees about their partnerships with referral agencies.

Two federal judges have temporarily barred the Trump administration from making changes to the Title X program that would restrict funding from clinics that provide abortion counseling or that refer patients for abortion services.

jsmith/iStockphoto

U.S. District Judge Stanley Bastian for the District of Eastern Washington on April 25 approved a temporary nationwide ban against the program changes in response to legal a challenge by Washington state. The same day, U.S. District Judge for the District of Oregon Michael J. McShane also preliminarily barred the restrictions from taking effect in response to a legal challenge by the American Medical Association and the Planned Parenthood Federation of America.

Judge McShane called the program restrictions “arbitrary and capricious,” and wrote that the rules ignore comprehensive, ethical, and evidence-based health care, and impermissibly interfere with the patient-doctor relationship. Judge Bastian agreed, writing in his order that the plaintiffs have demonstrated that the restrictions violate the central purpose of Title X, which is to equalize access to comprehensive, evidence-based, and voluntary family planning.

“Plaintiffs have demonstrated they are likely to suffer irreparable harm in the absence of a preliminary injunction by presenting facts and argument that the final rule may or likely will: seriously disrupt or destroy the existing network of Title X providers in both the State of Washington and throughout the entire nation,” Judge Bastian wrote in his order.

Changes to the Title X program – scheduled to take effect May 3 – would have made health clinics ineligible for Title X funding if they offer, promote, or support abortion as a method of family planning. Title X grants generally go to health centers that provide reproductive health care – such as STD-testing, cancer screenings, and contraception – to low-income families. Under the rule, the government would withdraw financial assistance to clinics if they allow counseling or referrals associated with abortion, regardless of whether the money is used for other health care services.

HHS officials said that the final rule will provide for clear financial and physical separation between Title X and non–Title X activities, reduce confusion on the part of Title X clinics and the public about permissible Title X activities, and improve program transparency by requiring more complete reporting by grantees about their partnerships with referral agencies.

CASE Adolescent seeks care without parent

A 15-year-old patient (G0) presents to the gynecology clinic requesting birth control. She reports being sexually active over the past 6 months and having several male partners over the past 2 years. She and her current male partner use condoms inconsistently. She reports being active in school sports, and her academic performance has been noteworthy. Her peers have encouraged her to seek out birth control; one of her good friends recently became pregnant and dropped out of school. She states that her best friend went to a similar clinic and received a “gynecologic encounter” that included information regarding safe sex and contraception, with no pelvic exam required for her to receive birth control pills.

The patient insists that her parents are not to know of her request for contraception due to sexual activity or that she is a patient at the clinic. The gynecologist covering the clinic is aware of the American College of Obstetricians and Gynecologists Committee on Adolescent Health Care and their many publications. The patient is counseled regarding human papillomavirus (HPV) vaccination and screened for sexually transmitted infections. In addition, the gynecologist discusses contraceptive options with the patient, ranging from oral contraceptives, vaginal rings, subdermal implants, depomedroxyprogesterone acetate, as well as intrauterine devices (IUDs). The gynecologist emphasizes safe sex and advises that her partner consider use of condoms independent of her method of birth control. The patient asks for oral contraceptives and is given information about their use and risks, and she indicates that she understands.
 

A few months later the patient requests an IUD, as she would like to have lighter menses and not have to remember to take a pill every day. The provider obtains informed consent for the insertion procedure; the patient signs the appropriate forms.

The IUD is inserted, with difficulty, by a resident physician in the clinic. The patient experiences severe pelvic pain during and immediately following the insertion. She is sent home and told to contact the clinic or another health care provider or proceed to the local emergency department should pain persist or if fever develops.

The patient returns 72 hours later in pain. Pelvic ultrasonography shows the IUD out of place and at risk of perforating the fundus of the uterus. Later that day the patient’s mother calls the clinic, saying that she found a statement of service with the clinic’s number on it in her daughter’s bedroom. She wants to know if her daughter is there, what is going on, and what services have been or are being provided. In passing she remarks that she has no intention of paying (or allowing her insurance to pay for) any care that was provided.

What are the provider’s obligations at this point, both medically and legally?

Medical and legal considerations

One of the most difficult and important health law questions in adolescent medicine is the ability of minors to consent to treatment and to control the health care information resulting from treatment. (“Minor” describes a child or adolescent who has not obtained the age of legal consent, generally 18 years old, to lawfully enter into a legal transaction.)

Continue to: The consent of minor patients...

The consent of minor patients

The traditional legal rule is that parents or guardians (“parent” refers to both) must consent to medical treatment for minor children. There is an exception for emergency situations but generally minors do not provide consent for medical care, a parent does.¹ The parent typically is obliged to provide payment (often through insurance) for those services.

This traditional rule has some exceptions—the emergency exception already noted and the case of emancipated minors, notably an adolescent who is living almost entirely independent of her parents (for example, she is married or not relying on parents in a meaningful way). In recent times there has been increasing authority for “mature minors” to make some medical decisions.² A mature minor is one who has sufficient understanding and judgment to appreciate the consequences, benefits, and risks of accepting proposed medical intervention.

No circumstance involving adolescent treatment has been more contentious than services related to abortion and, to a lesser degree, contraception.³ Both the law of consent to services and the rights of parents to obtain information about contraceptive and abortion services have been a matter of strong, continuing debate. The law in these areas varies greatly from state-to-state, and includes a mix of state law (statutes and court decisions) with an overlay of federal constitutional law related to reproduction-related decisions of adolescents. In addition, the law in this area of consent and information changes relatively frequently.⁴ Clinicians, of course, must focus on the consent laws of the state in which they practice.

STI counseling and treatment

All states permit a minor patient to consent to treatment for an STI (TABLE 1).⁵ A number of states expressly permit, but do not require, health care providers to inform parents of treatment when a physician determines it would be in the best interest of the minor. Thus, the clinic would not be required to provide proactively the information to our case patient’s mother (regarding any STI issues) when she called.⁶

Contraception

Consent for contraception is more complicated. About half the states allow minors who have reached a certain age (12, 14, or 16 years) to consent to contraception. About 20 other states allow some minors to consent to contraceptive services, but the “allowed group” may be fairly narrow (eg, be married, have a health issue, or be “mature”). In 4 states there is currently no clear legal authority to provide contraceptive services to minors, yet those states do not specifically prohibit it. The US Supreme Court has held that a state cannot completely prohibit the availability of contraception to minors.⁷ The reach of that decision, however, is not clear and may not extend beyond what the states currently permit.

The ability of minors to consent to contraception services does not mean that there is a right to consent to all contraceptive options. As contraception becomes more irreversible, permanent, or risky, it is more problematic. For example, consent to sterilization would not ordinarily be within a minor’s recognized ability to consent. Standard, low risk, reversible contraception generally is covered by these state laws.⁸

In our case here, the patient likely was able to consent to contraception—initially to the oral contraception and later to the IUD. The risks and reversibility of both are probably within her ability to consent.^9,10 Of course, if the care was provided in a state that does not include the patient within the groups that can give consent to contraception, it is possible that she might not have the legal authority to consent.

Continue to: General requirements of consent...

General requirements of consent

Even when adolescent consent is permitted for treatment, including in cases of contraception, it is essential that all of the legal and ethical requirements related to informed consent are met.

1. The adolescent has the capacity to consent. This means not only that the state-mandated requirements are met (age, for example) but also that the patient can and does understand the various elements of consent, and can make a sensible, informed decision.

The bottom line is “adolescent capacity is a complex process dependent upon the development of maturity of the adolescent, degree of intervention, expected benefit of the medical procedure, and the sociocultural context surrounding the decision.”¹¹ Other items of interest include the “evolving capacity” of the child,¹² which is the concept of increasing ability of the teen to process information and provide more appropriate informed consent. Central nervous system (CNS) maturation allows the adolescent to become increasingly more capable of decision making and has awareness of consequences of such decisions. Abstract thinking capabilities is a reflection of this CNS maturing process. If this competency is not established, the adolescent patient cannot give legitimate consent.

2. The patient must be given appropriate information (be “informed”). The discussion should include information relevant to the condition being treated (and the disease process if relevant). In addition, information about the treatment or intervention proposed and its risks and alternatives must be provided to the patient and in a way that is understandable.

3. As with all patients, consent must be voluntary and free of coercion or manipulation. These elements of informed consent are expanded on by the Joint Commission, which has established a number of components of informed consent (TABLE 2).^4,13

Confidentiality and release of information to parents and others

Similar to consent, parents historically have had the authority to obtain medical information about their minor children. This right generally continues today, with some limitations. The right to give consent generally carries with it the right to medical information. There are some times when parents may access medical information even if they have not given consent.

This right adds complexity to minor consent and is an important treatment issue and legal consideration because confidentiality for adolescents affects quality of care. Adolescents report that “confidentiality is an important factor in their decision to seek [medical] care.”¹⁴ Many parents are under the assumption that the health care provider will automatically inform them independent of whether or not the adolescent expressed precise instruction not to inform.^15,16

Of course if a minor patient authorizes the physician to provide information to her parents, that is consent and the health care provider may then provide the information. If the patient instructs the provider to convey the information, the practitioner would ordinarily be expected to be proactive in providing the information to the parent. The issue of “voluntariness” of the waiver of confidentiality can be a question, and the physician may discuss that question with the patient. Ordinarily, however, once a minor has authorized disclosure to the parent, the clinician has the authority to disclose the information to the parent, but not to others.

All of the usual considerations of confidentiality in health care apply to adolescent ObGyn services and care. This includes the general obligation not to disclose information without consent and to ensure that health care information is protected from accidental release as required by the Health Insurance Portability and Accountability Act (HIPAA) and other health information privacy laws.¹⁷

Continue to: How and when to protect minor confidentiality...

How and when to protect minor confidentiality

A clinician cannot assure minors of absolute confidentiality and should not agree to do so or imply that they are doing so.¹⁸ In our hypothetical case, when the patient told the physician that her parents were not to know of any of her treatment or communications, the provider should not have acquiesced by silence. He/she might have responded along these lines: “I have a strong commitment to confidentiality of your information, and we take many steps to protect that information. The law also allows some special protection of health care information. Despite the commitment to privacy, there are circumstances in which the law requires disclosure of information—and that might even be to parents. In addition, if you want any of your care covered by insurance, we would have to disclose that. While I expect that we can do as you ask about maintaining your confidentiality, no health care provider can absolutely guarantee it.”

Proactive vs reactive disclosure. There is “proactive” disclosure of information and “reactive” disclosure. Proactive is when the provider (without being asked) contacts a parent or others and provides information. Some states require proactive information about specific kinds of treatment (especially abortion services). For the most part, in states where a minor can legally consent to treatment, health care providers are not required to proactively disclose information.¹⁹

Clinicians may be required to respond to parental requests for information, which is reactive disclosure and is reflected in our case presentation. Even in such circumstances, however, the individual providing care may seek to avoid disclosure. In many states, the law would not require the release of this information (but would permit it if it is in the best interest of the patient). In addition, there are practical ways of avoiding the release of information. For example, the health care provider might acknowledge the interest and desire of the parent to have the information, but might humbly explain that in the experience of many clinicians protecting the confidentiality of patients is very important to successful treatment and it is the policy of the office/clinic not to breach the expectation of patient confidentiality except where that is clearly in the best interest of the patient or required by law.

In response to the likely question, “Well, isn’t that required by law?” the clinician can honestly reply, “I don’t know. There are many complex factors in the law regarding disclosure of medical information and as I am not an attorney I do not know how they all apply in this instance.” In some cases the parent may push the matter or take some kind of legal action. It is in this type of situation that an attorney familiar with health law and the clinician’s practice can be invaluable.

When parents are involved in the minor’s treatment (bringing the patient to the office/clinic, for example), there is an opportunity for an understanding, or agreement, among the patient, provider, and parent about what information the parent will receive. Ordinarily the agreement should not create the expectation of detailed information for the parent. Perhaps, for example, the physician will provide information only when he or she believes that doing so will be in the best interest of the patient. Even with parental agreement, complete confidentiality cannot be assured for minor patients. There may, for example, be another parent who will not feel bound by the established understanding, and the law requires some disclosures (in the case of child abuse or a court order).²⁰

Continue to: Accidental disclosure...

Accidental disclosure. Health care providers also should make sure that office procedures do not unnecessarily or accidentally disclose information about patients. For example, routinely gathering information about insurance coverage may well trigger the release of information to the policy holder (often a parent). Thus, there should be clear understandings about billing, insurance, and related issues before information is divulged by the patient. This should be part of the process of obtaining informed consent to treatment. It should be up front and honest. Developing a clear understanding of the legal requirements of the state is essential, so that assurance of confidentiality is on legal, solid ground.

Abuse reporting obligations

All states have mandatory child abuse reporting laws. These laws require medical professionals (and others) to report known, and often suspected, abuse of children. Abuse includes physical, sexual, or emotional, and generally also includes neglect that is harming a child. When there is apparent sexual or physical abuse, the health care provider is obligated to report it to designated state authorities, generally child protective services. Reporting laws vary from state to state based on the relationship between the suspected abuser and the minor, the nature of the harm, and how strong the suspicion of abuse needs to be. The failure to make required reports is a crime in most states and also may result in civil liability or licensure discipline. Criminal charges seldom result from the failure to report, but in some cases the failure to report may have serious consequences for the professional.

An ObGyn example of the complexity of reporting laws, and variation from state to state, is in the area of “statutory rape” reporting. Those state laws, which define serious criminal offenses, set out the age below which an individual is not legally capable of consenting to sexual activity. It varies among states, but may be an absolute age of consent, the age differential between the parties, or some combination of age and age differential.²¹ The question of reporting is further complicated by the issue of when statutory rape must be reported—for example, the circumstances when the harm to the underage person is sufficient to require reporting.²²

Laws are complex, as is practice navigation

It is apparent that navigating these issues makes it essential for an ObGyn practice to have clear policies and practices regarding reporting, yet the overall complexity is also why it is so difficult to develop those policies in the first place. Of course, they must be tailored to the state in which the practice resides. Once again, the need is clear for health care professionals to have an ongoing relationship with a health attorney who can help navigate ongoing questions.

CASE Adolescent seeks care without parent

A 15-year-old patient (G0) presents to the gynecology clinic requesting birth control. She reports being sexually active over the past 6 months and having several male partners over the past 2 years. She and her current male partner use condoms inconsistently. She reports being active in school sports, and her academic performance has been noteworthy. Her peers have encouraged her to seek out birth control; one of her good friends recently became pregnant and dropped out of school. She states that her best friend went to a similar clinic and received a “gynecologic encounter” that included information regarding safe sex and contraception, with no pelvic exam required for her to receive birth control pills.

The patient insists that her parents are not to know of her request for contraception due to sexual activity or that she is a patient at the clinic. The gynecologist covering the clinic is aware of the American College of Obstetricians and Gynecologists Committee on Adolescent Health Care and their many publications. The patient is counseled regarding human papillomavirus (HPV) vaccination and screened for sexually transmitted infections. In addition, the gynecologist discusses contraceptive options with the patient, ranging from oral contraceptives, vaginal rings, subdermal implants, depomedroxyprogesterone acetate, as well as intrauterine devices (IUDs). The gynecologist emphasizes safe sex and advises that her partner consider use of condoms independent of her method of birth control. The patient asks for oral contraceptives and is given information about their use and risks, and she indicates that she understands.
 

A few months later the patient requests an IUD, as she would like to have lighter menses and not have to remember to take a pill every day. The provider obtains informed consent for the insertion procedure; the patient signs the appropriate forms.

The IUD is inserted, with difficulty, by a resident physician in the clinic. The patient experiences severe pelvic pain during and immediately following the insertion. She is sent home and told to contact the clinic or another health care provider or proceed to the local emergency department should pain persist or if fever develops.

The patient returns 72 hours later in pain. Pelvic ultrasonography shows the IUD out of place and at risk of perforating the fundus of the uterus. Later that day the patient’s mother calls the clinic, saying that she found a statement of service with the clinic’s number on it in her daughter’s bedroom. She wants to know if her daughter is there, what is going on, and what services have been or are being provided. In passing she remarks that she has no intention of paying (or allowing her insurance to pay for) any care that was provided.

What are the provider’s obligations at this point, both medically and legally?

Medical and legal considerations

One of the most difficult and important health law questions in adolescent medicine is the ability of minors to consent to treatment and to control the health care information resulting from treatment. (“Minor” describes a child or adolescent who has not obtained the age of legal consent, generally 18 years old, to lawfully enter into a legal transaction.)

Continue to: The consent of minor patients...

The consent of minor patients

The traditional legal rule is that parents or guardians (“parent” refers to both) must consent to medical treatment for minor children. There is an exception for emergency situations but generally minors do not provide consent for medical care, a parent does.¹ The parent typically is obliged to provide payment (often through insurance) for those services.

This traditional rule has some exceptions—the emergency exception already noted and the case of emancipated minors, notably an adolescent who is living almost entirely independent of her parents (for example, she is married or not relying on parents in a meaningful way). In recent times there has been increasing authority for “mature minors” to make some medical decisions.² A mature minor is one who has sufficient understanding and judgment to appreciate the consequences, benefits, and risks of accepting proposed medical intervention.

No circumstance involving adolescent treatment has been more contentious than services related to abortion and, to a lesser degree, contraception.³ Both the law of consent to services and the rights of parents to obtain information about contraceptive and abortion services have been a matter of strong, continuing debate. The law in these areas varies greatly from state-to-state, and includes a mix of state law (statutes and court decisions) with an overlay of federal constitutional law related to reproduction-related decisions of adolescents. In addition, the law in this area of consent and information changes relatively frequently.⁴ Clinicians, of course, must focus on the consent laws of the state in which they practice.

STI counseling and treatment

All states permit a minor patient to consent to treatment for an STI (TABLE 1).⁵ A number of states expressly permit, but do not require, health care providers to inform parents of treatment when a physician determines it would be in the best interest of the minor. Thus, the clinic would not be required to provide proactively the information to our case patient’s mother (regarding any STI issues) when she called.⁶

Contraception

Consent for contraception is more complicated. About half the states allow minors who have reached a certain age (12, 14, or 16 years) to consent to contraception. About 20 other states allow some minors to consent to contraceptive services, but the “allowed group” may be fairly narrow (eg, be married, have a health issue, or be “mature”). In 4 states there is currently no clear legal authority to provide contraceptive services to minors, yet those states do not specifically prohibit it. The US Supreme Court has held that a state cannot completely prohibit the availability of contraception to minors.⁷ The reach of that decision, however, is not clear and may not extend beyond what the states currently permit.

The ability of minors to consent to contraception services does not mean that there is a right to consent to all contraceptive options. As contraception becomes more irreversible, permanent, or risky, it is more problematic. For example, consent to sterilization would not ordinarily be within a minor’s recognized ability to consent. Standard, low risk, reversible contraception generally is covered by these state laws.⁸

In our case here, the patient likely was able to consent to contraception—initially to the oral contraception and later to the IUD. The risks and reversibility of both are probably within her ability to consent.^9,10 Of course, if the care was provided in a state that does not include the patient within the groups that can give consent to contraception, it is possible that she might not have the legal authority to consent.

Continue to: General requirements of consent...

General requirements of consent

Even when adolescent consent is permitted for treatment, including in cases of contraception, it is essential that all of the legal and ethical requirements related to informed consent are met.

1. The adolescent has the capacity to consent. This means not only that the state-mandated requirements are met (age, for example) but also that the patient can and does understand the various elements of consent, and can make a sensible, informed decision.

The bottom line is “adolescent capacity is a complex process dependent upon the development of maturity of the adolescent, degree of intervention, expected benefit of the medical procedure, and the sociocultural context surrounding the decision.”¹¹ Other items of interest include the “evolving capacity” of the child,¹² which is the concept of increasing ability of the teen to process information and provide more appropriate informed consent. Central nervous system (CNS) maturation allows the adolescent to become increasingly more capable of decision making and has awareness of consequences of such decisions. Abstract thinking capabilities is a reflection of this CNS maturing process. If this competency is not established, the adolescent patient cannot give legitimate consent.

2. The patient must be given appropriate information (be “informed”). The discussion should include information relevant to the condition being treated (and the disease process if relevant). In addition, information about the treatment or intervention proposed and its risks and alternatives must be provided to the patient and in a way that is understandable.

3. As with all patients, consent must be voluntary and free of coercion or manipulation. These elements of informed consent are expanded on by the Joint Commission, which has established a number of components of informed consent (TABLE 2).^4,13

Confidentiality and release of information to parents and others

Similar to consent, parents historically have had the authority to obtain medical information about their minor children. This right generally continues today, with some limitations. The right to give consent generally carries with it the right to medical information. There are some times when parents may access medical information even if they have not given consent.

This right adds complexity to minor consent and is an important treatment issue and legal consideration because confidentiality for adolescents affects quality of care. Adolescents report that “confidentiality is an important factor in their decision to seek [medical] care.”¹⁴ Many parents are under the assumption that the health care provider will automatically inform them independent of whether or not the adolescent expressed precise instruction not to inform.^15,16

Of course if a minor patient authorizes the physician to provide information to her parents, that is consent and the health care provider may then provide the information. If the patient instructs the provider to convey the information, the practitioner would ordinarily be expected to be proactive in providing the information to the parent. The issue of “voluntariness” of the waiver of confidentiality can be a question, and the physician may discuss that question with the patient. Ordinarily, however, once a minor has authorized disclosure to the parent, the clinician has the authority to disclose the information to the parent, but not to others.

All of the usual considerations of confidentiality in health care apply to adolescent ObGyn services and care. This includes the general obligation not to disclose information without consent and to ensure that health care information is protected from accidental release as required by the Health Insurance Portability and Accountability Act (HIPAA) and other health information privacy laws.¹⁷

Continue to: How and when to protect minor confidentiality...

How and when to protect minor confidentiality

A clinician cannot assure minors of absolute confidentiality and should not agree to do so or imply that they are doing so.¹⁸ In our hypothetical case, when the patient told the physician that her parents were not to know of any of her treatment or communications, the provider should not have acquiesced by silence. He/she might have responded along these lines: “I have a strong commitment to confidentiality of your information, and we take many steps to protect that information. The law also allows some special protection of health care information. Despite the commitment to privacy, there are circumstances in which the law requires disclosure of information—and that might even be to parents. In addition, if you want any of your care covered by insurance, we would have to disclose that. While I expect that we can do as you ask about maintaining your confidentiality, no health care provider can absolutely guarantee it.”

Proactive vs reactive disclosure. There is “proactive” disclosure of information and “reactive” disclosure. Proactive is when the provider (without being asked) contacts a parent or others and provides information. Some states require proactive information about specific kinds of treatment (especially abortion services). For the most part, in states where a minor can legally consent to treatment, health care providers are not required to proactively disclose information.¹⁹

Clinicians may be required to respond to parental requests for information, which is reactive disclosure and is reflected in our case presentation. Even in such circumstances, however, the individual providing care may seek to avoid disclosure. In many states, the law would not require the release of this information (but would permit it if it is in the best interest of the patient). In addition, there are practical ways of avoiding the release of information. For example, the health care provider might acknowledge the interest and desire of the parent to have the information, but might humbly explain that in the experience of many clinicians protecting the confidentiality of patients is very important to successful treatment and it is the policy of the office/clinic not to breach the expectation of patient confidentiality except where that is clearly in the best interest of the patient or required by law.

In response to the likely question, “Well, isn’t that required by law?” the clinician can honestly reply, “I don’t know. There are many complex factors in the law regarding disclosure of medical information and as I am not an attorney I do not know how they all apply in this instance.” In some cases the parent may push the matter or take some kind of legal action. It is in this type of situation that an attorney familiar with health law and the clinician’s practice can be invaluable.

When parents are involved in the minor’s treatment (bringing the patient to the office/clinic, for example), there is an opportunity for an understanding, or agreement, among the patient, provider, and parent about what information the parent will receive. Ordinarily the agreement should not create the expectation of detailed information for the parent. Perhaps, for example, the physician will provide information only when he or she believes that doing so will be in the best interest of the patient. Even with parental agreement, complete confidentiality cannot be assured for minor patients. There may, for example, be another parent who will not feel bound by the established understanding, and the law requires some disclosures (in the case of child abuse or a court order).²⁰

Continue to: Accidental disclosure...

Accidental disclosure. Health care providers also should make sure that office procedures do not unnecessarily or accidentally disclose information about patients. For example, routinely gathering information about insurance coverage may well trigger the release of information to the policy holder (often a parent). Thus, there should be clear understandings about billing, insurance, and related issues before information is divulged by the patient. This should be part of the process of obtaining informed consent to treatment. It should be up front and honest. Developing a clear understanding of the legal requirements of the state is essential, so that assurance of confidentiality is on legal, solid ground.

Abuse reporting obligations

All states have mandatory child abuse reporting laws. These laws require medical professionals (and others) to report known, and often suspected, abuse of children. Abuse includes physical, sexual, or emotional, and generally also includes neglect that is harming a child. When there is apparent sexual or physical abuse, the health care provider is obligated to report it to designated state authorities, generally child protective services. Reporting laws vary from state to state based on the relationship between the suspected abuser and the minor, the nature of the harm, and how strong the suspicion of abuse needs to be. The failure to make required reports is a crime in most states and also may result in civil liability or licensure discipline. Criminal charges seldom result from the failure to report, but in some cases the failure to report may have serious consequences for the professional.

An ObGyn example of the complexity of reporting laws, and variation from state to state, is in the area of “statutory rape” reporting. Those state laws, which define serious criminal offenses, set out the age below which an individual is not legally capable of consenting to sexual activity. It varies among states, but may be an absolute age of consent, the age differential between the parties, or some combination of age and age differential.²¹ The question of reporting is further complicated by the issue of when statutory rape must be reported—for example, the circumstances when the harm to the underage person is sufficient to require reporting.²²

Laws are complex, as is practice navigation

It is apparent that navigating these issues makes it essential for an ObGyn practice to have clear policies and practices regarding reporting, yet the overall complexity is also why it is so difficult to develop those policies in the first place. Of course, they must be tailored to the state in which the practice resides. Once again, the need is clear for health care professionals to have an ongoing relationship with a health attorney who can help navigate ongoing questions.

CASE Adolescent seeks care without parent

A 15-year-old patient (G0) presents to the gynecology clinic requesting birth control. She reports being sexually active over the past 6 months and having several male partners over the past 2 years. She and her current male partner use condoms inconsistently. She reports being active in school sports, and her academic performance has been noteworthy. Her peers have encouraged her to seek out birth control; one of her good friends recently became pregnant and dropped out of school. She states that her best friend went to a similar clinic and received a “gynecologic encounter” that included information regarding safe sex and contraception, with no pelvic exam required for her to receive birth control pills.

The patient insists that her parents are not to know of her request for contraception due to sexual activity or that she is a patient at the clinic. The gynecologist covering the clinic is aware of the American College of Obstetricians and Gynecologists Committee on Adolescent Health Care and their many publications. The patient is counseled regarding human papillomavirus (HPV) vaccination and screened for sexually transmitted infections. In addition, the gynecologist discusses contraceptive options with the patient, ranging from oral contraceptives, vaginal rings, subdermal implants, depomedroxyprogesterone acetate, as well as intrauterine devices (IUDs). The gynecologist emphasizes safe sex and advises that her partner consider use of condoms independent of her method of birth control. The patient asks for oral contraceptives and is given information about their use and risks, and she indicates that she understands.
 

A few months later the patient requests an IUD, as she would like to have lighter menses and not have to remember to take a pill every day. The provider obtains informed consent for the insertion procedure; the patient signs the appropriate forms.

The IUD is inserted, with difficulty, by a resident physician in the clinic. The patient experiences severe pelvic pain during and immediately following the insertion. She is sent home and told to contact the clinic or another health care provider or proceed to the local emergency department should pain persist or if fever develops.

The patient returns 72 hours later in pain. Pelvic ultrasonography shows the IUD out of place and at risk of perforating the fundus of the uterus. Later that day the patient’s mother calls the clinic, saying that she found a statement of service with the clinic’s number on it in her daughter’s bedroom. She wants to know if her daughter is there, what is going on, and what services have been or are being provided. In passing she remarks that she has no intention of paying (or allowing her insurance to pay for) any care that was provided.

What are the provider’s obligations at this point, both medically and legally?

Medical and legal considerations

One of the most difficult and important health law questions in adolescent medicine is the ability of minors to consent to treatment and to control the health care information resulting from treatment. (“Minor” describes a child or adolescent who has not obtained the age of legal consent, generally 18 years old, to lawfully enter into a legal transaction.)

Continue to: The consent of minor patients...

The consent of minor patients

The traditional legal rule is that parents or guardians (“parent” refers to both) must consent to medical treatment for minor children. There is an exception for emergency situations but generally minors do not provide consent for medical care, a parent does.¹ The parent typically is obliged to provide payment (often through insurance) for those services.

This traditional rule has some exceptions—the emergency exception already noted and the case of emancipated minors, notably an adolescent who is living almost entirely independent of her parents (for example, she is married or not relying on parents in a meaningful way). In recent times there has been increasing authority for “mature minors” to make some medical decisions.² A mature minor is one who has sufficient understanding and judgment to appreciate the consequences, benefits, and risks of accepting proposed medical intervention.

No circumstance involving adolescent treatment has been more contentious than services related to abortion and, to a lesser degree, contraception.³ Both the law of consent to services and the rights of parents to obtain information about contraceptive and abortion services have been a matter of strong, continuing debate. The law in these areas varies greatly from state-to-state, and includes a mix of state law (statutes and court decisions) with an overlay of federal constitutional law related to reproduction-related decisions of adolescents. In addition, the law in this area of consent and information changes relatively frequently.⁴ Clinicians, of course, must focus on the consent laws of the state in which they practice.

STI counseling and treatment

All states permit a minor patient to consent to treatment for an STI (TABLE 1).⁵ A number of states expressly permit, but do not require, health care providers to inform parents of treatment when a physician determines it would be in the best interest of the minor. Thus, the clinic would not be required to provide proactively the information to our case patient’s mother (regarding any STI issues) when she called.⁶

Contraception

Consent for contraception is more complicated. About half the states allow minors who have reached a certain age (12, 14, or 16 years) to consent to contraception. About 20 other states allow some minors to consent to contraceptive services, but the “allowed group” may be fairly narrow (eg, be married, have a health issue, or be “mature”). In 4 states there is currently no clear legal authority to provide contraceptive services to minors, yet those states do not specifically prohibit it. The US Supreme Court has held that a state cannot completely prohibit the availability of contraception to minors.⁷ The reach of that decision, however, is not clear and may not extend beyond what the states currently permit.

The ability of minors to consent to contraception services does not mean that there is a right to consent to all contraceptive options. As contraception becomes more irreversible, permanent, or risky, it is more problematic. For example, consent to sterilization would not ordinarily be within a minor’s recognized ability to consent. Standard, low risk, reversible contraception generally is covered by these state laws.⁸

In our case here, the patient likely was able to consent to contraception—initially to the oral contraception and later to the IUD. The risks and reversibility of both are probably within her ability to consent.^9,10 Of course, if the care was provided in a state that does not include the patient within the groups that can give consent to contraception, it is possible that she might not have the legal authority to consent.

Continue to: General requirements of consent...

General requirements of consent

Even when adolescent consent is permitted for treatment, including in cases of contraception, it is essential that all of the legal and ethical requirements related to informed consent are met.

1. The adolescent has the capacity to consent. This means not only that the state-mandated requirements are met (age, for example) but also that the patient can and does understand the various elements of consent, and can make a sensible, informed decision.

The bottom line is “adolescent capacity is a complex process dependent upon the development of maturity of the adolescent, degree of intervention, expected benefit of the medical procedure, and the sociocultural context surrounding the decision.”¹¹ Other items of interest include the “evolving capacity” of the child,¹² which is the concept of increasing ability of the teen to process information and provide more appropriate informed consent. Central nervous system (CNS) maturation allows the adolescent to become increasingly more capable of decision making and has awareness of consequences of such decisions. Abstract thinking capabilities is a reflection of this CNS maturing process. If this competency is not established, the adolescent patient cannot give legitimate consent.

2. The patient must be given appropriate information (be “informed”). The discussion should include information relevant to the condition being treated (and the disease process if relevant). In addition, information about the treatment or intervention proposed and its risks and alternatives must be provided to the patient and in a way that is understandable.

3. As with all patients, consent must be voluntary and free of coercion or manipulation. These elements of informed consent are expanded on by the Joint Commission, which has established a number of components of informed consent (TABLE 2).^4,13

Confidentiality and release of information to parents and others

Similar to consent, parents historically have had the authority to obtain medical information about their minor children. This right generally continues today, with some limitations. The right to give consent generally carries with it the right to medical information. There are some times when parents may access medical information even if they have not given consent.

This right adds complexity to minor consent and is an important treatment issue and legal consideration because confidentiality for adolescents affects quality of care. Adolescents report that “confidentiality is an important factor in their decision to seek [medical] care.”¹⁴ Many parents are under the assumption that the health care provider will automatically inform them independent of whether or not the adolescent expressed precise instruction not to inform.^15,16

Of course if a minor patient authorizes the physician to provide information to her parents, that is consent and the health care provider may then provide the information. If the patient instructs the provider to convey the information, the practitioner would ordinarily be expected to be proactive in providing the information to the parent. The issue of “voluntariness” of the waiver of confidentiality can be a question, and the physician may discuss that question with the patient. Ordinarily, however, once a minor has authorized disclosure to the parent, the clinician has the authority to disclose the information to the parent, but not to others.

All of the usual considerations of confidentiality in health care apply to adolescent ObGyn services and care. This includes the general obligation not to disclose information without consent and to ensure that health care information is protected from accidental release as required by the Health Insurance Portability and Accountability Act (HIPAA) and other health information privacy laws.¹⁷

Continue to: How and when to protect minor confidentiality...

How and when to protect minor confidentiality

A clinician cannot assure minors of absolute confidentiality and should not agree to do so or imply that they are doing so.¹⁸ In our hypothetical case, when the patient told the physician that her parents were not to know of any of her treatment or communications, the provider should not have acquiesced by silence. He/she might have responded along these lines: “I have a strong commitment to confidentiality of your information, and we take many steps to protect that information. The law also allows some special protection of health care information. Despite the commitment to privacy, there are circumstances in which the law requires disclosure of information—and that might even be to parents. In addition, if you want any of your care covered by insurance, we would have to disclose that. While I expect that we can do as you ask about maintaining your confidentiality, no health care provider can absolutely guarantee it.”

Proactive vs reactive disclosure. There is “proactive” disclosure of information and “reactive” disclosure. Proactive is when the provider (without being asked) contacts a parent or others and provides information. Some states require proactive information about specific kinds of treatment (especially abortion services). For the most part, in states where a minor can legally consent to treatment, health care providers are not required to proactively disclose information.¹⁹

Clinicians may be required to respond to parental requests for information, which is reactive disclosure and is reflected in our case presentation. Even in such circumstances, however, the individual providing care may seek to avoid disclosure. In many states, the law would not require the release of this information (but would permit it if it is in the best interest of the patient). In addition, there are practical ways of avoiding the release of information. For example, the health care provider might acknowledge the interest and desire of the parent to have the information, but might humbly explain that in the experience of many clinicians protecting the confidentiality of patients is very important to successful treatment and it is the policy of the office/clinic not to breach the expectation of patient confidentiality except where that is clearly in the best interest of the patient or required by law.

In response to the likely question, “Well, isn’t that required by law?” the clinician can honestly reply, “I don’t know. There are many complex factors in the law regarding disclosure of medical information and as I am not an attorney I do not know how they all apply in this instance.” In some cases the parent may push the matter or take some kind of legal action. It is in this type of situation that an attorney familiar with health law and the clinician’s practice can be invaluable.

When parents are involved in the minor’s treatment (bringing the patient to the office/clinic, for example), there is an opportunity for an understanding, or agreement, among the patient, provider, and parent about what information the parent will receive. Ordinarily the agreement should not create the expectation of detailed information for the parent. Perhaps, for example, the physician will provide information only when he or she believes that doing so will be in the best interest of the patient. Even with parental agreement, complete confidentiality cannot be assured for minor patients. There may, for example, be another parent who will not feel bound by the established understanding, and the law requires some disclosures (in the case of child abuse or a court order).²⁰

Continue to: Accidental disclosure...

Accidental disclosure. Health care providers also should make sure that office procedures do not unnecessarily or accidentally disclose information about patients. For example, routinely gathering information about insurance coverage may well trigger the release of information to the policy holder (often a parent). Thus, there should be clear understandings about billing, insurance, and related issues before information is divulged by the patient. This should be part of the process of obtaining informed consent to treatment. It should be up front and honest. Developing a clear understanding of the legal requirements of the state is essential, so that assurance of confidentiality is on legal, solid ground.

Abuse reporting obligations

All states have mandatory child abuse reporting laws. These laws require medical professionals (and others) to report known, and often suspected, abuse of children. Abuse includes physical, sexual, or emotional, and generally also includes neglect that is harming a child. When there is apparent sexual or physical abuse, the health care provider is obligated to report it to designated state authorities, generally child protective services. Reporting laws vary from state to state based on the relationship between the suspected abuser and the minor, the nature of the harm, and how strong the suspicion of abuse needs to be. The failure to make required reports is a crime in most states and also may result in civil liability or licensure discipline. Criminal charges seldom result from the failure to report, but in some cases the failure to report may have serious consequences for the professional.

An ObGyn example of the complexity of reporting laws, and variation from state to state, is in the area of “statutory rape” reporting. Those state laws, which define serious criminal offenses, set out the age below which an individual is not legally capable of consenting to sexual activity. It varies among states, but may be an absolute age of consent, the age differential between the parties, or some combination of age and age differential.²¹ The question of reporting is further complicated by the issue of when statutory rape must be reported—for example, the circumstances when the harm to the underage person is sufficient to require reporting.²²

Laws are complex, as is practice navigation

It is apparent that navigating these issues makes it essential for an ObGyn practice to have clear policies and practices regarding reporting, yet the overall complexity is also why it is so difficult to develop those policies in the first place. Of course, they must be tailored to the state in which the practice resides. Once again, the need is clear for health care professionals to have an ongoing relationship with a health attorney who can help navigate ongoing questions.

Evidence-based research and guidelines regarding contraception are continually changing. Health care providers often have difficulty memorizing and staying up-to-date on all the important developments around family planning. Those who provide contraceptive counseling may not all use guidelines to inform their choices, and some may have misperceptions about patient eligibility for certain methods.^1,2 Mobile health applications (apps) that present this information in an easily accessible fashion have the potential to improve family planning services.

In a search for contraception apps, Dr. Rachel Perry and colleagues identified two contraception apps that were evaluated highly: 1) the Centers for Disease Control and Prevention (CDC) US Medical Eligibility Criteria for Contraceptive Use (MEC) app and 2) the iContraception app.³

Two free contraception apps for clinician use. Both the CDC Contraception and iContraception apps are based on CDC MEC information and provide guidance on contraceptive initiation and maintenance.⁴ Notably, the American College of Obstetricians and Gynecologists (ACOG) endorses the use of the CDC MEC.⁵

These two apps can aid physicians in prescribing appropriate and safe contraceptive methods and can help them tailor the extensive CDC MEC guidelines for an individual patient. Additionally, the iContraception app allows a user to input multiple clinical and demographic characteristics to determine an individual patient’s eligibility for a specific contraceptive method (that is, it incorporates a clinical decision tree).

The recommended contraception apps are listed in the TABLE and are detailed with a shortened version of the APPLICATIONS scoring system, APPLI (app comprehensiveness, price, platform, literature used, and important special features).⁶ I hope that the apps described here will assist you in managing patients who need contraception counseling.

Evidence-based research and guidelines regarding contraception are continually changing. Health care providers often have difficulty memorizing and staying up-to-date on all the important developments around family planning. Those who provide contraceptive counseling may not all use guidelines to inform their choices, and some may have misperceptions about patient eligibility for certain methods.^1,2 Mobile health applications (apps) that present this information in an easily accessible fashion have the potential to improve family planning services.

In a search for contraception apps, Dr. Rachel Perry and colleagues identified two contraception apps that were evaluated highly: 1) the Centers for Disease Control and Prevention (CDC) US Medical Eligibility Criteria for Contraceptive Use (MEC) app and 2) the iContraception app.³

Two free contraception apps for clinician use. Both the CDC Contraception and iContraception apps are based on CDC MEC information and provide guidance on contraceptive initiation and maintenance.⁴ Notably, the American College of Obstetricians and Gynecologists (ACOG) endorses the use of the CDC MEC.⁵

These two apps can aid physicians in prescribing appropriate and safe contraceptive methods and can help them tailor the extensive CDC MEC guidelines for an individual patient. Additionally, the iContraception app allows a user to input multiple clinical and demographic characteristics to determine an individual patient’s eligibility for a specific contraceptive method (that is, it incorporates a clinical decision tree).

The recommended contraception apps are listed in the TABLE and are detailed with a shortened version of the APPLICATIONS scoring system, APPLI (app comprehensiveness, price, platform, literature used, and important special features).⁶ I hope that the apps described here will assist you in managing patients who need contraception counseling.

Evidence-based research and guidelines regarding contraception are continually changing. Health care providers often have difficulty memorizing and staying up-to-date on all the important developments around family planning. Those who provide contraceptive counseling may not all use guidelines to inform their choices, and some may have misperceptions about patient eligibility for certain methods.^1,2 Mobile health applications (apps) that present this information in an easily accessible fashion have the potential to improve family planning services.

In a search for contraception apps, Dr. Rachel Perry and colleagues identified two contraception apps that were evaluated highly: 1) the Centers for Disease Control and Prevention (CDC) US Medical Eligibility Criteria for Contraceptive Use (MEC) app and 2) the iContraception app.³

Two free contraception apps for clinician use. Both the CDC Contraception and iContraception apps are based on CDC MEC information and provide guidance on contraceptive initiation and maintenance.⁴ Notably, the American College of Obstetricians and Gynecologists (ACOG) endorses the use of the CDC MEC.⁵

These two apps can aid physicians in prescribing appropriate and safe contraceptive methods and can help them tailor the extensive CDC MEC guidelines for an individual patient. Additionally, the iContraception app allows a user to input multiple clinical and demographic characteristics to determine an individual patient’s eligibility for a specific contraceptive method (that is, it incorporates a clinical decision tree).

The recommended contraception apps are listed in the TABLE and are detailed with a shortened version of the APPLICATIONS scoring system, APPLI (app comprehensiveness, price, platform, literature used, and important special features).⁶ I hope that the apps described here will assist you in managing patients who need contraception counseling.

The U.S. Supreme Court has temporarily barred a Louisiana law that would require stricter requirements for physicians who provide abortion care, the first abortion-related decision for the current conservative-leaning high court.

Courtesy Wikimedia Commons

In a Feb. 7, 2019, order, Supreme Court justices stopped the law from moving forward until they can decide whether to accept the case for oral argument. The law in question would require Louisiana physicians who perform abortions to have admitting privileges at a hospital within 30 miles of the clinic where they offer abortion care.

A group of health professionals sued over the Louisiana statute after it was enacted in 2014, arguing that the requirement was unconstitutional because it placed an undue burden on women seeking abortions. A federal court agreed, concluding that the law would leave a significant number of Louisiana women unable to get an abortion. The state appealed to the 5th U.S. Circuit Court of Appeals, which reversed the decision in January 2019. The physician plaintiffs then urged the Supreme Court to stop the law, scheduled to take effect on Feb. 4 while the case continued through the courts. The health professionals argue that no physicians in Louisiana would be available to perform abortions after 17 weeks of pregnancy if the law proceeds and that only one physician in the state would be available to provide an abortion in the earlier stages of pregnancy. Attorneys for the state countered that health providers are overestimating the law’s effect and requested that the measure be allowed to go forward.

In a Feb. 1 order, the Supreme Court provided the plaintiffs a short stay while they reviewed briefs in the case. Then, in a 5-4 decision on Feb. 7, the majority court halted the legal challenge indefinitely until they can decide whether to take up the case.

Four justices – Clarence Thomas, Samuel Alito, Neil Gorsuch, and Brett Kavanaugh – dissented from the majority, writing that they would have allowed Louisiana to enforce the law. Chief Justice John Roberts joined the high court’s four more liberal justices in stopping the law’s enactment.

The plaintiffs’ petition to the Supreme Court is due in April. If the case is accepted, oral arguments would likely be scheduled for fall 2019 or winter 2020, according to court analysts.

[email protected]

The U.S. Supreme Court has temporarily barred a Louisiana law that would require stricter requirements for physicians who provide abortion care, the first abortion-related decision for the current conservative-leaning high court.

Courtesy Wikimedia Commons

In a Feb. 7, 2019, order, Supreme Court justices stopped the law from moving forward until they can decide whether to accept the case for oral argument. The law in question would require Louisiana physicians who perform abortions to have admitting privileges at a hospital within 30 miles of the clinic where they offer abortion care.

A group of health professionals sued over the Louisiana statute after it was enacted in 2014, arguing that the requirement was unconstitutional because it placed an undue burden on women seeking abortions. A federal court agreed, concluding that the law would leave a significant number of Louisiana women unable to get an abortion. The state appealed to the 5th U.S. Circuit Court of Appeals, which reversed the decision in January 2019. The physician plaintiffs then urged the Supreme Court to stop the law, scheduled to take effect on Feb. 4 while the case continued through the courts. The health professionals argue that no physicians in Louisiana would be available to perform abortions after 17 weeks of pregnancy if the law proceeds and that only one physician in the state would be available to provide an abortion in the earlier stages of pregnancy. Attorneys for the state countered that health providers are overestimating the law’s effect and requested that the measure be allowed to go forward.

In a Feb. 1 order, the Supreme Court provided the plaintiffs a short stay while they reviewed briefs in the case. Then, in a 5-4 decision on Feb. 7, the majority court halted the legal challenge indefinitely until they can decide whether to take up the case.

Four justices – Clarence Thomas, Samuel Alito, Neil Gorsuch, and Brett Kavanaugh – dissented from the majority, writing that they would have allowed Louisiana to enforce the law. Chief Justice John Roberts joined the high court’s four more liberal justices in stopping the law’s enactment.

The plaintiffs’ petition to the Supreme Court is due in April. If the case is accepted, oral arguments would likely be scheduled for fall 2019 or winter 2020, according to court analysts.

[email protected]

The U.S. Supreme Court has temporarily barred a Louisiana law that would require stricter requirements for physicians who provide abortion care, the first abortion-related decision for the current conservative-leaning high court.

Courtesy Wikimedia Commons

In a Feb. 7, 2019, order, Supreme Court justices stopped the law from moving forward until they can decide whether to accept the case for oral argument. The law in question would require Louisiana physicians who perform abortions to have admitting privileges at a hospital within 30 miles of the clinic where they offer abortion care.

A group of health professionals sued over the Louisiana statute after it was enacted in 2014, arguing that the requirement was unconstitutional because it placed an undue burden on women seeking abortions. A federal court agreed, concluding that the law would leave a significant number of Louisiana women unable to get an abortion. The state appealed to the 5th U.S. Circuit Court of Appeals, which reversed the decision in January 2019. The physician plaintiffs then urged the Supreme Court to stop the law, scheduled to take effect on Feb. 4 while the case continued through the courts. The health professionals argue that no physicians in Louisiana would be available to perform abortions after 17 weeks of pregnancy if the law proceeds and that only one physician in the state would be available to provide an abortion in the earlier stages of pregnancy. Attorneys for the state countered that health providers are overestimating the law’s effect and requested that the measure be allowed to go forward.

In a Feb. 1 order, the Supreme Court provided the plaintiffs a short stay while they reviewed briefs in the case. Then, in a 5-4 decision on Feb. 7, the majority court halted the legal challenge indefinitely until they can decide whether to take up the case.

Four justices – Clarence Thomas, Samuel Alito, Neil Gorsuch, and Brett Kavanaugh – dissented from the majority, writing that they would have allowed Louisiana to enforce the law. Chief Justice John Roberts joined the high court’s four more liberal justices in stopping the law’s enactment.

The plaintiffs’ petition to the Supreme Court is due in April. If the case is accepted, oral arguments would likely be scheduled for fall 2019 or winter 2020, according to court analysts.

[email protected]

TREATMENT FOR VASOMOTOR SYMPTOMS

BIJUVA™ has been US Food and Drug Administration (FDA)–approved as the first oral treatment for moderate-to-severe vasomotor symptoms due to menopause in women with a uterus. BIJUVA offers a combination of bioidentical estradiol to reduce moderate-to-severe hot flashes and bioidentical progesterone to reduce the risk for endometrial hyperplasia.

TherapeuticsMD says that BIJUVA will be available Spring 2019 and is a proven treatment option for women who are experiencing bothersome symptoms of menopause, with clinical trial data demonstrating a statistically significant reduction in both the frequency and severity of moderate-to-severe vasomotor symptoms. The manufacturer also says that BIJUVA is developed to be identical in molecular structure to the hormones already produced by the body and is designed to help women restore what is lost during menopause.

BIJUVA estradiol and progesterone combination (1 mg/100 mg) will be available in capsule form.

FOR MORE INFORMATION, VISIT:https://bijuva.com/discover/

LILETTA USE EXTENDED

The FDA has approved LILETTA^® (levonorgestrel-releasing intrauterine system) 52 mg for 5-year use. This approval is based on efficacy and safety data from ACCESS IUS, the largest ongoing intrauterine device (IUD) Phase 3 clinical trial in the United States. Previously, LILETTA was indicated for use up to 4 years.

LILETTA continues to be greater than 99% effective in preventing pregnancy in a broad range of women, regardless of age, race, body mass index, or parity, according to Allergan and Medicines360. The extended duration and proven efficacy across a diverse population enables more women in the United States to obtain effective birth control, as the IUD is now available for a low cost at public health clinics.

FOR MORE INFORMATION, VISIT: https://www.liletta.com

Continue to: ENDOMETRIAL ABLATION TECHNOLOGY

ENDOMETRIAL ABLATION TECHNOLOGY

AEGEA Medical introduces the AEGEA Vapor System^TM, an innovative solution for endometrial ablation to treat menorrhagia.

The system uses Adaptive Vapor Ablation and is the first endometrial ablation system specifically designed for use in the doctor’s office, allowing minimal anesthesia/analgesia and rapid recovery, says AEGEA Medical.

AEGEA Medical describes the AEGEA Vapor System as a fully automated safety monitoring and vapor delivery system that uses a slender, flexible Vapor Probe with SmartSeal^TM technology and the Integrity Pro^TM safety feature, for an added level of confidence. The 4-minute procedure time includes 2 minutes of vapor treatment and can be performed in patients with a wider range of uterine anatomies than indicated for use with currently available treatments, says AEGEA Medical.

FOR MORE INFORMATION, VISIT: http://aegeamedical.com/

NATURAL CYCLES

The FDA has cleared Natural Cycles as the first digital method of birth control in the United States. Delivered in the form of an app, Natural Cycles is a fertility awareness–based contraceptive that uses a sophisticated algorithm to accurately and conveniently determine a woman’s daily fertility based on basal body temperature.

That data builds into a personalized fertility indicator that informs her when she needs to use protection to minimize the chance of conception. The app also can be used to help plan a pregnancy when the time is right, according to Natural Cycles.

A clinical study showed that the efficacy of a contraceptive mobile application is higher than usually reported for traditional fertility awareness–based methods. The application may contribute to reducing the unmet need for contraception, says Natural Cycles.

FOR MORE INFORMATION, VISIT: https://www.naturalcycles.com/en/hcp

TREATMENT FOR VASOMOTOR SYMPTOMS

BIJUVA™ has been US Food and Drug Administration (FDA)–approved as the first oral treatment for moderate-to-severe vasomotor symptoms due to menopause in women with a uterus. BIJUVA offers a combination of bioidentical estradiol to reduce moderate-to-severe hot flashes and bioidentical progesterone to reduce the risk for endometrial hyperplasia.

TherapeuticsMD says that BIJUVA will be available Spring 2019 and is a proven treatment option for women who are experiencing bothersome symptoms of menopause, with clinical trial data demonstrating a statistically significant reduction in both the frequency and severity of moderate-to-severe vasomotor symptoms. The manufacturer also says that BIJUVA is developed to be identical in molecular structure to the hormones already produced by the body and is designed to help women restore what is lost during menopause.

BIJUVA estradiol and progesterone combination (1 mg/100 mg) will be available in capsule form.

FOR MORE INFORMATION, VISIT:https://bijuva.com/discover/

LILETTA USE EXTENDED

The FDA has approved LILETTA^® (levonorgestrel-releasing intrauterine system) 52 mg for 5-year use. This approval is based on efficacy and safety data from ACCESS IUS, the largest ongoing intrauterine device (IUD) Phase 3 clinical trial in the United States. Previously, LILETTA was indicated for use up to 4 years.

LILETTA continues to be greater than 99% effective in preventing pregnancy in a broad range of women, regardless of age, race, body mass index, or parity, according to Allergan and Medicines360. The extended duration and proven efficacy across a diverse population enables more women in the United States to obtain effective birth control, as the IUD is now available for a low cost at public health clinics.

FOR MORE INFORMATION, VISIT: https://www.liletta.com

Continue to: ENDOMETRIAL ABLATION TECHNOLOGY

ENDOMETRIAL ABLATION TECHNOLOGY

AEGEA Medical introduces the AEGEA Vapor System^TM, an innovative solution for endometrial ablation to treat menorrhagia.

The system uses Adaptive Vapor Ablation and is the first endometrial ablation system specifically designed for use in the doctor’s office, allowing minimal anesthesia/analgesia and rapid recovery, says AEGEA Medical.

AEGEA Medical describes the AEGEA Vapor System as a fully automated safety monitoring and vapor delivery system that uses a slender, flexible Vapor Probe with SmartSeal^TM technology and the Integrity Pro^TM safety feature, for an added level of confidence. The 4-minute procedure time includes 2 minutes of vapor treatment and can be performed in patients with a wider range of uterine anatomies than indicated for use with currently available treatments, says AEGEA Medical.

FOR MORE INFORMATION, VISIT: http://aegeamedical.com/

NATURAL CYCLES

The FDA has cleared Natural Cycles as the first digital method of birth control in the United States. Delivered in the form of an app, Natural Cycles is a fertility awareness–based contraceptive that uses a sophisticated algorithm to accurately and conveniently determine a woman’s daily fertility based on basal body temperature.

That data builds into a personalized fertility indicator that informs her when she needs to use protection to minimize the chance of conception. The app also can be used to help plan a pregnancy when the time is right, according to Natural Cycles.

A clinical study showed that the efficacy of a contraceptive mobile application is higher than usually reported for traditional fertility awareness–based methods. The application may contribute to reducing the unmet need for contraception, says Natural Cycles.

FOR MORE INFORMATION, VISIT: https://www.naturalcycles.com/en/hcp

TREATMENT FOR VASOMOTOR SYMPTOMS

BIJUVA™ has been US Food and Drug Administration (FDA)–approved as the first oral treatment for moderate-to-severe vasomotor symptoms due to menopause in women with a uterus. BIJUVA offers a combination of bioidentical estradiol to reduce moderate-to-severe hot flashes and bioidentical progesterone to reduce the risk for endometrial hyperplasia.

TherapeuticsMD says that BIJUVA will be available Spring 2019 and is a proven treatment option for women who are experiencing bothersome symptoms of menopause, with clinical trial data demonstrating a statistically significant reduction in both the frequency and severity of moderate-to-severe vasomotor symptoms. The manufacturer also says that BIJUVA is developed to be identical in molecular structure to the hormones already produced by the body and is designed to help women restore what is lost during menopause.

BIJUVA estradiol and progesterone combination (1 mg/100 mg) will be available in capsule form.

FOR MORE INFORMATION, VISIT:https://bijuva.com/discover/

LILETTA USE EXTENDED

The FDA has approved LILETTA^® (levonorgestrel-releasing intrauterine system) 52 mg for 5-year use. This approval is based on efficacy and safety data from ACCESS IUS, the largest ongoing intrauterine device (IUD) Phase 3 clinical trial in the United States. Previously, LILETTA was indicated for use up to 4 years.

LILETTA continues to be greater than 99% effective in preventing pregnancy in a broad range of women, regardless of age, race, body mass index, or parity, according to Allergan and Medicines360. The extended duration and proven efficacy across a diverse population enables more women in the United States to obtain effective birth control, as the IUD is now available for a low cost at public health clinics.

FOR MORE INFORMATION, VISIT: https://www.liletta.com

Continue to: ENDOMETRIAL ABLATION TECHNOLOGY

ENDOMETRIAL ABLATION TECHNOLOGY

AEGEA Medical introduces the AEGEA Vapor System^TM, an innovative solution for endometrial ablation to treat menorrhagia.

The system uses Adaptive Vapor Ablation and is the first endometrial ablation system specifically designed for use in the doctor’s office, allowing minimal anesthesia/analgesia and rapid recovery, says AEGEA Medical.

AEGEA Medical describes the AEGEA Vapor System as a fully automated safety monitoring and vapor delivery system that uses a slender, flexible Vapor Probe with SmartSeal^TM technology and the Integrity Pro^TM safety feature, for an added level of confidence. The 4-minute procedure time includes 2 minutes of vapor treatment and can be performed in patients with a wider range of uterine anatomies than indicated for use with currently available treatments, says AEGEA Medical.

FOR MORE INFORMATION, VISIT: http://aegeamedical.com/

NATURAL CYCLES

The FDA has cleared Natural Cycles as the first digital method of birth control in the United States. Delivered in the form of an app, Natural Cycles is a fertility awareness–based contraceptive that uses a sophisticated algorithm to accurately and conveniently determine a woman’s daily fertility based on basal body temperature.

That data builds into a personalized fertility indicator that informs her when she needs to use protection to minimize the chance of conception. The app also can be used to help plan a pregnancy when the time is right, according to Natural Cycles.

A clinical study showed that the efficacy of a contraceptive mobile application is higher than usually reported for traditional fertility awareness–based methods. The application may contribute to reducing the unmet need for contraception, says Natural Cycles.

FOR MORE INFORMATION, VISIT: https://www.naturalcycles.com/en/hcp