Health Policy

The gender wage gap in physician compensation persists but is narrowing. According to information gleaned from self-reported compensation surveys, collected by Doximity and completed by 90,000 full-time, US-licensed physicians, while wages for men idled between 2017 and 2018, they increased for women by 2%.¹ So, whereas the gender wage gap was 27.7% in 2017, it dropped to 25.2% in 2018. This translates to female physicians making $90,490 less than male counterparts in 2018 vs $105,000 less in 2017.¹

Gender wage gap and geography. Metropolitan areas with the smallest gender wage gaps according to the Doximity report include Birmingham, Alabama (9%); Bridgeport, Connecticut (10%); and Seattle, Washington (15%). Areas with the largest gender wage gap include Louisville/Jefferson County, Kentucky-Indiana (40%); New Orleans, Louisiana (32%); and Austin, Texas (31%).¹

Gender wage gap and specialty. Specialties with the widest gender wage gaps are pediatric pulmonology (23%), otolaryngology (22%), and urology (22%). Those with the narrowest gaps are hematology (4%), rheumatology (8%), and radiation oncology (9%).¹

Interestingly, although female physicians continue to earn less than men across the board, women were the slight majority of US medical school applicants (50.9%) and matriculants (51.6%) in 2018.²

What are physicians earning?

The overall average salary for physicians in 2019 is $313,000, according to a Medscape report, and the average annual compensation for ObGyns is $303,000, up from $300,000 in 2018.³ Doximity’s figure was slightly different; it reported average annual compensation for ObGyns to be $335,000 in 2018, ranking ObGyns 20th in specialties with the highest annual compensation.¹

Compensation by specialty. The specialties with the highest average annual compensation in 2018 according to the Doximity report were neurosurgery ($617K), thoracic surgery ($584K), and orthopedic surgery ($526K). Those with the lowest were pediatric infectious disease ($186K), pediatric endocrinology ($201K), and general pediatrics ($223K).¹

While women make up 61% of the ObGyn workforce, fewer than 15% of cardiologists, urologists, and orthopedists—some of the highest paying specialties—are women, although this alone does not explain the gender wage gap.³

Compensation by employment type. While average annual compensation increased from 2017 to 2018 for physicians working in single specialty groups (1%), multispecialty groups (1%), solo practices (3%), and industry/pharmaceutical (17%), compensation decreased for those working in health maintenance organizations (-1%), hospitals (-7%), and academia (-9%).¹ Only 14% of private practices are owned by female physicians (TABLE 1).¹

Satisfaction with compensation. Exactly half (50%) of ObGyns report feeling fairly compensated.³ Those physicians working in public health and preventive medicine are the most likely to feel fairly compensated (73%), while those working in infectious disease are least likely (42%).³
 

Location matters and may surprise you

Contrary to what many believe, less populated metropolitan areas tend to pay better than larger, more populated cities.¹ This may be because metropolitan areas without academic institutions or nationally renowned health systems tend to offer slightly higher compensation than those with such facilities. The reason? The presence of large or prestigious medical schools ensures a pipeline of viable physician candidates for limited jobs, resulting in institutions and practices needing to pay less for qualified applicants.¹

The 5 markets paying the highest physician salaries in 2018 were (from highest to lowest) Milwaukee; New Orleans; Riverside, California; Minneapolis; and Charlotte, North Carolina. Those paying the lowest were Durham, North Carolina; Providence, Rhode Island; San Antonio; Virginia Beach; and New Haven, Connecticut.¹ Rural areas continue to have problems luring physicians (see “Cures for the famine of rural physicians?”^3,4).

Job satisfaction

ObGyns rank 16th in terms of specialists who are happiest at work; 27% responded that they were very or extremely happy. Plastic surgeons ranked first in happiness on the job (41%), while those in physical medicine and rehabilitation ranked last (19%).⁵

Physicians as a whole report that the most rewarding part of the job is the gratitude from and relationships with patients, followed by “being good at a what I do”/finding answers/diagnoses, and “knowing that I’m making the world a better place.”³ Three-quarters (74%) of ObGyns would choose medicine again, and 75% would choose the same specialty. Those most likely to choose medicine again are those in infectious disease (84%), while those least likely work in physical medicine and rehabilitation (62%). Those most satisfied with their chosen specialty are ophthalmologists; 96% would choose the specialty again, whereas only 62% of internists would do so.³

Burnout. In a Medscape survey of 15,000 physicians in 29 specialties, 45% of ObGyns reported being burned out.⁵ Another 15% reported being “colloquially” depressed (sad, despondent, but not clinically depressed), and 7% reported clinical depression. While physicians overall most frequently engage in exercise as a coping mechanism, ObGyns most frequently report isolating themselves from others (47%)(TABLE 2).⁶

Across all specialties, more female physicians report being burned out than men (50% vs 39%). The 3 highest contributors to burnout are too many bureaucratic tasks (charting, paperwork), spending too many hours at work/insufficient compensation, and the increasing computerization of practices (electronic health records [EHRs])(TABLE 3).⁶ While 44% of ObGyns report that their feelings of being burned out or depressed do not affect their interactions with patients, 39% say such feelings make them easily exasperated with their patients.⁶ One in five (20%) responding ObGyns reported having had thoughts of suicide (vs 14% for physicians as a whole).^5,6

Sources of frustration on the job

Long hours. Physicians responding to the Medscape survey say that the most frustrating part of their job is having so many rules and regulations, followed by having to work with an EHR, and having to work long hours.³

As for the latter, 60% of responding ObGyns reported working long hours, which places obstetrics/gynecology in the 11th position on a list of specialties with physicians reporting working too many hours.⁵ Surgeons were number 1 with 77% reporting working long hours, and emergency medicine physicians were last with only 13% reporting working long hours.

Paper and administrative tasks. Thirty-eight percent of the physicians responding to the Medscape survey report spending 10 to 19 hours per week on paperwork; another 36% report spending 20 hours or more.³ This is almost identical to last year when the figures were 38% and 32%, respectively. However, the trend in the last few years has been dramatic. In 2017, the total percentage of physicians spending 10 of more hours on paperwork per week was 57%, compared with this year’s 74%.³
 

The gender wage gap in physician compensation persists but is narrowing. According to information gleaned from self-reported compensation surveys, collected by Doximity and completed by 90,000 full-time, US-licensed physicians, while wages for men idled between 2017 and 2018, they increased for women by 2%.¹ So, whereas the gender wage gap was 27.7% in 2017, it dropped to 25.2% in 2018. This translates to female physicians making $90,490 less than male counterparts in 2018 vs $105,000 less in 2017.¹

Gender wage gap and geography. Metropolitan areas with the smallest gender wage gaps according to the Doximity report include Birmingham, Alabama (9%); Bridgeport, Connecticut (10%); and Seattle, Washington (15%). Areas with the largest gender wage gap include Louisville/Jefferson County, Kentucky-Indiana (40%); New Orleans, Louisiana (32%); and Austin, Texas (31%).¹

Gender wage gap and specialty. Specialties with the widest gender wage gaps are pediatric pulmonology (23%), otolaryngology (22%), and urology (22%). Those with the narrowest gaps are hematology (4%), rheumatology (8%), and radiation oncology (9%).¹

Interestingly, although female physicians continue to earn less than men across the board, women were the slight majority of US medical school applicants (50.9%) and matriculants (51.6%) in 2018.²

What are physicians earning?

The overall average salary for physicians in 2019 is $313,000, according to a Medscape report, and the average annual compensation for ObGyns is $303,000, up from $300,000 in 2018.³ Doximity’s figure was slightly different; it reported average annual compensation for ObGyns to be $335,000 in 2018, ranking ObGyns 20th in specialties with the highest annual compensation.¹

Compensation by specialty. The specialties with the highest average annual compensation in 2018 according to the Doximity report were neurosurgery ($617K), thoracic surgery ($584K), and orthopedic surgery ($526K). Those with the lowest were pediatric infectious disease ($186K), pediatric endocrinology ($201K), and general pediatrics ($223K).¹

While women make up 61% of the ObGyn workforce, fewer than 15% of cardiologists, urologists, and orthopedists—some of the highest paying specialties—are women, although this alone does not explain the gender wage gap.³

Compensation by employment type. While average annual compensation increased from 2017 to 2018 for physicians working in single specialty groups (1%), multispecialty groups (1%), solo practices (3%), and industry/pharmaceutical (17%), compensation decreased for those working in health maintenance organizations (-1%), hospitals (-7%), and academia (-9%).¹ Only 14% of private practices are owned by female physicians (TABLE 1).¹

Satisfaction with compensation. Exactly half (50%) of ObGyns report feeling fairly compensated.³ Those physicians working in public health and preventive medicine are the most likely to feel fairly compensated (73%), while those working in infectious disease are least likely (42%).³
 

Location matters and may surprise you

Contrary to what many believe, less populated metropolitan areas tend to pay better than larger, more populated cities.¹ This may be because metropolitan areas without academic institutions or nationally renowned health systems tend to offer slightly higher compensation than those with such facilities. The reason? The presence of large or prestigious medical schools ensures a pipeline of viable physician candidates for limited jobs, resulting in institutions and practices needing to pay less for qualified applicants.¹

The 5 markets paying the highest physician salaries in 2018 were (from highest to lowest) Milwaukee; New Orleans; Riverside, California; Minneapolis; and Charlotte, North Carolina. Those paying the lowest were Durham, North Carolina; Providence, Rhode Island; San Antonio; Virginia Beach; and New Haven, Connecticut.¹ Rural areas continue to have problems luring physicians (see “Cures for the famine of rural physicians?”^3,4).

Job satisfaction

ObGyns rank 16th in terms of specialists who are happiest at work; 27% responded that they were very or extremely happy. Plastic surgeons ranked first in happiness on the job (41%), while those in physical medicine and rehabilitation ranked last (19%).⁵

Physicians as a whole report that the most rewarding part of the job is the gratitude from and relationships with patients, followed by “being good at a what I do”/finding answers/diagnoses, and “knowing that I’m making the world a better place.”³ Three-quarters (74%) of ObGyns would choose medicine again, and 75% would choose the same specialty. Those most likely to choose medicine again are those in infectious disease (84%), while those least likely work in physical medicine and rehabilitation (62%). Those most satisfied with their chosen specialty are ophthalmologists; 96% would choose the specialty again, whereas only 62% of internists would do so.³

Burnout. In a Medscape survey of 15,000 physicians in 29 specialties, 45% of ObGyns reported being burned out.⁵ Another 15% reported being “colloquially” depressed (sad, despondent, but not clinically depressed), and 7% reported clinical depression. While physicians overall most frequently engage in exercise as a coping mechanism, ObGyns most frequently report isolating themselves from others (47%)(TABLE 2).⁶

Across all specialties, more female physicians report being burned out than men (50% vs 39%). The 3 highest contributors to burnout are too many bureaucratic tasks (charting, paperwork), spending too many hours at work/insufficient compensation, and the increasing computerization of practices (electronic health records [EHRs])(TABLE 3).⁶ While 44% of ObGyns report that their feelings of being burned out or depressed do not affect their interactions with patients, 39% say such feelings make them easily exasperated with their patients.⁶ One in five (20%) responding ObGyns reported having had thoughts of suicide (vs 14% for physicians as a whole).^5,6

Sources of frustration on the job

Long hours. Physicians responding to the Medscape survey say that the most frustrating part of their job is having so many rules and regulations, followed by having to work with an EHR, and having to work long hours.³

As for the latter, 60% of responding ObGyns reported working long hours, which places obstetrics/gynecology in the 11th position on a list of specialties with physicians reporting working too many hours.⁵ Surgeons were number 1 with 77% reporting working long hours, and emergency medicine physicians were last with only 13% reporting working long hours.

Paper and administrative tasks. Thirty-eight percent of the physicians responding to the Medscape survey report spending 10 to 19 hours per week on paperwork; another 36% report spending 20 hours or more.³ This is almost identical to last year when the figures were 38% and 32%, respectively. However, the trend in the last few years has been dramatic. In 2017, the total percentage of physicians spending 10 of more hours on paperwork per week was 57%, compared with this year’s 74%.³
 

The gender wage gap in physician compensation persists but is narrowing. According to information gleaned from self-reported compensation surveys, collected by Doximity and completed by 90,000 full-time, US-licensed physicians, while wages for men idled between 2017 and 2018, they increased for women by 2%.¹ So, whereas the gender wage gap was 27.7% in 2017, it dropped to 25.2% in 2018. This translates to female physicians making $90,490 less than male counterparts in 2018 vs $105,000 less in 2017.¹

Gender wage gap and geography. Metropolitan areas with the smallest gender wage gaps according to the Doximity report include Birmingham, Alabama (9%); Bridgeport, Connecticut (10%); and Seattle, Washington (15%). Areas with the largest gender wage gap include Louisville/Jefferson County, Kentucky-Indiana (40%); New Orleans, Louisiana (32%); and Austin, Texas (31%).¹

Gender wage gap and specialty. Specialties with the widest gender wage gaps are pediatric pulmonology (23%), otolaryngology (22%), and urology (22%). Those with the narrowest gaps are hematology (4%), rheumatology (8%), and radiation oncology (9%).¹

Interestingly, although female physicians continue to earn less than men across the board, women were the slight majority of US medical school applicants (50.9%) and matriculants (51.6%) in 2018.²

What are physicians earning?

The overall average salary for physicians in 2019 is $313,000, according to a Medscape report, and the average annual compensation for ObGyns is $303,000, up from $300,000 in 2018.³ Doximity’s figure was slightly different; it reported average annual compensation for ObGyns to be $335,000 in 2018, ranking ObGyns 20th in specialties with the highest annual compensation.¹

Compensation by specialty. The specialties with the highest average annual compensation in 2018 according to the Doximity report were neurosurgery ($617K), thoracic surgery ($584K), and orthopedic surgery ($526K). Those with the lowest were pediatric infectious disease ($186K), pediatric endocrinology ($201K), and general pediatrics ($223K).¹

While women make up 61% of the ObGyn workforce, fewer than 15% of cardiologists, urologists, and orthopedists—some of the highest paying specialties—are women, although this alone does not explain the gender wage gap.³

Compensation by employment type. While average annual compensation increased from 2017 to 2018 for physicians working in single specialty groups (1%), multispecialty groups (1%), solo practices (3%), and industry/pharmaceutical (17%), compensation decreased for those working in health maintenance organizations (-1%), hospitals (-7%), and academia (-9%).¹ Only 14% of private practices are owned by female physicians (TABLE 1).¹

Satisfaction with compensation. Exactly half (50%) of ObGyns report feeling fairly compensated.³ Those physicians working in public health and preventive medicine are the most likely to feel fairly compensated (73%), while those working in infectious disease are least likely (42%).³
 

Location matters and may surprise you

Contrary to what many believe, less populated metropolitan areas tend to pay better than larger, more populated cities.¹ This may be because metropolitan areas without academic institutions or nationally renowned health systems tend to offer slightly higher compensation than those with such facilities. The reason? The presence of large or prestigious medical schools ensures a pipeline of viable physician candidates for limited jobs, resulting in institutions and practices needing to pay less for qualified applicants.¹

The 5 markets paying the highest physician salaries in 2018 were (from highest to lowest) Milwaukee; New Orleans; Riverside, California; Minneapolis; and Charlotte, North Carolina. Those paying the lowest were Durham, North Carolina; Providence, Rhode Island; San Antonio; Virginia Beach; and New Haven, Connecticut.¹ Rural areas continue to have problems luring physicians (see “Cures for the famine of rural physicians?”^3,4).

Job satisfaction

ObGyns rank 16th in terms of specialists who are happiest at work; 27% responded that they were very or extremely happy. Plastic surgeons ranked first in happiness on the job (41%), while those in physical medicine and rehabilitation ranked last (19%).⁵

Physicians as a whole report that the most rewarding part of the job is the gratitude from and relationships with patients, followed by “being good at a what I do”/finding answers/diagnoses, and “knowing that I’m making the world a better place.”³ Three-quarters (74%) of ObGyns would choose medicine again, and 75% would choose the same specialty. Those most likely to choose medicine again are those in infectious disease (84%), while those least likely work in physical medicine and rehabilitation (62%). Those most satisfied with their chosen specialty are ophthalmologists; 96% would choose the specialty again, whereas only 62% of internists would do so.³

Burnout. In a Medscape survey of 15,000 physicians in 29 specialties, 45% of ObGyns reported being burned out.⁵ Another 15% reported being “colloquially” depressed (sad, despondent, but not clinically depressed), and 7% reported clinical depression. While physicians overall most frequently engage in exercise as a coping mechanism, ObGyns most frequently report isolating themselves from others (47%)(TABLE 2).⁶

Across all specialties, more female physicians report being burned out than men (50% vs 39%). The 3 highest contributors to burnout are too many bureaucratic tasks (charting, paperwork), spending too many hours at work/insufficient compensation, and the increasing computerization of practices (electronic health records [EHRs])(TABLE 3).⁶ While 44% of ObGyns report that their feelings of being burned out or depressed do not affect their interactions with patients, 39% say such feelings make them easily exasperated with their patients.⁶ One in five (20%) responding ObGyns reported having had thoughts of suicide (vs 14% for physicians as a whole).^5,6

Sources of frustration on the job

Long hours. Physicians responding to the Medscape survey say that the most frustrating part of their job is having so many rules and regulations, followed by having to work with an EHR, and having to work long hours.³

As for the latter, 60% of responding ObGyns reported working long hours, which places obstetrics/gynecology in the 11th position on a list of specialties with physicians reporting working too many hours.⁵ Surgeons were number 1 with 77% reporting working long hours, and emergency medicine physicians were last with only 13% reporting working long hours.

Paper and administrative tasks. Thirty-eight percent of the physicians responding to the Medscape survey report spending 10 to 19 hours per week on paperwork; another 36% report spending 20 hours or more.³ This is almost identical to last year when the figures were 38% and 32%, respectively. However, the trend in the last few years has been dramatic. In 2017, the total percentage of physicians spending 10 of more hours on paperwork per week was 57%, compared with this year’s 74%.³
 

The frequency of drug shortages in the United States has considerably increased over the last decade, affecting different areas of health care practice.^1,2 Basic products needed to care for patients in hospitals and clinics are many of the same drugs that are in short supply.³ This issue has become an ongoing public health concern that directly affects health care providers and their patients.⁴ In dermatology, similar to other specialties, success often is influenced by the efficacy of medications used to treat patients, and lack of appropriate medications has the potential to diminish health outcomes. Therefore, it is imperative for dermatology providers to recognize the factors that contribute to this issue, understand the effects of drug shortages on patients, and learn how they can improve stewardship of scarce resources and contribute to the solution.

Causes of Drug Shortages

Drug shortages can occur due to discontinuations, delays, or manufacturing and quality problems.⁵ Shortages of the most basic hospital products represent market failure.¹ In such cases, a small number of manufacturers supply these products, and if a manufacturer discontinues a particular product—as in the case of lidocaine with epinephrine—a shortage results, as the current system does not have the capacity to deal with such as issue.^1,6

An important playmaker affecting the market for medical supplies and drugs are group purchasing organizations (GPOs). The 4 largest GPOs in the United States account for 90% of the medical supply market.⁷ Although they have simplified the process for hospitals to purchase supplies by taking on the work and expense of dealing with hundreds of manufacturers, GPOs have considerable power to affect the supply chain. By allowing certain manufacturers to become the sole suppliers of products in return for premium fees, GPOs have narrowed the supply chain of key products to sometimes only 1 or 2 manufacturers.⁷ This practice may lead to decreased capacity of regional and national supply chains, setting up the system to eventual product shortage in scenarios of production problems or a decrease in the already limited number of manufacturers.

The US Food and Drug Administration (FDA) works closely with manufacturers to prevent or reduce the impact of drug shortages. Although the FDA recently has taken more action to address the issue, solutions such as allowing imported products and underlying or approving new suppliers are only temporary fixes.¹ The root of the problem needs to be dealt with by ensuring there is a broad competitive supply chain.

Impact on Dermatologists

The nationwide shortage of lidocaine with epinephrine that occurred in 2017 is a specific example of how drug shortages affect dermatologists.⁶ This product is used in the typical dermatology clinic on a daily basis for biopsies. Possible solutions to decrease usage include drawing up 1.5 mL lidocaine with epinephrine instead of 3 mL and mixing readily available normal saline with lidocaine to produce a 1:200,000 mixture to yield a 0.5% concentration that still maintains good vasoconstrictor effects. Options for dermatologists who run out of lidocaine with epinephrine are to either use lidocaine without epinephrine, which disrupts optimal patient care, or to purchase 1% lidocaine with epinephrine at a much higher cost.⁶ A study that analyzed changes in drug pricing following shortages in the United States indicated that prices of drugs facing a shortage increased more than twice as quickly as expected between 2015 and 2016 vs those that were not in shortage, which may reflect opportunistic behaviors of drug manufacturers during shortages.⁸

The American Academy of Dermatology Association has created a letter and encouraged patients to notify their lawmakers about the severity of the drug shortage issue. Given the shortage of local anesthetics and their importance to the practice of dermatology, the American Academy of Dermatology Association also has created guidelines discussing local anesthetics that could be an alternative to lidocaine for office-based dermatologic surgery.⁹

Final Thoughts

Dermatology practitioners should be aware of current shortages impacting their practice and address the potential shortage proactively. We propose that dermatology clinics should keep an emergency reservoir of products routinely used in practice that currently are on the FDA drug shortage list, particularly lidocaine hydrochloride (with and without epinephrine) and sodium bicarbonate,¹⁰ which may diminish the negative impact a shortage may have on the high quality of health care we strive to provide. On a bigger scale, providers should be more proactive to have their voices heard and get involved with policymaking given the potential for patient harm and suboptimal care associated with drug shortages.

The frequency of drug shortages in the United States has considerably increased over the last decade, affecting different areas of health care practice.^1,2 Basic products needed to care for patients in hospitals and clinics are many of the same drugs that are in short supply.³ This issue has become an ongoing public health concern that directly affects health care providers and their patients.⁴ In dermatology, similar to other specialties, success often is influenced by the efficacy of medications used to treat patients, and lack of appropriate medications has the potential to diminish health outcomes. Therefore, it is imperative for dermatology providers to recognize the factors that contribute to this issue, understand the effects of drug shortages on patients, and learn how they can improve stewardship of scarce resources and contribute to the solution.

Causes of Drug Shortages

Drug shortages can occur due to discontinuations, delays, or manufacturing and quality problems.⁵ Shortages of the most basic hospital products represent market failure.¹ In such cases, a small number of manufacturers supply these products, and if a manufacturer discontinues a particular product—as in the case of lidocaine with epinephrine—a shortage results, as the current system does not have the capacity to deal with such as issue.^1,6

An important playmaker affecting the market for medical supplies and drugs are group purchasing organizations (GPOs). The 4 largest GPOs in the United States account for 90% of the medical supply market.⁷ Although they have simplified the process for hospitals to purchase supplies by taking on the work and expense of dealing with hundreds of manufacturers, GPOs have considerable power to affect the supply chain. By allowing certain manufacturers to become the sole suppliers of products in return for premium fees, GPOs have narrowed the supply chain of key products to sometimes only 1 or 2 manufacturers.⁷ This practice may lead to decreased capacity of regional and national supply chains, setting up the system to eventual product shortage in scenarios of production problems or a decrease in the already limited number of manufacturers.

The US Food and Drug Administration (FDA) works closely with manufacturers to prevent or reduce the impact of drug shortages. Although the FDA recently has taken more action to address the issue, solutions such as allowing imported products and underlying or approving new suppliers are only temporary fixes.¹ The root of the problem needs to be dealt with by ensuring there is a broad competitive supply chain.

Impact on Dermatologists

The nationwide shortage of lidocaine with epinephrine that occurred in 2017 is a specific example of how drug shortages affect dermatologists.⁶ This product is used in the typical dermatology clinic on a daily basis for biopsies. Possible solutions to decrease usage include drawing up 1.5 mL lidocaine with epinephrine instead of 3 mL and mixing readily available normal saline with lidocaine to produce a 1:200,000 mixture to yield a 0.5% concentration that still maintains good vasoconstrictor effects. Options for dermatologists who run out of lidocaine with epinephrine are to either use lidocaine without epinephrine, which disrupts optimal patient care, or to purchase 1% lidocaine with epinephrine at a much higher cost.⁶ A study that analyzed changes in drug pricing following shortages in the United States indicated that prices of drugs facing a shortage increased more than twice as quickly as expected between 2015 and 2016 vs those that were not in shortage, which may reflect opportunistic behaviors of drug manufacturers during shortages.⁸

The American Academy of Dermatology Association has created a letter and encouraged patients to notify their lawmakers about the severity of the drug shortage issue. Given the shortage of local anesthetics and their importance to the practice of dermatology, the American Academy of Dermatology Association also has created guidelines discussing local anesthetics that could be an alternative to lidocaine for office-based dermatologic surgery.⁹

Final Thoughts

Dermatology practitioners should be aware of current shortages impacting their practice and address the potential shortage proactively. We propose that dermatology clinics should keep an emergency reservoir of products routinely used in practice that currently are on the FDA drug shortage list, particularly lidocaine hydrochloride (with and without epinephrine) and sodium bicarbonate,¹⁰ which may diminish the negative impact a shortage may have on the high quality of health care we strive to provide. On a bigger scale, providers should be more proactive to have their voices heard and get involved with policymaking given the potential for patient harm and suboptimal care associated with drug shortages.

The frequency of drug shortages in the United States has considerably increased over the last decade, affecting different areas of health care practice.^1,2 Basic products needed to care for patients in hospitals and clinics are many of the same drugs that are in short supply.³ This issue has become an ongoing public health concern that directly affects health care providers and their patients.⁴ In dermatology, similar to other specialties, success often is influenced by the efficacy of medications used to treat patients, and lack of appropriate medications has the potential to diminish health outcomes. Therefore, it is imperative for dermatology providers to recognize the factors that contribute to this issue, understand the effects of drug shortages on patients, and learn how they can improve stewardship of scarce resources and contribute to the solution.

Causes of Drug Shortages

Drug shortages can occur due to discontinuations, delays, or manufacturing and quality problems.⁵ Shortages of the most basic hospital products represent market failure.¹ In such cases, a small number of manufacturers supply these products, and if a manufacturer discontinues a particular product—as in the case of lidocaine with epinephrine—a shortage results, as the current system does not have the capacity to deal with such as issue.^1,6

An important playmaker affecting the market for medical supplies and drugs are group purchasing organizations (GPOs). The 4 largest GPOs in the United States account for 90% of the medical supply market.⁷ Although they have simplified the process for hospitals to purchase supplies by taking on the work and expense of dealing with hundreds of manufacturers, GPOs have considerable power to affect the supply chain. By allowing certain manufacturers to become the sole suppliers of products in return for premium fees, GPOs have narrowed the supply chain of key products to sometimes only 1 or 2 manufacturers.⁷ This practice may lead to decreased capacity of regional and national supply chains, setting up the system to eventual product shortage in scenarios of production problems or a decrease in the already limited number of manufacturers.

The US Food and Drug Administration (FDA) works closely with manufacturers to prevent or reduce the impact of drug shortages. Although the FDA recently has taken more action to address the issue, solutions such as allowing imported products and underlying or approving new suppliers are only temporary fixes.¹ The root of the problem needs to be dealt with by ensuring there is a broad competitive supply chain.

Impact on Dermatologists

The nationwide shortage of lidocaine with epinephrine that occurred in 2017 is a specific example of how drug shortages affect dermatologists.⁶ This product is used in the typical dermatology clinic on a daily basis for biopsies. Possible solutions to decrease usage include drawing up 1.5 mL lidocaine with epinephrine instead of 3 mL and mixing readily available normal saline with lidocaine to produce a 1:200,000 mixture to yield a 0.5% concentration that still maintains good vasoconstrictor effects. Options for dermatologists who run out of lidocaine with epinephrine are to either use lidocaine without epinephrine, which disrupts optimal patient care, or to purchase 1% lidocaine with epinephrine at a much higher cost.⁶ A study that analyzed changes in drug pricing following shortages in the United States indicated that prices of drugs facing a shortage increased more than twice as quickly as expected between 2015 and 2016 vs those that were not in shortage, which may reflect opportunistic behaviors of drug manufacturers during shortages.⁸

The American Academy of Dermatology Association has created a letter and encouraged patients to notify their lawmakers about the severity of the drug shortage issue. Given the shortage of local anesthetics and their importance to the practice of dermatology, the American Academy of Dermatology Association also has created guidelines discussing local anesthetics that could be an alternative to lidocaine for office-based dermatologic surgery.⁹

Final Thoughts

Dermatology practitioners should be aware of current shortages impacting their practice and address the potential shortage proactively. We propose that dermatology clinics should keep an emergency reservoir of products routinely used in practice that currently are on the FDA drug shortage list, particularly lidocaine hydrochloride (with and without epinephrine) and sodium bicarbonate,¹⁰ which may diminish the negative impact a shortage may have on the high quality of health care we strive to provide. On a bigger scale, providers should be more proactive to have their voices heard and get involved with policymaking given the potential for patient harm and suboptimal care associated with drug shortages.

The VA currently stipulates a 3-month maximum dispensing limit for all medications, including oral contraceptive pills (OCPs). But a 12-month cycle for OCPs improves adherence, reduces coverage gaps, and reduces unintended pregnancy, say researchers from University of Pittsburgh and the VA Pittsburgh Health Care System, both in Pennsylvania. Not only that, they add, the VA could save > $2 million a year.

OCPs are among the most commonly used methods of contraception among women veterans. VA data indicate that 43% of women dispensed 3-month supplies experience ≤ 1 gap of ≤ 7 days between refills during a year of use. Citing research that has found women on 12-month dispensing cycles have fewer gaps, which leads to fewer unintended pregnancies and abortions. US guidelines now recommend routine initial dispensing of up to 1-year supplies of hormonal contraception.

However, the financial consequences for such a switch in the VA were unclear, the researchers say. To find out, they developed a decision analysis model from the VA perspective to compare incremental costs of a 12-month supply vs a 3-month supply dispensed quarterly. Basing their model on a cohort of 24,309 women, the researchers looked at the effects of each strategy on resulting coverage gaps, discontinuation of OCPs, pregnancy, birth, miscarriage, and abortion.  

The model projected that the 12-month system would reduce unintended pregnancies by 14%, or 583 unintended pregnancies averted annually—a conservative estimate, the researchers say.

Overall, the model estimated total savings of > $2 million annually.

Their results suggest obvious financial benefits for the VA—for example, less money spent on intrapartum care, the researchers say. But they add, “it is vital that contraceptive policies serve first and foremost to augment women’s reproductive outcomes and autonomy.” They highlight the potential financial gains as a “secondary benefit to the more important and evidence-based goal of improving contraceptive access.”

The VA currently stipulates a 3-month maximum dispensing limit for all medications, including oral contraceptive pills (OCPs). But a 12-month cycle for OCPs improves adherence, reduces coverage gaps, and reduces unintended pregnancy, say researchers from University of Pittsburgh and the VA Pittsburgh Health Care System, both in Pennsylvania. Not only that, they add, the VA could save > $2 million a year.

OCPs are among the most commonly used methods of contraception among women veterans. VA data indicate that 43% of women dispensed 3-month supplies experience ≤ 1 gap of ≤ 7 days between refills during a year of use. Citing research that has found women on 12-month dispensing cycles have fewer gaps, which leads to fewer unintended pregnancies and abortions. US guidelines now recommend routine initial dispensing of up to 1-year supplies of hormonal contraception.

However, the financial consequences for such a switch in the VA were unclear, the researchers say. To find out, they developed a decision analysis model from the VA perspective to compare incremental costs of a 12-month supply vs a 3-month supply dispensed quarterly. Basing their model on a cohort of 24,309 women, the researchers looked at the effects of each strategy on resulting coverage gaps, discontinuation of OCPs, pregnancy, birth, miscarriage, and abortion.  

The model projected that the 12-month system would reduce unintended pregnancies by 14%, or 583 unintended pregnancies averted annually—a conservative estimate, the researchers say.

Overall, the model estimated total savings of > $2 million annually.

Their results suggest obvious financial benefits for the VA—for example, less money spent on intrapartum care, the researchers say. But they add, “it is vital that contraceptive policies serve first and foremost to augment women’s reproductive outcomes and autonomy.” They highlight the potential financial gains as a “secondary benefit to the more important and evidence-based goal of improving contraceptive access.”

The VA currently stipulates a 3-month maximum dispensing limit for all medications, including oral contraceptive pills (OCPs). But a 12-month cycle for OCPs improves adherence, reduces coverage gaps, and reduces unintended pregnancy, say researchers from University of Pittsburgh and the VA Pittsburgh Health Care System, both in Pennsylvania. Not only that, they add, the VA could save > $2 million a year.

OCPs are among the most commonly used methods of contraception among women veterans. VA data indicate that 43% of women dispensed 3-month supplies experience ≤ 1 gap of ≤ 7 days between refills during a year of use. Citing research that has found women on 12-month dispensing cycles have fewer gaps, which leads to fewer unintended pregnancies and abortions. US guidelines now recommend routine initial dispensing of up to 1-year supplies of hormonal contraception.

However, the financial consequences for such a switch in the VA were unclear, the researchers say. To find out, they developed a decision analysis model from the VA perspective to compare incremental costs of a 12-month supply vs a 3-month supply dispensed quarterly. Basing their model on a cohort of 24,309 women, the researchers looked at the effects of each strategy on resulting coverage gaps, discontinuation of OCPs, pregnancy, birth, miscarriage, and abortion.  

The model projected that the 12-month system would reduce unintended pregnancies by 14%, or 583 unintended pregnancies averted annually—a conservative estimate, the researchers say.

Overall, the model estimated total savings of > $2 million annually.

Their results suggest obvious financial benefits for the VA—for example, less money spent on intrapartum care, the researchers say. But they add, “it is vital that contraceptive policies serve first and foremost to augment women’s reproductive outcomes and autonomy.” They highlight the potential financial gains as a “secondary benefit to the more important and evidence-based goal of improving contraceptive access.”

Study Overview

Objective. To examine whether receiving primary care is associated with receipt of high-value services and low-value services and quality of patient experience.

Design. Secondary data analysis of the Medical Expenditure Panel Survey, which is an annual survey of a nationally representative sample of noninstitutionalized adults in the United States aged ≥ 18 years drawn from the National Health Interview Survey. The study used data from 2012 to 2014, and during these years the survey had a response rate ranging from 49% to 65%. The survey collected data through computer-assisted personal interviews and included data on demographic characteristics, health conditions, health status, medical services utilization, medications, costs, and experience with care. Between 21,905 and 26,509 respondents were surveyed each year.

To define whether a respondent received primary care, respondents were asked if they have a “usual source of care” and to provide the name of a physician they usually visit if they “are sick or need advice” about their health. Four additional questions asked respondents if they would visit their usual source of care for (1) “new health problems,” (2) “preventive health care such as general checkups, examinations, and immunizations,” (3) “ongoing health problems,” and (4) “referrals to other health professionals when needed.” These questions were intended to reflect the essential functions of primary care: providing first contact care that is comprehensive, continuous, and coordinated. Any respondents who indicated that they did not have a usual source of care or answered no to any of the 4 questions were considered to not have primary care. Among respondents who identified a usual source of care, 95% met criteria for having primary care.

Setting and participants. The study included 49,286 US adults with primary care and 21,133 US adults without primary care. The average age was 50 years (95% confidence interval [CI], 50-51) among those with primary care and 38 years (95% CI, 38-39) among those without primary care. Among those who had primary care, 55% were female, 50% were non-Hispanic white, 32% Hispanic, and 13% black; among those without primary care, 43% were female, 43% were non-Hispanic white, 35% Hispanic, and 13% black. Among respondents with primary care, 58% considered their health status to be excellent or very good, as compared with 66% of respondents without primary care. Lack of insurance was reported by 7% of respondents with primary care and 34% of respondents without primary care. Chronic disease was reported in 78% of respondents without primary care, as compared with 42% of respondents with primary care. The study uses propensity score matching methods to produce a matched cohort, taking into account potential confounders. The matching procedure resulted in a final sample of 43,766 respondents with primary care matched to 17,964 respondents without primary care.

Main outcome measures. Main study outcome measures included 39 quality measures aggregated into quality composites (6 high-value services and 4 low-value services), and 7 patient care experience measures aggregated into an overall patient experience rating and 2 experience composites. High-value services are defined as delivery of services that are likely of benefit, and include the use of recommended cancer screening such as colorectal cancer screening in appropriate age groups; recommended diagnostic and preventive testing such as cholesterol measurement and influenza vaccination; recommended diabetes care such as hemoglobin A1c measurement; recommended medical treatment for medical conditions such as heart failure, coronary artery disease, and chronic obstructive pulmonary disease; and recommended counseling such as smoking cessation. Low-value services are defined as delivery of services that are considered either inappropriate or of little to no benefit, and include cancer screening in older adults; inappropriate use of antibiotics such as for bronchitis; inappropriate medical treatment such as anxiolytic, sedative, or hypnotic prescriptions for older adults; and inappropriate imaging tests for certain conditions.

Composites of underuse (high-value care) and overuse (low-value care) were constructed from each measure of high- or low-value services by identifying respondents who were eligible for the measure and determining the proportion in which recommended care was delivered (for high-value measures) or avoided (for low-value measures). Patient care experience was measured by standardized CAHPS (Consumer Assessment of Healthcare Providers and Systems) measurement for global rating of health care, doctor communication, and access to care. The patient care experience measures were dichotomized into positive responses as a rating of 8, 9, or 10 on items scored from 0 to 10, and 4 for items scored from 1 to 4. The experience composite was constructed by computing the mean for each respondent and then the mean for all respondents.

Main results. The study found that respondents with primary care were more likely to receive high-value care in 4 of 5 composite measures—cancer screening, diagnostic and preventive testing, diabetes care, and recommended counseling such as smoking cessation—but not in the composite recommended treatment for specific medical conditions such as heart failure. Respondents with primary care were more likely to receive recommended cancer screening, as compared to those without primary care (78% vs 67%, respectively, with a difference of 10.8%; 95% CI, 8.5%-13.0%). Respondents with primary care were also more likely to receive recommended diagnostic and preventive testing (with a difference of 9.9%; 95% CI, 8.7%-11.2%), to receive high-value diabetes care (with a difference of 7.8%; 95% CI, 1.2%-14.4%), and to receive counselling (with a difference of 6.9%; 95% CI, 4.1%-9.7%) when compared to respondents without primary care. However the rates of receipt of high-value medical treatments were similar among respondents with or without primary care (with a difference of –4.6% (95% CI, –14.3% to 5.0%). In contrast, rates of low-value care were similar for those with or without primary care in 3 of 4 composites, including low-value cancer screening, medical treatment, and imaging, while those with primary care had higher rates of low-value antibiotic use (with a difference of 11.0%; 95% CI, 2.8%-19.3%). Respondents with primary care reported better patient care experience, including global rating of their health care, physician communication, and access to care, when compared to those without primary care.

Conclusion. Receipt of primary care is associated with a better patient care experience, more high-value care, and slightly more low-value care.

Commentary

Primary care has long been considered the bedrock of modern health care, and the delivery of comprehensive, continuous, high-quality primary care yields benefits to patients and the health care system.¹ Primary care is associated with better outcomes, such as lower mortality and reduced rates of potentially avoidable hospitalizations, and people living in areas with higher concentrations of primary care are more likely to report better health.² Primary care is also associated with reductions in health care cost and utilization while maintaining quality.² The current study adds to what is known about the potential benefits of primary care by directly examining the association of the use of primary care versus no primary care with outcomes of high-value care, low-value care, and patient care experience. Because this study used nationally representative data, it was able to examine adults in all age groups, not only older adults in Medicare, which prior studies have relied on.³ The study’s findings—that adults seen in primary care receive more high-value care and report better care experiences—are not surprising. The study also found that slightly more low-value care is being delivered in primary care. These findings are consistent with prior studies. Also, although primary care overall may be associated with health care benefits, there is substantial variation in the rates of overuse (of low-value care) and underuse (of high-value care) in primary care, and this may represent opportunities for improvement.⁴

This study has several limitations. Because the study defined primary care using questions that identify essential elements of primary care—first contact, comprehensiveness, continuity, and coordinated care—the findings may not apply to all individuals who have identified a primary care provider, but only to those who experience comprehensive, continuous, and coordinated care. Inclusion of all individuals who identify a usual source of primary care as the sole criteria may attenuate the association of primary care with the outcome measures. It is, however, reassuring that among those who identified a usual source of care (primary care), 95% indicated that they have care that is consistent with the principles of first contact care, comprehensiveness, continuity, and coordinated care. Another limitation is that the use of the criteria to indicate high- or low-value care may not capture the nuances of patient-centered care, preferences, or individualized decision-making that occurs in clinical care. Nonetheless, definitions used in the study for high- and low-value care are consistent with prior literature, and offer a standardized measure to indicate quality of care.

Applications for Clinical Practice

A recent trend in health care is the shift of continuity of care from primary care providers or practices to facility-based care or no continuity of care at all, and this shift disproportionately affects patients with low income and is associated with more emergency room visits.⁵ The current study makes a strong case for the potential benefits of receiving primary care that is comprehensive, continuous, and coordinated, as patients in primary care are more likely to receive high-value over low-value care, and to have a better care experience. The ongoing debate on changes to the health care system and insurance options must take into account the impact of any changes on the population receiving primary care coverage, with the goal that more, rather than fewer, individuals realize the potential benefits of comprehensive primary care.

— William W. Hung, MD MPH

Study Overview

Objective. To examine whether receiving primary care is associated with receipt of high-value services and low-value services and quality of patient experience.

Design. Secondary data analysis of the Medical Expenditure Panel Survey, which is an annual survey of a nationally representative sample of noninstitutionalized adults in the United States aged ≥ 18 years drawn from the National Health Interview Survey. The study used data from 2012 to 2014, and during these years the survey had a response rate ranging from 49% to 65%. The survey collected data through computer-assisted personal interviews and included data on demographic characteristics, health conditions, health status, medical services utilization, medications, costs, and experience with care. Between 21,905 and 26,509 respondents were surveyed each year.

To define whether a respondent received primary care, respondents were asked if they have a “usual source of care” and to provide the name of a physician they usually visit if they “are sick or need advice” about their health. Four additional questions asked respondents if they would visit their usual source of care for (1) “new health problems,” (2) “preventive health care such as general checkups, examinations, and immunizations,” (3) “ongoing health problems,” and (4) “referrals to other health professionals when needed.” These questions were intended to reflect the essential functions of primary care: providing first contact care that is comprehensive, continuous, and coordinated. Any respondents who indicated that they did not have a usual source of care or answered no to any of the 4 questions were considered to not have primary care. Among respondents who identified a usual source of care, 95% met criteria for having primary care.

Setting and participants. The study included 49,286 US adults with primary care and 21,133 US adults without primary care. The average age was 50 years (95% confidence interval [CI], 50-51) among those with primary care and 38 years (95% CI, 38-39) among those without primary care. Among those who had primary care, 55% were female, 50% were non-Hispanic white, 32% Hispanic, and 13% black; among those without primary care, 43% were female, 43% were non-Hispanic white, 35% Hispanic, and 13% black. Among respondents with primary care, 58% considered their health status to be excellent or very good, as compared with 66% of respondents without primary care. Lack of insurance was reported by 7% of respondents with primary care and 34% of respondents without primary care. Chronic disease was reported in 78% of respondents without primary care, as compared with 42% of respondents with primary care. The study uses propensity score matching methods to produce a matched cohort, taking into account potential confounders. The matching procedure resulted in a final sample of 43,766 respondents with primary care matched to 17,964 respondents without primary care.

Main outcome measures. Main study outcome measures included 39 quality measures aggregated into quality composites (6 high-value services and 4 low-value services), and 7 patient care experience measures aggregated into an overall patient experience rating and 2 experience composites. High-value services are defined as delivery of services that are likely of benefit, and include the use of recommended cancer screening such as colorectal cancer screening in appropriate age groups; recommended diagnostic and preventive testing such as cholesterol measurement and influenza vaccination; recommended diabetes care such as hemoglobin A1c measurement; recommended medical treatment for medical conditions such as heart failure, coronary artery disease, and chronic obstructive pulmonary disease; and recommended counseling such as smoking cessation. Low-value services are defined as delivery of services that are considered either inappropriate or of little to no benefit, and include cancer screening in older adults; inappropriate use of antibiotics such as for bronchitis; inappropriate medical treatment such as anxiolytic, sedative, or hypnotic prescriptions for older adults; and inappropriate imaging tests for certain conditions.

Composites of underuse (high-value care) and overuse (low-value care) were constructed from each measure of high- or low-value services by identifying respondents who were eligible for the measure and determining the proportion in which recommended care was delivered (for high-value measures) or avoided (for low-value measures). Patient care experience was measured by standardized CAHPS (Consumer Assessment of Healthcare Providers and Systems) measurement for global rating of health care, doctor communication, and access to care. The patient care experience measures were dichotomized into positive responses as a rating of 8, 9, or 10 on items scored from 0 to 10, and 4 for items scored from 1 to 4. The experience composite was constructed by computing the mean for each respondent and then the mean for all respondents.

Main results. The study found that respondents with primary care were more likely to receive high-value care in 4 of 5 composite measures—cancer screening, diagnostic and preventive testing, diabetes care, and recommended counseling such as smoking cessation—but not in the composite recommended treatment for specific medical conditions such as heart failure. Respondents with primary care were more likely to receive recommended cancer screening, as compared to those without primary care (78% vs 67%, respectively, with a difference of 10.8%; 95% CI, 8.5%-13.0%). Respondents with primary care were also more likely to receive recommended diagnostic and preventive testing (with a difference of 9.9%; 95% CI, 8.7%-11.2%), to receive high-value diabetes care (with a difference of 7.8%; 95% CI, 1.2%-14.4%), and to receive counselling (with a difference of 6.9%; 95% CI, 4.1%-9.7%) when compared to respondents without primary care. However the rates of receipt of high-value medical treatments were similar among respondents with or without primary care (with a difference of –4.6% (95% CI, –14.3% to 5.0%). In contrast, rates of low-value care were similar for those with or without primary care in 3 of 4 composites, including low-value cancer screening, medical treatment, and imaging, while those with primary care had higher rates of low-value antibiotic use (with a difference of 11.0%; 95% CI, 2.8%-19.3%). Respondents with primary care reported better patient care experience, including global rating of their health care, physician communication, and access to care, when compared to those without primary care.

Conclusion. Receipt of primary care is associated with a better patient care experience, more high-value care, and slightly more low-value care.

Commentary

Primary care has long been considered the bedrock of modern health care, and the delivery of comprehensive, continuous, high-quality primary care yields benefits to patients and the health care system.¹ Primary care is associated with better outcomes, such as lower mortality and reduced rates of potentially avoidable hospitalizations, and people living in areas with higher concentrations of primary care are more likely to report better health.² Primary care is also associated with reductions in health care cost and utilization while maintaining quality.² The current study adds to what is known about the potential benefits of primary care by directly examining the association of the use of primary care versus no primary care with outcomes of high-value care, low-value care, and patient care experience. Because this study used nationally representative data, it was able to examine adults in all age groups, not only older adults in Medicare, which prior studies have relied on.³ The study’s findings—that adults seen in primary care receive more high-value care and report better care experiences—are not surprising. The study also found that slightly more low-value care is being delivered in primary care. These findings are consistent with prior studies. Also, although primary care overall may be associated with health care benefits, there is substantial variation in the rates of overuse (of low-value care) and underuse (of high-value care) in primary care, and this may represent opportunities for improvement.⁴

This study has several limitations. Because the study defined primary care using questions that identify essential elements of primary care—first contact, comprehensiveness, continuity, and coordinated care—the findings may not apply to all individuals who have identified a primary care provider, but only to those who experience comprehensive, continuous, and coordinated care. Inclusion of all individuals who identify a usual source of primary care as the sole criteria may attenuate the association of primary care with the outcome measures. It is, however, reassuring that among those who identified a usual source of care (primary care), 95% indicated that they have care that is consistent with the principles of first contact care, comprehensiveness, continuity, and coordinated care. Another limitation is that the use of the criteria to indicate high- or low-value care may not capture the nuances of patient-centered care, preferences, or individualized decision-making that occurs in clinical care. Nonetheless, definitions used in the study for high- and low-value care are consistent with prior literature, and offer a standardized measure to indicate quality of care.

Applications for Clinical Practice

A recent trend in health care is the shift of continuity of care from primary care providers or practices to facility-based care or no continuity of care at all, and this shift disproportionately affects patients with low income and is associated with more emergency room visits.⁵ The current study makes a strong case for the potential benefits of receiving primary care that is comprehensive, continuous, and coordinated, as patients in primary care are more likely to receive high-value over low-value care, and to have a better care experience. The ongoing debate on changes to the health care system and insurance options must take into account the impact of any changes on the population receiving primary care coverage, with the goal that more, rather than fewer, individuals realize the potential benefits of comprehensive primary care.

— William W. Hung, MD MPH

Study Overview

Objective. To examine whether receiving primary care is associated with receipt of high-value services and low-value services and quality of patient experience.

Design. Secondary data analysis of the Medical Expenditure Panel Survey, which is an annual survey of a nationally representative sample of noninstitutionalized adults in the United States aged ≥ 18 years drawn from the National Health Interview Survey. The study used data from 2012 to 2014, and during these years the survey had a response rate ranging from 49% to 65%. The survey collected data through computer-assisted personal interviews and included data on demographic characteristics, health conditions, health status, medical services utilization, medications, costs, and experience with care. Between 21,905 and 26,509 respondents were surveyed each year.

To define whether a respondent received primary care, respondents were asked if they have a “usual source of care” and to provide the name of a physician they usually visit if they “are sick or need advice” about their health. Four additional questions asked respondents if they would visit their usual source of care for (1) “new health problems,” (2) “preventive health care such as general checkups, examinations, and immunizations,” (3) “ongoing health problems,” and (4) “referrals to other health professionals when needed.” These questions were intended to reflect the essential functions of primary care: providing first contact care that is comprehensive, continuous, and coordinated. Any respondents who indicated that they did not have a usual source of care or answered no to any of the 4 questions were considered to not have primary care. Among respondents who identified a usual source of care, 95% met criteria for having primary care.

Setting and participants. The study included 49,286 US adults with primary care and 21,133 US adults without primary care. The average age was 50 years (95% confidence interval [CI], 50-51) among those with primary care and 38 years (95% CI, 38-39) among those without primary care. Among those who had primary care, 55% were female, 50% were non-Hispanic white, 32% Hispanic, and 13% black; among those without primary care, 43% were female, 43% were non-Hispanic white, 35% Hispanic, and 13% black. Among respondents with primary care, 58% considered their health status to be excellent or very good, as compared with 66% of respondents without primary care. Lack of insurance was reported by 7% of respondents with primary care and 34% of respondents without primary care. Chronic disease was reported in 78% of respondents without primary care, as compared with 42% of respondents with primary care. The study uses propensity score matching methods to produce a matched cohort, taking into account potential confounders. The matching procedure resulted in a final sample of 43,766 respondents with primary care matched to 17,964 respondents without primary care.

Main outcome measures. Main study outcome measures included 39 quality measures aggregated into quality composites (6 high-value services and 4 low-value services), and 7 patient care experience measures aggregated into an overall patient experience rating and 2 experience composites. High-value services are defined as delivery of services that are likely of benefit, and include the use of recommended cancer screening such as colorectal cancer screening in appropriate age groups; recommended diagnostic and preventive testing such as cholesterol measurement and influenza vaccination; recommended diabetes care such as hemoglobin A1c measurement; recommended medical treatment for medical conditions such as heart failure, coronary artery disease, and chronic obstructive pulmonary disease; and recommended counseling such as smoking cessation. Low-value services are defined as delivery of services that are considered either inappropriate or of little to no benefit, and include cancer screening in older adults; inappropriate use of antibiotics such as for bronchitis; inappropriate medical treatment such as anxiolytic, sedative, or hypnotic prescriptions for older adults; and inappropriate imaging tests for certain conditions.

Composites of underuse (high-value care) and overuse (low-value care) were constructed from each measure of high- or low-value services by identifying respondents who were eligible for the measure and determining the proportion in which recommended care was delivered (for high-value measures) or avoided (for low-value measures). Patient care experience was measured by standardized CAHPS (Consumer Assessment of Healthcare Providers and Systems) measurement for global rating of health care, doctor communication, and access to care. The patient care experience measures were dichotomized into positive responses as a rating of 8, 9, or 10 on items scored from 0 to 10, and 4 for items scored from 1 to 4. The experience composite was constructed by computing the mean for each respondent and then the mean for all respondents.

Main results. The study found that respondents with primary care were more likely to receive high-value care in 4 of 5 composite measures—cancer screening, diagnostic and preventive testing, diabetes care, and recommended counseling such as smoking cessation—but not in the composite recommended treatment for specific medical conditions such as heart failure. Respondents with primary care were more likely to receive recommended cancer screening, as compared to those without primary care (78% vs 67%, respectively, with a difference of 10.8%; 95% CI, 8.5%-13.0%). Respondents with primary care were also more likely to receive recommended diagnostic and preventive testing (with a difference of 9.9%; 95% CI, 8.7%-11.2%), to receive high-value diabetes care (with a difference of 7.8%; 95% CI, 1.2%-14.4%), and to receive counselling (with a difference of 6.9%; 95% CI, 4.1%-9.7%) when compared to respondents without primary care. However the rates of receipt of high-value medical treatments were similar among respondents with or without primary care (with a difference of –4.6% (95% CI, –14.3% to 5.0%). In contrast, rates of low-value care were similar for those with or without primary care in 3 of 4 composites, including low-value cancer screening, medical treatment, and imaging, while those with primary care had higher rates of low-value antibiotic use (with a difference of 11.0%; 95% CI, 2.8%-19.3%). Respondents with primary care reported better patient care experience, including global rating of their health care, physician communication, and access to care, when compared to those without primary care.

Conclusion. Receipt of primary care is associated with a better patient care experience, more high-value care, and slightly more low-value care.

Commentary

Primary care has long been considered the bedrock of modern health care, and the delivery of comprehensive, continuous, high-quality primary care yields benefits to patients and the health care system.¹ Primary care is associated with better outcomes, such as lower mortality and reduced rates of potentially avoidable hospitalizations, and people living in areas with higher concentrations of primary care are more likely to report better health.² Primary care is also associated with reductions in health care cost and utilization while maintaining quality.² The current study adds to what is known about the potential benefits of primary care by directly examining the association of the use of primary care versus no primary care with outcomes of high-value care, low-value care, and patient care experience. Because this study used nationally representative data, it was able to examine adults in all age groups, not only older adults in Medicare, which prior studies have relied on.³ The study’s findings—that adults seen in primary care receive more high-value care and report better care experiences—are not surprising. The study also found that slightly more low-value care is being delivered in primary care. These findings are consistent with prior studies. Also, although primary care overall may be associated with health care benefits, there is substantial variation in the rates of overuse (of low-value care) and underuse (of high-value care) in primary care, and this may represent opportunities for improvement.⁴

This study has several limitations. Because the study defined primary care using questions that identify essential elements of primary care—first contact, comprehensiveness, continuity, and coordinated care—the findings may not apply to all individuals who have identified a primary care provider, but only to those who experience comprehensive, continuous, and coordinated care. Inclusion of all individuals who identify a usual source of primary care as the sole criteria may attenuate the association of primary care with the outcome measures. It is, however, reassuring that among those who identified a usual source of care (primary care), 95% indicated that they have care that is consistent with the principles of first contact care, comprehensiveness, continuity, and coordinated care. Another limitation is that the use of the criteria to indicate high- or low-value care may not capture the nuances of patient-centered care, preferences, or individualized decision-making that occurs in clinical care. Nonetheless, definitions used in the study for high- and low-value care are consistent with prior literature, and offer a standardized measure to indicate quality of care.

Applications for Clinical Practice

A recent trend in health care is the shift of continuity of care from primary care providers or practices to facility-based care or no continuity of care at all, and this shift disproportionately affects patients with low income and is associated with more emergency room visits.⁵ The current study makes a strong case for the potential benefits of receiving primary care that is comprehensive, continuous, and coordinated, as patients in primary care are more likely to receive high-value over low-value care, and to have a better care experience. The ongoing debate on changes to the health care system and insurance options must take into account the impact of any changes on the population receiving primary care coverage, with the goal that more, rather than fewer, individuals realize the potential benefits of comprehensive primary care.

— William W. Hung, MD MPH

The Affordable Care Act (ACA) was enacted on March 23, 2010. Controversies, complaints, and detractors have and continue to abound. But the ACA’s landmark women’s health gains are unmistakable. Contraceptive coverage, maternity coverage, Medicaid coverage of low-income women, coverage for individuals with preexisting conditions, and gender-neutral premiums are now a part of the fabric of our society. For most.

Many physicians and patients—many lawmakers, too—do not remember the serious problems people had with their insurance companies before the ACA. Maternity coverage was usually a free-standing rider to an insurance policy, making it very expensive. Insurance plans did not have to, and often did not, cover contraceptives, and none did without copays or deductibles. Women were routinely denied coverage if they had ever had a cesarean delivery, had once been the victim of domestic violence, or had any one of many common conditions, like diabetes. The many exclusionary conditions are so common, in fact, that one study estimated that around 52 million adults in the United States (27% of those younger than age 65 years) have preexisting conditions that would potentially make them uninsurable without the ACA’s protections.¹

Before the ACA, it also was common for women with insurance policies to find their coverage rescinded, often with no explanation, even though they paid their premiums every month. And women with serious medical conditions often saw their coverage ended midway through their course of treatment. That placed their ObGyns in a terrible situation, too.

The insurance industry as a whole was running rough-shod over its customers, and making a lot of money by creatively and routinely denying coverage and payment for care. People were often insured, but not covered. The ACA halted many of these practices, and required insurers to meet high medical loss ratios, guaranteeing that 80% of the premiums’ for individual and small market insurers (and 85% for large insurers) are returned to patients in care payments or even in checks. In fact, nearly $4 billion in premiums have been rebated to insured individuals over the last 7 years under the ACA.²

The commitment of the American College of Obstetricians and Gynecologists (ACOG) to women’s health and to our members’ ability to provide the best care has centered on preserving the critical gains of the ACA for women, improving them when we can, and making sure politicians don’t turn back the clock on women’s health. We have been busy.

In this article, we will look at what has happened to these landmark gains and promises of improved women’s health, specifically preexisting condition protections and contraceptive coverage, under a new Administration. What happens when good health care policy and political enmity collide?

Preexisting coverage protections

The 1996 Health Insurance Portability and Accountability Act (HIPAA) defines a preexisting condition exclusionas a “limitation or exclusion of benefits relating to a condition based on the fact that the condition was present before the date of enrollment for the coverage, whether or not any medical advice, diagnosis, care, or treatment was recommended or received before that date.” HIPPA prohibited employer-sponsored health plans from discriminating against individuals through denying them coverage or charging them more based on their or their family members’ health problems. The ACA expanded protections to prohibit the insurance practice of denying coverage altogether to an individual with a preexisting condition.³

Continue to: Under Congress...

Under Congress

Republicans held the majority in both chambers of the 115th Congress (2017–2018), and hoped to use their majority status to get an ACA repeal bill to the Republican President’s desk for speedy enactment. It was not easy, and they were not successful. Four major bills—the American Health Care Act, the Better Care Reconciliation Act, the Health Care Freedom Act, and the Graham-Cassidy Amendment—never made it over the finish line, with some not even making it to a vote. The Health Care Freedom Act was voted down in the Senate 51-49 when Senator John McCain came back from brain surgery to cast his famous thumbs-down vote.⁴ These bills all would have repealed or hobbled guaranteed issue, community rating, and essential health benefits of the ACA. Of all the legislative attempts to undermine the ACA, only the 2017 Tax Cuts and Jobs Act (TCJA) was signed into law, repealing the ACA individual mandate.

Handling by the courts

The TCJA gave ACA opponents their opening in court. Twenty Republican state attorneys general and governors brought suit in February 2018 (Texas v Azar), arguing that because the ACA relies on the mandate, and the mandate has been repealed, the rest of the ACA also should be struck down. A federal district judge agreed, on December 15, 2018, declaring the entire ACA unconstitutional.⁵

That decision has been limited in its practical effect so far, and maybe it was not altogether unexpected. What was unexpected was that the US Department of Justice (DOJ) refused to defend a federal law, in this case, the ACA. In June 2018, the DOJ declined to defend the individual mandate, as well as guaranteed issue, community rating, the ban on preexisting condition exclusions, and discrimination based on health status in the ACA. The DOJ at that time, however, did not agree with the plaintiffs that without the mandate the entire ACA should be struck down. It said, “There is no reason why the ACA’s particular expansion of Medicaid hinges on the individual mandate.” Later, after the December 15 ruling, the DOJ changed its position and agreed with the judge, in a two-sentence letter to the court, that the ACA should be stricken altogether—shortly after which 3 career DOJ attorneys resigned.⁶

A legal expert observed: “The DOJ’s decision not to defend the ACA breaks with the Department’s long-standing bipartisan commitment to defend federal laws if reasonable arguments can be made in their defense. Decisions not to defend federal law are exceedingly rare. It seems even rarer to change the government’s position mid-appeal in such a high-profile lawsuit that risks disrupting the entire health care system and health insurance coverage for millions of Americans.”⁷

Regulatory tactics

What a policy maker cannot do by law, he or she can try to accomplish by regulation. The Administration is using 3 regulatory routes to undercut the ACA preexisting coverage protections and market stability.

Route 1: Short-Term Limited Duration (STLD) plans. These plans were created in the ACA to provide bridge coverage for up to 3 months for individuals in between health insurance plans. These plans do not have to comply with ACA patient protections, can deny coverage for preexisting conditions, and do not cover maternity care. In 2018, the Administration moved to allow these plans to be marketed broadly and renewed for up to 3 years. Because these plans provide less coverage and often come with high deductibles, they can be marketed with lower premiums, skimming off healthier younger people who do not expect to need much care, as well as lower-income families. This destabilizes the market and leaves people insured but not covered, exactly the situation before the ACA. Seven public health and medical groups sued to challenge the Administration’s STLD regulation; the lawsuit is presently pending.

Continue to: Route 2: Association Health Plans (AHPs)...

Route 2: Association Health Plans (AHPs). The Administration also has allowed the sale of AHPs, marketed to small employers and self-employed individuals. These plans also do not have to comply with ACA consumer protections. They often do not cover maternity care or other essential benefits, and can charge women higher premiums for the same insurance. This regulation, too, resulted in litigation and a federal judge enjoined the rule, but the case is now on appeal.

Route 3: ACA Section 1332 waivers. These waivers were created in the ACA to encourage state innovation to increase access to health coverage, under certain guardrails: states must ensure coverage is at least as comprehensive as the Essential Health Benefits; cost sharing protections must be at least as affordable as under the ACA; the plan must cover at least a comparable number of its residents; and the plan must not increase the federal deficit.

The Adminstration has come under fire for approving 1332 waiver plans that do not meet these guardrails, and allow insurers to exclude coverage for individuals with preexisting conditions, as well as skirt other important ACA patient protections. In response, Seema Verma, Administrator of the Centers for Medicare & Medicaid Services, promised as recently as April 23, that the Administration will not allow any weakening of the ACA preexisting coverage guarantee.⁸ So far, however, we do not know what action this means, and not surprisingly, House Democrats, now in the majority, are waiting to see those assurances come true. Consistent polling shows that a large majority of Americans, across political parties, think preexisting coverage protections are very important.⁹

Already, the House passed HR986, to repeal the Administration’s changes to the 1332 waiver rules. The bill won only 4 Republican votes in the House and now waits a Senate vote.

The House is ready to vote on HR1010, which returns the STLD rules to the original ACA version. The Congressional Budget Office has determined that this bill will reduce the federal deficit by $8.9 billion over 10 years, in part by reestablishing a large risk pool. Lower ACA premiums would mean lower federal subsidies and small federal outlays.

Contraceptive coverage

Since 2012, the ACA has required non-grandfathered individual and group health plans to cover, with no copays or deductibles, women’s preventive services, as determined by the Health Resources and Services Administration (HRSA). HRSA asked the National Academy of Medicine (the Institute of Medicine [IOM] at the time) to develop these coverage guidelines based on clinical and scientific relevance. The IOM relied heavily on ACOG’s testimony and women’s health guidelines. The guidelines are updated every 5 years, based on extensive review by the Women’s Preventive Services Initiative, led by ACOG. By law and regulation, covered services include:

• well-woman visits
• contraceptive methods and counseling, including all methods approved for women by the FDA
• breast and cervical cancer screening
• counseling for sexually transmitted infections
• counseling and screening for HIV
• screening for gestational diabetes
• breastfeeding support, supplies, and counseling
• screening and counseling for interpersonal and domestic violence.

Continue to: The previous administration offered a narrow exemption...

The previous administration offered a narrow exemption—an accommodation—for churches, religious orders, and integrated auxiliaries (organizations with financial support primarily from churches). That accommodation was expanded in the Supreme Court’s decision in Hobby Lobby, for closely held for-profit organizations that had religious objections to covering some or all contraceptives. Under the accommodation, the entity’s insurer or third-party administrator was responsible for providing contraceptive services to the entity’s plan participants and beneficiaries.

In October 2017, the Trump administration acted to greatly expand the ability of any employer, college or university, individual, or insurer to opt out of the ACA’s contraceptive coverage requirement. You will read more about this later.

ACOG’s business case for contraception

Early in the Trump Administration, the White House released a statement saying, “Ensuring affordable, accessible, and quality healthcare is critical to improving women’s health and ensuring that it fits their priorities at any stage of life.”¹⁰ ACOG could not agree more, and we encouraged the President to accomplish this important goal by protecting the landmark women’s health gains of the ACA. Our call to the President and the US Congress was: “Don’t turn back the clock on women’s health.”

We made a business case for continued contraceptive coverage:

Contraception reduces unintended pregnancies and saves federal dollars.

• Approximately 45% of US pregnancies are unintended.¹¹
• No-copay coverage of contraception has contributed to a dramatic decline in the unintended pregnancy rate in the United States, now at a 30-year low.¹²
• When cost is not a barrier, women choose more effective forms of contraception, such as intrauterine devices and implants.¹³
• Unintended pregnancies cost approximately $12.5 billion in government expenditures in 2008.¹⁴
• Private health plans spend as much as $4.6 billion annually in costs related to unintended pregnancies.¹⁵

Contraception means healthier women and healthier families.

• Under the ACA, the uninsured rate among women ages 18 to 64 almost halved, decreasing from 19.3% to 10.8%.¹⁶
• More than 55 million women gained access to preventive services, including contraception, without a copay or a deductible.¹⁶
• Women with unintended pregnancies are more likely to delay prenatal care. Infants are at greater risk of birth defects, low birth weight, and poor mental and physical functioning in early childhood.¹⁷

Increased access to contraception helps families and improves economic security.

• Women saved $1.4 billion in out-of-pocket costs for contraception in 1 year.¹⁸
• Before the ACA, women were spending between 30% and 44% of their total out-of-pocket health costs just on birth control.¹⁹
• The ability to plan a pregnancy increases engagement of women in the workforce and improves economic stability for women and their families.²⁰

Administration expands religious exemptions to contraception coverage

Still, on October 6, 2017, the Trump Administration moved to curtail women’s access to and coverage of contraception with the Religious Exemptions and Accommodations for Coverage of Certain Preventive Services under the Affordable Care Act and Moral Exemptions and Accommodations for Coverage of Certain Preventive Services Under the Affordable Care Act. In November 2018, the Administration published a revised rule, to take effect in January 2019.²¹ The rule immediately was taken to court by more than a dozen states and, 1 month later, was subject to an injunction by the US Court of Appeals for the Ninth Circuit, blocking the rules from going into effect in those states.

Continue to: The rule vastly expands the Obama Administration’s religious accommodation...

The rule vastly expands the Obama Administration’s religious accommodation to include “nonprofit organizations, small businesses, and individuals that have nonreligious moral convictions opposing services covered by the contraceptive mandate.” The covered entities include²¹:

• churches, integrated auxiliaries, and religious orders with religious objections
• nonprofit organizations with religious or moral objections
• for-profit entities that are not publicly traded, with religious or moral objections
• for-profit entities that are publicly traded, with religious objections
• other nongovernmental employers with religious objections
• nongovernmental institutions of higher education with religious or moral objections
• individuals with religious or moral objections, with employer sponsored or individual market coverage, where the plan sponsor and/or issuer (as applicable) are willing to offer them a plan omitting contraceptive coverage to which they object
• issuers with religious or moral objections, to the extent they provide coverage to a plan sponsor or individual that is also exempt.

The Administration says women losing coverage can get contraceptives through Title X clinics or other government programs. Of course, many women losing coverage are employed, and earn above the low income (100% of the federal poverty level) eligibility requirement for Title X assistance. To address that, the Administration, through its proposed Title X regulations, broadens the definition of “low income” in that program to include women who lose their contraceptive coverage through the employer-base health insurance plan. This move further limits the ability of the Title X program to adequately care for already-qualified individuals.

The Administration’s rule also relied on major inaccuracies, which ACOG corrected.²² First, ACOG pointed out that, in fact, FDA-approved contraceptive methods are not abortifacients, countering the Administration’s contention that contraception is an abortifacient, and that contraceptives cause abortions or miscarriages. Every FDA-approved contraceptive acts before implantation, does not interfere with a pregnancy, and is not effective after a fertilized egg has implanted successfully in the uterus.²³ No credible research supports the false statement that birth control causes miscarriages.²⁴

Second, ACOG offered data proving that increased access to contraception is not associated with increased unsafe sexual behavior or increased sexual activity.^25,26 The facts are that:

• The percentage of teens who are having sex has declined significantly, by 14% for female and 22% for male teenagers, over the past 25 years.²⁷
• More women are using contraception the first time they have sex. Young women who do not use birth control at first sexual intercourse are twice as likely to become teen mothers.²⁸
• Increased access to and use of contraception has contributed to a dramatic decline in rates of adolescent pregnancy.²⁹
• School-based health centers that provide access to contraceptives are proven to increase use of contraceptives by already sexually active students, not to increase onset of sexual activity.^30,31

Third, ACOG made clear the benefits to women’s health from contraception. ACOG asserted: As with any medication, certain types of contraception may be contraindicated for patients with certain medical conditions, including high blood pressure, lupus, or a history of breast cancer.^32,33 For these and many other reasons, access to the full range of FDA-approved contraception, with no cost sharing or other barriers, is critical to women’s health. Regarding VTE, the risk among oral contraceptive users is very low. In fact, it is much lower than the risk of VTE during pregnancy or in the immediate postpartum period.³⁴

Continue to: Regarding breast cancer: there is no proven increased risk...

Regarding breast cancer: there is no proven increased risk of breast cancer among contraceptive users, particularly among those younger than age 40. For women older than 40, health care providers must consider both the risks of becoming pregnant at advanced reproductive age and the risks of continuing contraception use until menopause.³⁵

ACOG has 2 clear messages for politicians

ACOG has remained steadfast in its opposition to the Administration’s proposals to block access to contraception. ACOG expressed its strong opposition to political interference in medical care, saying “Every woman, regardless of her insurer, employer, state of residence, or income, should have affordable, seamless access to the right form of contraception for her, free from interference from her employer or politicians.”²²

ACOG’s voice has been joined by 5 other major medical associations—American Academy of Family Physicians, American Academy of Pediatrics, American Psychiatric Association, American Academy of Pediatrics, and American Osteopathic Association—together representing more than 560,000 physicians and medical students, in urging the Administration to immediately withdraw its proposals. This broad coalition unequivocally stated³⁶:

Contraception is an integral part of preventive care and a medical necessity for women during approximately 30 years of their lives. Access to no-copay contraception leads to healthier women and families. Changes to our healthcare system come with very high stakes – impacting tens of millions of our patients. Access to contraception allows women to achieve, lead and reach their full potentials, becoming key drivers of our Nation’s economic success. These rules would create a new standard whereby employers can deny their employees coverage, based on their own moral objections. This interferes in the personal health care decisions of our patients, and inappropriately inserts a patient’s employer into the physician-patient relationship. In addition, these rules open the door to moral exemptions for other essential health care, including vaccinations.

These are challenging days for women’s health policy and legislation federally, and in many states. ACOG has two clear messages for politicians: Don’t turn back the clock on women’s health, and stay out of our exam rooms.

The Affordable Care Act (ACA) was enacted on March 23, 2010. Controversies, complaints, and detractors have and continue to abound. But the ACA’s landmark women’s health gains are unmistakable. Contraceptive coverage, maternity coverage, Medicaid coverage of low-income women, coverage for individuals with preexisting conditions, and gender-neutral premiums are now a part of the fabric of our society. For most.

Many physicians and patients—many lawmakers, too—do not remember the serious problems people had with their insurance companies before the ACA. Maternity coverage was usually a free-standing rider to an insurance policy, making it very expensive. Insurance plans did not have to, and often did not, cover contraceptives, and none did without copays or deductibles. Women were routinely denied coverage if they had ever had a cesarean delivery, had once been the victim of domestic violence, or had any one of many common conditions, like diabetes. The many exclusionary conditions are so common, in fact, that one study estimated that around 52 million adults in the United States (27% of those younger than age 65 years) have preexisting conditions that would potentially make them uninsurable without the ACA’s protections.¹

Before the ACA, it also was common for women with insurance policies to find their coverage rescinded, often with no explanation, even though they paid their premiums every month. And women with serious medical conditions often saw their coverage ended midway through their course of treatment. That placed their ObGyns in a terrible situation, too.

The insurance industry as a whole was running rough-shod over its customers, and making a lot of money by creatively and routinely denying coverage and payment for care. People were often insured, but not covered. The ACA halted many of these practices, and required insurers to meet high medical loss ratios, guaranteeing that 80% of the premiums’ for individual and small market insurers (and 85% for large insurers) are returned to patients in care payments or even in checks. In fact, nearly $4 billion in premiums have been rebated to insured individuals over the last 7 years under the ACA.²

The commitment of the American College of Obstetricians and Gynecologists (ACOG) to women’s health and to our members’ ability to provide the best care has centered on preserving the critical gains of the ACA for women, improving them when we can, and making sure politicians don’t turn back the clock on women’s health. We have been busy.

In this article, we will look at what has happened to these landmark gains and promises of improved women’s health, specifically preexisting condition protections and contraceptive coverage, under a new Administration. What happens when good health care policy and political enmity collide?

Preexisting coverage protections

The 1996 Health Insurance Portability and Accountability Act (HIPAA) defines a preexisting condition exclusionas a “limitation or exclusion of benefits relating to a condition based on the fact that the condition was present before the date of enrollment for the coverage, whether or not any medical advice, diagnosis, care, or treatment was recommended or received before that date.” HIPPA prohibited employer-sponsored health plans from discriminating against individuals through denying them coverage or charging them more based on their or their family members’ health problems. The ACA expanded protections to prohibit the insurance practice of denying coverage altogether to an individual with a preexisting condition.³

Continue to: Under Congress...

Under Congress

Republicans held the majority in both chambers of the 115th Congress (2017–2018), and hoped to use their majority status to get an ACA repeal bill to the Republican President’s desk for speedy enactment. It was not easy, and they were not successful. Four major bills—the American Health Care Act, the Better Care Reconciliation Act, the Health Care Freedom Act, and the Graham-Cassidy Amendment—never made it over the finish line, with some not even making it to a vote. The Health Care Freedom Act was voted down in the Senate 51-49 when Senator John McCain came back from brain surgery to cast his famous thumbs-down vote.⁴ These bills all would have repealed or hobbled guaranteed issue, community rating, and essential health benefits of the ACA. Of all the legislative attempts to undermine the ACA, only the 2017 Tax Cuts and Jobs Act (TCJA) was signed into law, repealing the ACA individual mandate.

Handling by the courts

The TCJA gave ACA opponents their opening in court. Twenty Republican state attorneys general and governors brought suit in February 2018 (Texas v Azar), arguing that because the ACA relies on the mandate, and the mandate has been repealed, the rest of the ACA also should be struck down. A federal district judge agreed, on December 15, 2018, declaring the entire ACA unconstitutional.⁵

That decision has been limited in its practical effect so far, and maybe it was not altogether unexpected. What was unexpected was that the US Department of Justice (DOJ) refused to defend a federal law, in this case, the ACA. In June 2018, the DOJ declined to defend the individual mandate, as well as guaranteed issue, community rating, the ban on preexisting condition exclusions, and discrimination based on health status in the ACA. The DOJ at that time, however, did not agree with the plaintiffs that without the mandate the entire ACA should be struck down. It said, “There is no reason why the ACA’s particular expansion of Medicaid hinges on the individual mandate.” Later, after the December 15 ruling, the DOJ changed its position and agreed with the judge, in a two-sentence letter to the court, that the ACA should be stricken altogether—shortly after which 3 career DOJ attorneys resigned.⁶

A legal expert observed: “The DOJ’s decision not to defend the ACA breaks with the Department’s long-standing bipartisan commitment to defend federal laws if reasonable arguments can be made in their defense. Decisions not to defend federal law are exceedingly rare. It seems even rarer to change the government’s position mid-appeal in such a high-profile lawsuit that risks disrupting the entire health care system and health insurance coverage for millions of Americans.”⁷

Regulatory tactics

What a policy maker cannot do by law, he or she can try to accomplish by regulation. The Administration is using 3 regulatory routes to undercut the ACA preexisting coverage protections and market stability.

Route 1: Short-Term Limited Duration (STLD) plans. These plans were created in the ACA to provide bridge coverage for up to 3 months for individuals in between health insurance plans. These plans do not have to comply with ACA patient protections, can deny coverage for preexisting conditions, and do not cover maternity care. In 2018, the Administration moved to allow these plans to be marketed broadly and renewed for up to 3 years. Because these plans provide less coverage and often come with high deductibles, they can be marketed with lower premiums, skimming off healthier younger people who do not expect to need much care, as well as lower-income families. This destabilizes the market and leaves people insured but not covered, exactly the situation before the ACA. Seven public health and medical groups sued to challenge the Administration’s STLD regulation; the lawsuit is presently pending.

Continue to: Route 2: Association Health Plans (AHPs)...

Route 2: Association Health Plans (AHPs). The Administration also has allowed the sale of AHPs, marketed to small employers and self-employed individuals. These plans also do not have to comply with ACA consumer protections. They often do not cover maternity care or other essential benefits, and can charge women higher premiums for the same insurance. This regulation, too, resulted in litigation and a federal judge enjoined the rule, but the case is now on appeal.

Route 3: ACA Section 1332 waivers. These waivers were created in the ACA to encourage state innovation to increase access to health coverage, under certain guardrails: states must ensure coverage is at least as comprehensive as the Essential Health Benefits; cost sharing protections must be at least as affordable as under the ACA; the plan must cover at least a comparable number of its residents; and the plan must not increase the federal deficit.

The Adminstration has come under fire for approving 1332 waiver plans that do not meet these guardrails, and allow insurers to exclude coverage for individuals with preexisting conditions, as well as skirt other important ACA patient protections. In response, Seema Verma, Administrator of the Centers for Medicare & Medicaid Services, promised as recently as April 23, that the Administration will not allow any weakening of the ACA preexisting coverage guarantee.⁸ So far, however, we do not know what action this means, and not surprisingly, House Democrats, now in the majority, are waiting to see those assurances come true. Consistent polling shows that a large majority of Americans, across political parties, think preexisting coverage protections are very important.⁹

Already, the House passed HR986, to repeal the Administration’s changes to the 1332 waiver rules. The bill won only 4 Republican votes in the House and now waits a Senate vote.

The House is ready to vote on HR1010, which returns the STLD rules to the original ACA version. The Congressional Budget Office has determined that this bill will reduce the federal deficit by $8.9 billion over 10 years, in part by reestablishing a large risk pool. Lower ACA premiums would mean lower federal subsidies and small federal outlays.

Contraceptive coverage

Since 2012, the ACA has required non-grandfathered individual and group health plans to cover, with no copays or deductibles, women’s preventive services, as determined by the Health Resources and Services Administration (HRSA). HRSA asked the National Academy of Medicine (the Institute of Medicine [IOM] at the time) to develop these coverage guidelines based on clinical and scientific relevance. The IOM relied heavily on ACOG’s testimony and women’s health guidelines. The guidelines are updated every 5 years, based on extensive review by the Women’s Preventive Services Initiative, led by ACOG. By law and regulation, covered services include:

• well-woman visits
• contraceptive methods and counseling, including all methods approved for women by the FDA
• breast and cervical cancer screening
• counseling for sexually transmitted infections
• counseling and screening for HIV
• screening for gestational diabetes
• breastfeeding support, supplies, and counseling
• screening and counseling for interpersonal and domestic violence.

Continue to: The previous administration offered a narrow exemption...

The previous administration offered a narrow exemption—an accommodation—for churches, religious orders, and integrated auxiliaries (organizations with financial support primarily from churches). That accommodation was expanded in the Supreme Court’s decision in Hobby Lobby, for closely held for-profit organizations that had religious objections to covering some or all contraceptives. Under the accommodation, the entity’s insurer or third-party administrator was responsible for providing contraceptive services to the entity’s plan participants and beneficiaries.

In October 2017, the Trump administration acted to greatly expand the ability of any employer, college or university, individual, or insurer to opt out of the ACA’s contraceptive coverage requirement. You will read more about this later.

ACOG’s business case for contraception

Early in the Trump Administration, the White House released a statement saying, “Ensuring affordable, accessible, and quality healthcare is critical to improving women’s health and ensuring that it fits their priorities at any stage of life.”¹⁰ ACOG could not agree more, and we encouraged the President to accomplish this important goal by protecting the landmark women’s health gains of the ACA. Our call to the President and the US Congress was: “Don’t turn back the clock on women’s health.”

We made a business case for continued contraceptive coverage:

Contraception reduces unintended pregnancies and saves federal dollars.

• Approximately 45% of US pregnancies are unintended.¹¹
• No-copay coverage of contraception has contributed to a dramatic decline in the unintended pregnancy rate in the United States, now at a 30-year low.¹²
• When cost is not a barrier, women choose more effective forms of contraception, such as intrauterine devices and implants.¹³
• Unintended pregnancies cost approximately $12.5 billion in government expenditures in 2008.¹⁴
• Private health plans spend as much as $4.6 billion annually in costs related to unintended pregnancies.¹⁵

Contraception means healthier women and healthier families.

• Under the ACA, the uninsured rate among women ages 18 to 64 almost halved, decreasing from 19.3% to 10.8%.¹⁶
• More than 55 million women gained access to preventive services, including contraception, without a copay or a deductible.¹⁶
• Women with unintended pregnancies are more likely to delay prenatal care. Infants are at greater risk of birth defects, low birth weight, and poor mental and physical functioning in early childhood.¹⁷

Increased access to contraception helps families and improves economic security.

• Women saved $1.4 billion in out-of-pocket costs for contraception in 1 year.¹⁸
• Before the ACA, women were spending between 30% and 44% of their total out-of-pocket health costs just on birth control.¹⁹
• The ability to plan a pregnancy increases engagement of women in the workforce and improves economic stability for women and their families.²⁰

Administration expands religious exemptions to contraception coverage

Still, on October 6, 2017, the Trump Administration moved to curtail women’s access to and coverage of contraception with the Religious Exemptions and Accommodations for Coverage of Certain Preventive Services under the Affordable Care Act and Moral Exemptions and Accommodations for Coverage of Certain Preventive Services Under the Affordable Care Act. In November 2018, the Administration published a revised rule, to take effect in January 2019.²¹ The rule immediately was taken to court by more than a dozen states and, 1 month later, was subject to an injunction by the US Court of Appeals for the Ninth Circuit, blocking the rules from going into effect in those states.

Continue to: The rule vastly expands the Obama Administration’s religious accommodation...

The rule vastly expands the Obama Administration’s religious accommodation to include “nonprofit organizations, small businesses, and individuals that have nonreligious moral convictions opposing services covered by the contraceptive mandate.” The covered entities include²¹:

• churches, integrated auxiliaries, and religious orders with religious objections
• nonprofit organizations with religious or moral objections
• for-profit entities that are not publicly traded, with religious or moral objections
• for-profit entities that are publicly traded, with religious objections
• other nongovernmental employers with religious objections
• nongovernmental institutions of higher education with religious or moral objections
• individuals with religious or moral objections, with employer sponsored or individual market coverage, where the plan sponsor and/or issuer (as applicable) are willing to offer them a plan omitting contraceptive coverage to which they object
• issuers with religious or moral objections, to the extent they provide coverage to a plan sponsor or individual that is also exempt.

The Administration says women losing coverage can get contraceptives through Title X clinics or other government programs. Of course, many women losing coverage are employed, and earn above the low income (100% of the federal poverty level) eligibility requirement for Title X assistance. To address that, the Administration, through its proposed Title X regulations, broadens the definition of “low income” in that program to include women who lose their contraceptive coverage through the employer-base health insurance plan. This move further limits the ability of the Title X program to adequately care for already-qualified individuals.

The Administration’s rule also relied on major inaccuracies, which ACOG corrected.²² First, ACOG pointed out that, in fact, FDA-approved contraceptive methods are not abortifacients, countering the Administration’s contention that contraception is an abortifacient, and that contraceptives cause abortions or miscarriages. Every FDA-approved contraceptive acts before implantation, does not interfere with a pregnancy, and is not effective after a fertilized egg has implanted successfully in the uterus.²³ No credible research supports the false statement that birth control causes miscarriages.²⁴

Second, ACOG offered data proving that increased access to contraception is not associated with increased unsafe sexual behavior or increased sexual activity.^25,26 The facts are that:

• The percentage of teens who are having sex has declined significantly, by 14% for female and 22% for male teenagers, over the past 25 years.²⁷
• More women are using contraception the first time they have sex. Young women who do not use birth control at first sexual intercourse are twice as likely to become teen mothers.²⁸
• Increased access to and use of contraception has contributed to a dramatic decline in rates of adolescent pregnancy.²⁹
• School-based health centers that provide access to contraceptives are proven to increase use of contraceptives by already sexually active students, not to increase onset of sexual activity.^30,31

Third, ACOG made clear the benefits to women’s health from contraception. ACOG asserted: As with any medication, certain types of contraception may be contraindicated for patients with certain medical conditions, including high blood pressure, lupus, or a history of breast cancer.^32,33 For these and many other reasons, access to the full range of FDA-approved contraception, with no cost sharing or other barriers, is critical to women’s health. Regarding VTE, the risk among oral contraceptive users is very low. In fact, it is much lower than the risk of VTE during pregnancy or in the immediate postpartum period.³⁴

Continue to: Regarding breast cancer: there is no proven increased risk...

Regarding breast cancer: there is no proven increased risk of breast cancer among contraceptive users, particularly among those younger than age 40. For women older than 40, health care providers must consider both the risks of becoming pregnant at advanced reproductive age and the risks of continuing contraception use until menopause.³⁵

ACOG has 2 clear messages for politicians

ACOG has remained steadfast in its opposition to the Administration’s proposals to block access to contraception. ACOG expressed its strong opposition to political interference in medical care, saying “Every woman, regardless of her insurer, employer, state of residence, or income, should have affordable, seamless access to the right form of contraception for her, free from interference from her employer or politicians.”²²

ACOG’s voice has been joined by 5 other major medical associations—American Academy of Family Physicians, American Academy of Pediatrics, American Psychiatric Association, American Academy of Pediatrics, and American Osteopathic Association—together representing more than 560,000 physicians and medical students, in urging the Administration to immediately withdraw its proposals. This broad coalition unequivocally stated³⁶:

Contraception is an integral part of preventive care and a medical necessity for women during approximately 30 years of their lives. Access to no-copay contraception leads to healthier women and families. Changes to our healthcare system come with very high stakes – impacting tens of millions of our patients. Access to contraception allows women to achieve, lead and reach their full potentials, becoming key drivers of our Nation’s economic success. These rules would create a new standard whereby employers can deny their employees coverage, based on their own moral objections. This interferes in the personal health care decisions of our patients, and inappropriately inserts a patient’s employer into the physician-patient relationship. In addition, these rules open the door to moral exemptions for other essential health care, including vaccinations.

These are challenging days for women’s health policy and legislation federally, and in many states. ACOG has two clear messages for politicians: Don’t turn back the clock on women’s health, and stay out of our exam rooms.

The Affordable Care Act (ACA) was enacted on March 23, 2010. Controversies, complaints, and detractors have and continue to abound. But the ACA’s landmark women’s health gains are unmistakable. Contraceptive coverage, maternity coverage, Medicaid coverage of low-income women, coverage for individuals with preexisting conditions, and gender-neutral premiums are now a part of the fabric of our society. For most.

Many physicians and patients—many lawmakers, too—do not remember the serious problems people had with their insurance companies before the ACA. Maternity coverage was usually a free-standing rider to an insurance policy, making it very expensive. Insurance plans did not have to, and often did not, cover contraceptives, and none did without copays or deductibles. Women were routinely denied coverage if they had ever had a cesarean delivery, had once been the victim of domestic violence, or had any one of many common conditions, like diabetes. The many exclusionary conditions are so common, in fact, that one study estimated that around 52 million adults in the United States (27% of those younger than age 65 years) have preexisting conditions that would potentially make them uninsurable without the ACA’s protections.¹

Before the ACA, it also was common for women with insurance policies to find their coverage rescinded, often with no explanation, even though they paid their premiums every month. And women with serious medical conditions often saw their coverage ended midway through their course of treatment. That placed their ObGyns in a terrible situation, too.

The insurance industry as a whole was running rough-shod over its customers, and making a lot of money by creatively and routinely denying coverage and payment for care. People were often insured, but not covered. The ACA halted many of these practices, and required insurers to meet high medical loss ratios, guaranteeing that 80% of the premiums’ for individual and small market insurers (and 85% for large insurers) are returned to patients in care payments or even in checks. In fact, nearly $4 billion in premiums have been rebated to insured individuals over the last 7 years under the ACA.²

The commitment of the American College of Obstetricians and Gynecologists (ACOG) to women’s health and to our members’ ability to provide the best care has centered on preserving the critical gains of the ACA for women, improving them when we can, and making sure politicians don’t turn back the clock on women’s health. We have been busy.

In this article, we will look at what has happened to these landmark gains and promises of improved women’s health, specifically preexisting condition protections and contraceptive coverage, under a new Administration. What happens when good health care policy and political enmity collide?

Preexisting coverage protections

The 1996 Health Insurance Portability and Accountability Act (HIPAA) defines a preexisting condition exclusionas a “limitation or exclusion of benefits relating to a condition based on the fact that the condition was present before the date of enrollment for the coverage, whether or not any medical advice, diagnosis, care, or treatment was recommended or received before that date.” HIPPA prohibited employer-sponsored health plans from discriminating against individuals through denying them coverage or charging them more based on their or their family members’ health problems. The ACA expanded protections to prohibit the insurance practice of denying coverage altogether to an individual with a preexisting condition.³

Continue to: Under Congress...

Under Congress

Republicans held the majority in both chambers of the 115th Congress (2017–2018), and hoped to use their majority status to get an ACA repeal bill to the Republican President’s desk for speedy enactment. It was not easy, and they were not successful. Four major bills—the American Health Care Act, the Better Care Reconciliation Act, the Health Care Freedom Act, and the Graham-Cassidy Amendment—never made it over the finish line, with some not even making it to a vote. The Health Care Freedom Act was voted down in the Senate 51-49 when Senator John McCain came back from brain surgery to cast his famous thumbs-down vote.⁴ These bills all would have repealed or hobbled guaranteed issue, community rating, and essential health benefits of the ACA. Of all the legislative attempts to undermine the ACA, only the 2017 Tax Cuts and Jobs Act (TCJA) was signed into law, repealing the ACA individual mandate.

Handling by the courts

The TCJA gave ACA opponents their opening in court. Twenty Republican state attorneys general and governors brought suit in February 2018 (Texas v Azar), arguing that because the ACA relies on the mandate, and the mandate has been repealed, the rest of the ACA also should be struck down. A federal district judge agreed, on December 15, 2018, declaring the entire ACA unconstitutional.⁵

That decision has been limited in its practical effect so far, and maybe it was not altogether unexpected. What was unexpected was that the US Department of Justice (DOJ) refused to defend a federal law, in this case, the ACA. In June 2018, the DOJ declined to defend the individual mandate, as well as guaranteed issue, community rating, the ban on preexisting condition exclusions, and discrimination based on health status in the ACA. The DOJ at that time, however, did not agree with the plaintiffs that without the mandate the entire ACA should be struck down. It said, “There is no reason why the ACA’s particular expansion of Medicaid hinges on the individual mandate.” Later, after the December 15 ruling, the DOJ changed its position and agreed with the judge, in a two-sentence letter to the court, that the ACA should be stricken altogether—shortly after which 3 career DOJ attorneys resigned.⁶

A legal expert observed: “The DOJ’s decision not to defend the ACA breaks with the Department’s long-standing bipartisan commitment to defend federal laws if reasonable arguments can be made in their defense. Decisions not to defend federal law are exceedingly rare. It seems even rarer to change the government’s position mid-appeal in such a high-profile lawsuit that risks disrupting the entire health care system and health insurance coverage for millions of Americans.”⁷

Regulatory tactics

What a policy maker cannot do by law, he or she can try to accomplish by regulation. The Administration is using 3 regulatory routes to undercut the ACA preexisting coverage protections and market stability.

Route 1: Short-Term Limited Duration (STLD) plans. These plans were created in the ACA to provide bridge coverage for up to 3 months for individuals in between health insurance plans. These plans do not have to comply with ACA patient protections, can deny coverage for preexisting conditions, and do not cover maternity care. In 2018, the Administration moved to allow these plans to be marketed broadly and renewed for up to 3 years. Because these plans provide less coverage and often come with high deductibles, they can be marketed with lower premiums, skimming off healthier younger people who do not expect to need much care, as well as lower-income families. This destabilizes the market and leaves people insured but not covered, exactly the situation before the ACA. Seven public health and medical groups sued to challenge the Administration’s STLD regulation; the lawsuit is presently pending.

Continue to: Route 2: Association Health Plans (AHPs)...

Route 2: Association Health Plans (AHPs). The Administration also has allowed the sale of AHPs, marketed to small employers and self-employed individuals. These plans also do not have to comply with ACA consumer protections. They often do not cover maternity care or other essential benefits, and can charge women higher premiums for the same insurance. This regulation, too, resulted in litigation and a federal judge enjoined the rule, but the case is now on appeal.

Route 3: ACA Section 1332 waivers. These waivers were created in the ACA to encourage state innovation to increase access to health coverage, under certain guardrails: states must ensure coverage is at least as comprehensive as the Essential Health Benefits; cost sharing protections must be at least as affordable as under the ACA; the plan must cover at least a comparable number of its residents; and the plan must not increase the federal deficit.

The Adminstration has come under fire for approving 1332 waiver plans that do not meet these guardrails, and allow insurers to exclude coverage for individuals with preexisting conditions, as well as skirt other important ACA patient protections. In response, Seema Verma, Administrator of the Centers for Medicare & Medicaid Services, promised as recently as April 23, that the Administration will not allow any weakening of the ACA preexisting coverage guarantee.⁸ So far, however, we do not know what action this means, and not surprisingly, House Democrats, now in the majority, are waiting to see those assurances come true. Consistent polling shows that a large majority of Americans, across political parties, think preexisting coverage protections are very important.⁹

Already, the House passed HR986, to repeal the Administration’s changes to the 1332 waiver rules. The bill won only 4 Republican votes in the House and now waits a Senate vote.

The House is ready to vote on HR1010, which returns the STLD rules to the original ACA version. The Congressional Budget Office has determined that this bill will reduce the federal deficit by $8.9 billion over 10 years, in part by reestablishing a large risk pool. Lower ACA premiums would mean lower federal subsidies and small federal outlays.

Contraceptive coverage

Since 2012, the ACA has required non-grandfathered individual and group health plans to cover, with no copays or deductibles, women’s preventive services, as determined by the Health Resources and Services Administration (HRSA). HRSA asked the National Academy of Medicine (the Institute of Medicine [IOM] at the time) to develop these coverage guidelines based on clinical and scientific relevance. The IOM relied heavily on ACOG’s testimony and women’s health guidelines. The guidelines are updated every 5 years, based on extensive review by the Women’s Preventive Services Initiative, led by ACOG. By law and regulation, covered services include:

• well-woman visits
• contraceptive methods and counseling, including all methods approved for women by the FDA
• breast and cervical cancer screening
• counseling for sexually transmitted infections
• counseling and screening for HIV
• screening for gestational diabetes
• breastfeeding support, supplies, and counseling
• screening and counseling for interpersonal and domestic violence.

Continue to: The previous administration offered a narrow exemption...

The previous administration offered a narrow exemption—an accommodation—for churches, religious orders, and integrated auxiliaries (organizations with financial support primarily from churches). That accommodation was expanded in the Supreme Court’s decision in Hobby Lobby, for closely held for-profit organizations that had religious objections to covering some or all contraceptives. Under the accommodation, the entity’s insurer or third-party administrator was responsible for providing contraceptive services to the entity’s plan participants and beneficiaries.

In October 2017, the Trump administration acted to greatly expand the ability of any employer, college or university, individual, or insurer to opt out of the ACA’s contraceptive coverage requirement. You will read more about this later.

ACOG’s business case for contraception

Early in the Trump Administration, the White House released a statement saying, “Ensuring affordable, accessible, and quality healthcare is critical to improving women’s health and ensuring that it fits their priorities at any stage of life.”¹⁰ ACOG could not agree more, and we encouraged the President to accomplish this important goal by protecting the landmark women’s health gains of the ACA. Our call to the President and the US Congress was: “Don’t turn back the clock on women’s health.”

We made a business case for continued contraceptive coverage:

Contraception reduces unintended pregnancies and saves federal dollars.

• Approximately 45% of US pregnancies are unintended.¹¹
• No-copay coverage of contraception has contributed to a dramatic decline in the unintended pregnancy rate in the United States, now at a 30-year low.¹²
• When cost is not a barrier, women choose more effective forms of contraception, such as intrauterine devices and implants.¹³
• Unintended pregnancies cost approximately $12.5 billion in government expenditures in 2008.¹⁴
• Private health plans spend as much as $4.6 billion annually in costs related to unintended pregnancies.¹⁵

Contraception means healthier women and healthier families.

• Under the ACA, the uninsured rate among women ages 18 to 64 almost halved, decreasing from 19.3% to 10.8%.¹⁶
• More than 55 million women gained access to preventive services, including contraception, without a copay or a deductible.¹⁶
• Women with unintended pregnancies are more likely to delay prenatal care. Infants are at greater risk of birth defects, low birth weight, and poor mental and physical functioning in early childhood.¹⁷

Increased access to contraception helps families and improves economic security.

• Women saved $1.4 billion in out-of-pocket costs for contraception in 1 year.¹⁸
• Before the ACA, women were spending between 30% and 44% of their total out-of-pocket health costs just on birth control.¹⁹
• The ability to plan a pregnancy increases engagement of women in the workforce and improves economic stability for women and their families.²⁰

Administration expands religious exemptions to contraception coverage

Still, on October 6, 2017, the Trump Administration moved to curtail women’s access to and coverage of contraception with the Religious Exemptions and Accommodations for Coverage of Certain Preventive Services under the Affordable Care Act and Moral Exemptions and Accommodations for Coverage of Certain Preventive Services Under the Affordable Care Act. In November 2018, the Administration published a revised rule, to take effect in January 2019.²¹ The rule immediately was taken to court by more than a dozen states and, 1 month later, was subject to an injunction by the US Court of Appeals for the Ninth Circuit, blocking the rules from going into effect in those states.

Continue to: The rule vastly expands the Obama Administration’s religious accommodation...

The rule vastly expands the Obama Administration’s religious accommodation to include “nonprofit organizations, small businesses, and individuals that have nonreligious moral convictions opposing services covered by the contraceptive mandate.” The covered entities include²¹:

• churches, integrated auxiliaries, and religious orders with religious objections
• nonprofit organizations with religious or moral objections
• for-profit entities that are not publicly traded, with religious or moral objections
• for-profit entities that are publicly traded, with religious objections
• other nongovernmental employers with religious objections
• nongovernmental institutions of higher education with religious or moral objections
• individuals with religious or moral objections, with employer sponsored or individual market coverage, where the plan sponsor and/or issuer (as applicable) are willing to offer them a plan omitting contraceptive coverage to which they object
• issuers with religious or moral objections, to the extent they provide coverage to a plan sponsor or individual that is also exempt.

The Administration says women losing coverage can get contraceptives through Title X clinics or other government programs. Of course, many women losing coverage are employed, and earn above the low income (100% of the federal poverty level) eligibility requirement for Title X assistance. To address that, the Administration, through its proposed Title X regulations, broadens the definition of “low income” in that program to include women who lose their contraceptive coverage through the employer-base health insurance plan. This move further limits the ability of the Title X program to adequately care for already-qualified individuals.

The Administration’s rule also relied on major inaccuracies, which ACOG corrected.²² First, ACOG pointed out that, in fact, FDA-approved contraceptive methods are not abortifacients, countering the Administration’s contention that contraception is an abortifacient, and that contraceptives cause abortions or miscarriages. Every FDA-approved contraceptive acts before implantation, does not interfere with a pregnancy, and is not effective after a fertilized egg has implanted successfully in the uterus.²³ No credible research supports the false statement that birth control causes miscarriages.²⁴

Second, ACOG offered data proving that increased access to contraception is not associated with increased unsafe sexual behavior or increased sexual activity.^25,26 The facts are that:

• The percentage of teens who are having sex has declined significantly, by 14% for female and 22% for male teenagers, over the past 25 years.²⁷
• More women are using contraception the first time they have sex. Young women who do not use birth control at first sexual intercourse are twice as likely to become teen mothers.²⁸
• Increased access to and use of contraception has contributed to a dramatic decline in rates of adolescent pregnancy.²⁹
• School-based health centers that provide access to contraceptives are proven to increase use of contraceptives by already sexually active students, not to increase onset of sexual activity.^30,31

Third, ACOG made clear the benefits to women’s health from contraception. ACOG asserted: As with any medication, certain types of contraception may be contraindicated for patients with certain medical conditions, including high blood pressure, lupus, or a history of breast cancer.^32,33 For these and many other reasons, access to the full range of FDA-approved contraception, with no cost sharing or other barriers, is critical to women’s health. Regarding VTE, the risk among oral contraceptive users is very low. In fact, it is much lower than the risk of VTE during pregnancy or in the immediate postpartum period.³⁴

Continue to: Regarding breast cancer: there is no proven increased risk...

Regarding breast cancer: there is no proven increased risk of breast cancer among contraceptive users, particularly among those younger than age 40. For women older than 40, health care providers must consider both the risks of becoming pregnant at advanced reproductive age and the risks of continuing contraception use until menopause.³⁵

ACOG has 2 clear messages for politicians

ACOG has remained steadfast in its opposition to the Administration’s proposals to block access to contraception. ACOG expressed its strong opposition to political interference in medical care, saying “Every woman, regardless of her insurer, employer, state of residence, or income, should have affordable, seamless access to the right form of contraception for her, free from interference from her employer or politicians.”²²

ACOG’s voice has been joined by 5 other major medical associations—American Academy of Family Physicians, American Academy of Pediatrics, American Psychiatric Association, American Academy of Pediatrics, and American Osteopathic Association—together representing more than 560,000 physicians and medical students, in urging the Administration to immediately withdraw its proposals. This broad coalition unequivocally stated³⁶:

Contraception is an integral part of preventive care and a medical necessity for women during approximately 30 years of their lives. Access to no-copay contraception leads to healthier women and families. Changes to our healthcare system come with very high stakes – impacting tens of millions of our patients. Access to contraception allows women to achieve, lead and reach their full potentials, becoming key drivers of our Nation’s economic success. These rules would create a new standard whereby employers can deny their employees coverage, based on their own moral objections. This interferes in the personal health care decisions of our patients, and inappropriately inserts a patient’s employer into the physician-patient relationship. In addition, these rules open the door to moral exemptions for other essential health care, including vaccinations.

These are challenging days for women’s health policy and legislation federally, and in many states. ACOG has two clear messages for politicians: Don’t turn back the clock on women’s health, and stay out of our exam rooms.

More than 9 million veterans are enrolled in the Veterans Health Administration (VHA). A high percentage of veterans who use VHA services have multiple chronic conditions and complex medical needs.¹ In addition to receiving health care from the VHA, many of these patients receive additional services from non-VHA providers in the community. Furthermore, recent laws enacted, such as the 2018 VA MISSION Act and the 2014 VA Choice Program, have increased veterans’ use of community health care services.

VHA staff face considerable barriers when seeking documentation about non-VHA services delivered in the community, which can be fragmented across multiple health care systems. In many VHA medical centers, staff must telephone non-VHA sites of care and/or use time-consuming fax services to request community-based patient records. VA health care providers (HCPs) often complain that community records are not available to make timely clinical decisions or that they must do so without knowing past or co-occurring assessments or treatment plans. Without access to comprehensive health records, patients are at risk for duplicated treatment, medication errors, and death.^2,3

Background

To improve the continuity and safety of health care, US governmental and health information experts stimulated formal communication among HCPs via the 2009 Health Information Technology for Economic and Clinical Health (HITECH) Act.^4,5 One of the primary aims of the HITECH Act was to promote reliable and interoperable electronic sharing of clinical information through health information exchange (HIE) for both patients and HCPs. Monetary incentives encouraged regional, state, or state-funded organizations to create and promote HIE capabilities.

Presently, empirical data are not available that describe the effect of external HIE systems in VHA settings. However, data examining non-VHA settings suggest that HIE may improve quality of care, although findings are mixed. For example, some research has found that HIE reduces hospital admissions, duplicated test ordering, and health care costs and improves decision making, whereas other research has found no change.^3,6-13 Barriers to HIE use noted in community settings include poorly designed interfaces, inefficient workflow, and incomplete record availability.^3,6-10,14

A few US Department of Veterans Affairs (VA) medical centers have recently initiated contracts with HIE organizations. Because much of the present research evaluates internally developed HIE systems, scholars in the field have identified a pressing need for useful statistics before and after implementation of externally developed HIE systems.^13,15 Additionally, scholars call for data examining nonacademic settings (eg, VHA medical centers) and for diverse patient populations (eg, individuals with chronic disorders, veterans).¹³This quality improvement project had 2 goals. The first goal was to assess baseline descriptive statistics related to requesting/obtaining community health records in a VHA setting. The second goal was to evaluate VHA staff access to needed community health records (eg, records stemming from community consults) before and after implementation of an externally developed HIE system.

Methods

This project was a single-center, quality improvement evaluation examining the effect of implementing an HIE system, developed by an external nonprofit organization. The project protocol was approved by the VA Pacific Islands Healthcare System (VAPIHCS) Evidence-Based Practices Council. Clinicians’ responses were anonymous, and data were reported only in aggregate. Assessment was conducted by an evaluator who was not associated with the HIE system developers and its implementation, reducing the chance of bias.¹⁵

Coinciding with the HIE system implementation and prior to having access to it, VAPIHCS medical and managed care staff were invited to complete an online needs assessment tool. Voluntary trainings on the system were offered at various times on multiple days and lasted approximately 1 hour. Six months after the HIE system was implemented, a postassessment tool reevaluated HIE-related access.

VHA Setting and HIE System

VAPIHCS serves about 55,000 unique patients across a 2.6 million square-mile catchment area (Hawaii and Pacific Island territories). Facilities include a medium-sized, urban VA medical center and 7 suburban or rural/remote primary care outpatient clinics.

VAPIHCS contracted with Hawaii Health Information Exchange (HHIE), a nonprofit organization that was designated by the state of Hawaii to develop a seamless, secure HIE system. According to HHIE, 83% of the 23 hospitals in the state and 55% of Hawaii’s 2,927 active practicing physicians have adopted the HIE system (F. Chan, personal communication, December 12, 2018). HHIE’s data sources provide real-time access to a database of 20 million health records. Records include, among other records, data such as patients’ reasons for referral, encounter diagnoses, medications, immunizations, and discharge instructions from many (but not all) HCPs in Hawaii.

HHIE reports that it has the capacity to interface with all electronic health records systems currently in use in the community (F. Chan, personal communication, December 12, 2018). Although the HIE system can provide directed exchange (ie, sending and receiving secure information electronically between HCPs), the HIE system implemented in the VAPIHCS was limited to query-retrieve (ie, practitioner-initiated requests for information from other community HCPs). Specifically, to access patient records, practitioners log in to the HIE portal and enter a patient’s name in a search window. The system then generates a consolidated virtual chart with data collected from all HIE data-sharing participants. To share records, community HCPs either build or enable a profile in an integrated health care enterprise electronic communication interface into their data. However, VHA records were not made available to community HCPs at this initial stage.

Measures and Statistical Analysis

A template of quality improvement-related questions was adapted for this project with input from subject matter experts. Questions were then modified further based on interviews with 5 clinical and managed care staff members. The final online tool consisted of up to 20 multiple choice items and 2 open-ended questions delivered online. A 22-item evaluation tool was administered 6 months after system implementation. Frequencies were obtained for descriptive items, and group responses were compared across time.

Results

Thirty-nine staff (32 medical and 7 managed care staff) completed the needs assessment, and 20 staff (16 medical and 4 managed care staff) completed the postimplementation evaluation.

Before implementation of the HIE system, most staff (54%) indicated that they spent > 1 hour a week conducting tasks related to seeking and/or obtaining health records from the community. The largest percentage of staff (27%) requested > 10 community records during a typical week. Most respondents indicated that they would use an easy tool to instantly retrieve community health records at least 20 times per week (Table 1).

Preimplementation, 32.4% of respondents indicated that they could access community-based health records sometimes. Postimplementation, most respondents indicated they could access the records most of the time (Figure 1).

Preimplementation, staff most frequently indicated they were very dissatisfied with the current level of access to community records. Postimplementation, more staff were somewhat satisfied or very satisfied (Figure 2). Postimplementation, 48% of staff most often reported using the HIE system either several times a month or 2 to 4 times a week, 19% used the system daily, 19% used 1 to 2 times, and 14% never used the system. Most staff (67%) reported that the system improved access to records somewhat and supported continuing the contract with the HIE system. Conversely, 18% of respondents said that their access did not improve enough for the system to be of use to them.

Preimplementation, staff most frequently indicated that they did not have time (28.6%) or sufficient staff (25.7%) to request records (Table 2). Postimplementation, staff most frequently (33.3%) indicated that they had no problems accessing the HIE system, but 6.7% reported having time or interface/software difficulties.

Discussion

This report assessed a quality improvement project designed to increase VHA access to community health records via an external HIE system. Prior to this work, no data were available on use, barriers, and staff satisfaction related to implementing an externally developed HIE system within a VA medical center.^13,15

Before the medical center implemented the HIE system, logistical barriers prevented most HCPs and managed care staff from obtaining needed community records. Staff faced challenges such as lacking time as well as rudimentary barriers, such as community clinics not responding to requests or the fax machine not working. Time remained a challenge after implementation, but this work demonstrated that the HIE system helped staff overcome many logistical barriers.

After implementation of the HIE system, staff reported an improvement in access and satisfaction related to retrieving community health records. These findings are consistent with most but not all evaluations of HIE systems.^3,6,7,12,13 In the present work, staff used the system several times a month or several times a week, and most staff believed that access to the HIE system should be continued. Still, improvement was incomplete. The HIE system increased access to specific types of records (eg, reports) and health care systems (eg, large hospitals), but not others. As a result, the system was more useful for some staff than for others.

Research examining HIE systems in community and academic settings have identified factors that deter their use, such as poorly designed interfaces, inefficient workflow, and incomplete record availability.^3,6,7,14,16 In the present project, incomplete record availability was a noted barrier. Additionally, a few staff reported system interface issues. However, most staff found the system easy to use as part of their daily workflow.

Because the HIE system had a meaningful, positive impact on VHA providers and staff, it will be sustained at VAPIHCS. Specifically, the contract with the HHIE has been renewed, and the number of user licenses has increased. Staff users now self-refer for the service or can be referred by their service chiefs.

Limitations

This work was designed to evaluate the effect of an HIE system on staff in 1 VHA setting; thus, findings may not be generalizable to other settings or HIE systems. Limitations of the present work include small sample size of respondents; limited time frame for responses; and limited response rate. The logical next step would be research efforts to compare access to the HIE system with no access on factors such as workload productivity, cost savings, and patient safety.

Conclusion

The vision of the HITECH Act was to improve the continuity and safety of health care via reliable and interoperable electronic sharing of clinical information across health care entities.⁶ This VHA quality improvement project demonstrated a meaningful improvement in staff’s level of satisfaction with access to community health records when staff used an externally developed HIE system. Not all types of records (eg, progress notes) were accessible, which resulted in the system being useful for most but not all staff.

In the future, the federal government’s internally developed Veterans Health Information Exchange (formerly known as the Virtual Lifetime Electronic Record [VLER]) is expected to enable VHA, the Department of Defense, and participating community care providers to access shared electronic health records nationally. However, until we can achieve that envisioned interoperability, VHA staff can use HIE and other clinical support applications to access health records.

More than 9 million veterans are enrolled in the Veterans Health Administration (VHA). A high percentage of veterans who use VHA services have multiple chronic conditions and complex medical needs.¹ In addition to receiving health care from the VHA, many of these patients receive additional services from non-VHA providers in the community. Furthermore, recent laws enacted, such as the 2018 VA MISSION Act and the 2014 VA Choice Program, have increased veterans’ use of community health care services.

VHA staff face considerable barriers when seeking documentation about non-VHA services delivered in the community, which can be fragmented across multiple health care systems. In many VHA medical centers, staff must telephone non-VHA sites of care and/or use time-consuming fax services to request community-based patient records. VA health care providers (HCPs) often complain that community records are not available to make timely clinical decisions or that they must do so without knowing past or co-occurring assessments or treatment plans. Without access to comprehensive health records, patients are at risk for duplicated treatment, medication errors, and death.^2,3

Background

To improve the continuity and safety of health care, US governmental and health information experts stimulated formal communication among HCPs via the 2009 Health Information Technology for Economic and Clinical Health (HITECH) Act.^4,5 One of the primary aims of the HITECH Act was to promote reliable and interoperable electronic sharing of clinical information through health information exchange (HIE) for both patients and HCPs. Monetary incentives encouraged regional, state, or state-funded organizations to create and promote HIE capabilities.

Presently, empirical data are not available that describe the effect of external HIE systems in VHA settings. However, data examining non-VHA settings suggest that HIE may improve quality of care, although findings are mixed. For example, some research has found that HIE reduces hospital admissions, duplicated test ordering, and health care costs and improves decision making, whereas other research has found no change.^3,6-13 Barriers to HIE use noted in community settings include poorly designed interfaces, inefficient workflow, and incomplete record availability.^3,6-10,14

A few US Department of Veterans Affairs (VA) medical centers have recently initiated contracts with HIE organizations. Because much of the present research evaluates internally developed HIE systems, scholars in the field have identified a pressing need for useful statistics before and after implementation of externally developed HIE systems.^13,15 Additionally, scholars call for data examining nonacademic settings (eg, VHA medical centers) and for diverse patient populations (eg, individuals with chronic disorders, veterans).¹³This quality improvement project had 2 goals. The first goal was to assess baseline descriptive statistics related to requesting/obtaining community health records in a VHA setting. The second goal was to evaluate VHA staff access to needed community health records (eg, records stemming from community consults) before and after implementation of an externally developed HIE system.

Methods

This project was a single-center, quality improvement evaluation examining the effect of implementing an HIE system, developed by an external nonprofit organization. The project protocol was approved by the VA Pacific Islands Healthcare System (VAPIHCS) Evidence-Based Practices Council. Clinicians’ responses were anonymous, and data were reported only in aggregate. Assessment was conducted by an evaluator who was not associated with the HIE system developers and its implementation, reducing the chance of bias.¹⁵

Coinciding with the HIE system implementation and prior to having access to it, VAPIHCS medical and managed care staff were invited to complete an online needs assessment tool. Voluntary trainings on the system were offered at various times on multiple days and lasted approximately 1 hour. Six months after the HIE system was implemented, a postassessment tool reevaluated HIE-related access.

VHA Setting and HIE System

VAPIHCS serves about 55,000 unique patients across a 2.6 million square-mile catchment area (Hawaii and Pacific Island territories). Facilities include a medium-sized, urban VA medical center and 7 suburban or rural/remote primary care outpatient clinics.

VAPIHCS contracted with Hawaii Health Information Exchange (HHIE), a nonprofit organization that was designated by the state of Hawaii to develop a seamless, secure HIE system. According to HHIE, 83% of the 23 hospitals in the state and 55% of Hawaii’s 2,927 active practicing physicians have adopted the HIE system (F. Chan, personal communication, December 12, 2018). HHIE’s data sources provide real-time access to a database of 20 million health records. Records include, among other records, data such as patients’ reasons for referral, encounter diagnoses, medications, immunizations, and discharge instructions from many (but not all) HCPs in Hawaii.

HHIE reports that it has the capacity to interface with all electronic health records systems currently in use in the community (F. Chan, personal communication, December 12, 2018). Although the HIE system can provide directed exchange (ie, sending and receiving secure information electronically between HCPs), the HIE system implemented in the VAPIHCS was limited to query-retrieve (ie, practitioner-initiated requests for information from other community HCPs). Specifically, to access patient records, practitioners log in to the HIE portal and enter a patient’s name in a search window. The system then generates a consolidated virtual chart with data collected from all HIE data-sharing participants. To share records, community HCPs either build or enable a profile in an integrated health care enterprise electronic communication interface into their data. However, VHA records were not made available to community HCPs at this initial stage.

Measures and Statistical Analysis

A template of quality improvement-related questions was adapted for this project with input from subject matter experts. Questions were then modified further based on interviews with 5 clinical and managed care staff members. The final online tool consisted of up to 20 multiple choice items and 2 open-ended questions delivered online. A 22-item evaluation tool was administered 6 months after system implementation. Frequencies were obtained for descriptive items, and group responses were compared across time.

Results

Thirty-nine staff (32 medical and 7 managed care staff) completed the needs assessment, and 20 staff (16 medical and 4 managed care staff) completed the postimplementation evaluation.

Before implementation of the HIE system, most staff (54%) indicated that they spent > 1 hour a week conducting tasks related to seeking and/or obtaining health records from the community. The largest percentage of staff (27%) requested > 10 community records during a typical week. Most respondents indicated that they would use an easy tool to instantly retrieve community health records at least 20 times per week (Table 1).

Preimplementation, 32.4% of respondents indicated that they could access community-based health records sometimes. Postimplementation, most respondents indicated they could access the records most of the time (Figure 1).

Preimplementation, staff most frequently indicated they were very dissatisfied with the current level of access to community records. Postimplementation, more staff were somewhat satisfied or very satisfied (Figure 2). Postimplementation, 48% of staff most often reported using the HIE system either several times a month or 2 to 4 times a week, 19% used the system daily, 19% used 1 to 2 times, and 14% never used the system. Most staff (67%) reported that the system improved access to records somewhat and supported continuing the contract with the HIE system. Conversely, 18% of respondents said that their access did not improve enough for the system to be of use to them.

Preimplementation, staff most frequently indicated that they did not have time (28.6%) or sufficient staff (25.7%) to request records (Table 2). Postimplementation, staff most frequently (33.3%) indicated that they had no problems accessing the HIE system, but 6.7% reported having time or interface/software difficulties.

Discussion

This report assessed a quality improvement project designed to increase VHA access to community health records via an external HIE system. Prior to this work, no data were available on use, barriers, and staff satisfaction related to implementing an externally developed HIE system within a VA medical center.^13,15

Before the medical center implemented the HIE system, logistical barriers prevented most HCPs and managed care staff from obtaining needed community records. Staff faced challenges such as lacking time as well as rudimentary barriers, such as community clinics not responding to requests or the fax machine not working. Time remained a challenge after implementation, but this work demonstrated that the HIE system helped staff overcome many logistical barriers.

After implementation of the HIE system, staff reported an improvement in access and satisfaction related to retrieving community health records. These findings are consistent with most but not all evaluations of HIE systems.^3,6,7,12,13 In the present work, staff used the system several times a month or several times a week, and most staff believed that access to the HIE system should be continued. Still, improvement was incomplete. The HIE system increased access to specific types of records (eg, reports) and health care systems (eg, large hospitals), but not others. As a result, the system was more useful for some staff than for others.

Research examining HIE systems in community and academic settings have identified factors that deter their use, such as poorly designed interfaces, inefficient workflow, and incomplete record availability.^3,6,7,14,16 In the present project, incomplete record availability was a noted barrier. Additionally, a few staff reported system interface issues. However, most staff found the system easy to use as part of their daily workflow.

Because the HIE system had a meaningful, positive impact on VHA providers and staff, it will be sustained at VAPIHCS. Specifically, the contract with the HHIE has been renewed, and the number of user licenses has increased. Staff users now self-refer for the service or can be referred by their service chiefs.

Limitations

This work was designed to evaluate the effect of an HIE system on staff in 1 VHA setting; thus, findings may not be generalizable to other settings or HIE systems. Limitations of the present work include small sample size of respondents; limited time frame for responses; and limited response rate. The logical next step would be research efforts to compare access to the HIE system with no access on factors such as workload productivity, cost savings, and patient safety.

Conclusion

The vision of the HITECH Act was to improve the continuity and safety of health care via reliable and interoperable electronic sharing of clinical information across health care entities.⁶ This VHA quality improvement project demonstrated a meaningful improvement in staff’s level of satisfaction with access to community health records when staff used an externally developed HIE system. Not all types of records (eg, progress notes) were accessible, which resulted in the system being useful for most but not all staff.

In the future, the federal government’s internally developed Veterans Health Information Exchange (formerly known as the Virtual Lifetime Electronic Record [VLER]) is expected to enable VHA, the Department of Defense, and participating community care providers to access shared electronic health records nationally. However, until we can achieve that envisioned interoperability, VHA staff can use HIE and other clinical support applications to access health records.

More than 9 million veterans are enrolled in the Veterans Health Administration (VHA). A high percentage of veterans who use VHA services have multiple chronic conditions and complex medical needs.¹ In addition to receiving health care from the VHA, many of these patients receive additional services from non-VHA providers in the community. Furthermore, recent laws enacted, such as the 2018 VA MISSION Act and the 2014 VA Choice Program, have increased veterans’ use of community health care services.

VHA staff face considerable barriers when seeking documentation about non-VHA services delivered in the community, which can be fragmented across multiple health care systems. In many VHA medical centers, staff must telephone non-VHA sites of care and/or use time-consuming fax services to request community-based patient records. VA health care providers (HCPs) often complain that community records are not available to make timely clinical decisions or that they must do so without knowing past or co-occurring assessments or treatment plans. Without access to comprehensive health records, patients are at risk for duplicated treatment, medication errors, and death.^2,3

Background

To improve the continuity and safety of health care, US governmental and health information experts stimulated formal communication among HCPs via the 2009 Health Information Technology for Economic and Clinical Health (HITECH) Act.^4,5 One of the primary aims of the HITECH Act was to promote reliable and interoperable electronic sharing of clinical information through health information exchange (HIE) for both patients and HCPs. Monetary incentives encouraged regional, state, or state-funded organizations to create and promote HIE capabilities.

Presently, empirical data are not available that describe the effect of external HIE systems in VHA settings. However, data examining non-VHA settings suggest that HIE may improve quality of care, although findings are mixed. For example, some research has found that HIE reduces hospital admissions, duplicated test ordering, and health care costs and improves decision making, whereas other research has found no change.^3,6-13 Barriers to HIE use noted in community settings include poorly designed interfaces, inefficient workflow, and incomplete record availability.^3,6-10,14

A few US Department of Veterans Affairs (VA) medical centers have recently initiated contracts with HIE organizations. Because much of the present research evaluates internally developed HIE systems, scholars in the field have identified a pressing need for useful statistics before and after implementation of externally developed HIE systems.^13,15 Additionally, scholars call for data examining nonacademic settings (eg, VHA medical centers) and for diverse patient populations (eg, individuals with chronic disorders, veterans).¹³This quality improvement project had 2 goals. The first goal was to assess baseline descriptive statistics related to requesting/obtaining community health records in a VHA setting. The second goal was to evaluate VHA staff access to needed community health records (eg, records stemming from community consults) before and after implementation of an externally developed HIE system.

Methods

This project was a single-center, quality improvement evaluation examining the effect of implementing an HIE system, developed by an external nonprofit organization. The project protocol was approved by the VA Pacific Islands Healthcare System (VAPIHCS) Evidence-Based Practices Council. Clinicians’ responses were anonymous, and data were reported only in aggregate. Assessment was conducted by an evaluator who was not associated with the HIE system developers and its implementation, reducing the chance of bias.¹⁵

Coinciding with the HIE system implementation and prior to having access to it, VAPIHCS medical and managed care staff were invited to complete an online needs assessment tool. Voluntary trainings on the system were offered at various times on multiple days and lasted approximately 1 hour. Six months after the HIE system was implemented, a postassessment tool reevaluated HIE-related access.

VHA Setting and HIE System

VAPIHCS serves about 55,000 unique patients across a 2.6 million square-mile catchment area (Hawaii and Pacific Island territories). Facilities include a medium-sized, urban VA medical center and 7 suburban or rural/remote primary care outpatient clinics.

VAPIHCS contracted with Hawaii Health Information Exchange (HHIE), a nonprofit organization that was designated by the state of Hawaii to develop a seamless, secure HIE system. According to HHIE, 83% of the 23 hospitals in the state and 55% of Hawaii’s 2,927 active practicing physicians have adopted the HIE system (F. Chan, personal communication, December 12, 2018). HHIE’s data sources provide real-time access to a database of 20 million health records. Records include, among other records, data such as patients’ reasons for referral, encounter diagnoses, medications, immunizations, and discharge instructions from many (but not all) HCPs in Hawaii.

HHIE reports that it has the capacity to interface with all electronic health records systems currently in use in the community (F. Chan, personal communication, December 12, 2018). Although the HIE system can provide directed exchange (ie, sending and receiving secure information electronically between HCPs), the HIE system implemented in the VAPIHCS was limited to query-retrieve (ie, practitioner-initiated requests for information from other community HCPs). Specifically, to access patient records, practitioners log in to the HIE portal and enter a patient’s name in a search window. The system then generates a consolidated virtual chart with data collected from all HIE data-sharing participants. To share records, community HCPs either build or enable a profile in an integrated health care enterprise electronic communication interface into their data. However, VHA records were not made available to community HCPs at this initial stage.

Measures and Statistical Analysis

A template of quality improvement-related questions was adapted for this project with input from subject matter experts. Questions were then modified further based on interviews with 5 clinical and managed care staff members. The final online tool consisted of up to 20 multiple choice items and 2 open-ended questions delivered online. A 22-item evaluation tool was administered 6 months after system implementation. Frequencies were obtained for descriptive items, and group responses were compared across time.

Results

Thirty-nine staff (32 medical and 7 managed care staff) completed the needs assessment, and 20 staff (16 medical and 4 managed care staff) completed the postimplementation evaluation.

Before implementation of the HIE system, most staff (54%) indicated that they spent > 1 hour a week conducting tasks related to seeking and/or obtaining health records from the community. The largest percentage of staff (27%) requested > 10 community records during a typical week. Most respondents indicated that they would use an easy tool to instantly retrieve community health records at least 20 times per week (Table 1).

Preimplementation, 32.4% of respondents indicated that they could access community-based health records sometimes. Postimplementation, most respondents indicated they could access the records most of the time (Figure 1).

Preimplementation, staff most frequently indicated they were very dissatisfied with the current level of access to community records. Postimplementation, more staff were somewhat satisfied or very satisfied (Figure 2). Postimplementation, 48% of staff most often reported using the HIE system either several times a month or 2 to 4 times a week, 19% used the system daily, 19% used 1 to 2 times, and 14% never used the system. Most staff (67%) reported that the system improved access to records somewhat and supported continuing the contract with the HIE system. Conversely, 18% of respondents said that their access did not improve enough for the system to be of use to them.

Preimplementation, staff most frequently indicated that they did not have time (28.6%) or sufficient staff (25.7%) to request records (Table 2). Postimplementation, staff most frequently (33.3%) indicated that they had no problems accessing the HIE system, but 6.7% reported having time or interface/software difficulties.

Discussion

This report assessed a quality improvement project designed to increase VHA access to community health records via an external HIE system. Prior to this work, no data were available on use, barriers, and staff satisfaction related to implementing an externally developed HIE system within a VA medical center.^13,15

Before the medical center implemented the HIE system, logistical barriers prevented most HCPs and managed care staff from obtaining needed community records. Staff faced challenges such as lacking time as well as rudimentary barriers, such as community clinics not responding to requests or the fax machine not working. Time remained a challenge after implementation, but this work demonstrated that the HIE system helped staff overcome many logistical barriers.

After implementation of the HIE system, staff reported an improvement in access and satisfaction related to retrieving community health records. These findings are consistent with most but not all evaluations of HIE systems.^3,6,7,12,13 In the present work, staff used the system several times a month or several times a week, and most staff believed that access to the HIE system should be continued. Still, improvement was incomplete. The HIE system increased access to specific types of records (eg, reports) and health care systems (eg, large hospitals), but not others. As a result, the system was more useful for some staff than for others.

Research examining HIE systems in community and academic settings have identified factors that deter their use, such as poorly designed interfaces, inefficient workflow, and incomplete record availability.^3,6,7,14,16 In the present project, incomplete record availability was a noted barrier. Additionally, a few staff reported system interface issues. However, most staff found the system easy to use as part of their daily workflow.

Because the HIE system had a meaningful, positive impact on VHA providers and staff, it will be sustained at VAPIHCS. Specifically, the contract with the HHIE has been renewed, and the number of user licenses has increased. Staff users now self-refer for the service or can be referred by their service chiefs.

Limitations

This work was designed to evaluate the effect of an HIE system on staff in 1 VHA setting; thus, findings may not be generalizable to other settings or HIE systems. Limitations of the present work include small sample size of respondents; limited time frame for responses; and limited response rate. The logical next step would be research efforts to compare access to the HIE system with no access on factors such as workload productivity, cost savings, and patient safety.

Conclusion

The vision of the HITECH Act was to improve the continuity and safety of health care via reliable and interoperable electronic sharing of clinical information across health care entities.⁶ This VHA quality improvement project demonstrated a meaningful improvement in staff’s level of satisfaction with access to community health records when staff used an externally developed HIE system. Not all types of records (eg, progress notes) were accessible, which resulted in the system being useful for most but not all staff.

In the future, the federal government’s internally developed Veterans Health Information Exchange (formerly known as the Virtual Lifetime Electronic Record [VLER]) is expected to enable VHA, the Department of Defense, and participating community care providers to access shared electronic health records nationally. However, until we can achieve that envisioned interoperability, VHA staff can use HIE and other clinical support applications to access health records.

Here are 5 articles from the July issue of Clinician Reviews (individual articles are valid for one year from date of publication—expiration dates below):

1. Cloud of inconsistency hangs over cannabis data

To take the posttest, go to: https://bit.ly/2NfjaDS
Expires February 6, 2020

2. Roux-en-Y achieves diabetes remission in majority of patients

To take the posttest, go to: https://bit.ly/2x9hLnE
Expires February 6, 2020

3. Socioeconomic status, race found to impact CPAP compliance

To take the posttest, go to: https://bit.ly/2RBpLa9
Expires February 8, 2020

4. Exercise type matters for fall prevention among elderly

To take the posttest, go to: https://bit.ly/2X26OUh
Expires February 12, 2020

5. Adult HIV patients should receive standard vaccinations, with caveats

To take the posttest, go to: https://bit.ly/2X1S7LV
Expires February 12, 2020

Here are 5 articles from the July issue of Clinician Reviews (individual articles are valid for one year from date of publication—expiration dates below):

1. Cloud of inconsistency hangs over cannabis data

To take the posttest, go to: https://bit.ly/2NfjaDS
Expires February 6, 2020

2. Roux-en-Y achieves diabetes remission in majority of patients

To take the posttest, go to: https://bit.ly/2x9hLnE
Expires February 6, 2020

3. Socioeconomic status, race found to impact CPAP compliance

To take the posttest, go to: https://bit.ly/2RBpLa9
Expires February 8, 2020

4. Exercise type matters for fall prevention among elderly

To take the posttest, go to: https://bit.ly/2X26OUh
Expires February 12, 2020

5. Adult HIV patients should receive standard vaccinations, with caveats

To take the posttest, go to: https://bit.ly/2X1S7LV
Expires February 12, 2020

Here are 5 articles from the July issue of Clinician Reviews (individual articles are valid for one year from date of publication—expiration dates below):

1. Cloud of inconsistency hangs over cannabis data

To take the posttest, go to: https://bit.ly/2NfjaDS
Expires February 6, 2020

2. Roux-en-Y achieves diabetes remission in majority of patients

To take the posttest, go to: https://bit.ly/2x9hLnE
Expires February 6, 2020

3. Socioeconomic status, race found to impact CPAP compliance

To take the posttest, go to: https://bit.ly/2RBpLa9
Expires February 8, 2020

4. Exercise type matters for fall prevention among elderly

To take the posttest, go to: https://bit.ly/2X26OUh
Expires February 12, 2020

5. Adult HIV patients should receive standard vaccinations, with caveats

To take the posttest, go to: https://bit.ly/2X1S7LV
Expires February 12, 2020

Calling it a landmark initiative, the US Department of Veterans Affairs (VA) has launched its “new and improved” Veterans Community Care Program, implementing portions of the Maintaining Internal Systems and Strengthening Integrated Outside Networks Act of 2018 (MISSION Act). The initiative both ends the Veterans Choice Program, which expired June 6, and establishes a new Veterans Community Care Program. Senior VA leaders will visit > 30 VA hospitals across the country to support the rollout.

The MISSION Act is intended to provide veterans with more health care options. It also strengthens the VA’s ability to recruit and retain clinicians, authorizes “Anywhere to Anywhere” telehealth across state lines, gives veterans better access to community care, and establishes a new urgent care benefit.

 “The changes not only improve our ability to provide the health care veterans need, but also when and where they need it,” said VA Secretary Robert Wilkie. “It will also put veterans at the center of their care and offer options, including expanded telehealth and urgent care, so they can find the balance in the system that is right for them.”

Eligibility for community care does not require veterans to receive that care in the community; they can still choose to have VA care. A veteran may elect to receive care in the community if he or she:

• needs a service not available at any VA medical facility;
• lives in a US state or territory without a full-service VA medical facility (applies to veterans living in Alaska, Hawaii, New Hampshire, Guam, American Samoa, the Northern Mariana Islands and the US Virgin Islands);
• qualifies under the “grandfather” provision related to distance eligibility under the Veterans Choice Program; and/or
• meets specific access standards for average drive time or appointment wait times.

The veteran also is eligible if he or she and the referring clinician agree that it is in the best medical interest of the veteran to receive community care based on defined factors, or if the VA has determined that a VA medical service line is not providing care in a manner that complies with VA’s standards for quality based on specific conditions.

In addition to the new eligibility rules, the VA says it has made a variety of improvements that will “make community care work better for veterans.”

One is that existing programs will be combined into a single community care program, to reduce complexity and the “likelihood of errors and problems.” The VA also is streamlining internal processes and modernizing IT systems, aiming to “speed up all aspects of community care—eligibility, authorizations, appointments, care coordination, claims, payments—while improving overall communication between veterans, community providers, and VA staff members.”

 The VA has announced, as well, that 2 final regulations of the Veterans Community Care Program have been published in the Federal Register. One concerns the new urgent care benefit that provides eligible veterans with greater choice and access to timely, high-quality care for minor injuries and illnesses. The second regulation governs how eligible veterans receive necessary hospital care, medical services, and extended-care services from non-VA entities or providers in the community.

The VA will purchase most community care for veterans through its contracted network with third-party administrators (currently TriWest Healthcare Alliance and Optum Public). When the new Community Care Network of community providers is implemented, VA staff will work directly with veterans to schedule appointments and support care coordination.

A complete rollout of all 6 regions of the Community Care Network is expected by 2020. More detailed information is available at www.missionact.va.gov.

Calling it a landmark initiative, the US Department of Veterans Affairs (VA) has launched its “new and improved” Veterans Community Care Program, implementing portions of the Maintaining Internal Systems and Strengthening Integrated Outside Networks Act of 2018 (MISSION Act). The initiative both ends the Veterans Choice Program, which expired June 6, and establishes a new Veterans Community Care Program. Senior VA leaders will visit > 30 VA hospitals across the country to support the rollout.

The MISSION Act is intended to provide veterans with more health care options. It also strengthens the VA’s ability to recruit and retain clinicians, authorizes “Anywhere to Anywhere” telehealth across state lines, gives veterans better access to community care, and establishes a new urgent care benefit.

 “The changes not only improve our ability to provide the health care veterans need, but also when and where they need it,” said VA Secretary Robert Wilkie. “It will also put veterans at the center of their care and offer options, including expanded telehealth and urgent care, so they can find the balance in the system that is right for them.”

Eligibility for community care does not require veterans to receive that care in the community; they can still choose to have VA care. A veteran may elect to receive care in the community if he or she:

• needs a service not available at any VA medical facility;
• lives in a US state or territory without a full-service VA medical facility (applies to veterans living in Alaska, Hawaii, New Hampshire, Guam, American Samoa, the Northern Mariana Islands and the US Virgin Islands);
• qualifies under the “grandfather” provision related to distance eligibility under the Veterans Choice Program; and/or
• meets specific access standards for average drive time or appointment wait times.

The veteran also is eligible if he or she and the referring clinician agree that it is in the best medical interest of the veteran to receive community care based on defined factors, or if the VA has determined that a VA medical service line is not providing care in a manner that complies with VA’s standards for quality based on specific conditions.

In addition to the new eligibility rules, the VA says it has made a variety of improvements that will “make community care work better for veterans.”

One is that existing programs will be combined into a single community care program, to reduce complexity and the “likelihood of errors and problems.” The VA also is streamlining internal processes and modernizing IT systems, aiming to “speed up all aspects of community care—eligibility, authorizations, appointments, care coordination, claims, payments—while improving overall communication between veterans, community providers, and VA staff members.”

 The VA has announced, as well, that 2 final regulations of the Veterans Community Care Program have been published in the Federal Register. One concerns the new urgent care benefit that provides eligible veterans with greater choice and access to timely, high-quality care for minor injuries and illnesses. The second regulation governs how eligible veterans receive necessary hospital care, medical services, and extended-care services from non-VA entities or providers in the community.

The VA will purchase most community care for veterans through its contracted network with third-party administrators (currently TriWest Healthcare Alliance and Optum Public). When the new Community Care Network of community providers is implemented, VA staff will work directly with veterans to schedule appointments and support care coordination.

A complete rollout of all 6 regions of the Community Care Network is expected by 2020. More detailed information is available at www.missionact.va.gov.

Calling it a landmark initiative, the US Department of Veterans Affairs (VA) has launched its “new and improved” Veterans Community Care Program, implementing portions of the Maintaining Internal Systems and Strengthening Integrated Outside Networks Act of 2018 (MISSION Act). The initiative both ends the Veterans Choice Program, which expired June 6, and establishes a new Veterans Community Care Program. Senior VA leaders will visit > 30 VA hospitals across the country to support the rollout.

The MISSION Act is intended to provide veterans with more health care options. It also strengthens the VA’s ability to recruit and retain clinicians, authorizes “Anywhere to Anywhere” telehealth across state lines, gives veterans better access to community care, and establishes a new urgent care benefit.

 “The changes not only improve our ability to provide the health care veterans need, but also when and where they need it,” said VA Secretary Robert Wilkie. “It will also put veterans at the center of their care and offer options, including expanded telehealth and urgent care, so they can find the balance in the system that is right for them.”

Eligibility for community care does not require veterans to receive that care in the community; they can still choose to have VA care. A veteran may elect to receive care in the community if he or she:

• needs a service not available at any VA medical facility;
• lives in a US state or territory without a full-service VA medical facility (applies to veterans living in Alaska, Hawaii, New Hampshire, Guam, American Samoa, the Northern Mariana Islands and the US Virgin Islands);
• qualifies under the “grandfather” provision related to distance eligibility under the Veterans Choice Program; and/or
• meets specific access standards for average drive time or appointment wait times.

The veteran also is eligible if he or she and the referring clinician agree that it is in the best medical interest of the veteran to receive community care based on defined factors, or if the VA has determined that a VA medical service line is not providing care in a manner that complies with VA’s standards for quality based on specific conditions.

In addition to the new eligibility rules, the VA says it has made a variety of improvements that will “make community care work better for veterans.”

One is that existing programs will be combined into a single community care program, to reduce complexity and the “likelihood of errors and problems.” The VA also is streamlining internal processes and modernizing IT systems, aiming to “speed up all aspects of community care—eligibility, authorizations, appointments, care coordination, claims, payments—while improving overall communication between veterans, community providers, and VA staff members.”

 The VA has announced, as well, that 2 final regulations of the Veterans Community Care Program have been published in the Federal Register. One concerns the new urgent care benefit that provides eligible veterans with greater choice and access to timely, high-quality care for minor injuries and illnesses. The second regulation governs how eligible veterans receive necessary hospital care, medical services, and extended-care services from non-VA entities or providers in the community.

The VA will purchase most community care for veterans through its contracted network with third-party administrators (currently TriWest Healthcare Alliance and Optum Public). When the new Community Care Network of community providers is implemented, VA staff will work directly with veterans to schedule appointments and support care coordination.

A complete rollout of all 6 regions of the Community Care Network is expected by 2020. More detailed information is available at www.missionact.va.gov.

In an effort to reduce burden on physicians and qualified health care professionals, the Centers for Medicare and Medicaid Services ( CMS) has made changes to Evaluation and Management (E/M) documentation requirements and payment policies. Get ready for fairly extensive changes planned for CY 2021. Here we outline already-implemented and future changes and describe the commitment of the American College of Obstetricians and Gynecologists (ACOG) to ObGyn payment in its collaborations with CMS and the American Medical Association (AMA).

E/M services: CMS reduced documentation

Effective January 2019, the CMS made changes to the documentation requirements for E/M services to provide some common-sense relief for physicians facing excessive documentation requirements in their practices. Most physicians agree that modern medical practice, with the use of electronic health records (EHRs), is different now than in the mid-1990s, when the current E/M structures were developed and implemented. Streamlining documentation requirements reduces paperwork burden and some of the time-consuming duplicative work involved in medical practice today.

For instance, when relevant information is already contained in the medical record, it is not necessary to re-document a full medical history. Physicians will now be able to focus their documentation on the interval since the previous visit. Physicians should still review prior data, update as necessary, and indicate in the medical record that they have done so.

Also, for E/M office and outpatient visits for both new and established patients, physicians are no longer required to re-document information that has already been entered in the patient’s record by practice staff or by the patient. If the patient’s chief complaint and history already has been entered by ancillary staff or the beneficiary, the physician should simply indicate in the medical record that the information has been reviewed and verified.

For E/M visits furnished by teaching physicians, CMS has removed the requirement for potentially duplicative notations that may have been made previously in the medical records by residents or other members of the medical team.

Finally, CMS eliminated the requirement to document the medical necessity of a home visit in lieu of an office visit.

Continue to: Outpatient coding changes for 2021...

Outpatient coding changes for 2021

Outpatient coding for E/M will continue in its current form for the remainder of 2019 and 2020. However, in 2021, expect substantial changes to take effect. If the CMS rule is instituted, payment for E/M office and outpatient visits will be drastically “simplified.” The current CMS plan for 2021 is to collapse payment for existing E/M Levels 2 through 4 to one payment level for new patients and one payment level for established patients, with optional add-on codes. Level 5 visits will continue at a separate payment level and with continuation of current documentation requirements.

In addition to collapsing the payment in E/M Levels 2, 3, and 4, CMS also will allow flexibility in how those E/M office and outpatient visits are documented. Specifically, documentation may be based on any of the following:

• current framework (1995 or 1997 guidelines)
• medical decision making (MDM)
• time.

When using MDM or the current 1995/1997 framework to document an office visit, Medicare will only require documentation to support a Level 2 E/M outpatient visit code for history, exam, and/or MDM. When time is used as the basis for coding the visit, physicians will document the medical necessity of the visit and that the billing practitioner personally spent the required amount of time face-to-face with the beneficiary.

CMS also has finalized the creation of new add-on codes that describe the additional resources inherent in visits for primary care and particular kinds of nonprocedural specialized medical care (and will not be restricted by physician specialty). These codes would only be reportable with E/M office and outpatient level 2 through 4 visits, and their use generally would not impose new documentation requirements. It is not clear which types of visits would support the use of these add-on codes at this time.

Finally, a new “extended visit” add-on code will be available for use only with E/M Level 2 through 4 visits to account for the additional resources required when spending extended time with a patient.

CMS believes these policies will allow physicians, and all who bill E/M codes, greater flexibility to exercise clinical judgment in their documentation, so that they can focus on what is clinically relevant and medically necessary for the beneficiary.

ACOG’s voice in the process

ACOG strongly opposed several proposals that CMS made during the rule-making process that the agency decided not to finalize. These aspects of the proposal would have:

1. reduced payment by 50% for the least expensive procedure or visit when an E/M office or outpatient visit is furnished on the same day as a procedure by the same physician. These are separately identifiable E/M visits that normally would be reported with a modifier 25.
2. established separate coding and payment for podiatric E/M visits, or
3. standardized the allocation of practice expense relative value units (RVUs) for the codes that describe these services.

CMS has stated that they intend to engage in further discussions with the public and stakeholders to potentially further refine the policies for CY 2021.

Continue to: AMA-CPT and RUC initiative...

AMA-CPT and RUC initiative

Although the AMA, ACOG, and physicians in general applauded the CMS initiative to reduce the administrative and documentation burden on providers, there was concern about the unintended consequences of the payment changes that are currently scheduled to take effect in 2021. To address these concerns, the AMA convened a work group of physician experts who are knowledgeable in the Current Procedural Terminology (CPT) code development and valuation processes. The charge to the E/M work group is to collaborate across the provider, payer, and coding communities to establish or revise the coding structure and guidelines for outpatient E/M services. The members formed a multispecialty work group representing primary care and surgical specialties and have experience in developing, defining, and valuing codes.

Dr. Barbara Levy, ACOG’s Vice President of Health Policy, co-chaired this expert panel with geriatrician Dr. Peter Hollmann to develop comprehensive consensus-led changes to revise and modernize E/M codes. The work group followed 4 guiding principles to inform their E/M work:

1. to decrease the administrative burden of documentation and coding
2. to decrease the need for audits
3. to decrease unnecessary and redundant documentation in the medical record that is not needed for patient care
4. to ensure that payment for E/M services is resource based. There is no direct goal for payment redistribution among specialties.

A primary concern expressed by physicians about the CMS proposal was that the collapse of payment for E/M visit across levels 2–4 might lead to a lack of appropriate care for more complex patients since the CMS rule does not provide payment based on the resources required to perform the work of the visit. No one believes that the work needed to care for someone with a sore throat or pink eye is equivalent to the work involved in diagnosing and managing depression, for example.

Beginning in August 2018, the work group met regularly to build consensus. The work group worked at an accelerated pace to develop and value codes that better fit the current medical workflows and meet patient needs.

The work group submitted a code change proposal for E/M codes to the CPT Editorial Panel for consideration during the February 2019 meeting. The next step was the code valuation process through the AMA/Specialty Society RVS Update Committee (RUC) process.

CMS has stated that the 2-year delay to 2021 in implementation of their original proposed changes is to allow time for the E/M code change proposals to move through the development and valuation process and subsequent review by the agency. To date, commercial payers and coders have been supportive of the AMA E/M work group proposals. Dr. Levy, Dr. Hollmann, and AMA staff are meeting with CMS and Department of Health and Human Services staff to provide clarity as they review the CPT proposals. ACOG supports the changes, which would simplify documentation for outpatient E/M codes while retaining differential payments. CMS is closely following the progress of the code changes through the CPT process and RUC code valuation process. We await further rulemaking by CMS in defining and valuing this important code set.

Continue to: ACOG is at the helm, with a watchful eye...

ACOG is at the helm, with a watchful eye

This is a challenging undertaking because E/M codes are used across specialties for office visits and outpatient care. The potential for unintended consequences for all services that include E/M, such as the global obstetrical services or 90-day global surgical services, is substantial. ACOG is intimately involved in this undertaking, watching the developments carefully to ensure that the interests of ObGyns and their patients are protected.

In an effort to reduce burden on physicians and qualified health care professionals, the Centers for Medicare and Medicaid Services ( CMS) has made changes to Evaluation and Management (E/M) documentation requirements and payment policies. Get ready for fairly extensive changes planned for CY 2021. Here we outline already-implemented and future changes and describe the commitment of the American College of Obstetricians and Gynecologists (ACOG) to ObGyn payment in its collaborations with CMS and the American Medical Association (AMA).

E/M services: CMS reduced documentation

Effective January 2019, the CMS made changes to the documentation requirements for E/M services to provide some common-sense relief for physicians facing excessive documentation requirements in their practices. Most physicians agree that modern medical practice, with the use of electronic health records (EHRs), is different now than in the mid-1990s, when the current E/M structures were developed and implemented. Streamlining documentation requirements reduces paperwork burden and some of the time-consuming duplicative work involved in medical practice today.

For instance, when relevant information is already contained in the medical record, it is not necessary to re-document a full medical history. Physicians will now be able to focus their documentation on the interval since the previous visit. Physicians should still review prior data, update as necessary, and indicate in the medical record that they have done so.

Also, for E/M office and outpatient visits for both new and established patients, physicians are no longer required to re-document information that has already been entered in the patient’s record by practice staff or by the patient. If the patient’s chief complaint and history already has been entered by ancillary staff or the beneficiary, the physician should simply indicate in the medical record that the information has been reviewed and verified.

For E/M visits furnished by teaching physicians, CMS has removed the requirement for potentially duplicative notations that may have been made previously in the medical records by residents or other members of the medical team.

Finally, CMS eliminated the requirement to document the medical necessity of a home visit in lieu of an office visit.

Continue to: Outpatient coding changes for 2021...

Outpatient coding changes for 2021

Outpatient coding for E/M will continue in its current form for the remainder of 2019 and 2020. However, in 2021, expect substantial changes to take effect. If the CMS rule is instituted, payment for E/M office and outpatient visits will be drastically “simplified.” The current CMS plan for 2021 is to collapse payment for existing E/M Levels 2 through 4 to one payment level for new patients and one payment level for established patients, with optional add-on codes. Level 5 visits will continue at a separate payment level and with continuation of current documentation requirements.

In addition to collapsing the payment in E/M Levels 2, 3, and 4, CMS also will allow flexibility in how those E/M office and outpatient visits are documented. Specifically, documentation may be based on any of the following:

• current framework (1995 or 1997 guidelines)
• medical decision making (MDM)
• time.

When using MDM or the current 1995/1997 framework to document an office visit, Medicare will only require documentation to support a Level 2 E/M outpatient visit code for history, exam, and/or MDM. When time is used as the basis for coding the visit, physicians will document the medical necessity of the visit and that the billing practitioner personally spent the required amount of time face-to-face with the beneficiary.

CMS also has finalized the creation of new add-on codes that describe the additional resources inherent in visits for primary care and particular kinds of nonprocedural specialized medical care (and will not be restricted by physician specialty). These codes would only be reportable with E/M office and outpatient level 2 through 4 visits, and their use generally would not impose new documentation requirements. It is not clear which types of visits would support the use of these add-on codes at this time.

Finally, a new “extended visit” add-on code will be available for use only with E/M Level 2 through 4 visits to account for the additional resources required when spending extended time with a patient.

CMS believes these policies will allow physicians, and all who bill E/M codes, greater flexibility to exercise clinical judgment in their documentation, so that they can focus on what is clinically relevant and medically necessary for the beneficiary.

ACOG’s voice in the process

ACOG strongly opposed several proposals that CMS made during the rule-making process that the agency decided not to finalize. These aspects of the proposal would have:

1. reduced payment by 50% for the least expensive procedure or visit when an E/M office or outpatient visit is furnished on the same day as a procedure by the same physician. These are separately identifiable E/M visits that normally would be reported with a modifier 25.
2. established separate coding and payment for podiatric E/M visits, or
3. standardized the allocation of practice expense relative value units (RVUs) for the codes that describe these services.

CMS has stated that they intend to engage in further discussions with the public and stakeholders to potentially further refine the policies for CY 2021.

Continue to: AMA-CPT and RUC initiative...

AMA-CPT and RUC initiative

Although the AMA, ACOG, and physicians in general applauded the CMS initiative to reduce the administrative and documentation burden on providers, there was concern about the unintended consequences of the payment changes that are currently scheduled to take effect in 2021. To address these concerns, the AMA convened a work group of physician experts who are knowledgeable in the Current Procedural Terminology (CPT) code development and valuation processes. The charge to the E/M work group is to collaborate across the provider, payer, and coding communities to establish or revise the coding structure and guidelines for outpatient E/M services. The members formed a multispecialty work group representing primary care and surgical specialties and have experience in developing, defining, and valuing codes.

Dr. Barbara Levy, ACOG’s Vice President of Health Policy, co-chaired this expert panel with geriatrician Dr. Peter Hollmann to develop comprehensive consensus-led changes to revise and modernize E/M codes. The work group followed 4 guiding principles to inform their E/M work:

1. to decrease the administrative burden of documentation and coding
2. to decrease the need for audits
3. to decrease unnecessary and redundant documentation in the medical record that is not needed for patient care
4. to ensure that payment for E/M services is resource based. There is no direct goal for payment redistribution among specialties.

A primary concern expressed by physicians about the CMS proposal was that the collapse of payment for E/M visit across levels 2–4 might lead to a lack of appropriate care for more complex patients since the CMS rule does not provide payment based on the resources required to perform the work of the visit. No one believes that the work needed to care for someone with a sore throat or pink eye is equivalent to the work involved in diagnosing and managing depression, for example.

Beginning in August 2018, the work group met regularly to build consensus. The work group worked at an accelerated pace to develop and value codes that better fit the current medical workflows and meet patient needs.

The work group submitted a code change proposal for E/M codes to the CPT Editorial Panel for consideration during the February 2019 meeting. The next step was the code valuation process through the AMA/Specialty Society RVS Update Committee (RUC) process.

CMS has stated that the 2-year delay to 2021 in implementation of their original proposed changes is to allow time for the E/M code change proposals to move through the development and valuation process and subsequent review by the agency. To date, commercial payers and coders have been supportive of the AMA E/M work group proposals. Dr. Levy, Dr. Hollmann, and AMA staff are meeting with CMS and Department of Health and Human Services staff to provide clarity as they review the CPT proposals. ACOG supports the changes, which would simplify documentation for outpatient E/M codes while retaining differential payments. CMS is closely following the progress of the code changes through the CPT process and RUC code valuation process. We await further rulemaking by CMS in defining and valuing this important code set.

Continue to: ACOG is at the helm, with a watchful eye...

ACOG is at the helm, with a watchful eye

This is a challenging undertaking because E/M codes are used across specialties for office visits and outpatient care. The potential for unintended consequences for all services that include E/M, such as the global obstetrical services or 90-day global surgical services, is substantial. ACOG is intimately involved in this undertaking, watching the developments carefully to ensure that the interests of ObGyns and their patients are protected.

In an effort to reduce burden on physicians and qualified health care professionals, the Centers for Medicare and Medicaid Services ( CMS) has made changes to Evaluation and Management (E/M) documentation requirements and payment policies. Get ready for fairly extensive changes planned for CY 2021. Here we outline already-implemented and future changes and describe the commitment of the American College of Obstetricians and Gynecologists (ACOG) to ObGyn payment in its collaborations with CMS and the American Medical Association (AMA).

E/M services: CMS reduced documentation

Effective January 2019, the CMS made changes to the documentation requirements for E/M services to provide some common-sense relief for physicians facing excessive documentation requirements in their practices. Most physicians agree that modern medical practice, with the use of electronic health records (EHRs), is different now than in the mid-1990s, when the current E/M structures were developed and implemented. Streamlining documentation requirements reduces paperwork burden and some of the time-consuming duplicative work involved in medical practice today.

For instance, when relevant information is already contained in the medical record, it is not necessary to re-document a full medical history. Physicians will now be able to focus their documentation on the interval since the previous visit. Physicians should still review prior data, update as necessary, and indicate in the medical record that they have done so.

Also, for E/M office and outpatient visits for both new and established patients, physicians are no longer required to re-document information that has already been entered in the patient’s record by practice staff or by the patient. If the patient’s chief complaint and history already has been entered by ancillary staff or the beneficiary, the physician should simply indicate in the medical record that the information has been reviewed and verified.

For E/M visits furnished by teaching physicians, CMS has removed the requirement for potentially duplicative notations that may have been made previously in the medical records by residents or other members of the medical team.

Finally, CMS eliminated the requirement to document the medical necessity of a home visit in lieu of an office visit.

Continue to: Outpatient coding changes for 2021...

Outpatient coding changes for 2021

Outpatient coding for E/M will continue in its current form for the remainder of 2019 and 2020. However, in 2021, expect substantial changes to take effect. If the CMS rule is instituted, payment for E/M office and outpatient visits will be drastically “simplified.” The current CMS plan for 2021 is to collapse payment for existing E/M Levels 2 through 4 to one payment level for new patients and one payment level for established patients, with optional add-on codes. Level 5 visits will continue at a separate payment level and with continuation of current documentation requirements.

In addition to collapsing the payment in E/M Levels 2, 3, and 4, CMS also will allow flexibility in how those E/M office and outpatient visits are documented. Specifically, documentation may be based on any of the following:

• current framework (1995 or 1997 guidelines)
• medical decision making (MDM)
• time.

When using MDM or the current 1995/1997 framework to document an office visit, Medicare will only require documentation to support a Level 2 E/M outpatient visit code for history, exam, and/or MDM. When time is used as the basis for coding the visit, physicians will document the medical necessity of the visit and that the billing practitioner personally spent the required amount of time face-to-face with the beneficiary.

CMS also has finalized the creation of new add-on codes that describe the additional resources inherent in visits for primary care and particular kinds of nonprocedural specialized medical care (and will not be restricted by physician specialty). These codes would only be reportable with E/M office and outpatient level 2 through 4 visits, and their use generally would not impose new documentation requirements. It is not clear which types of visits would support the use of these add-on codes at this time.

Finally, a new “extended visit” add-on code will be available for use only with E/M Level 2 through 4 visits to account for the additional resources required when spending extended time with a patient.

CMS believes these policies will allow physicians, and all who bill E/M codes, greater flexibility to exercise clinical judgment in their documentation, so that they can focus on what is clinically relevant and medically necessary for the beneficiary.

ACOG’s voice in the process

ACOG strongly opposed several proposals that CMS made during the rule-making process that the agency decided not to finalize. These aspects of the proposal would have:

1. reduced payment by 50% for the least expensive procedure or visit when an E/M office or outpatient visit is furnished on the same day as a procedure by the same physician. These are separately identifiable E/M visits that normally would be reported with a modifier 25.
2. established separate coding and payment for podiatric E/M visits, or
3. standardized the allocation of practice expense relative value units (RVUs) for the codes that describe these services.

CMS has stated that they intend to engage in further discussions with the public and stakeholders to potentially further refine the policies for CY 2021.

Continue to: AMA-CPT and RUC initiative...

AMA-CPT and RUC initiative

Although the AMA, ACOG, and physicians in general applauded the CMS initiative to reduce the administrative and documentation burden on providers, there was concern about the unintended consequences of the payment changes that are currently scheduled to take effect in 2021. To address these concerns, the AMA convened a work group of physician experts who are knowledgeable in the Current Procedural Terminology (CPT) code development and valuation processes. The charge to the E/M work group is to collaborate across the provider, payer, and coding communities to establish or revise the coding structure and guidelines for outpatient E/M services. The members formed a multispecialty work group representing primary care and surgical specialties and have experience in developing, defining, and valuing codes.

Dr. Barbara Levy, ACOG’s Vice President of Health Policy, co-chaired this expert panel with geriatrician Dr. Peter Hollmann to develop comprehensive consensus-led changes to revise and modernize E/M codes. The work group followed 4 guiding principles to inform their E/M work:

1. to decrease the administrative burden of documentation and coding
2. to decrease the need for audits
3. to decrease unnecessary and redundant documentation in the medical record that is not needed for patient care
4. to ensure that payment for E/M services is resource based. There is no direct goal for payment redistribution among specialties.

A primary concern expressed by physicians about the CMS proposal was that the collapse of payment for E/M visit across levels 2–4 might lead to a lack of appropriate care for more complex patients since the CMS rule does not provide payment based on the resources required to perform the work of the visit. No one believes that the work needed to care for someone with a sore throat or pink eye is equivalent to the work involved in diagnosing and managing depression, for example.

Beginning in August 2018, the work group met regularly to build consensus. The work group worked at an accelerated pace to develop and value codes that better fit the current medical workflows and meet patient needs.

The work group submitted a code change proposal for E/M codes to the CPT Editorial Panel for consideration during the February 2019 meeting. The next step was the code valuation process through the AMA/Specialty Society RVS Update Committee (RUC) process.

CMS has stated that the 2-year delay to 2021 in implementation of their original proposed changes is to allow time for the E/M code change proposals to move through the development and valuation process and subsequent review by the agency. To date, commercial payers and coders have been supportive of the AMA E/M work group proposals. Dr. Levy, Dr. Hollmann, and AMA staff are meeting with CMS and Department of Health and Human Services staff to provide clarity as they review the CPT proposals. ACOG supports the changes, which would simplify documentation for outpatient E/M codes while retaining differential payments. CMS is closely following the progress of the code changes through the CPT process and RUC code valuation process. We await further rulemaking by CMS in defining and valuing this important code set.

Continue to: ACOG is at the helm, with a watchful eye...

ACOG is at the helm, with a watchful eye

This is a challenging undertaking because E/M codes are used across specialties for office visits and outpatient care. The potential for unintended consequences for all services that include E/M, such as the global obstetrical services or 90-day global surgical services, is substantial. ACOG is intimately involved in this undertaking, watching the developments carefully to ensure that the interests of ObGyns and their patients are protected.