Practice Management

ABSTRACT

Purpose Medical scribes are known to increase revenue by increasing visits to a medical practice. We examined whether medical scribes are associated with markers of financial benefit independent of increased visits.

Methods We conducted a pre- and post-­observational study with a control group, examining changes in the percentage of visits (1) coded as level of service 4 or 5, (2) with at least 1 hierarchical condition category code billed, and (3) at which orders for 3 pay-for-performance quality measures (screening for breast, cervical, and colon cancer) were placed, if due. We looked at changes in outcomes among scribed providers and compared them to nonscribed providers. We used generalized estimating equations with robust standard errors to account for repeated measures and the hierarchical nature of the data, controlling for patient demographics.

Results We examined 41,371 visits to 17 scribed providers and 230,297 visits to 78 nonscribed providers. In adjusted analyses, and compared to nonscribed providers, scribes were associated with an increase of:

• Frutiger LT Std9.2 percentage points in level-of-­service 4 or 5 billing (Frutiger LT StdP < .001)
• 3.6 percentage points in hierarchical condition category coding (Frutiger LT StdP < .001)
• 4.0 percentage points in breast cancer screening orders (Frutiger LT StdP = .01)
• 4.9 percentage points in colon cancer screening orders (Frutiger LT StdPFrutiger LT Std = .04).

Conclusions This study suggests that scribes are associated with financial benefit in addition to increased visit volume. Primary care practices should consider the financial benefit of scribes independent of their ability to add patient volume.

Increasingly, medical scribes are used in ambulatory care settings across the United States.¹ Scribes are trained personnel who accompany providers during visits to provide documentation support and assist with other administrative tasks. They are associated with reduced documentation time for providers^2-6 and improved provider satisfaction,^7-11 without detriment to^4-16 (or with possible improvement in^17-20) patient satisfaction in ambulatory care settings. At the same time, concerns remain that using scribes might inhibit patient communication, harm clinical reasoning, reduce the effectiveness of clinical decision-support tools, and simply serve as a work-around to fixing inefficiencies in the electronic medical record (EMR).^21-23

A driving force for the increased use of medical scribes is the expectation that they reduce the cost of providing care. Cost-­efficiency is typically described as resulting from a reduction in physician time per patient seen, which allows increased patient volume and, in turn, drives increased physician productivity.^{2,8,10,18,24-27} Whether scribes result in cost savings remains unclear; some papers suggest that scribes are cost efficient in ambulatory care,^2,10,18 while others have been unable to identify cost savings, particularly in primary care.⁴

One reason why scribes might not be associated with cost savings is that their financial benefit might be undercounted. Studies that focus on increased volume miss the opportunity to capture financial benefits conferred through mechanisms that are independent of seeing more patients:

• Scribes might help providers address and document more, and more complex, medical problems, allowing higher level-of-service (LOS) billing. For example, a provider chooses a lower LOS because they have insufficiently documented a visit to support a higher LOS; by assisting with documentation, the scribe might allow the provider to choose a higher LOS.
• Scribes might prompt a provider to use decision-support tools for risk coding (using appropriate medical codes to capture the patient’s level of medical complexity), thereby increasing reimbursement.
• Scribes might extend the time available during the visit for the provider to address pay-for-performance quality measures, such as cancer screening.

Continue to: Making visits count, not counting visits

Making visits count, not counting visits. In this study, we examined whether medical scribes in primary care are associated with improved markers of revenue that are independent of seeing more patients. Specifically, we examined whether scribes are associated with increased LOS coding, risk coding, and orders for pay-for-performance measures for all primary care visits and for nonpreventive primary care visits.

Methods

Design

This observational study compared the change in outcomes before implementation of scribes and during implementation of scribes, between scribed providers and nonscribed providers. We compared visits during the year prior to the implementation of scribes (July 2017–June 2018) with the year during their implementation (July 2018–2019).

The Cambridge Health Alliance Institutional Review Board considered this study exempt from review.

Setting

This study was conducted at a safety-net community academic health system that uses an EMR developed by Epic Systems [Verona, WI]. This EMR includes decision-support tools that prompt providers when pay-for-performance quality measures are due and when hierarchical condition category (HCC) codes—ie, specific diagnoses used by Medicare and other payers to reimburse providers for the complexity of their patients—might apply to the visit.

Primary care practices should consider the financial benefit of scribes, independent of their ability to add patient volume.

These EMR decision-support tools use algorithms that draw on age, gender, diagnoses that were billed previously or are on the problem list, laboratory findings, and prior imaging. They alert physicians when a patient is due for pay-for-performance quality measures, such as cancer screenings, and when HCC codes might be applicable.

Continue to: During the study period...

During the study period, the EMR ­decision-support tool for HCC coding underwent several changes designed to improve HCC coding. In addition, systematic changes to primary care visits took place, leading to an increase in the number of patients seen and screenings required.

Outcomes

We examined 2 categories of outcomes that confer financial benefit to many institutions: billing measures and pay-for-performance measures.

Billing measures included the percentage of visits (1) coded as LOS 4 or 5 and (2) with at least 1 HCC code billed (among those for which the decision-support tool identified at least 1 potential HCC code).

Pay-for-performance measures. We examined whether any of 3 pay-for-­performance quality measures were addressed during the visit, selecting 3 that are commonly addressed by primary care providers (PCPs) and that require PCPs to sign an order for screening during a primary care visit: breast cancer (mammography order), cervical cancer (Papanicolaou smear order), and colon cancer (an order for fecal occult blood testing or colonoscopy).

Intervention

Scribes were employees of Cambridge Health Alliance who had recently graduated from college and were interested in a career as a health care professional. Scribes received 3 days of training on how to function effectively in their role; 1 day of training in EMR functionality; and 2 hours of training on decision-support tools for pay-for-performance quality measures and risk coding. Scribes continued learning on the job through feedback from supervising PCPs. Scribes documented patient encounters, recording histories and findings on the physical exam and transcribing discussion of treatment plans and the PCP’s instructions to patients.

Continue to: The 14 scribes worked with 17 physician...

The 14 scribes worked with 17 physician and nurse practitioner PCPs beginning in July 2018. Participation by PCPs was voluntary; they received no compensation for participating in the scribe program. PCPs were not required to see additional patients to participate. PCPs who chose to work with a scribe were similar to those who declined a scribe, as regards gender, race, type of provider (MD or NP), tenure at the institution, and percentage of time in clinical work (see Table W-1).

The control group comprised providers who elected not to work with a scribe but who worked in the same clinics as the intervention providers.

Scribes might extend the time available during the visit for the provider to address pay-forperformance quality measures, such as cancer screening.

Scribes were assigned to a PCP based on availability during the PCP’s scheduled hours and worked with 1 PCP throughout the intervention (except for 1 PCP who worked with 2 scribes). All PCPs worked with their scribe(s) part time; on average, 49% of intervention PCPs’ visits were scribed.

Inclusion and exclusion criteria

Because the first year at an institution is a learning period for PCPs, we excluded those who worked at the institution for < 1 year before the start of the scribe program (n = 12). Based on the extensive clinical experience of 1 PCP (WA) with scribes, we excluded the first 200 visits or 6 weeks (whichever occurred first) with a scribe among all scribed providers, to account for an initial learning period (n = 2202, of 15,372 scribed visits [14%]). We also excluded 2 providers who left during the pre-intervention period or were in the intervention period for < 1 month.

To ensure that we captured visits to providers with clinically significant exposure to scribes, we required scribed providers to have ≥ 20% of their visits scribed during the intervention period. To minimize the potential for contamination, we excluded nonscribed visits to scribed providers during the intervention period (n = 2211), because such nonscribed visits were largely due to visits outside the scribe’s scheduled time.

Continue to: Analysis

We compared demographic characteristics for patients and providers using the chi-square test for categorical variables and the t test for continuous variables. We compared the change in outcomes from before implementation of scribes to during implementation of scribes among scribed providers, compared to nonscribed providers, using generalized estimating equations with robust standard errors to account for repeated measures (ie, multiple visits by the same patients) and the hierarchical nature of the data (ie, patients nested within providers). We then recalculated these estimates, controlling for patient demographics (age, gender, race, and ethnicity). We repeated these analyses for patients presenting for nonpreventive visits.

Results

Visit characteristics

We examined 271,768 visits, including 41,371 visits to 17 scribed providers and 230,397 visits to 78 nonscribed providers (Table 1). Patients were most likely to be female, > 21 years of age, have English as their language of care, and be non-White. Most visits were by established patients and were nonpreventive.

We noted no clinically significant differences in characteristics between visits with scribed providers and visits with nonscribed providers, and over time. Patient complexity measures, including care management enrollment and hospital admissions, were also similar between groups, and over time.

Billing measures

HCC coding. In 28.6% of visits, the decision-support tool identified at least 1 potential HCC code. Among these, the percentage of visits with at least 1 HCC code billed increased by 10.1 percentage points (from 3.9% before implementation of scribes to 14.0%) among scribed providers, compared to increasing by 6.5 percentage points (from 2.9% before implementation to 9.3%) among nonscribed providers (TABLE 2). Scribes were therefore associated with an additional 3.6 percentage-point increase in visits with at least 1 HCC code billed (P < .0001)—a difference that remained significant after adjusting for patient demographics (P < .0001).

LOS coding. Scribed providers increased the number of visits billed as LOS 4 or 5 by 9.6 percentage points (from 47.3% before implementation to 56.8%); during the same period, nonscribed providers increased the number of visits billed as LOS 4 or 5 by 1.3 percentage points (from 46.5% before implementation to 47.8%) (TABLE 2). Scribes were therefore associated with an additional 8.3 percentage points in LOS 4 or 5 billing (P < .001) (TABLE 2). This difference remained significant after adjusting for patient demographics (P < .001).

Continue to: Pay-for-performance quality measures

Breast cancer screening. Scribed providers increased the number of visits at which breast cancer screening was ordered by 2.7 percentage points (from 17.3% before implementation of scribes to 20.0%); during the same period, the number of visits at which breast cancer screening was ordered by nonscribed providers decreased by 1.9 percentage points (from 19.5% to 17.6%). Scribes were therefore associated with an increase of 4.6 percentage points in breast cancer screening orders, compared to nonscribed providers (P < .003) (TABLE 2). That difference remained significant after adjusting for patient demographics (P = .01).

Colon cancer screening. Similarly, scribed providers increased the number of visits at which colon cancer screening was ordered by 1.2 percentage points (from 19.2% before implementation of scribes to 20.3%); during the same period, the number of visits at which colon cancer screening was ordered by nonscribed providers decreased by 2.7 percentage points (from 18.5% to 15.9%) (P = .112). After adjusting for patient demographics, scribes were associated with an increase of 4.9 percentage points in colon cancer screening orders, compared to nonscribed providers (P = .044) (TABLE 2).

Cervical cancer screening. The rate at which cervical cancer screening was ordered did not change among scribed providers and decreased (by 2.5 percentage points) among nonscribed providers—a difference that was not statistically significant (P = .26).

Nonpreventive visits. Our findings overall did not change in analyses focused on nonpreventive visits, in which scribes were associated with an increase of 8.2 percentage points in LOS 4 or 5 billing (P < .001); an increase of 3.1 percentage points in HCC coding (P < .001); and an increase of 3.2 percentage points in breast cancer screening orders (P = .03) (TABLE 3). Although scribes were associated with an increase of 1.5 percentage points in cervical cancer screening orders and an increase of 3.1 percentage points in colon cancer screening orders, these increases did not reach statistical significance.

Discussion

We found that implementation of scribes is associated with (1) an increase in LOS coding and risk coding and (2) a higher frequency of addressing 2 of 3 pay-for-performance quality measures in primary care. In adjusted analyses in our study, and compared to nonscribed providers, scribes were associated with an additional 9.2 percentage points in LOS 4 or 5 billing; 3.6 percentage points in HCC coding; 4.0 percentage points in breast cancer screening orders; and 4.9 percentage points in colon cancer screening orders. Cervical cancer screening orders followed a similar pattern, with an increase of 2.3 percentage points in the adjusted screening order rate among scribed providers, compared to nonscribed providers, during implementation of scribes—although the increase was not significant. These findings did not change in analyses focused on nonpreventive visits.

Continue to: Our findings are consistent

Our findings are consistent with those of earlier studies. Prior examinations in ambulatory specialties found that scribes increased HCC coding,⁴ LOS billing,²⁴ and pay-for-performance metrics.¹⁸ The only study to examine these areas in primary care found that scribes were associated with increased pay-for-performance measure documentation,²⁰ a change that is necessary but insufficient to realize increased pay-for-­performance revenue. Therefore, our study confirms, for the first time, that PCPs can better address pay-for-performance measures, LOS billing, and HCC coding when working with a scribe in primary care.

Providers who used a scribe during the intervention period of our study increased the number of visits billed as LOS 4 or 5 by 9.6 percentage points.

Demands on primary care visits are increasing.²⁸ Physicians are required to provide more documentation; there is greater emphasis on PCPs meeting pay-for-­performance measures; and there are more data in the EMR to review. In this context, addressing pay-for-performance measures and gaps in risk coding is likely to be increasingly challenging. Our study suggests that scribes might provide a mechanism to increase risk coding, LOS billing, and pay-for-performance measures, despite increased demands on primary care visits.

Increase in LOS billing. In the settings in which we work, a fee-for-service LOS 4 primary care visit generates, on average, $20 to $75 more in revenue than an LOS 3 visit. Using an average of $50 additional revenue for LOS 4 billing, we estimate that a full-time scribe is associated with roughly $7,000 in additional revenue annually. We arrived at this estimate using an average of 1500 visits at LOS ≤ 3 for every PCP full-time equivalent. A 9.2 percentage–point increase in LOS 4 billing would lead to roughly 140 additional LOS 4 visits, with each visit generating an additional $50 in revenue.

This analysis does not account for increased revenue associated with increased pay for HCC coding identified in our study.

Our study also suggests that scribes might provide a mechanism to increase risk coding and payfor-performance, despite increased demands on primary care visits.

Furthermore, in our conservative assumption, the entire increase in LOS billing was from level 3 to level 4; in fact, a small percentage of that increase would be from level 2 and another small percentage would be to level 5—both of which would generate additional revenue. Our assumption therefore underestimates the full financial value associated with scribes in the absence of increased patient volume. Nonetheless, the assumption suggests that increases in LOS billing offset a substantial percentage of a scribe’s salary.

Continue to: Limitations of this study

Limitations of this study. Our study should be interpreted in the context of several limitations:

• The study was conducted at 1 institution. Our findings might not be generalizable beyond this setting.
• The study measures the impact of scribes when providers work with scribes part time. Because providers who utilize a scribe for all, or nearly all, their visits are likely to use a scribe more efficiently, our study might underestimate the full impact of a scribe.
• In some settings, team members such as medical assistants are trained to assist with documentation and other responsibilities (such as closing care gaps) in addition to other patient care responsibilities.^29-32 The extent to which our findings transfer to other models is unclear; studies comparing the impact of other models (which might provide even stronger outcomes) to the impact of medical scribes would be an interesting area for further research.
• In addition to the variability of models, there is likely variability in the quality and interactions of medical scribes, which might impact outcomes. We did not examine the qualities of scribes that led to outcomes in this study.
• We examined the impact of scribes on quality measure–ordering behaviors of providers, not on whether quality measures actually improved. Because scribes are associated with more face-to-face time with patients,²⁷ they might allow for increased attention being paid by physicians to barriers to pay-for-performance measures (eg, patient education). This could increase the likelihood that patients complete a multitude of screenings, and thus improve adherence and follow-up. However, the impact of scribes on quality measures is a topic for future study.

Value beyond volume. Any limitations notwithstanding, our study suggests that scribes are associated with financial benefit in addition to the benefit of increased volume. Primary care practices should therefore consider the financial benefit of scribes independent of their ability to add patient volume. By recognizing this additive value, primary care practices might more fully capture the benefit of scribes, which might then allow practices to employ scribes with less demand to increase volume. This added support without increased volume would, in turn, likely reduce provider burnout (and the costly associated turnover) and increase patient satisfaction, leading to a synergistic financial benefit.

CORRESPONDENCE
Wayne Altman, MD, FAAFP, Tufts University School of Medicine, 200 Harrison Avenue, Boston, MA 02111; wayne. [email protected]

ABSTRACT

Purpose Medical scribes are known to increase revenue by increasing visits to a medical practice. We examined whether medical scribes are associated with markers of financial benefit independent of increased visits.

Methods We conducted a pre- and post-­observational study with a control group, examining changes in the percentage of visits (1) coded as level of service 4 or 5, (2) with at least 1 hierarchical condition category code billed, and (3) at which orders for 3 pay-for-performance quality measures (screening for breast, cervical, and colon cancer) were placed, if due. We looked at changes in outcomes among scribed providers and compared them to nonscribed providers. We used generalized estimating equations with robust standard errors to account for repeated measures and the hierarchical nature of the data, controlling for patient demographics.

Results We examined 41,371 visits to 17 scribed providers and 230,297 visits to 78 nonscribed providers. In adjusted analyses, and compared to nonscribed providers, scribes were associated with an increase of:

• Frutiger LT Std9.2 percentage points in level-of-­service 4 or 5 billing (Frutiger LT StdP < .001)
• 3.6 percentage points in hierarchical condition category coding (Frutiger LT StdP < .001)
• 4.0 percentage points in breast cancer screening orders (Frutiger LT StdP = .01)
• 4.9 percentage points in colon cancer screening orders (Frutiger LT StdPFrutiger LT Std = .04).

Conclusions This study suggests that scribes are associated with financial benefit in addition to increased visit volume. Primary care practices should consider the financial benefit of scribes independent of their ability to add patient volume.

Increasingly, medical scribes are used in ambulatory care settings across the United States.¹ Scribes are trained personnel who accompany providers during visits to provide documentation support and assist with other administrative tasks. They are associated with reduced documentation time for providers^2-6 and improved provider satisfaction,^7-11 without detriment to^4-16 (or with possible improvement in^17-20) patient satisfaction in ambulatory care settings. At the same time, concerns remain that using scribes might inhibit patient communication, harm clinical reasoning, reduce the effectiveness of clinical decision-support tools, and simply serve as a work-around to fixing inefficiencies in the electronic medical record (EMR).^21-23

A driving force for the increased use of medical scribes is the expectation that they reduce the cost of providing care. Cost-­efficiency is typically described as resulting from a reduction in physician time per patient seen, which allows increased patient volume and, in turn, drives increased physician productivity.^{2,8,10,18,24-27} Whether scribes result in cost savings remains unclear; some papers suggest that scribes are cost efficient in ambulatory care,^2,10,18 while others have been unable to identify cost savings, particularly in primary care.⁴

One reason why scribes might not be associated with cost savings is that their financial benefit might be undercounted. Studies that focus on increased volume miss the opportunity to capture financial benefits conferred through mechanisms that are independent of seeing more patients:

• Scribes might help providers address and document more, and more complex, medical problems, allowing higher level-of-service (LOS) billing. For example, a provider chooses a lower LOS because they have insufficiently documented a visit to support a higher LOS; by assisting with documentation, the scribe might allow the provider to choose a higher LOS.
• Scribes might prompt a provider to use decision-support tools for risk coding (using appropriate medical codes to capture the patient’s level of medical complexity), thereby increasing reimbursement.
• Scribes might extend the time available during the visit for the provider to address pay-for-performance quality measures, such as cancer screening.

Continue to: Making visits count, not counting visits

Making visits count, not counting visits. In this study, we examined whether medical scribes in primary care are associated with improved markers of revenue that are independent of seeing more patients. Specifically, we examined whether scribes are associated with increased LOS coding, risk coding, and orders for pay-for-performance measures for all primary care visits and for nonpreventive primary care visits.

Methods

Design

This observational study compared the change in outcomes before implementation of scribes and during implementation of scribes, between scribed providers and nonscribed providers. We compared visits during the year prior to the implementation of scribes (July 2017–June 2018) with the year during their implementation (July 2018–2019).

The Cambridge Health Alliance Institutional Review Board considered this study exempt from review.

Setting

This study was conducted at a safety-net community academic health system that uses an EMR developed by Epic Systems [Verona, WI]. This EMR includes decision-support tools that prompt providers when pay-for-performance quality measures are due and when hierarchical condition category (HCC) codes—ie, specific diagnoses used by Medicare and other payers to reimburse providers for the complexity of their patients—might apply to the visit.

Primary care practices should consider the financial benefit of scribes, independent of their ability to add patient volume.

These EMR decision-support tools use algorithms that draw on age, gender, diagnoses that were billed previously or are on the problem list, laboratory findings, and prior imaging. They alert physicians when a patient is due for pay-for-performance quality measures, such as cancer screenings, and when HCC codes might be applicable.

Continue to: During the study period...

During the study period, the EMR ­decision-support tool for HCC coding underwent several changes designed to improve HCC coding. In addition, systematic changes to primary care visits took place, leading to an increase in the number of patients seen and screenings required.

Outcomes

We examined 2 categories of outcomes that confer financial benefit to many institutions: billing measures and pay-for-performance measures.

Billing measures included the percentage of visits (1) coded as LOS 4 or 5 and (2) with at least 1 HCC code billed (among those for which the decision-support tool identified at least 1 potential HCC code).

Pay-for-performance measures. We examined whether any of 3 pay-for-­performance quality measures were addressed during the visit, selecting 3 that are commonly addressed by primary care providers (PCPs) and that require PCPs to sign an order for screening during a primary care visit: breast cancer (mammography order), cervical cancer (Papanicolaou smear order), and colon cancer (an order for fecal occult blood testing or colonoscopy).

Intervention

Scribes were employees of Cambridge Health Alliance who had recently graduated from college and were interested in a career as a health care professional. Scribes received 3 days of training on how to function effectively in their role; 1 day of training in EMR functionality; and 2 hours of training on decision-support tools for pay-for-performance quality measures and risk coding. Scribes continued learning on the job through feedback from supervising PCPs. Scribes documented patient encounters, recording histories and findings on the physical exam and transcribing discussion of treatment plans and the PCP’s instructions to patients.

Continue to: The 14 scribes worked with 17 physician...

The 14 scribes worked with 17 physician and nurse practitioner PCPs beginning in July 2018. Participation by PCPs was voluntary; they received no compensation for participating in the scribe program. PCPs were not required to see additional patients to participate. PCPs who chose to work with a scribe were similar to those who declined a scribe, as regards gender, race, type of provider (MD or NP), tenure at the institution, and percentage of time in clinical work (see Table W-1).

The control group comprised providers who elected not to work with a scribe but who worked in the same clinics as the intervention providers.

Scribes might extend the time available during the visit for the provider to address pay-forperformance quality measures, such as cancer screening.

Scribes were assigned to a PCP based on availability during the PCP’s scheduled hours and worked with 1 PCP throughout the intervention (except for 1 PCP who worked with 2 scribes). All PCPs worked with their scribe(s) part time; on average, 49% of intervention PCPs’ visits were scribed.

Inclusion and exclusion criteria

Because the first year at an institution is a learning period for PCPs, we excluded those who worked at the institution for < 1 year before the start of the scribe program (n = 12). Based on the extensive clinical experience of 1 PCP (WA) with scribes, we excluded the first 200 visits or 6 weeks (whichever occurred first) with a scribe among all scribed providers, to account for an initial learning period (n = 2202, of 15,372 scribed visits [14%]). We also excluded 2 providers who left during the pre-intervention period or were in the intervention period for < 1 month.

To ensure that we captured visits to providers with clinically significant exposure to scribes, we required scribed providers to have ≥ 20% of their visits scribed during the intervention period. To minimize the potential for contamination, we excluded nonscribed visits to scribed providers during the intervention period (n = 2211), because such nonscribed visits were largely due to visits outside the scribe’s scheduled time.

Continue to: Analysis

We compared demographic characteristics for patients and providers using the chi-square test for categorical variables and the t test for continuous variables. We compared the change in outcomes from before implementation of scribes to during implementation of scribes among scribed providers, compared to nonscribed providers, using generalized estimating equations with robust standard errors to account for repeated measures (ie, multiple visits by the same patients) and the hierarchical nature of the data (ie, patients nested within providers). We then recalculated these estimates, controlling for patient demographics (age, gender, race, and ethnicity). We repeated these analyses for patients presenting for nonpreventive visits.

Results

Visit characteristics

We examined 271,768 visits, including 41,371 visits to 17 scribed providers and 230,397 visits to 78 nonscribed providers (Table 1). Patients were most likely to be female, > 21 years of age, have English as their language of care, and be non-White. Most visits were by established patients and were nonpreventive.

We noted no clinically significant differences in characteristics between visits with scribed providers and visits with nonscribed providers, and over time. Patient complexity measures, including care management enrollment and hospital admissions, were also similar between groups, and over time.

Billing measures

HCC coding. In 28.6% of visits, the decision-support tool identified at least 1 potential HCC code. Among these, the percentage of visits with at least 1 HCC code billed increased by 10.1 percentage points (from 3.9% before implementation of scribes to 14.0%) among scribed providers, compared to increasing by 6.5 percentage points (from 2.9% before implementation to 9.3%) among nonscribed providers (TABLE 2). Scribes were therefore associated with an additional 3.6 percentage-point increase in visits with at least 1 HCC code billed (P < .0001)—a difference that remained significant after adjusting for patient demographics (P < .0001).

LOS coding. Scribed providers increased the number of visits billed as LOS 4 or 5 by 9.6 percentage points (from 47.3% before implementation to 56.8%); during the same period, nonscribed providers increased the number of visits billed as LOS 4 or 5 by 1.3 percentage points (from 46.5% before implementation to 47.8%) (TABLE 2). Scribes were therefore associated with an additional 8.3 percentage points in LOS 4 or 5 billing (P < .001) (TABLE 2). This difference remained significant after adjusting for patient demographics (P < .001).

Continue to: Pay-for-performance quality measures

Breast cancer screening. Scribed providers increased the number of visits at which breast cancer screening was ordered by 2.7 percentage points (from 17.3% before implementation of scribes to 20.0%); during the same period, the number of visits at which breast cancer screening was ordered by nonscribed providers decreased by 1.9 percentage points (from 19.5% to 17.6%). Scribes were therefore associated with an increase of 4.6 percentage points in breast cancer screening orders, compared to nonscribed providers (P < .003) (TABLE 2). That difference remained significant after adjusting for patient demographics (P = .01).

Colon cancer screening. Similarly, scribed providers increased the number of visits at which colon cancer screening was ordered by 1.2 percentage points (from 19.2% before implementation of scribes to 20.3%); during the same period, the number of visits at which colon cancer screening was ordered by nonscribed providers decreased by 2.7 percentage points (from 18.5% to 15.9%) (P = .112). After adjusting for patient demographics, scribes were associated with an increase of 4.9 percentage points in colon cancer screening orders, compared to nonscribed providers (P = .044) (TABLE 2).

Cervical cancer screening. The rate at which cervical cancer screening was ordered did not change among scribed providers and decreased (by 2.5 percentage points) among nonscribed providers—a difference that was not statistically significant (P = .26).

Nonpreventive visits. Our findings overall did not change in analyses focused on nonpreventive visits, in which scribes were associated with an increase of 8.2 percentage points in LOS 4 or 5 billing (P < .001); an increase of 3.1 percentage points in HCC coding (P < .001); and an increase of 3.2 percentage points in breast cancer screening orders (P = .03) (TABLE 3). Although scribes were associated with an increase of 1.5 percentage points in cervical cancer screening orders and an increase of 3.1 percentage points in colon cancer screening orders, these increases did not reach statistical significance.

Discussion

We found that implementation of scribes is associated with (1) an increase in LOS coding and risk coding and (2) a higher frequency of addressing 2 of 3 pay-for-performance quality measures in primary care. In adjusted analyses in our study, and compared to nonscribed providers, scribes were associated with an additional 9.2 percentage points in LOS 4 or 5 billing; 3.6 percentage points in HCC coding; 4.0 percentage points in breast cancer screening orders; and 4.9 percentage points in colon cancer screening orders. Cervical cancer screening orders followed a similar pattern, with an increase of 2.3 percentage points in the adjusted screening order rate among scribed providers, compared to nonscribed providers, during implementation of scribes—although the increase was not significant. These findings did not change in analyses focused on nonpreventive visits.

Continue to: Our findings are consistent

Our findings are consistent with those of earlier studies. Prior examinations in ambulatory specialties found that scribes increased HCC coding,⁴ LOS billing,²⁴ and pay-for-performance metrics.¹⁸ The only study to examine these areas in primary care found that scribes were associated with increased pay-for-performance measure documentation,²⁰ a change that is necessary but insufficient to realize increased pay-for-­performance revenue. Therefore, our study confirms, for the first time, that PCPs can better address pay-for-performance measures, LOS billing, and HCC coding when working with a scribe in primary care.

Providers who used a scribe during the intervention period of our study increased the number of visits billed as LOS 4 or 5 by 9.6 percentage points.

Demands on primary care visits are increasing.²⁸ Physicians are required to provide more documentation; there is greater emphasis on PCPs meeting pay-for-­performance measures; and there are more data in the EMR to review. In this context, addressing pay-for-performance measures and gaps in risk coding is likely to be increasingly challenging. Our study suggests that scribes might provide a mechanism to increase risk coding, LOS billing, and pay-for-performance measures, despite increased demands on primary care visits.

Increase in LOS billing. In the settings in which we work, a fee-for-service LOS 4 primary care visit generates, on average, $20 to $75 more in revenue than an LOS 3 visit. Using an average of $50 additional revenue for LOS 4 billing, we estimate that a full-time scribe is associated with roughly $7,000 in additional revenue annually. We arrived at this estimate using an average of 1500 visits at LOS ≤ 3 for every PCP full-time equivalent. A 9.2 percentage–point increase in LOS 4 billing would lead to roughly 140 additional LOS 4 visits, with each visit generating an additional $50 in revenue.

This analysis does not account for increased revenue associated with increased pay for HCC coding identified in our study.

Our study also suggests that scribes might provide a mechanism to increase risk coding and payfor-performance, despite increased demands on primary care visits.

Furthermore, in our conservative assumption, the entire increase in LOS billing was from level 3 to level 4; in fact, a small percentage of that increase would be from level 2 and another small percentage would be to level 5—both of which would generate additional revenue. Our assumption therefore underestimates the full financial value associated with scribes in the absence of increased patient volume. Nonetheless, the assumption suggests that increases in LOS billing offset a substantial percentage of a scribe’s salary.

Continue to: Limitations of this study

Limitations of this study. Our study should be interpreted in the context of several limitations:

• The study was conducted at 1 institution. Our findings might not be generalizable beyond this setting.
• The study measures the impact of scribes when providers work with scribes part time. Because providers who utilize a scribe for all, or nearly all, their visits are likely to use a scribe more efficiently, our study might underestimate the full impact of a scribe.
• In some settings, team members such as medical assistants are trained to assist with documentation and other responsibilities (such as closing care gaps) in addition to other patient care responsibilities.^29-32 The extent to which our findings transfer to other models is unclear; studies comparing the impact of other models (which might provide even stronger outcomes) to the impact of medical scribes would be an interesting area for further research.
• In addition to the variability of models, there is likely variability in the quality and interactions of medical scribes, which might impact outcomes. We did not examine the qualities of scribes that led to outcomes in this study.
• We examined the impact of scribes on quality measure–ordering behaviors of providers, not on whether quality measures actually improved. Because scribes are associated with more face-to-face time with patients,²⁷ they might allow for increased attention being paid by physicians to barriers to pay-for-performance measures (eg, patient education). This could increase the likelihood that patients complete a multitude of screenings, and thus improve adherence and follow-up. However, the impact of scribes on quality measures is a topic for future study.

Value beyond volume. Any limitations notwithstanding, our study suggests that scribes are associated with financial benefit in addition to the benefit of increased volume. Primary care practices should therefore consider the financial benefit of scribes independent of their ability to add patient volume. By recognizing this additive value, primary care practices might more fully capture the benefit of scribes, which might then allow practices to employ scribes with less demand to increase volume. This added support without increased volume would, in turn, likely reduce provider burnout (and the costly associated turnover) and increase patient satisfaction, leading to a synergistic financial benefit.

CORRESPONDENCE
Wayne Altman, MD, FAAFP, Tufts University School of Medicine, 200 Harrison Avenue, Boston, MA 02111; wayne. [email protected]

ABSTRACT

Purpose Medical scribes are known to increase revenue by increasing visits to a medical practice. We examined whether medical scribes are associated with markers of financial benefit independent of increased visits.

Methods We conducted a pre- and post-­observational study with a control group, examining changes in the percentage of visits (1) coded as level of service 4 or 5, (2) with at least 1 hierarchical condition category code billed, and (3) at which orders for 3 pay-for-performance quality measures (screening for breast, cervical, and colon cancer) were placed, if due. We looked at changes in outcomes among scribed providers and compared them to nonscribed providers. We used generalized estimating equations with robust standard errors to account for repeated measures and the hierarchical nature of the data, controlling for patient demographics.

Results We examined 41,371 visits to 17 scribed providers and 230,297 visits to 78 nonscribed providers. In adjusted analyses, and compared to nonscribed providers, scribes were associated with an increase of:

• Frutiger LT Std9.2 percentage points in level-of-­service 4 or 5 billing (Frutiger LT StdP < .001)
• 3.6 percentage points in hierarchical condition category coding (Frutiger LT StdP < .001)
• 4.0 percentage points in breast cancer screening orders (Frutiger LT StdP = .01)
• 4.9 percentage points in colon cancer screening orders (Frutiger LT StdPFrutiger LT Std = .04).

Conclusions This study suggests that scribes are associated with financial benefit in addition to increased visit volume. Primary care practices should consider the financial benefit of scribes independent of their ability to add patient volume.

Increasingly, medical scribes are used in ambulatory care settings across the United States.¹ Scribes are trained personnel who accompany providers during visits to provide documentation support and assist with other administrative tasks. They are associated with reduced documentation time for providers^2-6 and improved provider satisfaction,^7-11 without detriment to^4-16 (or with possible improvement in^17-20) patient satisfaction in ambulatory care settings. At the same time, concerns remain that using scribes might inhibit patient communication, harm clinical reasoning, reduce the effectiveness of clinical decision-support tools, and simply serve as a work-around to fixing inefficiencies in the electronic medical record (EMR).^21-23

A driving force for the increased use of medical scribes is the expectation that they reduce the cost of providing care. Cost-­efficiency is typically described as resulting from a reduction in physician time per patient seen, which allows increased patient volume and, in turn, drives increased physician productivity.^{2,8,10,18,24-27} Whether scribes result in cost savings remains unclear; some papers suggest that scribes are cost efficient in ambulatory care,^2,10,18 while others have been unable to identify cost savings, particularly in primary care.⁴

One reason why scribes might not be associated with cost savings is that their financial benefit might be undercounted. Studies that focus on increased volume miss the opportunity to capture financial benefits conferred through mechanisms that are independent of seeing more patients:

• Scribes might help providers address and document more, and more complex, medical problems, allowing higher level-of-service (LOS) billing. For example, a provider chooses a lower LOS because they have insufficiently documented a visit to support a higher LOS; by assisting with documentation, the scribe might allow the provider to choose a higher LOS.
• Scribes might prompt a provider to use decision-support tools for risk coding (using appropriate medical codes to capture the patient’s level of medical complexity), thereby increasing reimbursement.
• Scribes might extend the time available during the visit for the provider to address pay-for-performance quality measures, such as cancer screening.

Continue to: Making visits count, not counting visits

Making visits count, not counting visits. In this study, we examined whether medical scribes in primary care are associated with improved markers of revenue that are independent of seeing more patients. Specifically, we examined whether scribes are associated with increased LOS coding, risk coding, and orders for pay-for-performance measures for all primary care visits and for nonpreventive primary care visits.

Methods

Design

This observational study compared the change in outcomes before implementation of scribes and during implementation of scribes, between scribed providers and nonscribed providers. We compared visits during the year prior to the implementation of scribes (July 2017–June 2018) with the year during their implementation (July 2018–2019).

The Cambridge Health Alliance Institutional Review Board considered this study exempt from review.

Setting

This study was conducted at a safety-net community academic health system that uses an EMR developed by Epic Systems [Verona, WI]. This EMR includes decision-support tools that prompt providers when pay-for-performance quality measures are due and when hierarchical condition category (HCC) codes—ie, specific diagnoses used by Medicare and other payers to reimburse providers for the complexity of their patients—might apply to the visit.

Primary care practices should consider the financial benefit of scribes, independent of their ability to add patient volume.

These EMR decision-support tools use algorithms that draw on age, gender, diagnoses that were billed previously or are on the problem list, laboratory findings, and prior imaging. They alert physicians when a patient is due for pay-for-performance quality measures, such as cancer screenings, and when HCC codes might be applicable.

Continue to: During the study period...

During the study period, the EMR ­decision-support tool for HCC coding underwent several changes designed to improve HCC coding. In addition, systematic changes to primary care visits took place, leading to an increase in the number of patients seen and screenings required.

Outcomes

We examined 2 categories of outcomes that confer financial benefit to many institutions: billing measures and pay-for-performance measures.

Billing measures included the percentage of visits (1) coded as LOS 4 or 5 and (2) with at least 1 HCC code billed (among those for which the decision-support tool identified at least 1 potential HCC code).

Pay-for-performance measures. We examined whether any of 3 pay-for-­performance quality measures were addressed during the visit, selecting 3 that are commonly addressed by primary care providers (PCPs) and that require PCPs to sign an order for screening during a primary care visit: breast cancer (mammography order), cervical cancer (Papanicolaou smear order), and colon cancer (an order for fecal occult blood testing or colonoscopy).

Intervention

Scribes were employees of Cambridge Health Alliance who had recently graduated from college and were interested in a career as a health care professional. Scribes received 3 days of training on how to function effectively in their role; 1 day of training in EMR functionality; and 2 hours of training on decision-support tools for pay-for-performance quality measures and risk coding. Scribes continued learning on the job through feedback from supervising PCPs. Scribes documented patient encounters, recording histories and findings on the physical exam and transcribing discussion of treatment plans and the PCP’s instructions to patients.

Continue to: The 14 scribes worked with 17 physician...

The 14 scribes worked with 17 physician and nurse practitioner PCPs beginning in July 2018. Participation by PCPs was voluntary; they received no compensation for participating in the scribe program. PCPs were not required to see additional patients to participate. PCPs who chose to work with a scribe were similar to those who declined a scribe, as regards gender, race, type of provider (MD or NP), tenure at the institution, and percentage of time in clinical work (see Table W-1).

The control group comprised providers who elected not to work with a scribe but who worked in the same clinics as the intervention providers.

Scribes might extend the time available during the visit for the provider to address pay-forperformance quality measures, such as cancer screening.

Scribes were assigned to a PCP based on availability during the PCP’s scheduled hours and worked with 1 PCP throughout the intervention (except for 1 PCP who worked with 2 scribes). All PCPs worked with their scribe(s) part time; on average, 49% of intervention PCPs’ visits were scribed.

Inclusion and exclusion criteria

Because the first year at an institution is a learning period for PCPs, we excluded those who worked at the institution for < 1 year before the start of the scribe program (n = 12). Based on the extensive clinical experience of 1 PCP (WA) with scribes, we excluded the first 200 visits or 6 weeks (whichever occurred first) with a scribe among all scribed providers, to account for an initial learning period (n = 2202, of 15,372 scribed visits [14%]). We also excluded 2 providers who left during the pre-intervention period or were in the intervention period for < 1 month.

To ensure that we captured visits to providers with clinically significant exposure to scribes, we required scribed providers to have ≥ 20% of their visits scribed during the intervention period. To minimize the potential for contamination, we excluded nonscribed visits to scribed providers during the intervention period (n = 2211), because such nonscribed visits were largely due to visits outside the scribe’s scheduled time.

Continue to: Analysis

We compared demographic characteristics for patients and providers using the chi-square test for categorical variables and the t test for continuous variables. We compared the change in outcomes from before implementation of scribes to during implementation of scribes among scribed providers, compared to nonscribed providers, using generalized estimating equations with robust standard errors to account for repeated measures (ie, multiple visits by the same patients) and the hierarchical nature of the data (ie, patients nested within providers). We then recalculated these estimates, controlling for patient demographics (age, gender, race, and ethnicity). We repeated these analyses for patients presenting for nonpreventive visits.

Results

Visit characteristics

We examined 271,768 visits, including 41,371 visits to 17 scribed providers and 230,397 visits to 78 nonscribed providers (Table 1). Patients were most likely to be female, > 21 years of age, have English as their language of care, and be non-White. Most visits were by established patients and were nonpreventive.

We noted no clinically significant differences in characteristics between visits with scribed providers and visits with nonscribed providers, and over time. Patient complexity measures, including care management enrollment and hospital admissions, were also similar between groups, and over time.

Billing measures

HCC coding. In 28.6% of visits, the decision-support tool identified at least 1 potential HCC code. Among these, the percentage of visits with at least 1 HCC code billed increased by 10.1 percentage points (from 3.9% before implementation of scribes to 14.0%) among scribed providers, compared to increasing by 6.5 percentage points (from 2.9% before implementation to 9.3%) among nonscribed providers (TABLE 2). Scribes were therefore associated with an additional 3.6 percentage-point increase in visits with at least 1 HCC code billed (P < .0001)—a difference that remained significant after adjusting for patient demographics (P < .0001).

LOS coding. Scribed providers increased the number of visits billed as LOS 4 or 5 by 9.6 percentage points (from 47.3% before implementation to 56.8%); during the same period, nonscribed providers increased the number of visits billed as LOS 4 or 5 by 1.3 percentage points (from 46.5% before implementation to 47.8%) (TABLE 2). Scribes were therefore associated with an additional 8.3 percentage points in LOS 4 or 5 billing (P < .001) (TABLE 2). This difference remained significant after adjusting for patient demographics (P < .001).

Continue to: Pay-for-performance quality measures

Breast cancer screening. Scribed providers increased the number of visits at which breast cancer screening was ordered by 2.7 percentage points (from 17.3% before implementation of scribes to 20.0%); during the same period, the number of visits at which breast cancer screening was ordered by nonscribed providers decreased by 1.9 percentage points (from 19.5% to 17.6%). Scribes were therefore associated with an increase of 4.6 percentage points in breast cancer screening orders, compared to nonscribed providers (P < .003) (TABLE 2). That difference remained significant after adjusting for patient demographics (P = .01).

Colon cancer screening. Similarly, scribed providers increased the number of visits at which colon cancer screening was ordered by 1.2 percentage points (from 19.2% before implementation of scribes to 20.3%); during the same period, the number of visits at which colon cancer screening was ordered by nonscribed providers decreased by 2.7 percentage points (from 18.5% to 15.9%) (P = .112). After adjusting for patient demographics, scribes were associated with an increase of 4.9 percentage points in colon cancer screening orders, compared to nonscribed providers (P = .044) (TABLE 2).

Cervical cancer screening. The rate at which cervical cancer screening was ordered did not change among scribed providers and decreased (by 2.5 percentage points) among nonscribed providers—a difference that was not statistically significant (P = .26).

Nonpreventive visits. Our findings overall did not change in analyses focused on nonpreventive visits, in which scribes were associated with an increase of 8.2 percentage points in LOS 4 or 5 billing (P < .001); an increase of 3.1 percentage points in HCC coding (P < .001); and an increase of 3.2 percentage points in breast cancer screening orders (P = .03) (TABLE 3). Although scribes were associated with an increase of 1.5 percentage points in cervical cancer screening orders and an increase of 3.1 percentage points in colon cancer screening orders, these increases did not reach statistical significance.

Discussion

We found that implementation of scribes is associated with (1) an increase in LOS coding and risk coding and (2) a higher frequency of addressing 2 of 3 pay-for-performance quality measures in primary care. In adjusted analyses in our study, and compared to nonscribed providers, scribes were associated with an additional 9.2 percentage points in LOS 4 or 5 billing; 3.6 percentage points in HCC coding; 4.0 percentage points in breast cancer screening orders; and 4.9 percentage points in colon cancer screening orders. Cervical cancer screening orders followed a similar pattern, with an increase of 2.3 percentage points in the adjusted screening order rate among scribed providers, compared to nonscribed providers, during implementation of scribes—although the increase was not significant. These findings did not change in analyses focused on nonpreventive visits.

Continue to: Our findings are consistent

Our findings are consistent with those of earlier studies. Prior examinations in ambulatory specialties found that scribes increased HCC coding,⁴ LOS billing,²⁴ and pay-for-performance metrics.¹⁸ The only study to examine these areas in primary care found that scribes were associated with increased pay-for-performance measure documentation,²⁰ a change that is necessary but insufficient to realize increased pay-for-­performance revenue. Therefore, our study confirms, for the first time, that PCPs can better address pay-for-performance measures, LOS billing, and HCC coding when working with a scribe in primary care.

Providers who used a scribe during the intervention period of our study increased the number of visits billed as LOS 4 or 5 by 9.6 percentage points.

Demands on primary care visits are increasing.²⁸ Physicians are required to provide more documentation; there is greater emphasis on PCPs meeting pay-for-­performance measures; and there are more data in the EMR to review. In this context, addressing pay-for-performance measures and gaps in risk coding is likely to be increasingly challenging. Our study suggests that scribes might provide a mechanism to increase risk coding, LOS billing, and pay-for-performance measures, despite increased demands on primary care visits.

Increase in LOS billing. In the settings in which we work, a fee-for-service LOS 4 primary care visit generates, on average, $20 to $75 more in revenue than an LOS 3 visit. Using an average of $50 additional revenue for LOS 4 billing, we estimate that a full-time scribe is associated with roughly $7,000 in additional revenue annually. We arrived at this estimate using an average of 1500 visits at LOS ≤ 3 for every PCP full-time equivalent. A 9.2 percentage–point increase in LOS 4 billing would lead to roughly 140 additional LOS 4 visits, with each visit generating an additional $50 in revenue.

This analysis does not account for increased revenue associated with increased pay for HCC coding identified in our study.

Our study also suggests that scribes might provide a mechanism to increase risk coding and payfor-performance, despite increased demands on primary care visits.

Furthermore, in our conservative assumption, the entire increase in LOS billing was from level 3 to level 4; in fact, a small percentage of that increase would be from level 2 and another small percentage would be to level 5—both of which would generate additional revenue. Our assumption therefore underestimates the full financial value associated with scribes in the absence of increased patient volume. Nonetheless, the assumption suggests that increases in LOS billing offset a substantial percentage of a scribe’s salary.

Continue to: Limitations of this study

Limitations of this study. Our study should be interpreted in the context of several limitations:

• The study was conducted at 1 institution. Our findings might not be generalizable beyond this setting.
• The study measures the impact of scribes when providers work with scribes part time. Because providers who utilize a scribe for all, or nearly all, their visits are likely to use a scribe more efficiently, our study might underestimate the full impact of a scribe.
• In some settings, team members such as medical assistants are trained to assist with documentation and other responsibilities (such as closing care gaps) in addition to other patient care responsibilities.^29-32 The extent to which our findings transfer to other models is unclear; studies comparing the impact of other models (which might provide even stronger outcomes) to the impact of medical scribes would be an interesting area for further research.
• In addition to the variability of models, there is likely variability in the quality and interactions of medical scribes, which might impact outcomes. We did not examine the qualities of scribes that led to outcomes in this study.
• We examined the impact of scribes on quality measure–ordering behaviors of providers, not on whether quality measures actually improved. Because scribes are associated with more face-to-face time with patients,²⁷ they might allow for increased attention being paid by physicians to barriers to pay-for-performance measures (eg, patient education). This could increase the likelihood that patients complete a multitude of screenings, and thus improve adherence and follow-up. However, the impact of scribes on quality measures is a topic for future study.

Value beyond volume. Any limitations notwithstanding, our study suggests that scribes are associated with financial benefit in addition to the benefit of increased volume. Primary care practices should therefore consider the financial benefit of scribes independent of their ability to add patient volume. By recognizing this additive value, primary care practices might more fully capture the benefit of scribes, which might then allow practices to employ scribes with less demand to increase volume. This added support without increased volume would, in turn, likely reduce provider burnout (and the costly associated turnover) and increase patient satisfaction, leading to a synergistic financial benefit.

CORRESPONDENCE
Wayne Altman, MD, FAAFP, Tufts University School of Medicine, 200 Harrison Avenue, Boston, MA 02111; wayne. [email protected]

In December 2020, the US Food and Drug Administration’s Emergency Use Authorization of the first COVID-19 vaccine presented us with a new tactic in the war against SARS-COV-2—and a new dilemma for obstetricians. What we had learned about COVID-19 infection in pregnancy by that point was alarming. While the vast majority (>90%) of pregnant women who contract COVID-19 recover without requiring hospitalization, pregnant women are at increased risk for severe illness and mechanical ventilation when compared with their nonpregnant counterparts.¹ Vertical transmission to the fetus is a rare event, but the increased risk of preterm birth, miscarriage, and preeclampsia makes the fetus a second victim in many cases.² Moreover, much is still unknown about the long-term impact of severe illness on maternal and fetal health.

Gaining vaccine approval

The COVID-19 vaccine, with its high efficacy rates in the nonpregnant adult population, presents an opportunity to reduce maternal morbidity related to this devastating illness. But unlike other vaccines, such as the flu shot and TDAP, results from prospective studies on COVID-19 vaccination of expectant women are pending. Under the best of circumstances, gaining acceptance of any vaccine during pregnancy faces barriers such as vaccine hesitancy and a general concern from pregnant women about the effect of medical interventions on the fetus. There is no reason to expect that either the mRNA vaccines or the replication-incompetent adenovirus recombinant vector vaccine could cause harm to the developing fetus, but the fact that currently available COVID-19 vaccines use newer technologies complicates the decision for many women.

Nevertheless, what we do know now is much more than we did in December, particularly when it comes to the mRNA vaccines. To date, observational studies of women who received the mRNA vaccine in pregnancy have shown no increased risk of adverse maternal, fetal, or obstetric outcomes.³ Emerging data also indicate that antibodies to the SARS-CoV-2 spike protein—the target of all 3 vaccines—is present in cord blood, potentially protecting the infant in the first months of life from contracting COVID-19 if the mother receives the vaccine during pregnancy.^4,5

Our approach to counseling

How can we best help our patients navigate the risks and benefits of the COVID-19 vaccine? First, by acknowledging the obvious: We are in the midst of a pandemic with high rates of community spread, which makes COVID-19 different from any other vaccine-preventable disease at this time. Providing patients with a structure for making an educated decision is essential, taking into account (1) what we know about COVID-19 infection during pregnancy, (2) what we know about vaccine efficacy and safety to date, and (3) individual factors such as:

• The presence of comorbidities such as obesity, heart disease, respiratory disease, and diabetes.
• Potential exposures—“Do you have children in school or daycare? Do childcare providers or other workers come to your home? What is your occupation?”
• The ability to take precautions (social distancing, wearing a mask, etc)

All things considered, the decision to accept the COVID-19 vaccine or not ultimately belongs to the patient. Given disease prevalence and the latest information on vaccine safety in pregnancy, I have been advising my patients in the second trimester or beyond to receive the vaccine with the caveat that delaying the vaccine until the postpartum period is a completely valid alternative. The most important gift we can offer our patients is to arm them with the necessary information so that they can make the choice best for them and their family as we continue to fight this war on COVID-19.

In December 2020, the US Food and Drug Administration’s Emergency Use Authorization of the first COVID-19 vaccine presented us with a new tactic in the war against SARS-COV-2—and a new dilemma for obstetricians. What we had learned about COVID-19 infection in pregnancy by that point was alarming. While the vast majority (>90%) of pregnant women who contract COVID-19 recover without requiring hospitalization, pregnant women are at increased risk for severe illness and mechanical ventilation when compared with their nonpregnant counterparts.¹ Vertical transmission to the fetus is a rare event, but the increased risk of preterm birth, miscarriage, and preeclampsia makes the fetus a second victim in many cases.² Moreover, much is still unknown about the long-term impact of severe illness on maternal and fetal health.

Gaining vaccine approval

The COVID-19 vaccine, with its high efficacy rates in the nonpregnant adult population, presents an opportunity to reduce maternal morbidity related to this devastating illness. But unlike other vaccines, such as the flu shot and TDAP, results from prospective studies on COVID-19 vaccination of expectant women are pending. Under the best of circumstances, gaining acceptance of any vaccine during pregnancy faces barriers such as vaccine hesitancy and a general concern from pregnant women about the effect of medical interventions on the fetus. There is no reason to expect that either the mRNA vaccines or the replication-incompetent adenovirus recombinant vector vaccine could cause harm to the developing fetus, but the fact that currently available COVID-19 vaccines use newer technologies complicates the decision for many women.

Nevertheless, what we do know now is much more than we did in December, particularly when it comes to the mRNA vaccines. To date, observational studies of women who received the mRNA vaccine in pregnancy have shown no increased risk of adverse maternal, fetal, or obstetric outcomes.³ Emerging data also indicate that antibodies to the SARS-CoV-2 spike protein—the target of all 3 vaccines—is present in cord blood, potentially protecting the infant in the first months of life from contracting COVID-19 if the mother receives the vaccine during pregnancy.^4,5

Our approach to counseling

How can we best help our patients navigate the risks and benefits of the COVID-19 vaccine? First, by acknowledging the obvious: We are in the midst of a pandemic with high rates of community spread, which makes COVID-19 different from any other vaccine-preventable disease at this time. Providing patients with a structure for making an educated decision is essential, taking into account (1) what we know about COVID-19 infection during pregnancy, (2) what we know about vaccine efficacy and safety to date, and (3) individual factors such as:

• The presence of comorbidities such as obesity, heart disease, respiratory disease, and diabetes.
• Potential exposures—“Do you have children in school or daycare? Do childcare providers or other workers come to your home? What is your occupation?”
• The ability to take precautions (social distancing, wearing a mask, etc)

All things considered, the decision to accept the COVID-19 vaccine or not ultimately belongs to the patient. Given disease prevalence and the latest information on vaccine safety in pregnancy, I have been advising my patients in the second trimester or beyond to receive the vaccine with the caveat that delaying the vaccine until the postpartum period is a completely valid alternative. The most important gift we can offer our patients is to arm them with the necessary information so that they can make the choice best for them and their family as we continue to fight this war on COVID-19.

In December 2020, the US Food and Drug Administration’s Emergency Use Authorization of the first COVID-19 vaccine presented us with a new tactic in the war against SARS-COV-2—and a new dilemma for obstetricians. What we had learned about COVID-19 infection in pregnancy by that point was alarming. While the vast majority (>90%) of pregnant women who contract COVID-19 recover without requiring hospitalization, pregnant women are at increased risk for severe illness and mechanical ventilation when compared with their nonpregnant counterparts.¹ Vertical transmission to the fetus is a rare event, but the increased risk of preterm birth, miscarriage, and preeclampsia makes the fetus a second victim in many cases.² Moreover, much is still unknown about the long-term impact of severe illness on maternal and fetal health.

Gaining vaccine approval

The COVID-19 vaccine, with its high efficacy rates in the nonpregnant adult population, presents an opportunity to reduce maternal morbidity related to this devastating illness. But unlike other vaccines, such as the flu shot and TDAP, results from prospective studies on COVID-19 vaccination of expectant women are pending. Under the best of circumstances, gaining acceptance of any vaccine during pregnancy faces barriers such as vaccine hesitancy and a general concern from pregnant women about the effect of medical interventions on the fetus. There is no reason to expect that either the mRNA vaccines or the replication-incompetent adenovirus recombinant vector vaccine could cause harm to the developing fetus, but the fact that currently available COVID-19 vaccines use newer technologies complicates the decision for many women.

Nevertheless, what we do know now is much more than we did in December, particularly when it comes to the mRNA vaccines. To date, observational studies of women who received the mRNA vaccine in pregnancy have shown no increased risk of adverse maternal, fetal, or obstetric outcomes.³ Emerging data also indicate that antibodies to the SARS-CoV-2 spike protein—the target of all 3 vaccines—is present in cord blood, potentially protecting the infant in the first months of life from contracting COVID-19 if the mother receives the vaccine during pregnancy.^4,5

Our approach to counseling

How can we best help our patients navigate the risks and benefits of the COVID-19 vaccine? First, by acknowledging the obvious: We are in the midst of a pandemic with high rates of community spread, which makes COVID-19 different from any other vaccine-preventable disease at this time. Providing patients with a structure for making an educated decision is essential, taking into account (1) what we know about COVID-19 infection during pregnancy, (2) what we know about vaccine efficacy and safety to date, and (3) individual factors such as:

• The presence of comorbidities such as obesity, heart disease, respiratory disease, and diabetes.
• Potential exposures—“Do you have children in school or daycare? Do childcare providers or other workers come to your home? What is your occupation?”
• The ability to take precautions (social distancing, wearing a mask, etc)

All things considered, the decision to accept the COVID-19 vaccine or not ultimately belongs to the patient. Given disease prevalence and the latest information on vaccine safety in pregnancy, I have been advising my patients in the second trimester or beyond to receive the vaccine with the caveat that delaying the vaccine until the postpartum period is a completely valid alternative. The most important gift we can offer our patients is to arm them with the necessary information so that they can make the choice best for them and their family as we continue to fight this war on COVID-19.

Improving maternal morbidity and mortality begins prior to conception. Numerous modifiable and nonmodifiable factors—lifestyle behaviors, chronic medical conditions, medications, immunizations, prior pregnancy events—have been shown to improve pregnancy outcomes if they are reviewed, identified, and optimized before conception.

Laying a solid foundation for a healthy pregnancy requires a comprehensive approach to patient counseling. However, the national Pregnancy Risk Assessment Monitoring System (PRAMS; a surveillance program of the Centers for Disease Control and Prevention) data from 2014 show that only about 20% of women receive counseling on at least 5 out of 11 healthy lifestyle behaviors and prevention strategies before pregnancy. The ability to leverage technology-enabled smart device applications can provide clinicians with immediate access to information necessary to address with patients at a preconception visit. Apps built specifically for physicians offer a convenient, thorough, and peer-vetted reference that can increase the efficiency and quality of consultation in a busy practice.

Prepregnancy care app considerations

When applying the ACOG-recommended rubric to evaluate the quality of an app targeted to address preconception counseling, the accuracy and objectivity of the content, as well as the app’s ease of use, are vital characteristics to consider, and these criteria should score 4 out of 4 on the rubric.

Several apps offer suggestions on how to address important components of health, including counseling and intervention strategies and evidence-based recommendations. The most efficacious apps offer embedded references to more detailed resources for use when complexities inevitably arise during consultation. Truly comprehensive prepregnancy care requires clinicians to take a step beyond the review of patients’ medications and comorbidities. It is therefore helpful to implement point-of-care apps that prompt evaluation of the often-overlooked aspects of prepregnancy counseling, including risk of interpersonal violence and infectious diseases, occupational exposures, and immunization status.

Physician-focused prepregnancy apps that provide reminders, prompts, and strategies for addressing a comprehensive set of health components prior to conception can be valuable tools to incorporate into both educational environments and busy practices to address maternal morbidity and mortality. ●

Improving maternal morbidity and mortality begins prior to conception. Numerous modifiable and nonmodifiable factors—lifestyle behaviors, chronic medical conditions, medications, immunizations, prior pregnancy events—have been shown to improve pregnancy outcomes if they are reviewed, identified, and optimized before conception.

Laying a solid foundation for a healthy pregnancy requires a comprehensive approach to patient counseling. However, the national Pregnancy Risk Assessment Monitoring System (PRAMS; a surveillance program of the Centers for Disease Control and Prevention) data from 2014 show that only about 20% of women receive counseling on at least 5 out of 11 healthy lifestyle behaviors and prevention strategies before pregnancy. The ability to leverage technology-enabled smart device applications can provide clinicians with immediate access to information necessary to address with patients at a preconception visit. Apps built specifically for physicians offer a convenient, thorough, and peer-vetted reference that can increase the efficiency and quality of consultation in a busy practice.

Prepregnancy care app considerations

When applying the ACOG-recommended rubric to evaluate the quality of an app targeted to address preconception counseling, the accuracy and objectivity of the content, as well as the app’s ease of use, are vital characteristics to consider, and these criteria should score 4 out of 4 on the rubric.

Several apps offer suggestions on how to address important components of health, including counseling and intervention strategies and evidence-based recommendations. The most efficacious apps offer embedded references to more detailed resources for use when complexities inevitably arise during consultation. Truly comprehensive prepregnancy care requires clinicians to take a step beyond the review of patients’ medications and comorbidities. It is therefore helpful to implement point-of-care apps that prompt evaluation of the often-overlooked aspects of prepregnancy counseling, including risk of interpersonal violence and infectious diseases, occupational exposures, and immunization status.

Physician-focused prepregnancy apps that provide reminders, prompts, and strategies for addressing a comprehensive set of health components prior to conception can be valuable tools to incorporate into both educational environments and busy practices to address maternal morbidity and mortality. ●

Improving maternal morbidity and mortality begins prior to conception. Numerous modifiable and nonmodifiable factors—lifestyle behaviors, chronic medical conditions, medications, immunizations, prior pregnancy events—have been shown to improve pregnancy outcomes if they are reviewed, identified, and optimized before conception.

Laying a solid foundation for a healthy pregnancy requires a comprehensive approach to patient counseling. However, the national Pregnancy Risk Assessment Monitoring System (PRAMS; a surveillance program of the Centers for Disease Control and Prevention) data from 2014 show that only about 20% of women receive counseling on at least 5 out of 11 healthy lifestyle behaviors and prevention strategies before pregnancy. The ability to leverage technology-enabled smart device applications can provide clinicians with immediate access to information necessary to address with patients at a preconception visit. Apps built specifically for physicians offer a convenient, thorough, and peer-vetted reference that can increase the efficiency and quality of consultation in a busy practice.

Prepregnancy care app considerations

When applying the ACOG-recommended rubric to evaluate the quality of an app targeted to address preconception counseling, the accuracy and objectivity of the content, as well as the app’s ease of use, are vital characteristics to consider, and these criteria should score 4 out of 4 on the rubric.

Several apps offer suggestions on how to address important components of health, including counseling and intervention strategies and evidence-based recommendations. The most efficacious apps offer embedded references to more detailed resources for use when complexities inevitably arise during consultation. Truly comprehensive prepregnancy care requires clinicians to take a step beyond the review of patients’ medications and comorbidities. It is therefore helpful to implement point-of-care apps that prompt evaluation of the often-overlooked aspects of prepregnancy counseling, including risk of interpersonal violence and infectious diseases, occupational exposures, and immunization status.

Physician-focused prepregnancy apps that provide reminders, prompts, and strategies for addressing a comprehensive set of health components prior to conception can be valuable tools to incorporate into both educational environments and busy practices to address maternal morbidity and mortality. ●

Personalizing care is at the heart of the American College of Obstetricians and Gynecologists (ACOG) 2020–2021 President Dr. Eva Chalas’ initiative to “Revisit the Visit.” As obstetrician-gynecologists, we care for patients across the entirety of their life. This role gives us the opportunity to form long-term partnerships with women to address important preventive health care measures.

Dr. Chalas established a Presidential Task Force that identified 5 areas of preventive health that significantly influence the long-term morbidity of women: obesity, cardiovascular disease, preconception counseling, diabetes, and cancer risk. The annual visit can serve as a particularly impactful point of care to achieve specific preventive care objectives and offer mitigation strategies based on patient-specific risk factors. We are uniquely positioned to identify and initiate the conversation and subsequently manage, treat, and address these critical health areas.

Harnessing modern technology

To adopt these health topics into practice, we need improved, more effective tools both to increase productivity during the office visit and to provide more personalized care. Notably, the widespread adoption of and proliferation of mobile devices—and the medical apps accessible on them—is creating new and innovative ways to improve health and health care delivery. More than 90% of physicians use a smartphone at work, and 62% of smartphone users have used their device to gather health data.¹

In addition, according to a US Food and Drug Administration (FDA) report, in 2017, 325,000 health care applications were available on smartphones; this equates to an expected 3.7 billion mobile health application downloads that year by 1.7 billion smartphone users worldwide.² As of October 2020, 48,000-plus health apps were available on the iOS mobile operating system alone.³

For patients and clinicians, picking the most suitable apps can be challenging in the face of evolving clinical evidence, emerging privacy risks, functionality concerns, and the fact that apps constantly update and change. Many have relied on star rating systems and user reviews in app stores to guide their selection process despite mounting evidence that suggests that such evaluation methods are misleading, not always addressing such important parameters as usability, validity, security, and privacy.^4,5

Approaches for evaluating medical apps

Many app evaluation frameworks have emerged, but none is universally accepted within the health care field.

The American Psychiatric Association’s (APA) App Evaluation Model represents a comprehensive resource to consider when evaluating medical apps. It stratifies numerous variables into 5 levels that form a pyramid. In this model, background information forms the base of this pyramid and includes factors such as business model, credibility, cost, and advertising of the app. The top of the pyramid is comprised of data integration that considers data ownership and therapeutic alliance.⁶ Although this model is beneficial in that it provides a framework, it is not practical for point-of-care purposes as it offers no objective way to rate or score an app for quick and easy comparison.

The privately owned and operated Health On the Net (HON) Foundation is well known for its HONcode, an ethical standard for quality medical information on the internet. It uses 8 principles to certify a health website. However, the HON website itself states that it cannot guarantee the accuracy or completeness of medical information presented by a site.⁷ Although HON certification by a website is a sign of good intention, it is not beneficial to the practicing clinician who is looking to use an app to directly assist in clinical care.

The Agency for Healthcare Research and Quality (AHRQ) is another well-respected body that has delineated essential details to consider when using a health website. The AHRQ identifies features (similar to those of the APA pyramid and HONcode) for users to consider, such as credibility, content, design, and disclosures.⁸ However, this model too lacks a concise user-friendly evaluating system.

Although the FDA plans to apply some regulatory authority to the evaluation of a certain subset of high-risk mobile medical apps, it is not planning to evaluate or regulate many of the medical apps that clinicians use in daily practice. This leaves us, and our patients, to be guided by the principle of caveat emptor, or “let the buyer beware.”

Thus, Dr. Chalas’ Presidential Task Force carefully considered various resources to provide a useful tool that would help obstetrician-gynecologists objectively vet a medical app in practice.

Continue to: The Task Force’s recommended rubric...

The Task Force’s recommended rubric

The rubric shown for evaluating mobile drug information apps was developed by the American Society of Health-System Pharmacists (ASHP). The ASHP rubric takes into account the criteria recognized by the APA pyramid, the HON Foundation, and the AHRQ and incorporates them into a user-friendly tool and scoring system that can be applied as an evaluation checklist.⁹ This tool is meant to aid clinicians in evaluating medical apps, but it ultimately is the user’s decision to determine if an app’s deficiencies should deter its use.

While all of the criteria are relevant and important, it is incumbent on us as medical experts to pay careful attention to the accuracy, authority, objectivity, timeliness, and security of any app we consider incorporating into clinical practice. A low score on these criteria would belie any perceived usefulness or value the app may have.

When applying the rubric to evaluate the quality of an app, we should be mindful of the primary user and which characteristics are more important than others to effect positive changes in health. For example, in addressing obesity, it is the patient who will be interacting with the app. Therefore, it’s important that the app should score, on a 1- to 4-point scale (1 point being major deficiencies, 4 points being no deficiencies), a 4 out of 4 on features like usefulness, functionality, and design. Coveted design features that enhance the user’s experience will appeal to patients and keep them engaged and motivated. However, when addressing a woman’s health with respect to cancer risk, the principal features on which the app should score 4 out of 4 would be authority, objectivity, timeliness, and accuracy.

In the upcoming articles in this series, a member of the Presidential Task Force will reference the ASHP rubric to guide clinicians in choosing apps to address one of the critical health areas with their patients. The author of the piece will highlight key features of an app to consider what would add the most value in incorporating its use in clinical practice.

It would be impossible to evaluate all health care apps even if we focused only on the medical apps relevant to obstetrics and gynecology. There is much value in having a framework for efficiently measuring an app’s benefit in clinical practice. The objective of this article series is to help clinicians Revisit the Visit by providing an effective tool to evaluate a medical app. ●

Personalizing care is at the heart of the American College of Obstetricians and Gynecologists (ACOG) 2020–2021 President Dr. Eva Chalas’ initiative to “Revisit the Visit.” As obstetrician-gynecologists, we care for patients across the entirety of their life. This role gives us the opportunity to form long-term partnerships with women to address important preventive health care measures.

Dr. Chalas established a Presidential Task Force that identified 5 areas of preventive health that significantly influence the long-term morbidity of women: obesity, cardiovascular disease, preconception counseling, diabetes, and cancer risk. The annual visit can serve as a particularly impactful point of care to achieve specific preventive care objectives and offer mitigation strategies based on patient-specific risk factors. We are uniquely positioned to identify and initiate the conversation and subsequently manage, treat, and address these critical health areas.

Harnessing modern technology

To adopt these health topics into practice, we need improved, more effective tools both to increase productivity during the office visit and to provide more personalized care. Notably, the widespread adoption of and proliferation of mobile devices—and the medical apps accessible on them—is creating new and innovative ways to improve health and health care delivery. More than 90% of physicians use a smartphone at work, and 62% of smartphone users have used their device to gather health data.¹

In addition, according to a US Food and Drug Administration (FDA) report, in 2017, 325,000 health care applications were available on smartphones; this equates to an expected 3.7 billion mobile health application downloads that year by 1.7 billion smartphone users worldwide.² As of October 2020, 48,000-plus health apps were available on the iOS mobile operating system alone.³

For patients and clinicians, picking the most suitable apps can be challenging in the face of evolving clinical evidence, emerging privacy risks, functionality concerns, and the fact that apps constantly update and change. Many have relied on star rating systems and user reviews in app stores to guide their selection process despite mounting evidence that suggests that such evaluation methods are misleading, not always addressing such important parameters as usability, validity, security, and privacy.^4,5

Approaches for evaluating medical apps

Many app evaluation frameworks have emerged, but none is universally accepted within the health care field.

The American Psychiatric Association’s (APA) App Evaluation Model represents a comprehensive resource to consider when evaluating medical apps. It stratifies numerous variables into 5 levels that form a pyramid. In this model, background information forms the base of this pyramid and includes factors such as business model, credibility, cost, and advertising of the app. The top of the pyramid is comprised of data integration that considers data ownership and therapeutic alliance.⁶ Although this model is beneficial in that it provides a framework, it is not practical for point-of-care purposes as it offers no objective way to rate or score an app for quick and easy comparison.

The privately owned and operated Health On the Net (HON) Foundation is well known for its HONcode, an ethical standard for quality medical information on the internet. It uses 8 principles to certify a health website. However, the HON website itself states that it cannot guarantee the accuracy or completeness of medical information presented by a site.⁷ Although HON certification by a website is a sign of good intention, it is not beneficial to the practicing clinician who is looking to use an app to directly assist in clinical care.

The Agency for Healthcare Research and Quality (AHRQ) is another well-respected body that has delineated essential details to consider when using a health website. The AHRQ identifies features (similar to those of the APA pyramid and HONcode) for users to consider, such as credibility, content, design, and disclosures.⁸ However, this model too lacks a concise user-friendly evaluating system.

Although the FDA plans to apply some regulatory authority to the evaluation of a certain subset of high-risk mobile medical apps, it is not planning to evaluate or regulate many of the medical apps that clinicians use in daily practice. This leaves us, and our patients, to be guided by the principle of caveat emptor, or “let the buyer beware.”

Thus, Dr. Chalas’ Presidential Task Force carefully considered various resources to provide a useful tool that would help obstetrician-gynecologists objectively vet a medical app in practice.

Continue to: The Task Force’s recommended rubric...

The Task Force’s recommended rubric

The rubric shown for evaluating mobile drug information apps was developed by the American Society of Health-System Pharmacists (ASHP). The ASHP rubric takes into account the criteria recognized by the APA pyramid, the HON Foundation, and the AHRQ and incorporates them into a user-friendly tool and scoring system that can be applied as an evaluation checklist.⁹ This tool is meant to aid clinicians in evaluating medical apps, but it ultimately is the user’s decision to determine if an app’s deficiencies should deter its use.

While all of the criteria are relevant and important, it is incumbent on us as medical experts to pay careful attention to the accuracy, authority, objectivity, timeliness, and security of any app we consider incorporating into clinical practice. A low score on these criteria would belie any perceived usefulness or value the app may have.

When applying the rubric to evaluate the quality of an app, we should be mindful of the primary user and which characteristics are more important than others to effect positive changes in health. For example, in addressing obesity, it is the patient who will be interacting with the app. Therefore, it’s important that the app should score, on a 1- to 4-point scale (1 point being major deficiencies, 4 points being no deficiencies), a 4 out of 4 on features like usefulness, functionality, and design. Coveted design features that enhance the user’s experience will appeal to patients and keep them engaged and motivated. However, when addressing a woman’s health with respect to cancer risk, the principal features on which the app should score 4 out of 4 would be authority, objectivity, timeliness, and accuracy.

In the upcoming articles in this series, a member of the Presidential Task Force will reference the ASHP rubric to guide clinicians in choosing apps to address one of the critical health areas with their patients. The author of the piece will highlight key features of an app to consider what would add the most value in incorporating its use in clinical practice.

It would be impossible to evaluate all health care apps even if we focused only on the medical apps relevant to obstetrics and gynecology. There is much value in having a framework for efficiently measuring an app’s benefit in clinical practice. The objective of this article series is to help clinicians Revisit the Visit by providing an effective tool to evaluate a medical app. ●

Personalizing care is at the heart of the American College of Obstetricians and Gynecologists (ACOG) 2020–2021 President Dr. Eva Chalas’ initiative to “Revisit the Visit.” As obstetrician-gynecologists, we care for patients across the entirety of their life. This role gives us the opportunity to form long-term partnerships with women to address important preventive health care measures.

Dr. Chalas established a Presidential Task Force that identified 5 areas of preventive health that significantly influence the long-term morbidity of women: obesity, cardiovascular disease, preconception counseling, diabetes, and cancer risk. The annual visit can serve as a particularly impactful point of care to achieve specific preventive care objectives and offer mitigation strategies based on patient-specific risk factors. We are uniquely positioned to identify and initiate the conversation and subsequently manage, treat, and address these critical health areas.

Harnessing modern technology

To adopt these health topics into practice, we need improved, more effective tools both to increase productivity during the office visit and to provide more personalized care. Notably, the widespread adoption of and proliferation of mobile devices—and the medical apps accessible on them—is creating new and innovative ways to improve health and health care delivery. More than 90% of physicians use a smartphone at work, and 62% of smartphone users have used their device to gather health data.¹

In addition, according to a US Food and Drug Administration (FDA) report, in 2017, 325,000 health care applications were available on smartphones; this equates to an expected 3.7 billion mobile health application downloads that year by 1.7 billion smartphone users worldwide.² As of October 2020, 48,000-plus health apps were available on the iOS mobile operating system alone.³

For patients and clinicians, picking the most suitable apps can be challenging in the face of evolving clinical evidence, emerging privacy risks, functionality concerns, and the fact that apps constantly update and change. Many have relied on star rating systems and user reviews in app stores to guide their selection process despite mounting evidence that suggests that such evaluation methods are misleading, not always addressing such important parameters as usability, validity, security, and privacy.^4,5

Approaches for evaluating medical apps

Many app evaluation frameworks have emerged, but none is universally accepted within the health care field.

The American Psychiatric Association’s (APA) App Evaluation Model represents a comprehensive resource to consider when evaluating medical apps. It stratifies numerous variables into 5 levels that form a pyramid. In this model, background information forms the base of this pyramid and includes factors such as business model, credibility, cost, and advertising of the app. The top of the pyramid is comprised of data integration that considers data ownership and therapeutic alliance.⁶ Although this model is beneficial in that it provides a framework, it is not practical for point-of-care purposes as it offers no objective way to rate or score an app for quick and easy comparison.

The privately owned and operated Health On the Net (HON) Foundation is well known for its HONcode, an ethical standard for quality medical information on the internet. It uses 8 principles to certify a health website. However, the HON website itself states that it cannot guarantee the accuracy or completeness of medical information presented by a site.⁷ Although HON certification by a website is a sign of good intention, it is not beneficial to the practicing clinician who is looking to use an app to directly assist in clinical care.

The Agency for Healthcare Research and Quality (AHRQ) is another well-respected body that has delineated essential details to consider when using a health website. The AHRQ identifies features (similar to those of the APA pyramid and HONcode) for users to consider, such as credibility, content, design, and disclosures.⁸ However, this model too lacks a concise user-friendly evaluating system.

Although the FDA plans to apply some regulatory authority to the evaluation of a certain subset of high-risk mobile medical apps, it is not planning to evaluate or regulate many of the medical apps that clinicians use in daily practice. This leaves us, and our patients, to be guided by the principle of caveat emptor, or “let the buyer beware.”

Thus, Dr. Chalas’ Presidential Task Force carefully considered various resources to provide a useful tool that would help obstetrician-gynecologists objectively vet a medical app in practice.

Continue to: The Task Force’s recommended rubric...

The Task Force’s recommended rubric

The rubric shown for evaluating mobile drug information apps was developed by the American Society of Health-System Pharmacists (ASHP). The ASHP rubric takes into account the criteria recognized by the APA pyramid, the HON Foundation, and the AHRQ and incorporates them into a user-friendly tool and scoring system that can be applied as an evaluation checklist.⁹ This tool is meant to aid clinicians in evaluating medical apps, but it ultimately is the user’s decision to determine if an app’s deficiencies should deter its use.

While all of the criteria are relevant and important, it is incumbent on us as medical experts to pay careful attention to the accuracy, authority, objectivity, timeliness, and security of any app we consider incorporating into clinical practice. A low score on these criteria would belie any perceived usefulness or value the app may have.

When applying the rubric to evaluate the quality of an app, we should be mindful of the primary user and which characteristics are more important than others to effect positive changes in health. For example, in addressing obesity, it is the patient who will be interacting with the app. Therefore, it’s important that the app should score, on a 1- to 4-point scale (1 point being major deficiencies, 4 points being no deficiencies), a 4 out of 4 on features like usefulness, functionality, and design. Coveted design features that enhance the user’s experience will appeal to patients and keep them engaged and motivated. However, when addressing a woman’s health with respect to cancer risk, the principal features on which the app should score 4 out of 4 would be authority, objectivity, timeliness, and accuracy.

In the upcoming articles in this series, a member of the Presidential Task Force will reference the ASHP rubric to guide clinicians in choosing apps to address one of the critical health areas with their patients. The author of the piece will highlight key features of an app to consider what would add the most value in incorporating its use in clinical practice.

It would be impossible to evaluate all health care apps even if we focused only on the medical apps relevant to obstetrics and gynecology. There is much value in having a framework for efficiently measuring an app’s benefit in clinical practice. The objective of this article series is to help clinicians Revisit the Visit by providing an effective tool to evaluate a medical app. ●

To help ObGyns evaluate mobile apps for use in clinical practice, the American College of Obstetricians and Gynecologists Presidential Task Force of Dr. Eva Chalas recommends a quantitative rubric that was developed by the American Society of Health-System Pharmacists (ASHP) for evaluating drug information apps (TABLE).¹ Criteria are graded on a point scale of 1 to 4, with 1 point indicating major deficiencies and 4 points indicating no deficiencies.

The ASHP used the following criteria in evaluating mobile apps:

• Usefulness: the app’s overall usefulness in a particular practice setting
• Accuracy: overall accuracy of the app should be thoroughly examined
• Authority: it is critical to assess authority or authorship to determine that the developers are reputable, qualified, and authoritative enough to create the medical content in question
• Objectivity: to determine if content is fair, balanced, and unbiased
• Timeliness: given that medical information is continually changing, an app must be evaluated based on the timeliness of its content
• Functionality: how the app downloads, deploys, and operates across devices and software platforms (that is, iOS, Android)
• Design: well-designed apps are generally more user friendly and, therefore, useful. They should require minimal or no training and have easily discernible buttons, a clean and uncluttered format, consistent graphics layout, terminology appropriate for the intended audience, streamlined navigation without extraneous steps/gestures, appropriate-sized text, and sufficient white space to improve readability.
• Security: Many apps collect a wide array of personal and device data. Collected data has the potential for being sold to third parties for marketing and advertising purposes. Apps should disclose their privacy policy and provide an explanation as to why personal data are being collected. If personal identifiable information (PII) is collected, then the app should be encrypted. If protected health information (PHI) is collected, the app must follow compliance with HIPAA/HITECH (Health Insurance Portability and Accountability Act/Health Information Technology for Economic and Clinical Health Act). Additionally, apps should not compromise the security or functionality of the mobile device being used.
• Value: appropriateness of an app's cost. ●

To help ObGyns evaluate mobile apps for use in clinical practice, the American College of Obstetricians and Gynecologists Presidential Task Force of Dr. Eva Chalas recommends a quantitative rubric that was developed by the American Society of Health-System Pharmacists (ASHP) for evaluating drug information apps (TABLE).¹ Criteria are graded on a point scale of 1 to 4, with 1 point indicating major deficiencies and 4 points indicating no deficiencies.

The ASHP used the following criteria in evaluating mobile apps:

• Usefulness: the app’s overall usefulness in a particular practice setting
• Accuracy: overall accuracy of the app should be thoroughly examined
• Authority: it is critical to assess authority or authorship to determine that the developers are reputable, qualified, and authoritative enough to create the medical content in question
• Objectivity: to determine if content is fair, balanced, and unbiased
• Timeliness: given that medical information is continually changing, an app must be evaluated based on the timeliness of its content
• Functionality: how the app downloads, deploys, and operates across devices and software platforms (that is, iOS, Android)
• Design: well-designed apps are generally more user friendly and, therefore, useful. They should require minimal or no training and have easily discernible buttons, a clean and uncluttered format, consistent graphics layout, terminology appropriate for the intended audience, streamlined navigation without extraneous steps/gestures, appropriate-sized text, and sufficient white space to improve readability.
• Security: Many apps collect a wide array of personal and device data. Collected data has the potential for being sold to third parties for marketing and advertising purposes. Apps should disclose their privacy policy and provide an explanation as to why personal data are being collected. If personal identifiable information (PII) is collected, then the app should be encrypted. If protected health information (PHI) is collected, the app must follow compliance with HIPAA/HITECH (Health Insurance Portability and Accountability Act/Health Information Technology for Economic and Clinical Health Act). Additionally, apps should not compromise the security or functionality of the mobile device being used.
• Value: appropriateness of an app's cost. ●

To help ObGyns evaluate mobile apps for use in clinical practice, the American College of Obstetricians and Gynecologists Presidential Task Force of Dr. Eva Chalas recommends a quantitative rubric that was developed by the American Society of Health-System Pharmacists (ASHP) for evaluating drug information apps (TABLE).¹ Criteria are graded on a point scale of 1 to 4, with 1 point indicating major deficiencies and 4 points indicating no deficiencies.

The ASHP used the following criteria in evaluating mobile apps:

• Usefulness: the app’s overall usefulness in a particular practice setting
• Accuracy: overall accuracy of the app should be thoroughly examined
• Authority: it is critical to assess authority or authorship to determine that the developers are reputable, qualified, and authoritative enough to create the medical content in question
• Objectivity: to determine if content is fair, balanced, and unbiased
• Timeliness: given that medical information is continually changing, an app must be evaluated based on the timeliness of its content
• Functionality: how the app downloads, deploys, and operates across devices and software platforms (that is, iOS, Android)
• Design: well-designed apps are generally more user friendly and, therefore, useful. They should require minimal or no training and have easily discernible buttons, a clean and uncluttered format, consistent graphics layout, terminology appropriate for the intended audience, streamlined navigation without extraneous steps/gestures, appropriate-sized text, and sufficient white space to improve readability.
• Security: Many apps collect a wide array of personal and device data. Collected data has the potential for being sold to third parties for marketing and advertising purposes. Apps should disclose their privacy policy and provide an explanation as to why personal data are being collected. If personal identifiable information (PII) is collected, then the app should be encrypted. If protected health information (PHI) is collected, the app must follow compliance with HIPAA/HITECH (Health Insurance Portability and Accountability Act/Health Information Technology for Economic and Clinical Health Act). Additionally, apps should not compromise the security or functionality of the mobile device being used.
• Value: appropriateness of an app's cost. ●

CASE Mixed CP diagnosed at age 6 months

After learning that the statute of limitations was to run out in the near future, the parents of a 17-year-old with cerebral palsy (CP) initiated a lawsuit. At the time of her pregnancy, the mother (G2P2002) was age 39 and first sought prenatal care at 14 weeks.

Her past medical history was largely noncontributory to her current pregnancy, except for that she had hypothyroidism that was being treated with levothyroxine. She also had a history of asthma, but had had no acute episodes for years. During the course of the pregnancy there was evidence of polyhydramnios; her initial thyroid studies were abnormal (thyroid-stimulating hormone levels, 7.1 mIU/L), in part due to lack of adherence with prescribed medications. She was noted to have elevated blood pressure (BP) 150/100 mm Hg but no proteinuria, with BP monitoring during her last trimester.

The patient went into labor at 40 3/7 weeks, after spontaneous rupture of membranes. In labor and delivery she was placed on a monitor, and irregular contractions were noted. The initial vaginal examination was noted as 1-cm cervical dilation, 90% effaced, and station zero. The obstetrician evaluated the patient and ordered Pitocin augmentation. The next vaginal exam several hours later noted 3-cm dilation and 100% effacement. The Pitocin was continued. Several early decelerations, moderate variability, and better contraction pattern was noted. Eight hours into the Pitocin, there were repetitive late decelerations; the obstetrician was not notified. The nursing staff proceeded with vaginal examination, and the patient was fully dilated at station +1. Again, the doctor was not informed of the patient’s status. At 10 hours post-Pitocin initiation, the patient felt the urge to push. The obstetrician was notified, and he promptly arrived to the unit and patient’s bedside. His decision was to use forceps for the delivery, feeling this would be the most expedient way to proceed, although cesarean delivery (CD) was a definite consideration. Forceps were applied, and as the nursing staff noted,” the doctor really had to pull to deliver the head.” A male baby, 8 lb 8 oz, was delivered. A second-degree tear was noted and easily repaired following delivery of the placenta. Apgar scores were 5 and 7 at 1 and 5 minutes after birth, respectively.

The patient’s postpartum course was uneventful. The patient and baby were discharged on the third day postpartum.

As the child was evaluated by the pediatrician, the mother noted at 6 months that the child’s head lagged behind when he was picked up. He appeared stiff at times and floppy at other times according to the parents. As the child progressed he had problems with hand-to-mouth coordination, and when he would crawl he seemed to “scoot his butt,” as they stated.

The child was tested and a diagnosis of mixed cerebral palsy was made, implying a combination of spastic CP and dyskinetic CP. He is wheelchair bound. The parents filed a lawsuit against the obstetrician and the hospital, focused on hypoxic-ischemic encephalopathy (HIE) due to labor and delivery management being below the standard of care. They claimed that the obstetrician should have been informed by the hospital staff during the course of labor, and the obstetrician should have been more proactive in monitoring the deteriorating circumstances. This included performing a CD based on “the Category III fetal heart tracing.”

At trial, the plaintiff expert argued that failure of nursing staff to properly communicate with the obstetrician led to mismanagement. Furthermore, the obstetrician used poor judgement (ie, below the standard of care) in not performing a CD. The defense expert argued that, overall, the fetal heart tracing was Category II, and the events occurred in utero, in part reflected by the mother having polyhydramnios and hypothyroidism that was not well controlled due to lack of adherence with prescribed medications. The child in his wheelchair was brought into the courtroom. The trial went on for more than 1 week, and the jury deliberated for several hours. (Note: This case is a composite of several different events and claims.)

Continue to: WHAT’S THE VERDICT?

WHAT’S THE VERDICT?

The jury returns a verdict for the defense.

Should anything have been done differently in this trial?

Medical considerations

Cerebral palsy is a neurodevelopmental disorder affecting 1 in 500 children.¹ Other prevalence data (from a European study) indicate an incidence of 1.3–1.9 cases per 1,000 livebirths.¹ The controversy continues with respect to the disorder’s etiology, especially when the infant’s magnetic resonance imaging (MRI) does not identify specific pathology. The finger is then pointed at HIE and thus the fault of the obstetrician and labor and delivery staff. In reality, HIE accounts for less than 10% of all cases of CP.² Overall, CP is a condition focused on progressive motor impairments, many times associated with specific MRI findings.³ In addition, “MRI-negative” CP is a more vague diagnosis as discussed among neurologists.

The International Consensus Definition of CP is “a group of permanent disorders of the development of movement and posture, causing activity limitations, that are attributed to nonprogressive disturbances that occurred in the developing fetal or infant brain.”⁴ The International Cerebral Palsy Genomics Consortium have provided a consensus statement that defines CP based upon clinical type as opposed to etiology.⁵ Many times, however, ascribing an HIE cause to CP is “barking up the wrong tree,” in that we now know there are clear cut genetic causes of CP, and etiology attributed to perinatal causes, in reality, are genetic in up to 80% of cases.³ Types of CP are addressed in FIGURE 1. Overall, the pathophysiology of the disorder remains unknown. Some affected children have intellectual disabilities, as well as visual, hearing, and/or speech impairment.

DNA sequencing

The DNA story continues to unfold with the concept that DNA variants alter susceptibility to environmental influences. These insults are, for example, thrombosis or hemorrhage, all of which affect motor function.¹ Duplications or deletions of portions of a chromosome, related to copy number variants (CNVs) as well as advances in human-genome sequencing, can identify a single gene mutation leading to CP.¹ Microdeletions, microduplications, and single nucleotide variants (SNVs) are to be included in genetic-related problems causing CP.³

A number of candidate genes have been considered and include “de novo heterozygous mutations in known Online Mendelian Inheritance (OMIM).” TIBA1A and SCN8A genes are highly associated with CP.⁸ Genetic assessment, as it evolves and more recently with the advent of exome sequencing, appears to provide a new and unprecedented level of understanding of CP. Specifically, exome sequencing provides a diagnostic tool with which to identify the prevalence of pathogenic and pathogenic variants (the latter encompassing genomic variants) with CP.⁹ A retrospective study assessed a cohort of patients with CP and noted that 32.7% of the pediatric-aged patients who underwent exome sequencing had pathogenic and pathogenic variants in the sequencing.⁹ Thus, we have a tool to identify underlying genetic pathogenesis with CP. This theoretically can change the outcome of lawsuits initiated for CP that ascribe an HIE etiology. Clinicians need to stay tuned as the genetic repertoire continues to unfold.

Continue to: Legal considerations...

Legal considerations

Although CP is not a common event, it has been a major factor in the total malpractice payments for ObGyns, neonatologists, and related medical disciplines. That is because the per-event liability can be staggering. Some law firms provide a “checklist” for plaintiffs early on in assessing a potential case (FIGURE 2).¹⁰

The financial risks and incentives

To understand what the current settlements and verdicts are in birth-related CP cases, a search of Lexis files revealed the reported outcomes of cases in 2019 and 2020 (FIGURE 3). Taking into account that the pandemic limited legal activity, 23 unduplicated cases were described with a reported settlement or verdict. Four cases resulted in verdicts for the injured patients, with the mean of these awards substantially higher than the settlements ($88.3 million vs $11.1 million, respectively).

These numbers are a glimpse at some of the very high settlements and verdicts that are common in CP cases. Notably, these are not a random sample of CP cases, but only those with the amount of the verdict or settlement reported. Potentially tried cases that may have been simply abandoned or dismissed are not reported. Furthermore, most settlements include confidentiality clauses, which may preclude the release of the financial value of the settlement. Cases in which the defense won (for example, a jury verdict in favor of the physician) are not included.

The high monetary awards in some CP cases are indirectly backed by Google search results for “cerebral palsy and liability” or “cerebral palsy and malpractice.” A very large number of results for law firms seeking clients with CP injuries is produced. Some of the websites note that only 10% (or 20% on some sites) of CP cases are caused by medical negligence, offering a “free legal case review” and a phone number for callers to “ask a legal question.” In the fine print one site notes that, “if you request any information you may receive a phone call or email from a partner law firm.”¹¹ US physicians may be interested to note that a recent study of CP-based malpractice cases in China found that, although nearly 90% of the claims resulted in compensation, the mean damage award was $73,500.¹² This was compared with a mean actual loss to the family of $128,200.

The interest by law firms in CP cases may be generated in part by the opportunity to assist a settlement or judgement that may be in the tens of millions of dollars. It is financially sensible to take a substantial risk on a contingency fee in a CP case compared with many other malpractice areas or claims where the likely damages are much lower. In addition, the vast majority of the damages in CP cases are for economic damages (cost of care and treatment and lost earning capacity), not noneconomic damages (pain and suffering). Therefore, the cap on noneconomic damages available in many states would not reduce the damages by a significant percentage.

CP cases are a significant part of the malpractice costs for ObGyns. Nearly one-third of obstetric claims are for neurologic injuries, including CP.^13,14 These cases are often very complex and difficult, meaning that, in addition to the payments to the injured, there are considerable litigation costs associated with defending the cases. Perhaps as much as 60% of malpractice costs in obstetrics are in some way related to CP claims.^15,16

Continue to: Negligence...

Negligence

Malpractice cases require not only damages (which clearly there are with CP) but also negligence and causation. (A more complete discussion of the elements of professional liability are included in a recent “What’s the Verdict?” column within OBG Management.)¹⁷ CP cases are somewhat unusual in that, frequently, both negligence and causation are bitterly disputed. In a CP case, even where negligence is obvious (and it usually is not), causation may not be obvious and is likely to become a key to the defense of a very big case.

Several areas of negligence are common in CP related to delivery, including failure to monitor properly or ignoring, or not responding to, fetal heart rate (FHR) monitoring.^18,19 For FHR monitoring, the claim is that problems can lead to asphyxia, resulting in HIE. Electronic fetal monitoring (EFM) has been an especially contentious matter. On one hand, the evidence of its efficacy is doubtful, but it has remained a standard practice, and it is often a centerpiece of delivery.²⁰ Attorney Thomas Sartwelle has been prolific in suggesting that it not only has created legal problems for physicians but also results in unnecessary cesarean deliveries (CDs), which carry attendant risks for mother and infant.²¹ (It should be noted that other attorneys have expressed quite different views.²²) He has argued that experts relying on EFM should be excluded from testifying because the technology is not based on sufficient science to meet the standard criteria used to determine the admissibility of expert witness (the Daubert standard).²³ This argument is a difficult one so long as EFM is standard practice. Other claims of negligence include improper use of instruments at delivery, resulting in physical damage to the baby’s head, neck, or shoulders or internal hemorrhage. In addition, failure to deal with neonatal infection may be the basis for negligence.²⁴

Causation

The question of whether or not the negligence (no matter how bad it was) caused the CP still needs to be addressed. Because a number of factors may cause CP, it has often been difficult to determine for any individual what the cause, or contributing causes, were. This fact would ordinarily work to the advantage of defendant-physicians and hospitals because the plaintiff in a malpractice case must prove by a preponderance of the evidence that the defendant’s negligence caused the CP. “Caused” is a term of art in the law; at the most basic level it means that the harm would not have occurred (or would have been less severe) but for the negligence.

In most CP cases the real cause is unknowable. It is, therefore, important to understand the difference between the certainty required in negligence cases and the certainty required in scientific studies (eg, 95% confidence). Negligence and causation in civil cases (including malpractice) must only be demonstrated by a preponderance of the evidence, which means “more likely than not.” For recovery in malpractice cases, states may require only that negligence be a “substantial factor.”

The theory that this lack of knowledge means that the plaintiff cannot prove causation, however, does not always hold.²⁵ The following is what a jury might see: a child who will have a lifetime of medical, social, and financial burdens. Clear negligent practice by the physician coupled with severe injury can create considerable sympathy for the family. Then there are experts on both sides claiming that it is reasonably certain, in their opinions, that the injury was/was not caused by the negligence of the physician and health care team. The plaintiff’s witnesses will start eliminating other causes of CP in a form of differential diagnosis, stating that the remaining possibilities of causation clearly point to malpractice as the cause of CP. At some point, the elimination of alternative explanations for CP makes malpractice more likely than not to be a substantial factor in causing CP. On the other hand, the defense witnesses will stress that CP occurs most often without any negligence, and that, in this case, there are remaining, perhaps unknown, possible causes that are more likely than malpractice.

In this trial mix, it is not unthinkable that a jury or judge might find the plaintiff’s opinions more appealing. As a practical matter, and contrary to the technical rules, the burden of proof can seem to shift. The defendant clinician may, in effect, have to prove that the CP was caused by something other than the clinician’s negligence.

The role of insurance in award amounts

One reason that malpractice insurance companies settle CP cases for millions of dollars is that they face the possibility of judgements in the tens of millions. We saw even more than $100 million, in the 2019-2020 CP cases reported above. Another risk for malpractice insurance companies is that, if they do not settle, they may have liability beyond the policy limits. (Policy limits are the maximum an insurance policy is obligated to pay for any occurrence, or the total for all claims for the time covered by the premium.) For example, assume a malpractice policy has a $5 million policy limit covering Dr. Defendant, who has been sued for CP resulting from malpractice. There was apparently negligence during delivery in monitoring the fetus, but on the issue of causation the best estimate is that there is a 75% probability a jury would find no causal link between the negligence and the CP. If there is liability, damages would likely range from $5 to $25 million. Assume that the plaintiff has signaled it would settle for the policy limits ($5 million). Based purely on the odds and the policy limits, the insurance company should go to trial as opposed to settling for $5 million. That is because the physician personally (as opposed to the insurance company) is responsible for that part of a verdict that exceeds $5 million.

To prevent just such abuse (or bad faith), in most states, if the insurance company declines to settle the case for $5 million, it may become liable for the excess verdict above the policy limits. One reason that the cases that result in a verdict on damages—the 4 cases reported above for 2019‒2020—are interesting is that they help establish the risk of failing to settle a CP case.

Genetic understanding of causation

Given the importance of defendant-clinicians to be able to find a cause other than negligence to explain CP, the recent research of Moreno-De-Luca and colleagues may be especially meaningful.⁹ Using exome sequencing, the researchers found that 32.7% of pediatric-aged CP patients had pathogenic variance in the sequencing. In theory, this might mean that for about one-third of the CP plaintiffs, there may be genomic (rather than malpractice) explanations for CP, which might ultimately result in fewer cases of CP.

As significant as these findings are, caution is warranted. As the authors note, “this was an observational study and a causal relationship between detected gene variants and phenotypes in participants was not definitively established.”⁹ Until the causal relationship is established, it is not clear how much influence such a study would have in CP malpractice cases. Another caveat is that, at most, the genetic variants accounted for less than a third of CP cases studied, leaving many cases in which the cause remains unknown. In those cases in which a genomic association was not found, the case may be stronger for the “malpractice was the cause” claim. The follow-up research will likely shed light on some of these issues. Of course, if the genetic research demonstrates that in some proportion of cases there are genetic factors that contribute to the probability of CP, then the search will be for other triggering elements, which could possibly include poor care (that might well be a substantial factor for malpractice). Therefore, the preliminary genetic research likely represents only a part of the CP puzzle in malpractice cases.

Continue to: Why the opening case outcome was for the defense...

Why the opening case outcome was for the defense

Juries, of course, do not write opinions, so the basis for the jury’s decision in the example case is somewhat speculative. It seems most likely that causation had not been established. That is, the plaintiff-patient did not demonstrate that any malpractice was the likely, or substantial contributing, cause of the CP. The case illustrates several important issues.

Statute of limitations. This issue is common in CP cases because the condition may not be diagnosed for some time after birth. The statute of limitations can vary by state for medical malpractice cases “from 2 years to 22 years.”²⁶ Many states begin with a 2-year statute but extend it if the injury or harm is not discovered. The extension is sometimes referred to as a statute of repose because, after that time, there is no extension even if the harm is discovered only later. In some states the statute does not run until the plaintiff is at or near the time of majority (usually age 18).²⁷

Establishing negligence. The information provided about the presented case is mixed on the question of negligence, both regarding the hospital (through its nursing staff) for not properly contacting the obstetrician over the 10 hours, or the physician for inadequate monitoring. In addition, the reference to “really had to pull to deliver the head” may be the basis for claiming excessive, and potentially harmful use of force, which may have caused injury. In addition, the question remains whether the combination of these factors, including the Category III fetal heart tracing, made a cesarean delivery the appropriate standard of care.

Addressing causation. Assuming negligence, there is still a question of causation. It is far from clear that what the clinician did, or did not do, in terms of monitoring caused the CP injury. There is, however, no alternative causation that appeared in the case record, and this may be because of dueling expert witnesses.

The plaintiff sued both the obstetrician and the hospital, which is common among CP cases. While the legal interest of the two parties are aligned in some areas (causation), they may be in conflict in others (the failure of the hospital staff to keep the obstetrician informed). These potential conflicts are not for the clinicians to try to work out on their own. There is the potential for their actions to be misunderstood. When such a case is filed or threatened, the obstetrician should immediately discuss these matters with their attorney. In malpractice cases, malpractice insurance companies often select the attorneys who are experienced in such conflicts. If clinicians are not entirely comfortable that the appointed attorney is representing their interest and preserving a relationship with the hospital or other institution, however, they may engage their own legal counsel to protect their interests.

Practical considerations for avoiding malpractice claims

Good practices for avoiding malpractice claims apply with special force as it relates to CP.^28,29

Uphold practice standards and good patient records. The causation element of these legal cases will remain problematic in the foreseeable future. But causation does not matter if negligent practice is not demonstrated. Therefore, maintaining best practices and continuous efforts at quality assurance and following all relevant professional practice guidelines is a good start. More than good intentions, it is essential that policies are implemented and reviewed. Among the areas of ongoing concern is the failure to monitor patients sufficiently. The long period of labor—where perhaps no physician is present for many hours—can introduce problems, as laypersons may have the impression that medical personnel were not on top of the situation.

Maintaining excellent records is also key for clinicians. The more complete the record, the fewer opportunities there are for faulty memories of parties and caregivers to fill in the gaps (especially when causation is so difficult to establish). Under absolutely no circumstances should records be changed or modified to eliminate damaging or an otherwise unfortunate notation. Few things are as harmful to credibility as discovered record tampering.

Inform patients of what is to come. Expectations are an important part of patient satisfaction. While not unduly frightening pregnant patients or eliminating reassurance, the informed consent process and patient counseling should be opportunities to avoid unreasonable expectations.

Stay alert to early genetic counseling, which is becoming increasingly available and important. Maintaining currency with what early testing can be done will become a critical part of ObGyn practice. For CP cases, in the near future, genetic testing may become part of determining causation. In the longer term, it will be part of counseling women and couples in deciding whether to have children, or potentially to end a pregnancy.

Expect the unexpected, and plan for it. Sometimes things just go wrong—there is a bad outcome, mistakes are made, patients are upset. It is important that any practice or institution have a clear plan for when such things happen. Some organizations have used apologies when appropriate,³⁰ others have more complex plans for dealing with bad outcomes.³¹ Implement developed plans when they are needed. Individual practitioners also should consult with their attorney, who is familiar with their practice and who can help them maintain adherence to legal requirements and good legal problem prevention. ●

CASE Mixed CP diagnosed at age 6 months

After learning that the statute of limitations was to run out in the near future, the parents of a 17-year-old with cerebral palsy (CP) initiated a lawsuit. At the time of her pregnancy, the mother (G2P2002) was age 39 and first sought prenatal care at 14 weeks.

Her past medical history was largely noncontributory to her current pregnancy, except for that she had hypothyroidism that was being treated with levothyroxine. She also had a history of asthma, but had had no acute episodes for years. During the course of the pregnancy there was evidence of polyhydramnios; her initial thyroid studies were abnormal (thyroid-stimulating hormone levels, 7.1 mIU/L), in part due to lack of adherence with prescribed medications. She was noted to have elevated blood pressure (BP) 150/100 mm Hg but no proteinuria, with BP monitoring during her last trimester.

The patient went into labor at 40 3/7 weeks, after spontaneous rupture of membranes. In labor and delivery she was placed on a monitor, and irregular contractions were noted. The initial vaginal examination was noted as 1-cm cervical dilation, 90% effaced, and station zero. The obstetrician evaluated the patient and ordered Pitocin augmentation. The next vaginal exam several hours later noted 3-cm dilation and 100% effacement. The Pitocin was continued. Several early decelerations, moderate variability, and better contraction pattern was noted. Eight hours into the Pitocin, there were repetitive late decelerations; the obstetrician was not notified. The nursing staff proceeded with vaginal examination, and the patient was fully dilated at station +1. Again, the doctor was not informed of the patient’s status. At 10 hours post-Pitocin initiation, the patient felt the urge to push. The obstetrician was notified, and he promptly arrived to the unit and patient’s bedside. His decision was to use forceps for the delivery, feeling this would be the most expedient way to proceed, although cesarean delivery (CD) was a definite consideration. Forceps were applied, and as the nursing staff noted,” the doctor really had to pull to deliver the head.” A male baby, 8 lb 8 oz, was delivered. A second-degree tear was noted and easily repaired following delivery of the placenta. Apgar scores were 5 and 7 at 1 and 5 minutes after birth, respectively.

The patient’s postpartum course was uneventful. The patient and baby were discharged on the third day postpartum.

As the child was evaluated by the pediatrician, the mother noted at 6 months that the child’s head lagged behind when he was picked up. He appeared stiff at times and floppy at other times according to the parents. As the child progressed he had problems with hand-to-mouth coordination, and when he would crawl he seemed to “scoot his butt,” as they stated.

The child was tested and a diagnosis of mixed cerebral palsy was made, implying a combination of spastic CP and dyskinetic CP. He is wheelchair bound. The parents filed a lawsuit against the obstetrician and the hospital, focused on hypoxic-ischemic encephalopathy (HIE) due to labor and delivery management being below the standard of care. They claimed that the obstetrician should have been informed by the hospital staff during the course of labor, and the obstetrician should have been more proactive in monitoring the deteriorating circumstances. This included performing a CD based on “the Category III fetal heart tracing.”

At trial, the plaintiff expert argued that failure of nursing staff to properly communicate with the obstetrician led to mismanagement. Furthermore, the obstetrician used poor judgement (ie, below the standard of care) in not performing a CD. The defense expert argued that, overall, the fetal heart tracing was Category II, and the events occurred in utero, in part reflected by the mother having polyhydramnios and hypothyroidism that was not well controlled due to lack of adherence with prescribed medications. The child in his wheelchair was brought into the courtroom. The trial went on for more than 1 week, and the jury deliberated for several hours. (Note: This case is a composite of several different events and claims.)

Continue to: WHAT’S THE VERDICT?

WHAT’S THE VERDICT?

The jury returns a verdict for the defense.

Should anything have been done differently in this trial?

Medical considerations

Cerebral palsy is a neurodevelopmental disorder affecting 1 in 500 children.¹ Other prevalence data (from a European study) indicate an incidence of 1.3–1.9 cases per 1,000 livebirths.¹ The controversy continues with respect to the disorder’s etiology, especially when the infant’s magnetic resonance imaging (MRI) does not identify specific pathology. The finger is then pointed at HIE and thus the fault of the obstetrician and labor and delivery staff. In reality, HIE accounts for less than 10% of all cases of CP.² Overall, CP is a condition focused on progressive motor impairments, many times associated with specific MRI findings.³ In addition, “MRI-negative” CP is a more vague diagnosis as discussed among neurologists.

The International Consensus Definition of CP is “a group of permanent disorders of the development of movement and posture, causing activity limitations, that are attributed to nonprogressive disturbances that occurred in the developing fetal or infant brain.”⁴ The International Cerebral Palsy Genomics Consortium have provided a consensus statement that defines CP based upon clinical type as opposed to etiology.⁵ Many times, however, ascribing an HIE cause to CP is “barking up the wrong tree,” in that we now know there are clear cut genetic causes of CP, and etiology attributed to perinatal causes, in reality, are genetic in up to 80% of cases.³ Types of CP are addressed in FIGURE 1. Overall, the pathophysiology of the disorder remains unknown. Some affected children have intellectual disabilities, as well as visual, hearing, and/or speech impairment.

DNA sequencing

The DNA story continues to unfold with the concept that DNA variants alter susceptibility to environmental influences. These insults are, for example, thrombosis or hemorrhage, all of which affect motor function.¹ Duplications or deletions of portions of a chromosome, related to copy number variants (CNVs) as well as advances in human-genome sequencing, can identify a single gene mutation leading to CP.¹ Microdeletions, microduplications, and single nucleotide variants (SNVs) are to be included in genetic-related problems causing CP.³

A number of candidate genes have been considered and include “de novo heterozygous mutations in known Online Mendelian Inheritance (OMIM).” TIBA1A and SCN8A genes are highly associated with CP.⁸ Genetic assessment, as it evolves and more recently with the advent of exome sequencing, appears to provide a new and unprecedented level of understanding of CP. Specifically, exome sequencing provides a diagnostic tool with which to identify the prevalence of pathogenic and pathogenic variants (the latter encompassing genomic variants) with CP.⁹ A retrospective study assessed a cohort of patients with CP and noted that 32.7% of the pediatric-aged patients who underwent exome sequencing had pathogenic and pathogenic variants in the sequencing.⁹ Thus, we have a tool to identify underlying genetic pathogenesis with CP. This theoretically can change the outcome of lawsuits initiated for CP that ascribe an HIE etiology. Clinicians need to stay tuned as the genetic repertoire continues to unfold.

Continue to: Legal considerations...

Legal considerations

Although CP is not a common event, it has been a major factor in the total malpractice payments for ObGyns, neonatologists, and related medical disciplines. That is because the per-event liability can be staggering. Some law firms provide a “checklist” for plaintiffs early on in assessing a potential case (FIGURE 2).¹⁰

The financial risks and incentives

To understand what the current settlements and verdicts are in birth-related CP cases, a search of Lexis files revealed the reported outcomes of cases in 2019 and 2020 (FIGURE 3). Taking into account that the pandemic limited legal activity, 23 unduplicated cases were described with a reported settlement or verdict. Four cases resulted in verdicts for the injured patients, with the mean of these awards substantially higher than the settlements ($88.3 million vs $11.1 million, respectively).

These numbers are a glimpse at some of the very high settlements and verdicts that are common in CP cases. Notably, these are not a random sample of CP cases, but only those with the amount of the verdict or settlement reported. Potentially tried cases that may have been simply abandoned or dismissed are not reported. Furthermore, most settlements include confidentiality clauses, which may preclude the release of the financial value of the settlement. Cases in which the defense won (for example, a jury verdict in favor of the physician) are not included.

The high monetary awards in some CP cases are indirectly backed by Google search results for “cerebral palsy and liability” or “cerebral palsy and malpractice.” A very large number of results for law firms seeking clients with CP injuries is produced. Some of the websites note that only 10% (or 20% on some sites) of CP cases are caused by medical negligence, offering a “free legal case review” and a phone number for callers to “ask a legal question.” In the fine print one site notes that, “if you request any information you may receive a phone call or email from a partner law firm.”¹¹ US physicians may be interested to note that a recent study of CP-based malpractice cases in China found that, although nearly 90% of the claims resulted in compensation, the mean damage award was $73,500.¹² This was compared with a mean actual loss to the family of $128,200.

The interest by law firms in CP cases may be generated in part by the opportunity to assist a settlement or judgement that may be in the tens of millions of dollars. It is financially sensible to take a substantial risk on a contingency fee in a CP case compared with many other malpractice areas or claims where the likely damages are much lower. In addition, the vast majority of the damages in CP cases are for economic damages (cost of care and treatment and lost earning capacity), not noneconomic damages (pain and suffering). Therefore, the cap on noneconomic damages available in many states would not reduce the damages by a significant percentage.

CP cases are a significant part of the malpractice costs for ObGyns. Nearly one-third of obstetric claims are for neurologic injuries, including CP.^13,14 These cases are often very complex and difficult, meaning that, in addition to the payments to the injured, there are considerable litigation costs associated with defending the cases. Perhaps as much as 60% of malpractice costs in obstetrics are in some way related to CP claims.^15,16

Continue to: Negligence...

Negligence

Malpractice cases require not only damages (which clearly there are with CP) but also negligence and causation. (A more complete discussion of the elements of professional liability are included in a recent “What’s the Verdict?” column within OBG Management.)¹⁷ CP cases are somewhat unusual in that, frequently, both negligence and causation are bitterly disputed. In a CP case, even where negligence is obvious (and it usually is not), causation may not be obvious and is likely to become a key to the defense of a very big case.

Several areas of negligence are common in CP related to delivery, including failure to monitor properly or ignoring, or not responding to, fetal heart rate (FHR) monitoring.^18,19 For FHR monitoring, the claim is that problems can lead to asphyxia, resulting in HIE. Electronic fetal monitoring (EFM) has been an especially contentious matter. On one hand, the evidence of its efficacy is doubtful, but it has remained a standard practice, and it is often a centerpiece of delivery.²⁰ Attorney Thomas Sartwelle has been prolific in suggesting that it not only has created legal problems for physicians but also results in unnecessary cesarean deliveries (CDs), which carry attendant risks for mother and infant.²¹ (It should be noted that other attorneys have expressed quite different views.²²) He has argued that experts relying on EFM should be excluded from testifying because the technology is not based on sufficient science to meet the standard criteria used to determine the admissibility of expert witness (the Daubert standard).²³ This argument is a difficult one so long as EFM is standard practice. Other claims of negligence include improper use of instruments at delivery, resulting in physical damage to the baby’s head, neck, or shoulders or internal hemorrhage. In addition, failure to deal with neonatal infection may be the basis for negligence.²⁴

Causation

The question of whether or not the negligence (no matter how bad it was) caused the CP still needs to be addressed. Because a number of factors may cause CP, it has often been difficult to determine for any individual what the cause, or contributing causes, were. This fact would ordinarily work to the advantage of defendant-physicians and hospitals because the plaintiff in a malpractice case must prove by a preponderance of the evidence that the defendant’s negligence caused the CP. “Caused” is a term of art in the law; at the most basic level it means that the harm would not have occurred (or would have been less severe) but for the negligence.

In most CP cases the real cause is unknowable. It is, therefore, important to understand the difference between the certainty required in negligence cases and the certainty required in scientific studies (eg, 95% confidence). Negligence and causation in civil cases (including malpractice) must only be demonstrated by a preponderance of the evidence, which means “more likely than not.” For recovery in malpractice cases, states may require only that negligence be a “substantial factor.”

The theory that this lack of knowledge means that the plaintiff cannot prove causation, however, does not always hold.²⁵ The following is what a jury might see: a child who will have a lifetime of medical, social, and financial burdens. Clear negligent practice by the physician coupled with severe injury can create considerable sympathy for the family. Then there are experts on both sides claiming that it is reasonably certain, in their opinions, that the injury was/was not caused by the negligence of the physician and health care team. The plaintiff’s witnesses will start eliminating other causes of CP in a form of differential diagnosis, stating that the remaining possibilities of causation clearly point to malpractice as the cause of CP. At some point, the elimination of alternative explanations for CP makes malpractice more likely than not to be a substantial factor in causing CP. On the other hand, the defense witnesses will stress that CP occurs most often without any negligence, and that, in this case, there are remaining, perhaps unknown, possible causes that are more likely than malpractice.

In this trial mix, it is not unthinkable that a jury or judge might find the plaintiff’s opinions more appealing. As a practical matter, and contrary to the technical rules, the burden of proof can seem to shift. The defendant clinician may, in effect, have to prove that the CP was caused by something other than the clinician’s negligence.

The role of insurance in award amounts

One reason that malpractice insurance companies settle CP cases for millions of dollars is that they face the possibility of judgements in the tens of millions. We saw even more than $100 million, in the 2019-2020 CP cases reported above. Another risk for malpractice insurance companies is that, if they do not settle, they may have liability beyond the policy limits. (Policy limits are the maximum an insurance policy is obligated to pay for any occurrence, or the total for all claims for the time covered by the premium.) For example, assume a malpractice policy has a $5 million policy limit covering Dr. Defendant, who has been sued for CP resulting from malpractice. There was apparently negligence during delivery in monitoring the fetus, but on the issue of causation the best estimate is that there is a 75% probability a jury would find no causal link between the negligence and the CP. If there is liability, damages would likely range from $5 to $25 million. Assume that the plaintiff has signaled it would settle for the policy limits ($5 million). Based purely on the odds and the policy limits, the insurance company should go to trial as opposed to settling for $5 million. That is because the physician personally (as opposed to the insurance company) is responsible for that part of a verdict that exceeds $5 million.

To prevent just such abuse (or bad faith), in most states, if the insurance company declines to settle the case for $5 million, it may become liable for the excess verdict above the policy limits. One reason that the cases that result in a verdict on damages—the 4 cases reported above for 2019‒2020—are interesting is that they help establish the risk of failing to settle a CP case.

Genetic understanding of causation

Given the importance of defendant-clinicians to be able to find a cause other than negligence to explain CP, the recent research of Moreno-De-Luca and colleagues may be especially meaningful.⁹ Using exome sequencing, the researchers found that 32.7% of pediatric-aged CP patients had pathogenic variance in the sequencing. In theory, this might mean that for about one-third of the CP plaintiffs, there may be genomic (rather than malpractice) explanations for CP, which might ultimately result in fewer cases of CP.

As significant as these findings are, caution is warranted. As the authors note, “this was an observational study and a causal relationship between detected gene variants and phenotypes in participants was not definitively established.”⁹ Until the causal relationship is established, it is not clear how much influence such a study would have in CP malpractice cases. Another caveat is that, at most, the genetic variants accounted for less than a third of CP cases studied, leaving many cases in which the cause remains unknown. In those cases in which a genomic association was not found, the case may be stronger for the “malpractice was the cause” claim. The follow-up research will likely shed light on some of these issues. Of course, if the genetic research demonstrates that in some proportion of cases there are genetic factors that contribute to the probability of CP, then the search will be for other triggering elements, which could possibly include poor care (that might well be a substantial factor for malpractice). Therefore, the preliminary genetic research likely represents only a part of the CP puzzle in malpractice cases.

Continue to: Why the opening case outcome was for the defense...

Why the opening case outcome was for the defense

Juries, of course, do not write opinions, so the basis for the jury’s decision in the example case is somewhat speculative. It seems most likely that causation had not been established. That is, the plaintiff-patient did not demonstrate that any malpractice was the likely, or substantial contributing, cause of the CP. The case illustrates several important issues.

Statute of limitations. This issue is common in CP cases because the condition may not be diagnosed for some time after birth. The statute of limitations can vary by state for medical malpractice cases “from 2 years to 22 years.”²⁶ Many states begin with a 2-year statute but extend it if the injury or harm is not discovered. The extension is sometimes referred to as a statute of repose because, after that time, there is no extension even if the harm is discovered only later. In some states the statute does not run until the plaintiff is at or near the time of majority (usually age 18).²⁷

Establishing negligence. The information provided about the presented case is mixed on the question of negligence, both regarding the hospital (through its nursing staff) for not properly contacting the obstetrician over the 10 hours, or the physician for inadequate monitoring. In addition, the reference to “really had to pull to deliver the head” may be the basis for claiming excessive, and potentially harmful use of force, which may have caused injury. In addition, the question remains whether the combination of these factors, including the Category III fetal heart tracing, made a cesarean delivery the appropriate standard of care.

Addressing causation. Assuming negligence, there is still a question of causation. It is far from clear that what the clinician did, or did not do, in terms of monitoring caused the CP injury. There is, however, no alternative causation that appeared in the case record, and this may be because of dueling expert witnesses.

The plaintiff sued both the obstetrician and the hospital, which is common among CP cases. While the legal interest of the two parties are aligned in some areas (causation), they may be in conflict in others (the failure of the hospital staff to keep the obstetrician informed). These potential conflicts are not for the clinicians to try to work out on their own. There is the potential for their actions to be misunderstood. When such a case is filed or threatened, the obstetrician should immediately discuss these matters with their attorney. In malpractice cases, malpractice insurance companies often select the attorneys who are experienced in such conflicts. If clinicians are not entirely comfortable that the appointed attorney is representing their interest and preserving a relationship with the hospital or other institution, however, they may engage their own legal counsel to protect their interests.

Practical considerations for avoiding malpractice claims

Good practices for avoiding malpractice claims apply with special force as it relates to CP.^28,29

Uphold practice standards and good patient records. The causation element of these legal cases will remain problematic in the foreseeable future. But causation does not matter if negligent practice is not demonstrated. Therefore, maintaining best practices and continuous efforts at quality assurance and following all relevant professional practice guidelines is a good start. More than good intentions, it is essential that policies are implemented and reviewed. Among the areas of ongoing concern is the failure to monitor patients sufficiently. The long period of labor—where perhaps no physician is present for many hours—can introduce problems, as laypersons may have the impression that medical personnel were not on top of the situation.

Maintaining excellent records is also key for clinicians. The more complete the record, the fewer opportunities there are for faulty memories of parties and caregivers to fill in the gaps (especially when causation is so difficult to establish). Under absolutely no circumstances should records be changed or modified to eliminate damaging or an otherwise unfortunate notation. Few things are as harmful to credibility as discovered record tampering.

Inform patients of what is to come. Expectations are an important part of patient satisfaction. While not unduly frightening pregnant patients or eliminating reassurance, the informed consent process and patient counseling should be opportunities to avoid unreasonable expectations.

Stay alert to early genetic counseling, which is becoming increasingly available and important. Maintaining currency with what early testing can be done will become a critical part of ObGyn practice. For CP cases, in the near future, genetic testing may become part of determining causation. In the longer term, it will be part of counseling women and couples in deciding whether to have children, or potentially to end a pregnancy.

Expect the unexpected, and plan for it. Sometimes things just go wrong—there is a bad outcome, mistakes are made, patients are upset. It is important that any practice or institution have a clear plan for when such things happen. Some organizations have used apologies when appropriate,³⁰ others have more complex plans for dealing with bad outcomes.³¹ Implement developed plans when they are needed. Individual practitioners also should consult with their attorney, who is familiar with their practice and who can help them maintain adherence to legal requirements and good legal problem prevention. ●

CASE Mixed CP diagnosed at age 6 months

After learning that the statute of limitations was to run out in the near future, the parents of a 17-year-old with cerebral palsy (CP) initiated a lawsuit. At the time of her pregnancy, the mother (G2P2002) was age 39 and first sought prenatal care at 14 weeks.

Her past medical history was largely noncontributory to her current pregnancy, except for that she had hypothyroidism that was being treated with levothyroxine. She also had a history of asthma, but had had no acute episodes for years. During the course of the pregnancy there was evidence of polyhydramnios; her initial thyroid studies were abnormal (thyroid-stimulating hormone levels, 7.1 mIU/L), in part due to lack of adherence with prescribed medications. She was noted to have elevated blood pressure (BP) 150/100 mm Hg but no proteinuria, with BP monitoring during her last trimester.

The patient went into labor at 40 3/7 weeks, after spontaneous rupture of membranes. In labor and delivery she was placed on a monitor, and irregular contractions were noted. The initial vaginal examination was noted as 1-cm cervical dilation, 90% effaced, and station zero. The obstetrician evaluated the patient and ordered Pitocin augmentation. The next vaginal exam several hours later noted 3-cm dilation and 100% effacement. The Pitocin was continued. Several early decelerations, moderate variability, and better contraction pattern was noted. Eight hours into the Pitocin, there were repetitive late decelerations; the obstetrician was not notified. The nursing staff proceeded with vaginal examination, and the patient was fully dilated at station +1. Again, the doctor was not informed of the patient’s status. At 10 hours post-Pitocin initiation, the patient felt the urge to push. The obstetrician was notified, and he promptly arrived to the unit and patient’s bedside. His decision was to use forceps for the delivery, feeling this would be the most expedient way to proceed, although cesarean delivery (CD) was a definite consideration. Forceps were applied, and as the nursing staff noted,” the doctor really had to pull to deliver the head.” A male baby, 8 lb 8 oz, was delivered. A second-degree tear was noted and easily repaired following delivery of the placenta. Apgar scores were 5 and 7 at 1 and 5 minutes after birth, respectively.

The patient’s postpartum course was uneventful. The patient and baby were discharged on the third day postpartum.

As the child was evaluated by the pediatrician, the mother noted at 6 months that the child’s head lagged behind when he was picked up. He appeared stiff at times and floppy at other times according to the parents. As the child progressed he had problems with hand-to-mouth coordination, and when he would crawl he seemed to “scoot his butt,” as they stated.

The child was tested and a diagnosis of mixed cerebral palsy was made, implying a combination of spastic CP and dyskinetic CP. He is wheelchair bound. The parents filed a lawsuit against the obstetrician and the hospital, focused on hypoxic-ischemic encephalopathy (HIE) due to labor and delivery management being below the standard of care. They claimed that the obstetrician should have been informed by the hospital staff during the course of labor, and the obstetrician should have been more proactive in monitoring the deteriorating circumstances. This included performing a CD based on “the Category III fetal heart tracing.”

At trial, the plaintiff expert argued that failure of nursing staff to properly communicate with the obstetrician led to mismanagement. Furthermore, the obstetrician used poor judgement (ie, below the standard of care) in not performing a CD. The defense expert argued that, overall, the fetal heart tracing was Category II, and the events occurred in utero, in part reflected by the mother having polyhydramnios and hypothyroidism that was not well controlled due to lack of adherence with prescribed medications. The child in his wheelchair was brought into the courtroom. The trial went on for more than 1 week, and the jury deliberated for several hours. (Note: This case is a composite of several different events and claims.)

Continue to: WHAT’S THE VERDICT?

WHAT’S THE VERDICT?

The jury returns a verdict for the defense.

Should anything have been done differently in this trial?

Medical considerations

Cerebral palsy is a neurodevelopmental disorder affecting 1 in 500 children.¹ Other prevalence data (from a European study) indicate an incidence of 1.3–1.9 cases per 1,000 livebirths.¹ The controversy continues with respect to the disorder’s etiology, especially when the infant’s magnetic resonance imaging (MRI) does not identify specific pathology. The finger is then pointed at HIE and thus the fault of the obstetrician and labor and delivery staff. In reality, HIE accounts for less than 10% of all cases of CP.² Overall, CP is a condition focused on progressive motor impairments, many times associated with specific MRI findings.³ In addition, “MRI-negative” CP is a more vague diagnosis as discussed among neurologists.

The International Consensus Definition of CP is “a group of permanent disorders of the development of movement and posture, causing activity limitations, that are attributed to nonprogressive disturbances that occurred in the developing fetal or infant brain.”⁴ The International Cerebral Palsy Genomics Consortium have provided a consensus statement that defines CP based upon clinical type as opposed to etiology.⁵ Many times, however, ascribing an HIE cause to CP is “barking up the wrong tree,” in that we now know there are clear cut genetic causes of CP, and etiology attributed to perinatal causes, in reality, are genetic in up to 80% of cases.³ Types of CP are addressed in FIGURE 1. Overall, the pathophysiology of the disorder remains unknown. Some affected children have intellectual disabilities, as well as visual, hearing, and/or speech impairment.

DNA sequencing

The DNA story continues to unfold with the concept that DNA variants alter susceptibility to environmental influences. These insults are, for example, thrombosis or hemorrhage, all of which affect motor function.¹ Duplications or deletions of portions of a chromosome, related to copy number variants (CNVs) as well as advances in human-genome sequencing, can identify a single gene mutation leading to CP.¹ Microdeletions, microduplications, and single nucleotide variants (SNVs) are to be included in genetic-related problems causing CP.³

A number of candidate genes have been considered and include “de novo heterozygous mutations in known Online Mendelian Inheritance (OMIM).” TIBA1A and SCN8A genes are highly associated with CP.⁸ Genetic assessment, as it evolves and more recently with the advent of exome sequencing, appears to provide a new and unprecedented level of understanding of CP. Specifically, exome sequencing provides a diagnostic tool with which to identify the prevalence of pathogenic and pathogenic variants (the latter encompassing genomic variants) with CP.⁹ A retrospective study assessed a cohort of patients with CP and noted that 32.7% of the pediatric-aged patients who underwent exome sequencing had pathogenic and pathogenic variants in the sequencing.⁹ Thus, we have a tool to identify underlying genetic pathogenesis with CP. This theoretically can change the outcome of lawsuits initiated for CP that ascribe an HIE etiology. Clinicians need to stay tuned as the genetic repertoire continues to unfold.

Continue to: Legal considerations...

Legal considerations

Although CP is not a common event, it has been a major factor in the total malpractice payments for ObGyns, neonatologists, and related medical disciplines. That is because the per-event liability can be staggering. Some law firms provide a “checklist” for plaintiffs early on in assessing a potential case (FIGURE 2).¹⁰

The financial risks and incentives

To understand what the current settlements and verdicts are in birth-related CP cases, a search of Lexis files revealed the reported outcomes of cases in 2019 and 2020 (FIGURE 3). Taking into account that the pandemic limited legal activity, 23 unduplicated cases were described with a reported settlement or verdict. Four cases resulted in verdicts for the injured patients, with the mean of these awards substantially higher than the settlements ($88.3 million vs $11.1 million, respectively).

These numbers are a glimpse at some of the very high settlements and verdicts that are common in CP cases. Notably, these are not a random sample of CP cases, but only those with the amount of the verdict or settlement reported. Potentially tried cases that may have been simply abandoned or dismissed are not reported. Furthermore, most settlements include confidentiality clauses, which may preclude the release of the financial value of the settlement. Cases in which the defense won (for example, a jury verdict in favor of the physician) are not included.

The high monetary awards in some CP cases are indirectly backed by Google search results for “cerebral palsy and liability” or “cerebral palsy and malpractice.” A very large number of results for law firms seeking clients with CP injuries is produced. Some of the websites note that only 10% (or 20% on some sites) of CP cases are caused by medical negligence, offering a “free legal case review” and a phone number for callers to “ask a legal question.” In the fine print one site notes that, “if you request any information you may receive a phone call or email from a partner law firm.”¹¹ US physicians may be interested to note that a recent study of CP-based malpractice cases in China found that, although nearly 90% of the claims resulted in compensation, the mean damage award was $73,500.¹² This was compared with a mean actual loss to the family of $128,200.

The interest by law firms in CP cases may be generated in part by the opportunity to assist a settlement or judgement that may be in the tens of millions of dollars. It is financially sensible to take a substantial risk on a contingency fee in a CP case compared with many other malpractice areas or claims where the likely damages are much lower. In addition, the vast majority of the damages in CP cases are for economic damages (cost of care and treatment and lost earning capacity), not noneconomic damages (pain and suffering). Therefore, the cap on noneconomic damages available in many states would not reduce the damages by a significant percentage.

CP cases are a significant part of the malpractice costs for ObGyns. Nearly one-third of obstetric claims are for neurologic injuries, including CP.^13,14 These cases are often very complex and difficult, meaning that, in addition to the payments to the injured, there are considerable litigation costs associated with defending the cases. Perhaps as much as 60% of malpractice costs in obstetrics are in some way related to CP claims.^15,16

Continue to: Negligence...

Negligence

Malpractice cases require not only damages (which clearly there are with CP) but also negligence and causation. (A more complete discussion of the elements of professional liability are included in a recent “What’s the Verdict?” column within OBG Management.)¹⁷ CP cases are somewhat unusual in that, frequently, both negligence and causation are bitterly disputed. In a CP case, even where negligence is obvious (and it usually is not), causation may not be obvious and is likely to become a key to the defense of a very big case.

Several areas of negligence are common in CP related to delivery, including failure to monitor properly or ignoring, or not responding to, fetal heart rate (FHR) monitoring.^18,19 For FHR monitoring, the claim is that problems can lead to asphyxia, resulting in HIE. Electronic fetal monitoring (EFM) has been an especially contentious matter. On one hand, the evidence of its efficacy is doubtful, but it has remained a standard practice, and it is often a centerpiece of delivery.²⁰ Attorney Thomas Sartwelle has been prolific in suggesting that it not only has created legal problems for physicians but also results in unnecessary cesarean deliveries (CDs), which carry attendant risks for mother and infant.²¹ (It should be noted that other attorneys have expressed quite different views.²²) He has argued that experts relying on EFM should be excluded from testifying because the technology is not based on sufficient science to meet the standard criteria used to determine the admissibility of expert witness (the Daubert standard).²³ This argument is a difficult one so long as EFM is standard practice. Other claims of negligence include improper use of instruments at delivery, resulting in physical damage to the baby’s head, neck, or shoulders or internal hemorrhage. In addition, failure to deal with neonatal infection may be the basis for negligence.²⁴

Causation

The question of whether or not the negligence (no matter how bad it was) caused the CP still needs to be addressed. Because a number of factors may cause CP, it has often been difficult to determine for any individual what the cause, or contributing causes, were. This fact would ordinarily work to the advantage of defendant-physicians and hospitals because the plaintiff in a malpractice case must prove by a preponderance of the evidence that the defendant’s negligence caused the CP. “Caused” is a term of art in the law; at the most basic level it means that the harm would not have occurred (or would have been less severe) but for the negligence.

In most CP cases the real cause is unknowable. It is, therefore, important to understand the difference between the certainty required in negligence cases and the certainty required in scientific studies (eg, 95% confidence). Negligence and causation in civil cases (including malpractice) must only be demonstrated by a preponderance of the evidence, which means “more likely than not.” For recovery in malpractice cases, states may require only that negligence be a “substantial factor.”

The theory that this lack of knowledge means that the plaintiff cannot prove causation, however, does not always hold.²⁵ The following is what a jury might see: a child who will have a lifetime of medical, social, and financial burdens. Clear negligent practice by the physician coupled with severe injury can create considerable sympathy for the family. Then there are experts on both sides claiming that it is reasonably certain, in their opinions, that the injury was/was not caused by the negligence of the physician and health care team. The plaintiff’s witnesses will start eliminating other causes of CP in a form of differential diagnosis, stating that the remaining possibilities of causation clearly point to malpractice as the cause of CP. At some point, the elimination of alternative explanations for CP makes malpractice more likely than not to be a substantial factor in causing CP. On the other hand, the defense witnesses will stress that CP occurs most often without any negligence, and that, in this case, there are remaining, perhaps unknown, possible causes that are more likely than malpractice.

In this trial mix, it is not unthinkable that a jury or judge might find the plaintiff’s opinions more appealing. As a practical matter, and contrary to the technical rules, the burden of proof can seem to shift. The defendant clinician may, in effect, have to prove that the CP was caused by something other than the clinician’s negligence.

The role of insurance in award amounts

One reason that malpractice insurance companies settle CP cases for millions of dollars is that they face the possibility of judgements in the tens of millions. We saw even more than $100 million, in the 2019-2020 CP cases reported above. Another risk for malpractice insurance companies is that, if they do not settle, they may have liability beyond the policy limits. (Policy limits are the maximum an insurance policy is obligated to pay for any occurrence, or the total for all claims for the time covered by the premium.) For example, assume a malpractice policy has a $5 million policy limit covering Dr. Defendant, who has been sued for CP resulting from malpractice. There was apparently negligence during delivery in monitoring the fetus, but on the issue of causation the best estimate is that there is a 75% probability a jury would find no causal link between the negligence and the CP. If there is liability, damages would likely range from $5 to $25 million. Assume that the plaintiff has signaled it would settle for the policy limits ($5 million). Based purely on the odds and the policy limits, the insurance company should go to trial as opposed to settling for $5 million. That is because the physician personally (as opposed to the insurance company) is responsible for that part of a verdict that exceeds $5 million.

To prevent just such abuse (or bad faith), in most states, if the insurance company declines to settle the case for $5 million, it may become liable for the excess verdict above the policy limits. One reason that the cases that result in a verdict on damages—the 4 cases reported above for 2019‒2020—are interesting is that they help establish the risk of failing to settle a CP case.

Genetic understanding of causation

Given the importance of defendant-clinicians to be able to find a cause other than negligence to explain CP, the recent research of Moreno-De-Luca and colleagues may be especially meaningful.⁹ Using exome sequencing, the researchers found that 32.7% of pediatric-aged CP patients had pathogenic variance in the sequencing. In theory, this might mean that for about one-third of the CP plaintiffs, there may be genomic (rather than malpractice) explanations for CP, which might ultimately result in fewer cases of CP.

As significant as these findings are, caution is warranted. As the authors note, “this was an observational study and a causal relationship between detected gene variants and phenotypes in participants was not definitively established.”⁹ Until the causal relationship is established, it is not clear how much influence such a study would have in CP malpractice cases. Another caveat is that, at most, the genetic variants accounted for less than a third of CP cases studied, leaving many cases in which the cause remains unknown. In those cases in which a genomic association was not found, the case may be stronger for the “malpractice was the cause” claim. The follow-up research will likely shed light on some of these issues. Of course, if the genetic research demonstrates that in some proportion of cases there are genetic factors that contribute to the probability of CP, then the search will be for other triggering elements, which could possibly include poor care (that might well be a substantial factor for malpractice). Therefore, the preliminary genetic research likely represents only a part of the CP puzzle in malpractice cases.

Continue to: Why the opening case outcome was for the defense...

Why the opening case outcome was for the defense

Juries, of course, do not write opinions, so the basis for the jury’s decision in the example case is somewhat speculative. It seems most likely that causation had not been established. That is, the plaintiff-patient did not demonstrate that any malpractice was the likely, or substantial contributing, cause of the CP. The case illustrates several important issues.

Statute of limitations. This issue is common in CP cases because the condition may not be diagnosed for some time after birth. The statute of limitations can vary by state for medical malpractice cases “from 2 years to 22 years.”²⁶ Many states begin with a 2-year statute but extend it if the injury or harm is not discovered. The extension is sometimes referred to as a statute of repose because, after that time, there is no extension even if the harm is discovered only later. In some states the statute does not run until the plaintiff is at or near the time of majority (usually age 18).²⁷

Establishing negligence. The information provided about the presented case is mixed on the question of negligence, both regarding the hospital (through its nursing staff) for not properly contacting the obstetrician over the 10 hours, or the physician for inadequate monitoring. In addition, the reference to “really had to pull to deliver the head” may be the basis for claiming excessive, and potentially harmful use of force, which may have caused injury. In addition, the question remains whether the combination of these factors, including the Category III fetal heart tracing, made a cesarean delivery the appropriate standard of care.

Addressing causation. Assuming negligence, there is still a question of causation. It is far from clear that what the clinician did, or did not do, in terms of monitoring caused the CP injury. There is, however, no alternative causation that appeared in the case record, and this may be because of dueling expert witnesses.

The plaintiff sued both the obstetrician and the hospital, which is common among CP cases. While the legal interest of the two parties are aligned in some areas (causation), they may be in conflict in others (the failure of the hospital staff to keep the obstetrician informed). These potential conflicts are not for the clinicians to try to work out on their own. There is the potential for their actions to be misunderstood. When such a case is filed or threatened, the obstetrician should immediately discuss these matters with their attorney. In malpractice cases, malpractice insurance companies often select the attorneys who are experienced in such conflicts. If clinicians are not entirely comfortable that the appointed attorney is representing their interest and preserving a relationship with the hospital or other institution, however, they may engage their own legal counsel to protect their interests.

Practical considerations for avoiding malpractice claims

Good practices for avoiding malpractice claims apply with special force as it relates to CP.^28,29

Uphold practice standards and good patient records. The causation element of these legal cases will remain problematic in the foreseeable future. But causation does not matter if negligent practice is not demonstrated. Therefore, maintaining best practices and continuous efforts at quality assurance and following all relevant professional practice guidelines is a good start. More than good intentions, it is essential that policies are implemented and reviewed. Among the areas of ongoing concern is the failure to monitor patients sufficiently. The long period of labor—where perhaps no physician is present for many hours—can introduce problems, as laypersons may have the impression that medical personnel were not on top of the situation.

Maintaining excellent records is also key for clinicians. The more complete the record, the fewer opportunities there are for faulty memories of parties and caregivers to fill in the gaps (especially when causation is so difficult to establish). Under absolutely no circumstances should records be changed or modified to eliminate damaging or an otherwise unfortunate notation. Few things are as harmful to credibility as discovered record tampering.

Inform patients of what is to come. Expectations are an important part of patient satisfaction. While not unduly frightening pregnant patients or eliminating reassurance, the informed consent process and patient counseling should be opportunities to avoid unreasonable expectations.

Stay alert to early genetic counseling, which is becoming increasingly available and important. Maintaining currency with what early testing can be done will become a critical part of ObGyn practice. For CP cases, in the near future, genetic testing may become part of determining causation. In the longer term, it will be part of counseling women and couples in deciding whether to have children, or potentially to end a pregnancy.

Expect the unexpected, and plan for it. Sometimes things just go wrong—there is a bad outcome, mistakes are made, patients are upset. It is important that any practice or institution have a clear plan for when such things happen. Some organizations have used apologies when appropriate,³⁰ others have more complex plans for dealing with bad outcomes.³¹ Implement developed plans when they are needed. Individual practitioners also should consult with their attorney, who is familiar with their practice and who can help them maintain adherence to legal requirements and good legal problem prevention. ●

CASE 34-year-old woman with lipid panel results from 1 year ago

A woman with no chronic medical conditions was seen by her gynecologist for a routine well-woman examination. She does not see another primary care provider. She is age 34 years and has a levonorgestrel intrauterine device that was placed after the birth of her second child 2 years prior. She does not take any other medications. She has never smoked and drinks a glass of wine with dinner a couple of times each week. She finds it challenging with her full-time job and her parental responsibilities with 2 young children to get regular exercise but otherwise is active. She does not have a family history of premature cardiovascular disease. Last year, during her prior well-woman examination, she had a fasting lipid panel: her low-density lipoprotein (LDL) was 102 mg/dL (reference range, ≤160 mg/dL), high-density lipoprotein (HDL) 52 mg/dL (reference range, ≥40 mg/dL), triglycerides 140 mg/dL (reference range, <160 mg/dL), and total cholesterol 182 mg/dL (reference range, <200 mg/dL).

During this visit, the patient’s vitals are normal (blood pressure 116/58) and her physical examination is unremarkable. Her physician orders routine labs to be checked, including a fasting lipid panel. She has to figure out when she will be able to get these labs drawn, as she needs to coordinate with her work and childcare schedules. A week later, she leaves work at 4:00 PM and picks up her young children (aged 2 and 4 years) from childcare, bringing them to the laboratory to have her blood drawn. Not only are her children cranky in the waiting room, but she is feeling tired as she hasn’t eaten all day because her physician told her she is supposed to be fasting. She has to pay for parking at the lot for the laboratory since it is connected to the medical center.

Was this lipid panel high value?

When and how often should we be checking lipid panels?

Do patients need to fast for these tests?
 

The potential benefits and costs of routine lipid panel screening

Hyperlipidemia is relatively prevalent, usually asymptomatic, and has been linked to cardiovascular outcomes. Thus, screening for lipid abnormalities is recommended to identify patients that would benefit from various interventions aimed at reducing cardiovascular disease risk, including lipid-lowering therapy.¹ High levels of LDL cholesterol and low levels of HDL cholesterol are important risk factors for coronary heart disease.

Lipid panels are widely available blood tests with modest monetary costs, generally ranging from about $10 to $100 in the outpatient setting. Of note, a 2014 study examining inpatient charges for this common laboratory test found that hospital charges in California ranged from about $10 to $10,000 for a lipid panel.² Despite the relatively low cost of each individual lipid panel, the aggregate costs to the health system of these frequently and widely performed tests are large. In fact, low-cost, high-volume health services, such as repeat cholesterol testing, account for the majority of unnecessary health spending in the United States, contributing nearly twice as much unnecessary cost as high-priced low-value services.³

To the patient, the cost is not only monetary. Some patients will need to take an additional hour or two off work as well as consider childcare, transportation, parking, and other mundane logistics to sit in a laboratory waiting room—a cost that may not be considered modest at all by the patient.^4,5

Therefore, like most services in health care, the answer to whether or not a lipid panel is high-value care is: it depends.⁵ In the correct circumstances, the test generally is regarded as high value due to well-documented potential benefits and low monetary costs. However, when performed unnecessarily—either in patient groups that are unlikely to benefit or at intervals that are too soon to add helpful information—then all that is left are the financial and psychosocial costs, which make this a low-value test in these scenarios. For this patient, this test contributed to inconvenience and mild hardships with essentially no benefit, thus would be considered low-value care.

Continue to: When should we perform lipid screening in low-risk women?

When should we perform lipid screening in low-risk women?

There are conflicting guidelines and opinions about at what age lipid screening should be routinely performed in adults. The United States Preventive Services Task Force (USPSTF) 2016 guidelines found “insufficient evidence that screening for dyslipidemia before age 40 years has an effect on either short- or longer-term cardiovascular outcomes.”⁶ Therefore, the USPSTF “recommends neither for nor against screening for dyslipidemia in this age group,” and instead encourages “clinicians to use their clinical judgment for [these] patients.”⁶

A common practice is to obtain a baseline lipid profile at the time of initiation of care with an adult primary care practitioner, if the patient was not previously screened, and to then determine subsequent testing based on these results and the patient’s risk factors for cardiovascular disease. For patients with normal lipid screening results and lower cardiovascular risk factors (no hypertension, diabetes mellitus, cigarette smoking, family history of premature coronary heart disease), experts suggest follow-up lipid screening be performed in men at age 35 and in women at age 45.⁷ Therefore, for this patient who had essentially a normal lipid panel a year prior, she should not have required repeat lipid testing until she is age 45.

As for how frequently subsequent lipid testing should be performed, the Centers for Disease Control and Prevention states, “most healthy adults should have their cholesterol checked every 4 to 6 years.”⁸ Those taking lipid-lowering medications or those with risk factors such as heart disease, diabetes, or concerning family history should have their cholesterol checked more frequently. If patients are near a threshold for treatment, some experts suggest repeating measurements every 3 years, but even in these settings, annual testing would be considered excessive.⁷

A standard lipid panel screen includes total cholesterol, LDL, HDL, and triglycerides. While a variety of assays have been developed that subfractionate lipoprotein particles based on size, density, or charge, these tests do not add value for low-risk patient screening and should only be used on an individualized basis for selected intermediate to high-risk patients. The American Society for Clinical Pathology released a Choosing Wisely recommendation that advises, “Do not routinely order expanded lipid panels (particle sizing, nuclear magnetic resonance) as screening tests for cardiovascular disease.”⁹

Do lipid panels need to be fasting?

For adults who are not taking lipid-lowering therapy, measurement of either a fasting or a nonfasting plasma lipid profile is effective for documenting baseline LDL and estimating cardiovascular risk.¹ In other words, nonfasting lipid testing is appropriate for most low-risk screening. Nonfasting testing generally is more convenient for patients; however, nonfasting lipid panels could result in elevated triglyceride levels. If an initial nonfasting lipid profile reveals a triglyceride level of 400 mg/dL or higher, then a repeat lipid profile in the fasting state should be performed for assessment of fasting triglyceride levels and baseline LDL.¹ Some patients may prefer to simply get a fasting lipid panel initially so that they do not run the risk of having to return for a second test, especially if they are at increased risk for high triglyceride levels (ie, if they are obese, have diabetes, or are taking medications such as steroids, which can increase triglyceride levels).

The bottom line

Some patients receive primary care directly from their gynecologist, and thus it is important for women’s health clinicians to be aware of appropriate cholesterol screening practices. While lipid panels may commonly be ordered routinely as part of annual health check-ups, the evidence suggests that this is an unnecessary practice that contributes to wasteful health spending at both individual and system levels; it also is an avoidable inconvenience for patients. It is unclear when lipid screening should be initiated for adult patients, but it seems reasonable to check baseline levels for a new patient who has not previously been screened. In low-risk patients with normal lipid panel levels, experts recommend initiating retesting at age 45 for women and obtaining repeat lipid levels no more than every 4 to 6 years. For most patients, nonfasting lipid levels will suffice for screening. Avoiding common unnecessary testing is an effective way to improve value for patients. ●

CASE 34-year-old woman with lipid panel results from 1 year ago

A woman with no chronic medical conditions was seen by her gynecologist for a routine well-woman examination. She does not see another primary care provider. She is age 34 years and has a levonorgestrel intrauterine device that was placed after the birth of her second child 2 years prior. She does not take any other medications. She has never smoked and drinks a glass of wine with dinner a couple of times each week. She finds it challenging with her full-time job and her parental responsibilities with 2 young children to get regular exercise but otherwise is active. She does not have a family history of premature cardiovascular disease. Last year, during her prior well-woman examination, she had a fasting lipid panel: her low-density lipoprotein (LDL) was 102 mg/dL (reference range, ≤160 mg/dL), high-density lipoprotein (HDL) 52 mg/dL (reference range, ≥40 mg/dL), triglycerides 140 mg/dL (reference range, <160 mg/dL), and total cholesterol 182 mg/dL (reference range, <200 mg/dL).

During this visit, the patient’s vitals are normal (blood pressure 116/58) and her physical examination is unremarkable. Her physician orders routine labs to be checked, including a fasting lipid panel. She has to figure out when she will be able to get these labs drawn, as she needs to coordinate with her work and childcare schedules. A week later, she leaves work at 4:00 PM and picks up her young children (aged 2 and 4 years) from childcare, bringing them to the laboratory to have her blood drawn. Not only are her children cranky in the waiting room, but she is feeling tired as she hasn’t eaten all day because her physician told her she is supposed to be fasting. She has to pay for parking at the lot for the laboratory since it is connected to the medical center.

Was this lipid panel high value?

When and how often should we be checking lipid panels?

Do patients need to fast for these tests?
 

The potential benefits and costs of routine lipid panel screening

Hyperlipidemia is relatively prevalent, usually asymptomatic, and has been linked to cardiovascular outcomes. Thus, screening for lipid abnormalities is recommended to identify patients that would benefit from various interventions aimed at reducing cardiovascular disease risk, including lipid-lowering therapy.¹ High levels of LDL cholesterol and low levels of HDL cholesterol are important risk factors for coronary heart disease.

Lipid panels are widely available blood tests with modest monetary costs, generally ranging from about $10 to $100 in the outpatient setting. Of note, a 2014 study examining inpatient charges for this common laboratory test found that hospital charges in California ranged from about $10 to $10,000 for a lipid panel.² Despite the relatively low cost of each individual lipid panel, the aggregate costs to the health system of these frequently and widely performed tests are large. In fact, low-cost, high-volume health services, such as repeat cholesterol testing, account for the majority of unnecessary health spending in the United States, contributing nearly twice as much unnecessary cost as high-priced low-value services.³

To the patient, the cost is not only monetary. Some patients will need to take an additional hour or two off work as well as consider childcare, transportation, parking, and other mundane logistics to sit in a laboratory waiting room—a cost that may not be considered modest at all by the patient.^4,5

Therefore, like most services in health care, the answer to whether or not a lipid panel is high-value care is: it depends.⁵ In the correct circumstances, the test generally is regarded as high value due to well-documented potential benefits and low monetary costs. However, when performed unnecessarily—either in patient groups that are unlikely to benefit or at intervals that are too soon to add helpful information—then all that is left are the financial and psychosocial costs, which make this a low-value test in these scenarios. For this patient, this test contributed to inconvenience and mild hardships with essentially no benefit, thus would be considered low-value care.

Continue to: When should we perform lipid screening in low-risk women?

When should we perform lipid screening in low-risk women?

There are conflicting guidelines and opinions about at what age lipid screening should be routinely performed in adults. The United States Preventive Services Task Force (USPSTF) 2016 guidelines found “insufficient evidence that screening for dyslipidemia before age 40 years has an effect on either short- or longer-term cardiovascular outcomes.”⁶ Therefore, the USPSTF “recommends neither for nor against screening for dyslipidemia in this age group,” and instead encourages “clinicians to use their clinical judgment for [these] patients.”⁶

A common practice is to obtain a baseline lipid profile at the time of initiation of care with an adult primary care practitioner, if the patient was not previously screened, and to then determine subsequent testing based on these results and the patient’s risk factors for cardiovascular disease. For patients with normal lipid screening results and lower cardiovascular risk factors (no hypertension, diabetes mellitus, cigarette smoking, family history of premature coronary heart disease), experts suggest follow-up lipid screening be performed in men at age 35 and in women at age 45.⁷ Therefore, for this patient who had essentially a normal lipid panel a year prior, she should not have required repeat lipid testing until she is age 45.

As for how frequently subsequent lipid testing should be performed, the Centers for Disease Control and Prevention states, “most healthy adults should have their cholesterol checked every 4 to 6 years.”⁸ Those taking lipid-lowering medications or those with risk factors such as heart disease, diabetes, or concerning family history should have their cholesterol checked more frequently. If patients are near a threshold for treatment, some experts suggest repeating measurements every 3 years, but even in these settings, annual testing would be considered excessive.⁷

A standard lipid panel screen includes total cholesterol, LDL, HDL, and triglycerides. While a variety of assays have been developed that subfractionate lipoprotein particles based on size, density, or charge, these tests do not add value for low-risk patient screening and should only be used on an individualized basis for selected intermediate to high-risk patients. The American Society for Clinical Pathology released a Choosing Wisely recommendation that advises, “Do not routinely order expanded lipid panels (particle sizing, nuclear magnetic resonance) as screening tests for cardiovascular disease.”⁹

Do lipid panels need to be fasting?

For adults who are not taking lipid-lowering therapy, measurement of either a fasting or a nonfasting plasma lipid profile is effective for documenting baseline LDL and estimating cardiovascular risk.¹ In other words, nonfasting lipid testing is appropriate for most low-risk screening. Nonfasting testing generally is more convenient for patients; however, nonfasting lipid panels could result in elevated triglyceride levels. If an initial nonfasting lipid profile reveals a triglyceride level of 400 mg/dL or higher, then a repeat lipid profile in the fasting state should be performed for assessment of fasting triglyceride levels and baseline LDL.¹ Some patients may prefer to simply get a fasting lipid panel initially so that they do not run the risk of having to return for a second test, especially if they are at increased risk for high triglyceride levels (ie, if they are obese, have diabetes, or are taking medications such as steroids, which can increase triglyceride levels).

The bottom line

Some patients receive primary care directly from their gynecologist, and thus it is important for women’s health clinicians to be aware of appropriate cholesterol screening practices. While lipid panels may commonly be ordered routinely as part of annual health check-ups, the evidence suggests that this is an unnecessary practice that contributes to wasteful health spending at both individual and system levels; it also is an avoidable inconvenience for patients. It is unclear when lipid screening should be initiated for adult patients, but it seems reasonable to check baseline levels for a new patient who has not previously been screened. In low-risk patients with normal lipid panel levels, experts recommend initiating retesting at age 45 for women and obtaining repeat lipid levels no more than every 4 to 6 years. For most patients, nonfasting lipid levels will suffice for screening. Avoiding common unnecessary testing is an effective way to improve value for patients. ●

CASE 34-year-old woman with lipid panel results from 1 year ago

A woman with no chronic medical conditions was seen by her gynecologist for a routine well-woman examination. She does not see another primary care provider. She is age 34 years and has a levonorgestrel intrauterine device that was placed after the birth of her second child 2 years prior. She does not take any other medications. She has never smoked and drinks a glass of wine with dinner a couple of times each week. She finds it challenging with her full-time job and her parental responsibilities with 2 young children to get regular exercise but otherwise is active. She does not have a family history of premature cardiovascular disease. Last year, during her prior well-woman examination, she had a fasting lipid panel: her low-density lipoprotein (LDL) was 102 mg/dL (reference range, ≤160 mg/dL), high-density lipoprotein (HDL) 52 mg/dL (reference range, ≥40 mg/dL), triglycerides 140 mg/dL (reference range, <160 mg/dL), and total cholesterol 182 mg/dL (reference range, <200 mg/dL).

During this visit, the patient’s vitals are normal (blood pressure 116/58) and her physical examination is unremarkable. Her physician orders routine labs to be checked, including a fasting lipid panel. She has to figure out when she will be able to get these labs drawn, as she needs to coordinate with her work and childcare schedules. A week later, she leaves work at 4:00 PM and picks up her young children (aged 2 and 4 years) from childcare, bringing them to the laboratory to have her blood drawn. Not only are her children cranky in the waiting room, but she is feeling tired as she hasn’t eaten all day because her physician told her she is supposed to be fasting. She has to pay for parking at the lot for the laboratory since it is connected to the medical center.

Was this lipid panel high value?

When and how often should we be checking lipid panels?

Do patients need to fast for these tests?
 

The potential benefits and costs of routine lipid panel screening

Hyperlipidemia is relatively prevalent, usually asymptomatic, and has been linked to cardiovascular outcomes. Thus, screening for lipid abnormalities is recommended to identify patients that would benefit from various interventions aimed at reducing cardiovascular disease risk, including lipid-lowering therapy.¹ High levels of LDL cholesterol and low levels of HDL cholesterol are important risk factors for coronary heart disease.

Lipid panels are widely available blood tests with modest monetary costs, generally ranging from about $10 to $100 in the outpatient setting. Of note, a 2014 study examining inpatient charges for this common laboratory test found that hospital charges in California ranged from about $10 to $10,000 for a lipid panel.² Despite the relatively low cost of each individual lipid panel, the aggregate costs to the health system of these frequently and widely performed tests are large. In fact, low-cost, high-volume health services, such as repeat cholesterol testing, account for the majority of unnecessary health spending in the United States, contributing nearly twice as much unnecessary cost as high-priced low-value services.³

To the patient, the cost is not only monetary. Some patients will need to take an additional hour or two off work as well as consider childcare, transportation, parking, and other mundane logistics to sit in a laboratory waiting room—a cost that may not be considered modest at all by the patient.^4,5

Therefore, like most services in health care, the answer to whether or not a lipid panel is high-value care is: it depends.⁵ In the correct circumstances, the test generally is regarded as high value due to well-documented potential benefits and low monetary costs. However, when performed unnecessarily—either in patient groups that are unlikely to benefit or at intervals that are too soon to add helpful information—then all that is left are the financial and psychosocial costs, which make this a low-value test in these scenarios. For this patient, this test contributed to inconvenience and mild hardships with essentially no benefit, thus would be considered low-value care.

Continue to: When should we perform lipid screening in low-risk women?

When should we perform lipid screening in low-risk women?

There are conflicting guidelines and opinions about at what age lipid screening should be routinely performed in adults. The United States Preventive Services Task Force (USPSTF) 2016 guidelines found “insufficient evidence that screening for dyslipidemia before age 40 years has an effect on either short- or longer-term cardiovascular outcomes.”⁶ Therefore, the USPSTF “recommends neither for nor against screening for dyslipidemia in this age group,” and instead encourages “clinicians to use their clinical judgment for [these] patients.”⁶

A common practice is to obtain a baseline lipid profile at the time of initiation of care with an adult primary care practitioner, if the patient was not previously screened, and to then determine subsequent testing based on these results and the patient’s risk factors for cardiovascular disease. For patients with normal lipid screening results and lower cardiovascular risk factors (no hypertension, diabetes mellitus, cigarette smoking, family history of premature coronary heart disease), experts suggest follow-up lipid screening be performed in men at age 35 and in women at age 45.⁷ Therefore, for this patient who had essentially a normal lipid panel a year prior, she should not have required repeat lipid testing until she is age 45.

As for how frequently subsequent lipid testing should be performed, the Centers for Disease Control and Prevention states, “most healthy adults should have their cholesterol checked every 4 to 6 years.”⁸ Those taking lipid-lowering medications or those with risk factors such as heart disease, diabetes, or concerning family history should have their cholesterol checked more frequently. If patients are near a threshold for treatment, some experts suggest repeating measurements every 3 years, but even in these settings, annual testing would be considered excessive.⁷

A standard lipid panel screen includes total cholesterol, LDL, HDL, and triglycerides. While a variety of assays have been developed that subfractionate lipoprotein particles based on size, density, or charge, these tests do not add value for low-risk patient screening and should only be used on an individualized basis for selected intermediate to high-risk patients. The American Society for Clinical Pathology released a Choosing Wisely recommendation that advises, “Do not routinely order expanded lipid panels (particle sizing, nuclear magnetic resonance) as screening tests for cardiovascular disease.”⁹

Do lipid panels need to be fasting?

For adults who are not taking lipid-lowering therapy, measurement of either a fasting or a nonfasting plasma lipid profile is effective for documenting baseline LDL and estimating cardiovascular risk.¹ In other words, nonfasting lipid testing is appropriate for most low-risk screening. Nonfasting testing generally is more convenient for patients; however, nonfasting lipid panels could result in elevated triglyceride levels. If an initial nonfasting lipid profile reveals a triglyceride level of 400 mg/dL or higher, then a repeat lipid profile in the fasting state should be performed for assessment of fasting triglyceride levels and baseline LDL.¹ Some patients may prefer to simply get a fasting lipid panel initially so that they do not run the risk of having to return for a second test, especially if they are at increased risk for high triglyceride levels (ie, if they are obese, have diabetes, or are taking medications such as steroids, which can increase triglyceride levels).

The bottom line

Some patients receive primary care directly from their gynecologist, and thus it is important for women’s health clinicians to be aware of appropriate cholesterol screening practices. While lipid panels may commonly be ordered routinely as part of annual health check-ups, the evidence suggests that this is an unnecessary practice that contributes to wasteful health spending at both individual and system levels; it also is an avoidable inconvenience for patients. It is unclear when lipid screening should be initiated for adult patients, but it seems reasonable to check baseline levels for a new patient who has not previously been screened. In low-risk patients with normal lipid panel levels, experts recommend initiating retesting at age 45 for women and obtaining repeat lipid levels no more than every 4 to 6 years. For most patients, nonfasting lipid levels will suffice for screening. Avoiding common unnecessary testing is an effective way to improve value for patients. ●

Obesity affects approximately 30% of American women, and while it is easy to diagnose, it is often difficult to address with our patients. Healthy eating and regular physical activity are the time-tested ways to achieve and maintain an appropriate weight.

For women with moderate obesity, leveraging technology is a great way to help them sensibly achieve weight loss. To evaluate the quality of a mobile app targeted to address obesity, it is particularly important to consider an app’s usefulness, functionality, and design. Clinicians can evaluate these elements with the use of the ACOG-recommended rubric, which provides criteria for judging usefulness, accuracy, authority, objectivity, timeliness, functionality, design, security, and value.

Obesity app considerations

A particularly valuable app feature that rates high on the usefulness measure is the capability for real-time motivational guidance that encourages the user to meet her daily goals. The ability to quickly and accurately scan and upload food items to an app and quantify portions using common comparative illustrations for measurement would give an app a high score on functionality. Coveted design features to enhance the user’s experience, such as syncing real time with wearable devices and catering to both visual and text learners, increase the value of an app.

In addition, an app with the combined features of a personal dietitian and a fitness trainer can employ techniques to encourage healthy eating and physical activity to self-monitor food intake and exercise. Features that calculate the user’s calorie level based on age, sex, height, and activity and offer a personalized dashboard to track carbohydrates, proteins, and fat breakdown (including nutrients and water intake) also can increase effectiveness. These features engage users to become more motivated toward an active lifestyle to balance food intake.

By incorporating apps that combine behavioral strategies with individualization, community presence, and feedback, we can successfully partner with our patients to address obesity. ●

Obesity affects approximately 30% of American women, and while it is easy to diagnose, it is often difficult to address with our patients. Healthy eating and regular physical activity are the time-tested ways to achieve and maintain an appropriate weight.

For women with moderate obesity, leveraging technology is a great way to help them sensibly achieve weight loss. To evaluate the quality of a mobile app targeted to address obesity, it is particularly important to consider an app’s usefulness, functionality, and design. Clinicians can evaluate these elements with the use of the ACOG-recommended rubric, which provides criteria for judging usefulness, accuracy, authority, objectivity, timeliness, functionality, design, security, and value.

Obesity app considerations

A particularly valuable app feature that rates high on the usefulness measure is the capability for real-time motivational guidance that encourages the user to meet her daily goals. The ability to quickly and accurately scan and upload food items to an app and quantify portions using common comparative illustrations for measurement would give an app a high score on functionality. Coveted design features to enhance the user’s experience, such as syncing real time with wearable devices and catering to both visual and text learners, increase the value of an app.

In addition, an app with the combined features of a personal dietitian and a fitness trainer can employ techniques to encourage healthy eating and physical activity to self-monitor food intake and exercise. Features that calculate the user’s calorie level based on age, sex, height, and activity and offer a personalized dashboard to track carbohydrates, proteins, and fat breakdown (including nutrients and water intake) also can increase effectiveness. These features engage users to become more motivated toward an active lifestyle to balance food intake.

By incorporating apps that combine behavioral strategies with individualization, community presence, and feedback, we can successfully partner with our patients to address obesity. ●

Obesity affects approximately 30% of American women, and while it is easy to diagnose, it is often difficult to address with our patients. Healthy eating and regular physical activity are the time-tested ways to achieve and maintain an appropriate weight.

For women with moderate obesity, leveraging technology is a great way to help them sensibly achieve weight loss. To evaluate the quality of a mobile app targeted to address obesity, it is particularly important to consider an app’s usefulness, functionality, and design. Clinicians can evaluate these elements with the use of the ACOG-recommended rubric, which provides criteria for judging usefulness, accuracy, authority, objectivity, timeliness, functionality, design, security, and value.

Obesity app considerations

A particularly valuable app feature that rates high on the usefulness measure is the capability for real-time motivational guidance that encourages the user to meet her daily goals. The ability to quickly and accurately scan and upload food items to an app and quantify portions using common comparative illustrations for measurement would give an app a high score on functionality. Coveted design features to enhance the user’s experience, such as syncing real time with wearable devices and catering to both visual and text learners, increase the value of an app.

In addition, an app with the combined features of a personal dietitian and a fitness trainer can employ techniques to encourage healthy eating and physical activity to self-monitor food intake and exercise. Features that calculate the user’s calorie level based on age, sex, height, and activity and offer a personalized dashboard to track carbohydrates, proteins, and fat breakdown (including nutrients and water intake) also can increase effectiveness. These features engage users to become more motivated toward an active lifestyle to balance food intake.

By incorporating apps that combine behavioral strategies with individualization, community presence, and feedback, we can successfully partner with our patients to address obesity. ●

Information is scarce regarding the impact of COVID-19 on pregnant women and newborns; health care workers (HCWs), particularly pregnant women,¹ who are caring for patients during the pandemic might experience concern and uncertainty. The American College of Obstetricians and Gynecologists (ACOG) released recommendations, based on expert consensus, regarding pregnant HCWs on December 14, 2020.² We propose an appropriation of the ACOG recommendations for dermatologists and their teams caring for patients during the COVID-19 pandemic.

Risks to Pregnant HCWs

Worldwide, viral pneumonia is a leading cause of death during pregnancy,³ with higher mortality documented among pregnant patients during the 1918 influenza pandemic and the 2003 severe acute respiratory syndrome–associated coronavirus pandemic,³ and an increased rate of hospital admission documented among these patients compared to the general population during the 2009 H1N1 influenza pandemic.⁴

Data from the Centers for Disease Control and Prevention (CDC) suggest that pregnant women with symptomatic COVID-19 (n=30,415) are at increased risk for the following (compared to nonpregnant women with symptomatic COVID-19 [n=431,410])⁵:

• Admission to the intensive care unit (10.5 of every 1000 cases vs 3.9 of every 1000 cases; adjusted risk ratio [aRR]=3.0; 95% CI, 2.6-3.4)

• Receipt of invasive ventilation (2.9 of every 1000 cases vs 1.1 of every 1000 cases; aRR=2.9; 95% CI, 2.2-3.8)

• Receipt of extracorporeal membrane oxygenation (0.7 of every 1000 cases vs 0.3 of every 1000 cases; aRR=2.4; 95% CI, 1.5-4.0)

• Death (1.5 of every 1000 cases vs 1.2 of every 1000 cases; aRR=1.7; 95% CI, 1.2-2.4).

Although the absolute risk of severe COVID-19–related outcomes is low, the CDC includes pregnant women in its increased risk category for COVID-19. Furthermore, in a systematic review of 61 studies comprising 790 COVID-19–positive pregnant women and 548 newborns, the rates of cesarean delivery, premature birth, low birth weight, and adverse pregnancy events (the latter comprising preterm birth, death or stillbirth, and early termination of pregnancy) were estimated to be 72%, 23%, 7%, and 27%, respectively.⁶ In a systematic review of 39 studies (case series and cohort studies), comprising 936 SARS-CoV-2–tested newborns of mothers with COVID-19, mother-to-fetus transmission of SARS-CoV-2 occurred during the third trimester in approximately 3.2% of infected mothers.⁷

In pregnant women with COVID-19 who develop cytokine storm syndrome, a fetal inflammatory response syndrome can ensue, which has been shown to cause ventricular expansion and bleeding in animal models.⁸ In addition, underlying conditions, such as cardiovascular disease, diabetes mellitus, pre-existing lung disease, and obesity, which are well-established risks factors for severe COVID-19 in nonpregnant patients, can increase the severity of COVID-19 in pregnant women.^5,9-11

Recommendations From ACOG for Pregnant HCWs

The American College of Obstetricians and Gynecologists recommends that health care facilities consider limiting the exposure of pregnant HCWs to patients with confirmed or suspected COVID-19. They also recommend that pregnant women continue to work in patient-facing roles if they want to, if recommended personal protective equipment (PPE) is available for them to wear.² The US Food and Drug Administration issued an Emergency Use Authorization for 2 messenger RNA COVID-19 vaccines. Although these vaccines have not been tested in pregnant women, ACOG recommends that COVID-19 vaccines not be withheld from pregnant women who fulfill the criteria for vaccination; pregnant women who decline vaccination should be supported in their decision.¹² In dermatology, telemedicine is an effective alternative to face-to-face visits, reducing the risk of transmitting SARS-CoV-2 to physicians and patients.

Ideally, pregnant dermatology attending physicians and residents can continue to provide care through teledermatology. They also can continue to provide in-person care, if they choose to; however, higher-risk procedures should be avoided.¹² In dermatology, that might include ablative laser procedures to the face, prolonged surgery, such as hair transplantation, and intraoral or intranasal procedures. Alternatively, pregnant dermatology residents can be allocated to clinical rotations in which face-to-face contact with patients is not required such as dermatopathology and a research rotation. Likewise, telework options can be encouraged for other pregnant members of dermatology teams, including front-desk staff, nurses, medical assistants, and remaining ancillary staff.

Guidance on Face Masks for Pregnant HCWs

Universal masking of HCWs has been shown to reduce the rate of health care–related acquisition of SARS-CoV-2.¹³ However, extended use or reuse of N95 respirators might contribute to SARS-CoV-2 transmission.¹⁴ The American College of Obstetricians and Gynecologists recommends that all HCWs wear a face mask at all times while working in a health care facility, even if patients are wearing a face covering or face mask.² Based on CDC guidelines,¹⁵ HCWs in regions where community transmission is moderate or substantial should wear eye protection in addition to a face mask, and they should wear an N95, N95-equivalent, or higher-level respirator instead of a face mask when performing aerosol-generating procedures and surgical procedures. If working in a patient-facing role caring for patients with suspected or confirmed COVID-19, HCWs should wear an N95, N95-equivalent, or higher-level respirator; gown; gloves; and eye protection (goggles or a disposable face shield).¹⁵

Final Thoughts

COVID-19 has brought about acute and likely permanent changes to the US health care system. Dermatologists are integral members of that system and are essential to the treatment of patients with skin, hair, and nail disorders. Pregnant dermatologists and residents should refrain from patient-facing roles when feasible; however, when all recommended PPE are available, they may continue to work in patient-facing roles until they give birth if they desire to do so. Alternatively, teledermatology and non–face-to-face rotations should be encouraged. Higher-risk and aerosol-generating procedures are of particular concern regarding the risk for transmitting SARS-CoV-2 and should be avoided. Correct and universal use of PPE is paramount; when all recommended PPE is not available, pregnant HCWs should avoid exposure to patients with suspected or confirmed COVID-19. These recommendations will help safeguard pregnant members of dermatology teams during the COVID-19 pandemic while maximizing patient care.

Information is scarce regarding the impact of COVID-19 on pregnant women and newborns; health care workers (HCWs), particularly pregnant women,¹ who are caring for patients during the pandemic might experience concern and uncertainty. The American College of Obstetricians and Gynecologists (ACOG) released recommendations, based on expert consensus, regarding pregnant HCWs on December 14, 2020.² We propose an appropriation of the ACOG recommendations for dermatologists and their teams caring for patients during the COVID-19 pandemic.

Risks to Pregnant HCWs

Worldwide, viral pneumonia is a leading cause of death during pregnancy,³ with higher mortality documented among pregnant patients during the 1918 influenza pandemic and the 2003 severe acute respiratory syndrome–associated coronavirus pandemic,³ and an increased rate of hospital admission documented among these patients compared to the general population during the 2009 H1N1 influenza pandemic.⁴

Data from the Centers for Disease Control and Prevention (CDC) suggest that pregnant women with symptomatic COVID-19 (n=30,415) are at increased risk for the following (compared to nonpregnant women with symptomatic COVID-19 [n=431,410])⁵:

• Admission to the intensive care unit (10.5 of every 1000 cases vs 3.9 of every 1000 cases; adjusted risk ratio [aRR]=3.0; 95% CI, 2.6-3.4)

• Receipt of invasive ventilation (2.9 of every 1000 cases vs 1.1 of every 1000 cases; aRR=2.9; 95% CI, 2.2-3.8)

• Receipt of extracorporeal membrane oxygenation (0.7 of every 1000 cases vs 0.3 of every 1000 cases; aRR=2.4; 95% CI, 1.5-4.0)

• Death (1.5 of every 1000 cases vs 1.2 of every 1000 cases; aRR=1.7; 95% CI, 1.2-2.4).

Although the absolute risk of severe COVID-19–related outcomes is low, the CDC includes pregnant women in its increased risk category for COVID-19. Furthermore, in a systematic review of 61 studies comprising 790 COVID-19–positive pregnant women and 548 newborns, the rates of cesarean delivery, premature birth, low birth weight, and adverse pregnancy events (the latter comprising preterm birth, death or stillbirth, and early termination of pregnancy) were estimated to be 72%, 23%, 7%, and 27%, respectively.⁶ In a systematic review of 39 studies (case series and cohort studies), comprising 936 SARS-CoV-2–tested newborns of mothers with COVID-19, mother-to-fetus transmission of SARS-CoV-2 occurred during the third trimester in approximately 3.2% of infected mothers.⁷

In pregnant women with COVID-19 who develop cytokine storm syndrome, a fetal inflammatory response syndrome can ensue, which has been shown to cause ventricular expansion and bleeding in animal models.⁸ In addition, underlying conditions, such as cardiovascular disease, diabetes mellitus, pre-existing lung disease, and obesity, which are well-established risks factors for severe COVID-19 in nonpregnant patients, can increase the severity of COVID-19 in pregnant women.^5,9-11

Recommendations From ACOG for Pregnant HCWs

The American College of Obstetricians and Gynecologists recommends that health care facilities consider limiting the exposure of pregnant HCWs to patients with confirmed or suspected COVID-19. They also recommend that pregnant women continue to work in patient-facing roles if they want to, if recommended personal protective equipment (PPE) is available for them to wear.² The US Food and Drug Administration issued an Emergency Use Authorization for 2 messenger RNA COVID-19 vaccines. Although these vaccines have not been tested in pregnant women, ACOG recommends that COVID-19 vaccines not be withheld from pregnant women who fulfill the criteria for vaccination; pregnant women who decline vaccination should be supported in their decision.¹² In dermatology, telemedicine is an effective alternative to face-to-face visits, reducing the risk of transmitting SARS-CoV-2 to physicians and patients.

Ideally, pregnant dermatology attending physicians and residents can continue to provide care through teledermatology. They also can continue to provide in-person care, if they choose to; however, higher-risk procedures should be avoided.¹² In dermatology, that might include ablative laser procedures to the face, prolonged surgery, such as hair transplantation, and intraoral or intranasal procedures. Alternatively, pregnant dermatology residents can be allocated to clinical rotations in which face-to-face contact with patients is not required such as dermatopathology and a research rotation. Likewise, telework options can be encouraged for other pregnant members of dermatology teams, including front-desk staff, nurses, medical assistants, and remaining ancillary staff.

Guidance on Face Masks for Pregnant HCWs

Universal masking of HCWs has been shown to reduce the rate of health care–related acquisition of SARS-CoV-2.¹³ However, extended use or reuse of N95 respirators might contribute to SARS-CoV-2 transmission.¹⁴ The American College of Obstetricians and Gynecologists recommends that all HCWs wear a face mask at all times while working in a health care facility, even if patients are wearing a face covering or face mask.² Based on CDC guidelines,¹⁵ HCWs in regions where community transmission is moderate or substantial should wear eye protection in addition to a face mask, and they should wear an N95, N95-equivalent, or higher-level respirator instead of a face mask when performing aerosol-generating procedures and surgical procedures. If working in a patient-facing role caring for patients with suspected or confirmed COVID-19, HCWs should wear an N95, N95-equivalent, or higher-level respirator; gown; gloves; and eye protection (goggles or a disposable face shield).¹⁵

Final Thoughts

COVID-19 has brought about acute and likely permanent changes to the US health care system. Dermatologists are integral members of that system and are essential to the treatment of patients with skin, hair, and nail disorders. Pregnant dermatologists and residents should refrain from patient-facing roles when feasible; however, when all recommended PPE are available, they may continue to work in patient-facing roles until they give birth if they desire to do so. Alternatively, teledermatology and non–face-to-face rotations should be encouraged. Higher-risk and aerosol-generating procedures are of particular concern regarding the risk for transmitting SARS-CoV-2 and should be avoided. Correct and universal use of PPE is paramount; when all recommended PPE is not available, pregnant HCWs should avoid exposure to patients with suspected or confirmed COVID-19. These recommendations will help safeguard pregnant members of dermatology teams during the COVID-19 pandemic while maximizing patient care.

Information is scarce regarding the impact of COVID-19 on pregnant women and newborns; health care workers (HCWs), particularly pregnant women,¹ who are caring for patients during the pandemic might experience concern and uncertainty. The American College of Obstetricians and Gynecologists (ACOG) released recommendations, based on expert consensus, regarding pregnant HCWs on December 14, 2020.² We propose an appropriation of the ACOG recommendations for dermatologists and their teams caring for patients during the COVID-19 pandemic.

Risks to Pregnant HCWs

Worldwide, viral pneumonia is a leading cause of death during pregnancy,³ with higher mortality documented among pregnant patients during the 1918 influenza pandemic and the 2003 severe acute respiratory syndrome–associated coronavirus pandemic,³ and an increased rate of hospital admission documented among these patients compared to the general population during the 2009 H1N1 influenza pandemic.⁴

Data from the Centers for Disease Control and Prevention (CDC) suggest that pregnant women with symptomatic COVID-19 (n=30,415) are at increased risk for the following (compared to nonpregnant women with symptomatic COVID-19 [n=431,410])⁵:

• Admission to the intensive care unit (10.5 of every 1000 cases vs 3.9 of every 1000 cases; adjusted risk ratio [aRR]=3.0; 95% CI, 2.6-3.4)

• Receipt of invasive ventilation (2.9 of every 1000 cases vs 1.1 of every 1000 cases; aRR=2.9; 95% CI, 2.2-3.8)

• Receipt of extracorporeal membrane oxygenation (0.7 of every 1000 cases vs 0.3 of every 1000 cases; aRR=2.4; 95% CI, 1.5-4.0)

• Death (1.5 of every 1000 cases vs 1.2 of every 1000 cases; aRR=1.7; 95% CI, 1.2-2.4).

Although the absolute risk of severe COVID-19–related outcomes is low, the CDC includes pregnant women in its increased risk category for COVID-19. Furthermore, in a systematic review of 61 studies comprising 790 COVID-19–positive pregnant women and 548 newborns, the rates of cesarean delivery, premature birth, low birth weight, and adverse pregnancy events (the latter comprising preterm birth, death or stillbirth, and early termination of pregnancy) were estimated to be 72%, 23%, 7%, and 27%, respectively.⁶ In a systematic review of 39 studies (case series and cohort studies), comprising 936 SARS-CoV-2–tested newborns of mothers with COVID-19, mother-to-fetus transmission of SARS-CoV-2 occurred during the third trimester in approximately 3.2% of infected mothers.⁷

In pregnant women with COVID-19 who develop cytokine storm syndrome, a fetal inflammatory response syndrome can ensue, which has been shown to cause ventricular expansion and bleeding in animal models.⁸ In addition, underlying conditions, such as cardiovascular disease, diabetes mellitus, pre-existing lung disease, and obesity, which are well-established risks factors for severe COVID-19 in nonpregnant patients, can increase the severity of COVID-19 in pregnant women.^5,9-11

Recommendations From ACOG for Pregnant HCWs

The American College of Obstetricians and Gynecologists recommends that health care facilities consider limiting the exposure of pregnant HCWs to patients with confirmed or suspected COVID-19. They also recommend that pregnant women continue to work in patient-facing roles if they want to, if recommended personal protective equipment (PPE) is available for them to wear.² The US Food and Drug Administration issued an Emergency Use Authorization for 2 messenger RNA COVID-19 vaccines. Although these vaccines have not been tested in pregnant women, ACOG recommends that COVID-19 vaccines not be withheld from pregnant women who fulfill the criteria for vaccination; pregnant women who decline vaccination should be supported in their decision.¹² In dermatology, telemedicine is an effective alternative to face-to-face visits, reducing the risk of transmitting SARS-CoV-2 to physicians and patients.

Ideally, pregnant dermatology attending physicians and residents can continue to provide care through teledermatology. They also can continue to provide in-person care, if they choose to; however, higher-risk procedures should be avoided.¹² In dermatology, that might include ablative laser procedures to the face, prolonged surgery, such as hair transplantation, and intraoral or intranasal procedures. Alternatively, pregnant dermatology residents can be allocated to clinical rotations in which face-to-face contact with patients is not required such as dermatopathology and a research rotation. Likewise, telework options can be encouraged for other pregnant members of dermatology teams, including front-desk staff, nurses, medical assistants, and remaining ancillary staff.

Guidance on Face Masks for Pregnant HCWs

Universal masking of HCWs has been shown to reduce the rate of health care–related acquisition of SARS-CoV-2.¹³ However, extended use or reuse of N95 respirators might contribute to SARS-CoV-2 transmission.¹⁴ The American College of Obstetricians and Gynecologists recommends that all HCWs wear a face mask at all times while working in a health care facility, even if patients are wearing a face covering or face mask.² Based on CDC guidelines,¹⁵ HCWs in regions where community transmission is moderate or substantial should wear eye protection in addition to a face mask, and they should wear an N95, N95-equivalent, or higher-level respirator instead of a face mask when performing aerosol-generating procedures and surgical procedures. If working in a patient-facing role caring for patients with suspected or confirmed COVID-19, HCWs should wear an N95, N95-equivalent, or higher-level respirator; gown; gloves; and eye protection (goggles or a disposable face shield).¹⁵

Final Thoughts

COVID-19 has brought about acute and likely permanent changes to the US health care system. Dermatologists are integral members of that system and are essential to the treatment of patients with skin, hair, and nail disorders. Pregnant dermatologists and residents should refrain from patient-facing roles when feasible; however, when all recommended PPE are available, they may continue to work in patient-facing roles until they give birth if they desire to do so. Alternatively, teledermatology and non–face-to-face rotations should be encouraged. Higher-risk and aerosol-generating procedures are of particular concern regarding the risk for transmitting SARS-CoV-2 and should be avoided. Correct and universal use of PPE is paramount; when all recommended PPE is not available, pregnant HCWs should avoid exposure to patients with suspected or confirmed COVID-19. These recommendations will help safeguard pregnant members of dermatology teams during the COVID-19 pandemic while maximizing patient care.

Cardiothoracic surgeon J. Marvin Smith III, MD, had always thrived on a busy practice schedule, often performing 20-30 surgeries a week. A practicing surgeon for more than 40 years, Dr. Smith said he had no plans to slow down anytime soon.

But Dr. Smith said his career was derailed when leaders at Methodist Healthcare System of San Antonio initiated a sudden peer review proceeding against him. The hospital system alleged certain surgeries performed by Dr. Smith had excessive mortality rates. When he proved the data inaccurate, Dr. Smith said administrators next claimed he was cognitively impaired and wasn’t safe to practice.

Dr. Smith has now been embroiled in a peer review dispute with the hospital system for more than 2 years and says the conflict has essentially forced him out of surgical practice. He believes the peer review was “malicious” and was really launched because of complaints he made about nurse staffing and other issues at the hospital.

“I think it is absolutely in bad faith and is disingenuous what they’ve told me along the way,” said Dr. Smith, 73. “It’s because I pointed out deficiencies in nursing care, and they want to get rid of me. It would be a lot easier for them if I had a contract and they could control me better. But the fact that I was independent, meant they had to resort to a malicious peer review to try and push me out.”

Dr. Smith had a peer review hearing with Methodist in March 2021, and in April, a panel found in Dr. Smith’s favor, according to Dr. Smith. The findings were sent to the hospital’s medical board for review, which issued a decision in early May.

Eric A. Pullen, an attorney for Dr. Smith, said he could not go into detail about the board’s decision for legal reasons, but that “the medical board’s decision did not completely resolve the matter, and Dr. Smith intends to exercise his procedural rights, which could include an appeal.”

Methodist Hospital Texsan and its parent company, Methodist Health System of San Antonio, did not respond to messages seeking comment about the case. Without hearing from the hospital system, its side is unknown and it is unclear if there is more to the story from Methodist’s view.

Malicious peer review – also called sham peer review – is defined as misusing the medical peer review process for malevolent purposes, such as to silence or to remove a physician. The problem is not new, but some experts, such as Lawrence Huntoon, MD, PhD, say the practice has become more common in recent years, particularly against independent doctors.

Dr. Huntoon believes there is a nationwide trend at many hospitals to get rid of independent physicians and replace them with employed doctors, he said.

However, because most sham peer reviews go on behind closed doors, there are no data to pinpoint its prevalence or measure its growth.

“Independent physicians are basically being purged from medical staffs across the United States,” said Dr. Huntoon, who is chair of the Association of American Physicians and Surgeons’ Committee to Combat Sham Peer Review. “The hospitals want more control over how physicians practice and who they refer to, and they do that by having employees.”

Anthony P. Weiss, MD, MBA, chief medical officer for Beth Israel Deaconess Medical Center said it has not been his experience that independent physicians are being targeted in such a way. Dr. Weiss responded to an inquiry sent to the American Hospital Association for this story.

“As the authority for peer review rests with the organized medical staff (i.e., physicians), and not formally with the hospital per se, the peer review lever is not typically available as a management tool for hospital administration,” said Dr. Weiss, who is a former member of the AHA’s Committee on Clinical Leadership, but who was speaking on behalf of himself.

A spokesman for the AHA said the organization stands behinds Dr. Weiss’ comments.

Peer review remains a foundational aspect of overseeing the safety and appropriateness of healthcare provided by physicians, Dr. Weiss said. Peer review likely varies from hospital to hospital, he added, although the Healthcare Quality Improvement Act provides some level of guidance as does the American Medical Association Code of Medical Ethics (section 9.4.1).

“In essence, both require that the evaluation be conducted in good faith with the intention to improve care, by physicians with adequate training and knowledge, using a process that is fair and inclusive of the physician under review,” he said. “I believe that most medical staffs abide by these ethical principles, but we have little data to confirm this supposition.”
 

Did hospital target doc for being vocal?

When members of Methodist’s medical staff first approached Dr. Smith with concerns about his surgery outcomes in November 2018, the physician says he was surprised, but that he was open to an assessment.

“They came to me and said they thought my numbers were bad, and I said: ‘Well my gosh, I certainly don’t want that to be the case. I need to see what numbers you are talking about,’ ” Dr. Smith recalled. “I’ve been president of the Bexar County Medical Society; I’ve been involved with standards and ethics for the Society of Thoracic Surgeons. Quality health care means a whole lot to me.”

The statistical information provided by hospital administrators indicated that Dr. Smith’s mortality rates for coronary artery surgery in 2018 were “excessive” and that his rates for aortic surgery were “unacceptable,” according to a lawsuit Dr. Smith filed against the hospital system. Dr. Smith, who is double boarded with the American Board of Surgery and the American Board of Thoracic Surgery, said his outcomes had never come into question in the past. Dr. Smith said the timing was suspicious to him, however, considering he had recently raised concerns with the hospital through letters about nursing performance, staffing, and compensation.

A peer review investigation was initiated. In the meantime, Dr. Smith agreed to intensivist consults on his postoperative patients and consults with the hospital’s “Heart Team” on all preoperative cardiac, valve, and aortic cases. A vocal critic of the Heart Team, Dr. Smith had long contended the entity provided no meaningful benefit to his patients in most cases and, rather, increased hospital stays and raised medical expenses. Despite his agreement, Dr. Smith was later asked to voluntarily stop performing surgeries at the hospital.

“I agreed, convinced that we’d get this all settled,” he said.

Another report issued by the hospital in 2019 also indicated elevated mortality rates associated with some of Smith’s surgeries, although the document differed from the first report, according to the lawsuit. Dr. Smith says he was ignored when he pointed out problems with the data, including a lack of appropriate risk stratification in the report, departure from Society of Thoracic Surgeons data rules, and improper inclusion of his cases in the denominator of the ratio when a comparison was made of his outcomes with those hospitalwide. A subsequent report from Methodist in March 2019 indicated Dr. Smith’s surgery outcomes were “within the expected parameters of performance,” according to court documents.

The surgery accusations were dropped, but the peer review proceeding against Dr. Smith wasn’t over. The hospital next requested that Dr. Smith undergo a competency evaluation.

“When they realized the data was bad, they then changed their argument in the peer review proceeding and essentially started to argue that Dr. Smith had some sort of cognitive disability that prevented him from continuing to practice,” said Mr. Pullen. “The way I look at it, when the initial basis for the peer review was proven false, the hospital found something else and some other reason to try to keep Dr. Smith from practicing.”

Thus began a lengthy disagreement about which entity would conduct the evaluation, who would pay, and the type of acceptable assessment. An evaluation by the hospital’s preferred organization resulted in a finding of mild cognitive impairment, Dr. Smith said. He hired his own experts who conducted separate evaluations, finding no impairment and no basis for the former evaluation’s conclusion.

“Literally, the determinant as to whether I was normal or below normal on their test was one point, which was associated with a finding that I didn’t draw a clock correctly,” Dr. Smith claimed. “The reviewer said my minute hand was a little too short and docked me a point. It was purely subjective. To me, the gold standard of whether you are learned in thoracic surgery is the American Board of Thoracic Surgery’s test. The board’s test shows my cognitive ability is entirely in keeping with my practice. That contrasts with the one point off I got for drawing a clock wrong in somebody’s estimation.”
 

Conflict leads to legal case

In September 2020, Dr. Smith filed a lawsuit against Methodist Healthcare System of San Antonio, alleging business disparagement by Methodist for allegedly publishing false and disparaging information about Dr. Smith and tortious interference with business relations. The latter claim stems from Methodist refusing to provide documents to other hospitals about the status of Dr. Smith’s privileges at Methodist, Mr. Pullen said.

Because Methodist refused to confirm his status, the renewal process for Baptist Health System could not be completed and Dr. Smith lost his privileges at Baptist Health System facilities, according to the lawsuit.

Notably, Dr. Smith’s legal challenge also asks the court to take a stance against alleged amendments by Methodist to its Unified Medical Staff Bylaws. The hospital allegedly proposed changes that would prevent physicians from seeking legal action against the hospital for malicious peer review, according to Dr. Smith’s lawsuit.

The amendments would make the peer review process itself the “sole and exclusive remedy with respect to any action or recommendation taken at the hospital affecting medical staff appointment and/or clinical privileges,” according to an excerpt of the proposed amendments included in Dr. Smith’s lawsuit. In addition, the changes would hold practitioners liable for lost revenues if the doctor initiates “any type of legal action challenging credentialing, privileging, or other medical peer review or professional review activity,” according to the lawsuit.

Dr. Smith’s lawsuit seeks a declaration that the proposed amendments to the bylaws are “void as against public policy,” and a declaration that the proposed amendments to the bylaws cannot take away physicians’ statutory right to bring litigation against Methodist for malicious peer review.

“The proposed amendments have a tendency to and will injure the public good,” Dr. Smith argued in the lawsuit. “The proposed amendments allow Methodist to act with malice and in bad faith in conducting peer review proceedings and face no legal repercussions.”

Regardless of the final outcome of the peer review proceeding, Mr. Pullen said the harm Dr. Smith has already endured cannot be reversed.

“Even if comes out in his favor, the damage is already done,” he said. “It will not remedy the damage Dr. Smith has incurred.”
 

Fighting sham peer review is difficult

Battling a malicious peer review has long been an uphill battle for physicians, according to Dr. Huntoon. That’s because the Health Care Quality Improvement Act (HCQIA), a federal law passed in 1986, provides near absolute immunity to hospitals and peer reviewers in legal disputes.

The HCQIA was created by Congress to extend immunity to good-faith peer review of doctors and to increase overall participation in peer review by removing fear of litigation. However, the act has also enabled abuse of peer review by shielding bad-faith reviewers from accountability, said Dr. Huntoon.

“The Health Care Quality Improvement Act presumes that what the hospital did was warranted and reasonable and shifts the burden to the physician to prove his innocence by a preponderance of evidence,” he said. “That’s an entirely foreign concept to most people who think a person should be considered innocent until proven guilty. Here, it’s the exact opposite.”

The HCQIA has been challenged numerous times over the years and tested at the appellate level, but continues to survive and remain settled law, added Richard B. Willner, DPM, founder and director of the Center for Peer Review Justice, which assists and counsels physicians about sham peer review.

In 2011, former Rep. Joe Heck, DO, (R-Nev.) introduced a bill that would have amended the HCQIA to prohibit a professional review entity from submitting a report to the National Practitioner Data Bank (NPDB) while the doctor was still under investigation and before the doctor was afforded adequate notice and a hearing. Although the measure had 16 cosponsors and plenty of support from the physician community, it failed.

In addition to a heavy legal burden, physicians who experience malicious peer reviews also face ramifications from being reported to the NPDB. Peer review organizations are required to report certain negative actions or findings to the NPDB.

“A databank entry is a scarlet letter on your forehead,” Dr. Willner said. “The rules at a lot of institutions are not to take anyone who has been databanked, rightfully or wrongfully. And what is the evidence necessary to databank you? None. There’s no evidence needed to databank somebody.”

Despite the bleak landscape, experts say progress has been made on a case-by-case basis by physicians who have succeeded in fighting back against questionable peer reviews in recent years.

In January 2020, Indiana ob.gyn. Rebecca Denman, MD, prevailed in her defamation lawsuit against St Vincent Carmel Hospital and St Vincent Carmel Medical Group, winning $4.75 million in damages. Dr. Denman alleged administrators failed to conduct a proper peer review investigation after a false allegation by a nurse that she was under the influence while on the job.

Indianapolis attorney Kathleen A. DeLaney, who represented Dr. Denman, said hospital leaders misled Dr. Denman into believing a peer review had occurred when no formal peer review hearing or proceeding took place.

“The CMO of the medical group claimed that he performed a peer review ‘screening,’ but he never informed the other members of the peer review executive committee of the matter until after he had placed Dr. Denman on administrative leave,” Ms. DeLaney said. “He also neglected to tell the peer review executive committee that the substance abuse policy had not been followed, or that Dr. Denman had not been tested for alcohol use – due to the 12-hour delay in report.”

Dr. Denman was ultimately required to undergo an alcohol abuse evaluation, enter a treatment program, and sign a 5-year monitoring contract with the Indiana State Medical Association as a condition of her employment, according to the lawsuit. She claimed repercussions from the false allegation resulted in lost compensation, out-of-pocket expenses, emotional distress, and damage to her professional reputation.

She sued the hospital in July 2018, alleging fraud, defamation, tortious interference with an employment relationship, and negligent misrepresentation. After a 4-day trial, jurors found in her favor, awarding Dr. Denman $2 million for her defamation claims, $2 million for her claims of fraud and constructive fraud, $500,000 for her claim of tortious interference with an employment relationship, and $250,000 for her claim of negligent misrepresentation.

A hospital spokesperson said Ascension St Vincent is pursuing an appeal, and that it looks “forward to the opportunity to bring this matter before the Indiana Court of Appeals in June.”

In another case, South Dakota surgeon Linda Miller, MD, was awarded $1.1 million in 2017 after a federal jury found Huron Regional Medical Center breached her contract and violated her due process rights. Dr. Miller became the subject of a peer review at Huron Regional Medical Center when the hospital began analyzing some of her surgery outcomes.

Ken Barker, an attorney for Dr. Miller, said he feels it became evident at trial that the campaign to force Dr. Miller to either resign or lose her privileges was led by the lay board of directors of the hospital and upper-level administration at the hospital.

“They began the process by ordering an unprecedented 90-day review of her medical charts, looking for errors in the medical care she provided patients,” he said. “They could find nothing, so they did a second 90-day review, waiting for a patient’s ‘bad outcome.’ As any general surgeon will say, a ‘bad outcome’ is inevitable. And so it was. Upon that occurrence, they had a medical review committee review the patient’s chart and use it as an excuse to force her to reduce her privileges. Unbeknown to Dr. Miller, an external review had been conducted on another patient’s chart, in which the external review found her care above the standards and, in some measure, ‘exemplary.’ ”

Dr. Miller was eventually pressured to resign, according to her claim. Because of reports made to the NPDB by the medical center, including a patient complication that was allegedly falsified by the hospital, Dr. Miller said she was unable to find work as a general surgeon and went to work as a wound care doctor. At trial, jurors awarded Dr. Miller $586,617 in lost wages, $343,640 for lost future earning capacity, and $250,000 for mental anguish. (The mental anguish award was subsequently struck by a district court.)

Attorneys for Huron Regional Medical Center argued the jury improperly awarded damages and requested a new trial, which was denied by an appeals court.

In the end, the evidence came to light and the jury’s verdict spoke loudly that the hospital had taken unfair advantage of Dr. Miller, Mr. Barker said. But he emphasized that such cases often end differently.

“There are a handful of cases in which physicians like Dr. Miller have challenged the system and won,” he said. “In most cases, however, it is a ‘David vs. Goliath’ scenario where the giant prevails.”
 

What to do if faced with malicious peer review

An important step when doctors encounter a peer review that they believe is malicious is to consult with an experienced attorney as early as possible, Dr. Huntoon said. “Not all attorneys who set themselves out to be health law attorneys necessarily have knowledge and expertise in sham peer review. And before such a thing happens, I always encourage physicians to read their medical staff bylaws. That’s where everything is set forth, [such as] the corrective action section that tells how peer review is to take place.”

Mr. Barker added that documentation is also key in the event of a potential malicious peer review.

“When a physician senses [the] administration has targeted them, they should start documenting their conversations and actions very carefully, and if possible, recruit another ‘observer’ who can provide a third-party perspective, if necessary,” Mr. Barker said.

Dr. Huntoon recently wrote an article with advice about preparedness and defense of sham peer reviews. The guidance includes that physicians educate themselves about the tactics used by some hospitals to conduct sham peer reviews and the factors that place doctors more at risk. Factors that may raise a doctor’s danger of being targeted include being in solo practice or a small group, being new on staff, or being an older physician approaching retirement as some bad-actor hospitals may view older physicians as being less likely to fight back, said Dr. Huntoon.

Doctors should also keep detailed records and a timeline in the event of a malicious peer review and insist that an independent court reporter record all peer review hearings, even if that means the physician has to pay for the reporter him or herself, according to the guidance. An independent record is invaluable should the physician ultimately issue a future legal challenge against the hospital.

Mr. Willner encourages physicians to call the Center for Peer Review Justice hotline at (504) 621-1670 or visit the website for help with peer review and NPDB issues.

As for Dr. Smith, his days are much quieter and slower today, compared with the active practice he was accustomed to for more than half his life. He misses the fast pace, the patients, and the work that always brought him great joy.

“I hope to get back to doing surgeries eventually,” he said. “I graduated medical school in 1972. Practicing surgery has been my whole life and my career. They have taken my identity and my livelihood away from me based on false numbers and false premises. I want it back.”

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

Cardiothoracic surgeon J. Marvin Smith III, MD, had always thrived on a busy practice schedule, often performing 20-30 surgeries a week. A practicing surgeon for more than 40 years, Dr. Smith said he had no plans to slow down anytime soon.

But Dr. Smith said his career was derailed when leaders at Methodist Healthcare System of San Antonio initiated a sudden peer review proceeding against him. The hospital system alleged certain surgeries performed by Dr. Smith had excessive mortality rates. When he proved the data inaccurate, Dr. Smith said administrators next claimed he was cognitively impaired and wasn’t safe to practice.

Dr. Smith has now been embroiled in a peer review dispute with the hospital system for more than 2 years and says the conflict has essentially forced him out of surgical practice. He believes the peer review was “malicious” and was really launched because of complaints he made about nurse staffing and other issues at the hospital.

“I think it is absolutely in bad faith and is disingenuous what they’ve told me along the way,” said Dr. Smith, 73. “It’s because I pointed out deficiencies in nursing care, and they want to get rid of me. It would be a lot easier for them if I had a contract and they could control me better. But the fact that I was independent, meant they had to resort to a malicious peer review to try and push me out.”

Dr. Smith had a peer review hearing with Methodist in March 2021, and in April, a panel found in Dr. Smith’s favor, according to Dr. Smith. The findings were sent to the hospital’s medical board for review, which issued a decision in early May.

Eric A. Pullen, an attorney for Dr. Smith, said he could not go into detail about the board’s decision for legal reasons, but that “the medical board’s decision did not completely resolve the matter, and Dr. Smith intends to exercise his procedural rights, which could include an appeal.”

Methodist Hospital Texsan and its parent company, Methodist Health System of San Antonio, did not respond to messages seeking comment about the case. Without hearing from the hospital system, its side is unknown and it is unclear if there is more to the story from Methodist’s view.

Malicious peer review – also called sham peer review – is defined as misusing the medical peer review process for malevolent purposes, such as to silence or to remove a physician. The problem is not new, but some experts, such as Lawrence Huntoon, MD, PhD, say the practice has become more common in recent years, particularly against independent doctors.

Dr. Huntoon believes there is a nationwide trend at many hospitals to get rid of independent physicians and replace them with employed doctors, he said.

However, because most sham peer reviews go on behind closed doors, there are no data to pinpoint its prevalence or measure its growth.

“Independent physicians are basically being purged from medical staffs across the United States,” said Dr. Huntoon, who is chair of the Association of American Physicians and Surgeons’ Committee to Combat Sham Peer Review. “The hospitals want more control over how physicians practice and who they refer to, and they do that by having employees.”

Anthony P. Weiss, MD, MBA, chief medical officer for Beth Israel Deaconess Medical Center said it has not been his experience that independent physicians are being targeted in such a way. Dr. Weiss responded to an inquiry sent to the American Hospital Association for this story.

“As the authority for peer review rests with the organized medical staff (i.e., physicians), and not formally with the hospital per se, the peer review lever is not typically available as a management tool for hospital administration,” said Dr. Weiss, who is a former member of the AHA’s Committee on Clinical Leadership, but who was speaking on behalf of himself.

A spokesman for the AHA said the organization stands behinds Dr. Weiss’ comments.

Peer review remains a foundational aspect of overseeing the safety and appropriateness of healthcare provided by physicians, Dr. Weiss said. Peer review likely varies from hospital to hospital, he added, although the Healthcare Quality Improvement Act provides some level of guidance as does the American Medical Association Code of Medical Ethics (section 9.4.1).

“In essence, both require that the evaluation be conducted in good faith with the intention to improve care, by physicians with adequate training and knowledge, using a process that is fair and inclusive of the physician under review,” he said. “I believe that most medical staffs abide by these ethical principles, but we have little data to confirm this supposition.”
 

Did hospital target doc for being vocal?

When members of Methodist’s medical staff first approached Dr. Smith with concerns about his surgery outcomes in November 2018, the physician says he was surprised, but that he was open to an assessment.

“They came to me and said they thought my numbers were bad, and I said: ‘Well my gosh, I certainly don’t want that to be the case. I need to see what numbers you are talking about,’ ” Dr. Smith recalled. “I’ve been president of the Bexar County Medical Society; I’ve been involved with standards and ethics for the Society of Thoracic Surgeons. Quality health care means a whole lot to me.”

The statistical information provided by hospital administrators indicated that Dr. Smith’s mortality rates for coronary artery surgery in 2018 were “excessive” and that his rates for aortic surgery were “unacceptable,” according to a lawsuit Dr. Smith filed against the hospital system. Dr. Smith, who is double boarded with the American Board of Surgery and the American Board of Thoracic Surgery, said his outcomes had never come into question in the past. Dr. Smith said the timing was suspicious to him, however, considering he had recently raised concerns with the hospital through letters about nursing performance, staffing, and compensation.

A peer review investigation was initiated. In the meantime, Dr. Smith agreed to intensivist consults on his postoperative patients and consults with the hospital’s “Heart Team” on all preoperative cardiac, valve, and aortic cases. A vocal critic of the Heart Team, Dr. Smith had long contended the entity provided no meaningful benefit to his patients in most cases and, rather, increased hospital stays and raised medical expenses. Despite his agreement, Dr. Smith was later asked to voluntarily stop performing surgeries at the hospital.

“I agreed, convinced that we’d get this all settled,” he said.

Another report issued by the hospital in 2019 also indicated elevated mortality rates associated with some of Smith’s surgeries, although the document differed from the first report, according to the lawsuit. Dr. Smith says he was ignored when he pointed out problems with the data, including a lack of appropriate risk stratification in the report, departure from Society of Thoracic Surgeons data rules, and improper inclusion of his cases in the denominator of the ratio when a comparison was made of his outcomes with those hospitalwide. A subsequent report from Methodist in March 2019 indicated Dr. Smith’s surgery outcomes were “within the expected parameters of performance,” according to court documents.

The surgery accusations were dropped, but the peer review proceeding against Dr. Smith wasn’t over. The hospital next requested that Dr. Smith undergo a competency evaluation.

“When they realized the data was bad, they then changed their argument in the peer review proceeding and essentially started to argue that Dr. Smith had some sort of cognitive disability that prevented him from continuing to practice,” said Mr. Pullen. “The way I look at it, when the initial basis for the peer review was proven false, the hospital found something else and some other reason to try to keep Dr. Smith from practicing.”

Thus began a lengthy disagreement about which entity would conduct the evaluation, who would pay, and the type of acceptable assessment. An evaluation by the hospital’s preferred organization resulted in a finding of mild cognitive impairment, Dr. Smith said. He hired his own experts who conducted separate evaluations, finding no impairment and no basis for the former evaluation’s conclusion.

“Literally, the determinant as to whether I was normal or below normal on their test was one point, which was associated with a finding that I didn’t draw a clock correctly,” Dr. Smith claimed. “The reviewer said my minute hand was a little too short and docked me a point. It was purely subjective. To me, the gold standard of whether you are learned in thoracic surgery is the American Board of Thoracic Surgery’s test. The board’s test shows my cognitive ability is entirely in keeping with my practice. That contrasts with the one point off I got for drawing a clock wrong in somebody’s estimation.”
 

Conflict leads to legal case

In September 2020, Dr. Smith filed a lawsuit against Methodist Healthcare System of San Antonio, alleging business disparagement by Methodist for allegedly publishing false and disparaging information about Dr. Smith and tortious interference with business relations. The latter claim stems from Methodist refusing to provide documents to other hospitals about the status of Dr. Smith’s privileges at Methodist, Mr. Pullen said.

Because Methodist refused to confirm his status, the renewal process for Baptist Health System could not be completed and Dr. Smith lost his privileges at Baptist Health System facilities, according to the lawsuit.

Notably, Dr. Smith’s legal challenge also asks the court to take a stance against alleged amendments by Methodist to its Unified Medical Staff Bylaws. The hospital allegedly proposed changes that would prevent physicians from seeking legal action against the hospital for malicious peer review, according to Dr. Smith’s lawsuit.

The amendments would make the peer review process itself the “sole and exclusive remedy with respect to any action or recommendation taken at the hospital affecting medical staff appointment and/or clinical privileges,” according to an excerpt of the proposed amendments included in Dr. Smith’s lawsuit. In addition, the changes would hold practitioners liable for lost revenues if the doctor initiates “any type of legal action challenging credentialing, privileging, or other medical peer review or professional review activity,” according to the lawsuit.

Dr. Smith’s lawsuit seeks a declaration that the proposed amendments to the bylaws are “void as against public policy,” and a declaration that the proposed amendments to the bylaws cannot take away physicians’ statutory right to bring litigation against Methodist for malicious peer review.

“The proposed amendments have a tendency to and will injure the public good,” Dr. Smith argued in the lawsuit. “The proposed amendments allow Methodist to act with malice and in bad faith in conducting peer review proceedings and face no legal repercussions.”

Regardless of the final outcome of the peer review proceeding, Mr. Pullen said the harm Dr. Smith has already endured cannot be reversed.

“Even if comes out in his favor, the damage is already done,” he said. “It will not remedy the damage Dr. Smith has incurred.”
 

Fighting sham peer review is difficult

Battling a malicious peer review has long been an uphill battle for physicians, according to Dr. Huntoon. That’s because the Health Care Quality Improvement Act (HCQIA), a federal law passed in 1986, provides near absolute immunity to hospitals and peer reviewers in legal disputes.

The HCQIA was created by Congress to extend immunity to good-faith peer review of doctors and to increase overall participation in peer review by removing fear of litigation. However, the act has also enabled abuse of peer review by shielding bad-faith reviewers from accountability, said Dr. Huntoon.

“The Health Care Quality Improvement Act presumes that what the hospital did was warranted and reasonable and shifts the burden to the physician to prove his innocence by a preponderance of evidence,” he said. “That’s an entirely foreign concept to most people who think a person should be considered innocent until proven guilty. Here, it’s the exact opposite.”

The HCQIA has been challenged numerous times over the years and tested at the appellate level, but continues to survive and remain settled law, added Richard B. Willner, DPM, founder and director of the Center for Peer Review Justice, which assists and counsels physicians about sham peer review.

In 2011, former Rep. Joe Heck, DO, (R-Nev.) introduced a bill that would have amended the HCQIA to prohibit a professional review entity from submitting a report to the National Practitioner Data Bank (NPDB) while the doctor was still under investigation and before the doctor was afforded adequate notice and a hearing. Although the measure had 16 cosponsors and plenty of support from the physician community, it failed.

In addition to a heavy legal burden, physicians who experience malicious peer reviews also face ramifications from being reported to the NPDB. Peer review organizations are required to report certain negative actions or findings to the NPDB.

“A databank entry is a scarlet letter on your forehead,” Dr. Willner said. “The rules at a lot of institutions are not to take anyone who has been databanked, rightfully or wrongfully. And what is the evidence necessary to databank you? None. There’s no evidence needed to databank somebody.”

Despite the bleak landscape, experts say progress has been made on a case-by-case basis by physicians who have succeeded in fighting back against questionable peer reviews in recent years.

In January 2020, Indiana ob.gyn. Rebecca Denman, MD, prevailed in her defamation lawsuit against St Vincent Carmel Hospital and St Vincent Carmel Medical Group, winning $4.75 million in damages. Dr. Denman alleged administrators failed to conduct a proper peer review investigation after a false allegation by a nurse that she was under the influence while on the job.

Indianapolis attorney Kathleen A. DeLaney, who represented Dr. Denman, said hospital leaders misled Dr. Denman into believing a peer review had occurred when no formal peer review hearing or proceeding took place.

“The CMO of the medical group claimed that he performed a peer review ‘screening,’ but he never informed the other members of the peer review executive committee of the matter until after he had placed Dr. Denman on administrative leave,” Ms. DeLaney said. “He also neglected to tell the peer review executive committee that the substance abuse policy had not been followed, or that Dr. Denman had not been tested for alcohol use – due to the 12-hour delay in report.”

Dr. Denman was ultimately required to undergo an alcohol abuse evaluation, enter a treatment program, and sign a 5-year monitoring contract with the Indiana State Medical Association as a condition of her employment, according to the lawsuit. She claimed repercussions from the false allegation resulted in lost compensation, out-of-pocket expenses, emotional distress, and damage to her professional reputation.

She sued the hospital in July 2018, alleging fraud, defamation, tortious interference with an employment relationship, and negligent misrepresentation. After a 4-day trial, jurors found in her favor, awarding Dr. Denman $2 million for her defamation claims, $2 million for her claims of fraud and constructive fraud, $500,000 for her claim of tortious interference with an employment relationship, and $250,000 for her claim of negligent misrepresentation.

A hospital spokesperson said Ascension St Vincent is pursuing an appeal, and that it looks “forward to the opportunity to bring this matter before the Indiana Court of Appeals in June.”

In another case, South Dakota surgeon Linda Miller, MD, was awarded $1.1 million in 2017 after a federal jury found Huron Regional Medical Center breached her contract and violated her due process rights. Dr. Miller became the subject of a peer review at Huron Regional Medical Center when the hospital began analyzing some of her surgery outcomes.

Ken Barker, an attorney for Dr. Miller, said he feels it became evident at trial that the campaign to force Dr. Miller to either resign or lose her privileges was led by the lay board of directors of the hospital and upper-level administration at the hospital.

“They began the process by ordering an unprecedented 90-day review of her medical charts, looking for errors in the medical care she provided patients,” he said. “They could find nothing, so they did a second 90-day review, waiting for a patient’s ‘bad outcome.’ As any general surgeon will say, a ‘bad outcome’ is inevitable. And so it was. Upon that occurrence, they had a medical review committee review the patient’s chart and use it as an excuse to force her to reduce her privileges. Unbeknown to Dr. Miller, an external review had been conducted on another patient’s chart, in which the external review found her care above the standards and, in some measure, ‘exemplary.’ ”

Dr. Miller was eventually pressured to resign, according to her claim. Because of reports made to the NPDB by the medical center, including a patient complication that was allegedly falsified by the hospital, Dr. Miller said she was unable to find work as a general surgeon and went to work as a wound care doctor. At trial, jurors awarded Dr. Miller $586,617 in lost wages, $343,640 for lost future earning capacity, and $250,000 for mental anguish. (The mental anguish award was subsequently struck by a district court.)

Attorneys for Huron Regional Medical Center argued the jury improperly awarded damages and requested a new trial, which was denied by an appeals court.

In the end, the evidence came to light and the jury’s verdict spoke loudly that the hospital had taken unfair advantage of Dr. Miller, Mr. Barker said. But he emphasized that such cases often end differently.

“There are a handful of cases in which physicians like Dr. Miller have challenged the system and won,” he said. “In most cases, however, it is a ‘David vs. Goliath’ scenario where the giant prevails.”
 

What to do if faced with malicious peer review

An important step when doctors encounter a peer review that they believe is malicious is to consult with an experienced attorney as early as possible, Dr. Huntoon said. “Not all attorneys who set themselves out to be health law attorneys necessarily have knowledge and expertise in sham peer review. And before such a thing happens, I always encourage physicians to read their medical staff bylaws. That’s where everything is set forth, [such as] the corrective action section that tells how peer review is to take place.”

Mr. Barker added that documentation is also key in the event of a potential malicious peer review.

“When a physician senses [the] administration has targeted them, they should start documenting their conversations and actions very carefully, and if possible, recruit another ‘observer’ who can provide a third-party perspective, if necessary,” Mr. Barker said.

Dr. Huntoon recently wrote an article with advice about preparedness and defense of sham peer reviews. The guidance includes that physicians educate themselves about the tactics used by some hospitals to conduct sham peer reviews and the factors that place doctors more at risk. Factors that may raise a doctor’s danger of being targeted include being in solo practice or a small group, being new on staff, or being an older physician approaching retirement as some bad-actor hospitals may view older physicians as being less likely to fight back, said Dr. Huntoon.

Doctors should also keep detailed records and a timeline in the event of a malicious peer review and insist that an independent court reporter record all peer review hearings, even if that means the physician has to pay for the reporter him or herself, according to the guidance. An independent record is invaluable should the physician ultimately issue a future legal challenge against the hospital.

Mr. Willner encourages physicians to call the Center for Peer Review Justice hotline at (504) 621-1670 or visit the website for help with peer review and NPDB issues.

As for Dr. Smith, his days are much quieter and slower today, compared with the active practice he was accustomed to for more than half his life. He misses the fast pace, the patients, and the work that always brought him great joy.

“I hope to get back to doing surgeries eventually,” he said. “I graduated medical school in 1972. Practicing surgery has been my whole life and my career. They have taken my identity and my livelihood away from me based on false numbers and false premises. I want it back.”

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

Cardiothoracic surgeon J. Marvin Smith III, MD, had always thrived on a busy practice schedule, often performing 20-30 surgeries a week. A practicing surgeon for more than 40 years, Dr. Smith said he had no plans to slow down anytime soon.

But Dr. Smith said his career was derailed when leaders at Methodist Healthcare System of San Antonio initiated a sudden peer review proceeding against him. The hospital system alleged certain surgeries performed by Dr. Smith had excessive mortality rates. When he proved the data inaccurate, Dr. Smith said administrators next claimed he was cognitively impaired and wasn’t safe to practice.

Dr. Smith has now been embroiled in a peer review dispute with the hospital system for more than 2 years and says the conflict has essentially forced him out of surgical practice. He believes the peer review was “malicious” and was really launched because of complaints he made about nurse staffing and other issues at the hospital.

“I think it is absolutely in bad faith and is disingenuous what they’ve told me along the way,” said Dr. Smith, 73. “It’s because I pointed out deficiencies in nursing care, and they want to get rid of me. It would be a lot easier for them if I had a contract and they could control me better. But the fact that I was independent, meant they had to resort to a malicious peer review to try and push me out.”

Dr. Smith had a peer review hearing with Methodist in March 2021, and in April, a panel found in Dr. Smith’s favor, according to Dr. Smith. The findings were sent to the hospital’s medical board for review, which issued a decision in early May.

Eric A. Pullen, an attorney for Dr. Smith, said he could not go into detail about the board’s decision for legal reasons, but that “the medical board’s decision did not completely resolve the matter, and Dr. Smith intends to exercise his procedural rights, which could include an appeal.”

Methodist Hospital Texsan and its parent company, Methodist Health System of San Antonio, did not respond to messages seeking comment about the case. Without hearing from the hospital system, its side is unknown and it is unclear if there is more to the story from Methodist’s view.

Malicious peer review – also called sham peer review – is defined as misusing the medical peer review process for malevolent purposes, such as to silence or to remove a physician. The problem is not new, but some experts, such as Lawrence Huntoon, MD, PhD, say the practice has become more common in recent years, particularly against independent doctors.

Dr. Huntoon believes there is a nationwide trend at many hospitals to get rid of independent physicians and replace them with employed doctors, he said.

However, because most sham peer reviews go on behind closed doors, there are no data to pinpoint its prevalence or measure its growth.

“Independent physicians are basically being purged from medical staffs across the United States,” said Dr. Huntoon, who is chair of the Association of American Physicians and Surgeons’ Committee to Combat Sham Peer Review. “The hospitals want more control over how physicians practice and who they refer to, and they do that by having employees.”

Anthony P. Weiss, MD, MBA, chief medical officer for Beth Israel Deaconess Medical Center said it has not been his experience that independent physicians are being targeted in such a way. Dr. Weiss responded to an inquiry sent to the American Hospital Association for this story.

“As the authority for peer review rests with the organized medical staff (i.e., physicians), and not formally with the hospital per se, the peer review lever is not typically available as a management tool for hospital administration,” said Dr. Weiss, who is a former member of the AHA’s Committee on Clinical Leadership, but who was speaking on behalf of himself.

A spokesman for the AHA said the organization stands behinds Dr. Weiss’ comments.

Peer review remains a foundational aspect of overseeing the safety and appropriateness of healthcare provided by physicians, Dr. Weiss said. Peer review likely varies from hospital to hospital, he added, although the Healthcare Quality Improvement Act provides some level of guidance as does the American Medical Association Code of Medical Ethics (section 9.4.1).

“In essence, both require that the evaluation be conducted in good faith with the intention to improve care, by physicians with adequate training and knowledge, using a process that is fair and inclusive of the physician under review,” he said. “I believe that most medical staffs abide by these ethical principles, but we have little data to confirm this supposition.”
 

Did hospital target doc for being vocal?

When members of Methodist’s medical staff first approached Dr. Smith with concerns about his surgery outcomes in November 2018, the physician says he was surprised, but that he was open to an assessment.

“They came to me and said they thought my numbers were bad, and I said: ‘Well my gosh, I certainly don’t want that to be the case. I need to see what numbers you are talking about,’ ” Dr. Smith recalled. “I’ve been president of the Bexar County Medical Society; I’ve been involved with standards and ethics for the Society of Thoracic Surgeons. Quality health care means a whole lot to me.”

The statistical information provided by hospital administrators indicated that Dr. Smith’s mortality rates for coronary artery surgery in 2018 were “excessive” and that his rates for aortic surgery were “unacceptable,” according to a lawsuit Dr. Smith filed against the hospital system. Dr. Smith, who is double boarded with the American Board of Surgery and the American Board of Thoracic Surgery, said his outcomes had never come into question in the past. Dr. Smith said the timing was suspicious to him, however, considering he had recently raised concerns with the hospital through letters about nursing performance, staffing, and compensation.

A peer review investigation was initiated. In the meantime, Dr. Smith agreed to intensivist consults on his postoperative patients and consults with the hospital’s “Heart Team” on all preoperative cardiac, valve, and aortic cases. A vocal critic of the Heart Team, Dr. Smith had long contended the entity provided no meaningful benefit to his patients in most cases and, rather, increased hospital stays and raised medical expenses. Despite his agreement, Dr. Smith was later asked to voluntarily stop performing surgeries at the hospital.

“I agreed, convinced that we’d get this all settled,” he said.

Another report issued by the hospital in 2019 also indicated elevated mortality rates associated with some of Smith’s surgeries, although the document differed from the first report, according to the lawsuit. Dr. Smith says he was ignored when he pointed out problems with the data, including a lack of appropriate risk stratification in the report, departure from Society of Thoracic Surgeons data rules, and improper inclusion of his cases in the denominator of the ratio when a comparison was made of his outcomes with those hospitalwide. A subsequent report from Methodist in March 2019 indicated Dr. Smith’s surgery outcomes were “within the expected parameters of performance,” according to court documents.

The surgery accusations were dropped, but the peer review proceeding against Dr. Smith wasn’t over. The hospital next requested that Dr. Smith undergo a competency evaluation.

“When they realized the data was bad, they then changed their argument in the peer review proceeding and essentially started to argue that Dr. Smith had some sort of cognitive disability that prevented him from continuing to practice,” said Mr. Pullen. “The way I look at it, when the initial basis for the peer review was proven false, the hospital found something else and some other reason to try to keep Dr. Smith from practicing.”

Thus began a lengthy disagreement about which entity would conduct the evaluation, who would pay, and the type of acceptable assessment. An evaluation by the hospital’s preferred organization resulted in a finding of mild cognitive impairment, Dr. Smith said. He hired his own experts who conducted separate evaluations, finding no impairment and no basis for the former evaluation’s conclusion.

“Literally, the determinant as to whether I was normal or below normal on their test was one point, which was associated with a finding that I didn’t draw a clock correctly,” Dr. Smith claimed. “The reviewer said my minute hand was a little too short and docked me a point. It was purely subjective. To me, the gold standard of whether you are learned in thoracic surgery is the American Board of Thoracic Surgery’s test. The board’s test shows my cognitive ability is entirely in keeping with my practice. That contrasts with the one point off I got for drawing a clock wrong in somebody’s estimation.”
 

Conflict leads to legal case

In September 2020, Dr. Smith filed a lawsuit against Methodist Healthcare System of San Antonio, alleging business disparagement by Methodist for allegedly publishing false and disparaging information about Dr. Smith and tortious interference with business relations. The latter claim stems from Methodist refusing to provide documents to other hospitals about the status of Dr. Smith’s privileges at Methodist, Mr. Pullen said.

Because Methodist refused to confirm his status, the renewal process for Baptist Health System could not be completed and Dr. Smith lost his privileges at Baptist Health System facilities, according to the lawsuit.

Notably, Dr. Smith’s legal challenge also asks the court to take a stance against alleged amendments by Methodist to its Unified Medical Staff Bylaws. The hospital allegedly proposed changes that would prevent physicians from seeking legal action against the hospital for malicious peer review, according to Dr. Smith’s lawsuit.

The amendments would make the peer review process itself the “sole and exclusive remedy with respect to any action or recommendation taken at the hospital affecting medical staff appointment and/or clinical privileges,” according to an excerpt of the proposed amendments included in Dr. Smith’s lawsuit. In addition, the changes would hold practitioners liable for lost revenues if the doctor initiates “any type of legal action challenging credentialing, privileging, or other medical peer review or professional review activity,” according to the lawsuit.

Dr. Smith’s lawsuit seeks a declaration that the proposed amendments to the bylaws are “void as against public policy,” and a declaration that the proposed amendments to the bylaws cannot take away physicians’ statutory right to bring litigation against Methodist for malicious peer review.

“The proposed amendments have a tendency to and will injure the public good,” Dr. Smith argued in the lawsuit. “The proposed amendments allow Methodist to act with malice and in bad faith in conducting peer review proceedings and face no legal repercussions.”

Regardless of the final outcome of the peer review proceeding, Mr. Pullen said the harm Dr. Smith has already endured cannot be reversed.

“Even if comes out in his favor, the damage is already done,” he said. “It will not remedy the damage Dr. Smith has incurred.”
 

Fighting sham peer review is difficult

Battling a malicious peer review has long been an uphill battle for physicians, according to Dr. Huntoon. That’s because the Health Care Quality Improvement Act (HCQIA), a federal law passed in 1986, provides near absolute immunity to hospitals and peer reviewers in legal disputes.

The HCQIA was created by Congress to extend immunity to good-faith peer review of doctors and to increase overall participation in peer review by removing fear of litigation. However, the act has also enabled abuse of peer review by shielding bad-faith reviewers from accountability, said Dr. Huntoon.

“The Health Care Quality Improvement Act presumes that what the hospital did was warranted and reasonable and shifts the burden to the physician to prove his innocence by a preponderance of evidence,” he said. “That’s an entirely foreign concept to most people who think a person should be considered innocent until proven guilty. Here, it’s the exact opposite.”

The HCQIA has been challenged numerous times over the years and tested at the appellate level, but continues to survive and remain settled law, added Richard B. Willner, DPM, founder and director of the Center for Peer Review Justice, which assists and counsels physicians about sham peer review.

In 2011, former Rep. Joe Heck, DO, (R-Nev.) introduced a bill that would have amended the HCQIA to prohibit a professional review entity from submitting a report to the National Practitioner Data Bank (NPDB) while the doctor was still under investigation and before the doctor was afforded adequate notice and a hearing. Although the measure had 16 cosponsors and plenty of support from the physician community, it failed.

In addition to a heavy legal burden, physicians who experience malicious peer reviews also face ramifications from being reported to the NPDB. Peer review organizations are required to report certain negative actions or findings to the NPDB.

“A databank entry is a scarlet letter on your forehead,” Dr. Willner said. “The rules at a lot of institutions are not to take anyone who has been databanked, rightfully or wrongfully. And what is the evidence necessary to databank you? None. There’s no evidence needed to databank somebody.”

Despite the bleak landscape, experts say progress has been made on a case-by-case basis by physicians who have succeeded in fighting back against questionable peer reviews in recent years.

In January 2020, Indiana ob.gyn. Rebecca Denman, MD, prevailed in her defamation lawsuit against St Vincent Carmel Hospital and St Vincent Carmel Medical Group, winning $4.75 million in damages. Dr. Denman alleged administrators failed to conduct a proper peer review investigation after a false allegation by a nurse that she was under the influence while on the job.

Indianapolis attorney Kathleen A. DeLaney, who represented Dr. Denman, said hospital leaders misled Dr. Denman into believing a peer review had occurred when no formal peer review hearing or proceeding took place.

“The CMO of the medical group claimed that he performed a peer review ‘screening,’ but he never informed the other members of the peer review executive committee of the matter until after he had placed Dr. Denman on administrative leave,” Ms. DeLaney said. “He also neglected to tell the peer review executive committee that the substance abuse policy had not been followed, or that Dr. Denman had not been tested for alcohol use – due to the 12-hour delay in report.”

Dr. Denman was ultimately required to undergo an alcohol abuse evaluation, enter a treatment program, and sign a 5-year monitoring contract with the Indiana State Medical Association as a condition of her employment, according to the lawsuit. She claimed repercussions from the false allegation resulted in lost compensation, out-of-pocket expenses, emotional distress, and damage to her professional reputation.

She sued the hospital in July 2018, alleging fraud, defamation, tortious interference with an employment relationship, and negligent misrepresentation. After a 4-day trial, jurors found in her favor, awarding Dr. Denman $2 million for her defamation claims, $2 million for her claims of fraud and constructive fraud, $500,000 for her claim of tortious interference with an employment relationship, and $250,000 for her claim of negligent misrepresentation.

A hospital spokesperson said Ascension St Vincent is pursuing an appeal, and that it looks “forward to the opportunity to bring this matter before the Indiana Court of Appeals in June.”

In another case, South Dakota surgeon Linda Miller, MD, was awarded $1.1 million in 2017 after a federal jury found Huron Regional Medical Center breached her contract and violated her due process rights. Dr. Miller became the subject of a peer review at Huron Regional Medical Center when the hospital began analyzing some of her surgery outcomes.

Ken Barker, an attorney for Dr. Miller, said he feels it became evident at trial that the campaign to force Dr. Miller to either resign or lose her privileges was led by the lay board of directors of the hospital and upper-level administration at the hospital.

“They began the process by ordering an unprecedented 90-day review of her medical charts, looking for errors in the medical care she provided patients,” he said. “They could find nothing, so they did a second 90-day review, waiting for a patient’s ‘bad outcome.’ As any general surgeon will say, a ‘bad outcome’ is inevitable. And so it was. Upon that occurrence, they had a medical review committee review the patient’s chart and use it as an excuse to force her to reduce her privileges. Unbeknown to Dr. Miller, an external review had been conducted on another patient’s chart, in which the external review found her care above the standards and, in some measure, ‘exemplary.’ ”

Dr. Miller was eventually pressured to resign, according to her claim. Because of reports made to the NPDB by the medical center, including a patient complication that was allegedly falsified by the hospital, Dr. Miller said she was unable to find work as a general surgeon and went to work as a wound care doctor. At trial, jurors awarded Dr. Miller $586,617 in lost wages, $343,640 for lost future earning capacity, and $250,000 for mental anguish. (The mental anguish award was subsequently struck by a district court.)

Attorneys for Huron Regional Medical Center argued the jury improperly awarded damages and requested a new trial, which was denied by an appeals court.

In the end, the evidence came to light and the jury’s verdict spoke loudly that the hospital had taken unfair advantage of Dr. Miller, Mr. Barker said. But he emphasized that such cases often end differently.

“There are a handful of cases in which physicians like Dr. Miller have challenged the system and won,” he said. “In most cases, however, it is a ‘David vs. Goliath’ scenario where the giant prevails.”
 

What to do if faced with malicious peer review

An important step when doctors encounter a peer review that they believe is malicious is to consult with an experienced attorney as early as possible, Dr. Huntoon said. “Not all attorneys who set themselves out to be health law attorneys necessarily have knowledge and expertise in sham peer review. And before such a thing happens, I always encourage physicians to read their medical staff bylaws. That’s where everything is set forth, [such as] the corrective action section that tells how peer review is to take place.”

Mr. Barker added that documentation is also key in the event of a potential malicious peer review.

“When a physician senses [the] administration has targeted them, they should start documenting their conversations and actions very carefully, and if possible, recruit another ‘observer’ who can provide a third-party perspective, if necessary,” Mr. Barker said.

Dr. Huntoon recently wrote an article with advice about preparedness and defense of sham peer reviews. The guidance includes that physicians educate themselves about the tactics used by some hospitals to conduct sham peer reviews and the factors that place doctors more at risk. Factors that may raise a doctor’s danger of being targeted include being in solo practice or a small group, being new on staff, or being an older physician approaching retirement as some bad-actor hospitals may view older physicians as being less likely to fight back, said Dr. Huntoon.

Doctors should also keep detailed records and a timeline in the event of a malicious peer review and insist that an independent court reporter record all peer review hearings, even if that means the physician has to pay for the reporter him or herself, according to the guidance. An independent record is invaluable should the physician ultimately issue a future legal challenge against the hospital.

Mr. Willner encourages physicians to call the Center for Peer Review Justice hotline at (504) 621-1670 or visit the website for help with peer review and NPDB issues.

As for Dr. Smith, his days are much quieter and slower today, compared with the active practice he was accustomed to for more than half his life. He misses the fast pace, the patients, and the work that always brought him great joy.

“I hope to get back to doing surgeries eventually,” he said. “I graduated medical school in 1972. Practicing surgery has been my whole life and my career. They have taken my identity and my livelihood away from me based on false numbers and false premises. I want it back.”

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