Did the Affordable Care Act Reach Penetrating Trauma Patients?

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Did the Affordable Care Act Reach Penetrating Trauma Patients? Sharven Taghavi, MD, MPH, MS,a,* Sudesh Srivastav, PhD,b Danielle Tatum, PhD,c Alison Smith, MD, PhD,a Chrissy Guidry, MD,a Patrick McGrew, MD,a Charles Harris, MD,a Rebecca Schroll, MD,a and Juan Duchesne, MDa a

Division of Trauma and Critical Care, Tulane University School of Medicine, New Orleans, Louisiana Department of Biostatistics and Data Science, Tulane University School of Medicine, New Orleans, Louisiana c Our Lady of the Lake Regional Medical Center, Trauma Specialist Program, Baton Rouge, Louisiana b

article info

abstract

Article history:

Background: The benefits of the Affordable Care Act (ACA) for trauma patients have been

Received 7 November 2019

well established. However, the ACA’s impact on penetrating trauma patients (PTPs), a

Received in revised form

population that is historically young and uninsured, has not been defined. We hypothe-

10 December 2019

sized that PTPs in the post-ACA era would have better outcomes.

Accepted 12 December 2019

Material and methods: The National Trauma Data Bank (NTDB) was queried for all PTPs from

Available online xxx

2009 (pre-ACA) and 2011-2014 (post-ACA). Subset analysis was performed in patients aged 19-25 y, as this group was eligible for the ACA’s dependent care provision (DCP). Results: There were 9,714,471 patients in the study, with 2,053,501 (21.1%) pre-ACA and 7,660,970 (78.9%) post-ACA. When compared to pre-ACA, patients in the post-ACA cohort were more likely to have commercial/private insurance, less likely to have Medicaid, and more likely to be uninsured. On logistic regression, the pre-ACA era was associated with mortality (HR: 1.02, 95% CI: 1.01-1.04, P ¼ 0.004). Being uninsured was associated with mortality (HR: 1.89, 95% CI: 1.87-1.92, P < 0.001). On subset analysis of the DCP age group, post-ACA patients were more likely to be uninsured (24.1% versus 17.6%; P < 0.001). In addition, for the DCP age group, pre-ACA era was not associated with mortality (HR: 1.03, 95% CI: 0.99-1.06, P ¼ 0.20). Conclusions: Although the ACA provided a survival benefit to PTPs overall, it did not increase insurance coverage for this population. In addition, the DCP of the ACA did not improve insurance access for PTP in the eligible age group. Further efforts are needed to extend insurance access to this population. ª 2019 Published by Elsevier Inc.

Introduction Lack of insurance is associated with later and more complex presentation of emergency general surgical conditions.1,2 However, whether being uninsured affects the trauma

population is controversial,3-5 especially in victims of penetrating trauma.6,7 As a direct result of the Affordable Care Act (ACA), over 20 million uninsured people were given insurance coverage. The Dependent Care Provision (DCP) of the ACA extended insurance coverage to over 3 million young adults

This study was presented at the American College of Surgeons Annual Clinical Congress on October 27-31st, 2019, in San Francisco, CA. * Corresponding author. Tulane University School of Medicine, 1430 Tulane Avenue, Suite 8527, Mailbox 8622, New Orleans, LA 70119. Tel.: þ504 988-5111; fax: þ504 988-3683. E-mail address: [email protected] (S. Taghavi). 0022-4804/$ e see front matter ª 2019 Published by Elsevier Inc. https://doi.org/10.1016/j.jss.2019.12.020

taghavi et al  aca in penetrating trauma patients

aged 19-25 y. Until then, this vulnerable population had the highest uninsured rate among all age groups.8 The benefits of the ACA have been well documented. The ACA has been shown to improve the financial security of trauma centers that often times serve as a safety net for their surrounding communities.9,10 Outcomes in trauma patients are also improved, with a decline in mortality and failure to rescue rates.11 The ACA also appears to have reduced health care disparities, as it has decreased the number of uninsured among black and Hispanic populations.12 As a result, black and Hispanic trauma patients with traumatic brain injury have lower mortality after implementation of the ACA.3 These benefits are not just limited to trauma patients as the ACA is credited with improving the care of cancer patients, psychiatric patients, and numerous other medical conditions.8,13,14 Penetrating trauma patients represent a vulnerable population, as they are generally victims of violence, uninsured, and from impoverished communities.6,15,16 Whether the ACA improved outcomes in the penetrating trauma patient has yet to be determined. The goal of this study was to determine if the ACA resulted in better outcomes for victims of penetrating trauma. We hypothesized that penetrating trauma patients in the post-ACA era would have better outcomes.

Methods The National Trauma Data Bank (NTDB) of the American College of Surgeons (ACS) was queried for all penetrating trauma patients from 2009 to 2014. All data provided by the NTDB are deidentified and subject to quality screening. Because the ACA was implemented in 2010, 2009 was considered the pre-ACA group, whereas 2011-2014 was analyzed as the post-ACA group. Because the law was implemented in 2010, we excluded this year from the analysis as performed in prior studies.1,3 The DCP of the ACA allowed young adults aged 19-25 y to remain on their parents’ health insurance plan. Subset analysis was performed on this age group to determine if the DCP had any impact on outcomes.

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Data examined included baseline patient characteristics such as age, gender, payer status, facility description, injury mechanism, presenting systolic blood pressure (SBP), Glasgow Coma Scale (GCS), and injury severity score (ISS). Primary outcome measured was in-hospital mortality. Secondary outcomes included length of stay, intensive care unit length of stay, discharge disposition, and in-hospital complications. Inhospital complications included acute respiratory distress syndrome, renal failure, sepsis, surgical site stroke/cerebrovascular accident, urinary tract infection, venous thromboembolism, and any complication.

Statistical analysis The study data were described on various descriptive measures by their means  standard deviations, simple proportions, and percentages. Continuous variables, group means, and standard deviations were calculated accordingly. Chi-square tests and the Mantel Haenszel chi-square tests were used for categorical data. Analysis of variance methods were used at the 5% level of significance to compare mean values of interest of variables. The predictive model for categorical data was analyzed using logistic regression methods. The results from the analysis of the categorical data will be expressed as odds ratios together with the corresponding 95% confidence intervals. Predictive models were developed, using multiple logistic regression analysis by means of backward regression procedure. All statistical analysis was run first on the entire sample and then separately for each interest of variables. All the study hypotheses were tested at the 5% level of significance, and all statistical analyses were performed using SAS version 9.4 (SAS Institute Inc., Cary, NC).

Results As shown in Figure, there were a total of 9,714, 471 patients with penetrating injuries in the study period. Of these, 2,053,501 (21.1%) were injured in the pre-ACA era and 7,660,970 (78.9%) in the post-ACA era. Of the patients injured

Pre-ACA Injured 2009 N = 2,053,501 (21.1%) PaƟents aged 18-64 in NTDB database with gunshot or stab wound N = 9,714,471

Post-ACA Injured 2011-2014 N = 7,660,970 (78.9%)

Dependent Care Provision Group Ages 19-25 N = 403,726

Not Dependent Care Eligible Ages 26-34 N = 1,554,971

Fig e A summary of patients included in the study. (Color version of figure is available online.)

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Table 1 e Patient demographics. Variable

Pre-ACA (n ¼ 2,053,501) % (n)

Post-ACA (n ¼ 7,660,970) % (n)

P Value

Age, mean

39.6 (14)

39.3 (14)

<0.001

Male

72.4 (1,486,187)

72.5 (5,560,764)

<0.001

Female

27.6 (566,843)

27.4 (2,096,957)

<0.001

White

67.1 (1,377,790)

65.8 (5,041,758)

<0.001

Black

17.4 (358,038)

16.5 (1,267,068)

<0.001

Asian

1.8 (37,308)

1.6 (122,004)

<0.001

American Indian

1.0 (20,437)

1.0 (74,157)

<0.001

Native Hawaiian

0.2 (4811)

0.25 (19,004)

<0.001

Other race

9.3 (189,999)

10.2 (777,356)

<0.001

Unknown race/not recorded

3.2 (65,118)

4.7 (359,623)

<0.001

12.8 (263,044)

12.2 (937,291)

<0.001

Hispanic Injury Severity Score (ISS)

10 (5,17)

9 (5,17)

0.02

Commercial/private

50.9 (809,656)

51.3 (2,916,305)

<0.001

Medicaid

20.1 (329,485)

14.9 (847,512)

<0.001

Medicare

6.7 (106,644)

6.5 (367,989)

<0.001

Other government

3.0 (62,165)

3.8 (293,068)

<0.001

15.6 (361,150)

21.5 (1,645,275)

<0.001

Self-pay Unknown payer/not billed

0.6 (8890)

0.8 (43,880)

in the post-ACA era, 403,726 (5.3%) were eligible for the DCP. On subset analysis, patients eligible for the DCP were compared with 1,554,971 (20.3%) patients in the 26- to 34-y age group that were not in the DCP age group.

<0.001

insurance (50.9% 51.3%, P < 0.001) and less likely to have Medicaid (20.1% versus 14.9%, P < 0.001) or Medicare (6.7% versus 6.5%, P < 0.001).

In-hospital outcomes Patient characteristics Patient demographics are shown in Table 1. The pre-ACA group was older (39.6 versus 39.3 y, P < 0.001), more likely to be female (27.6% versus 27.4%, P < 0.001), and had higher ISS (10 versus 9 d, P ¼ 0.02). Penetrating trauma patients were less likely to be black (17.4% versus 16.5%, P < 0.001), Asian (1.8% versus 1.6%, P < 0.001), or Hispanic (12.8% versus 12.2%, P < 0.001) after the ACA. After the ACA, penetrating trauma patients were more likely to have commercial/private

A comparison of in-hospital outcomes between the pre- and post-ACA cohorts is shown in Table 2. Patients in the postACA cohort had higher length of stay (7.4 versus 7.5 d, P < 0.001) and in-hospital mortality rates (4.1% versus 4.0%, P < 0.001). Patients in the post-ACA group had higher rates of complications in almost every category as shown in Table 2. A comparison of hospital disposition status is shown in Table 3. Patients in the post-ACA cohort were more likely to be discharged to a rehabilitation facility (10.6% versus 11.7%,

Table 2 e Complications in pre-ACA versus post-ACA. Complications

Pre-ACA (n ¼ 2,053,501) % (n)

Post-ACA (n ¼ 7,660,970) % (n)

P Value <0.001

Total length of stay

7.4 (11.4)

7.5 (11.7)

ICU length of stay

7.2 (9.3)

7.2 (9.6)

Ventilator days

7.4 (9.9)

7.5 (10.2)

<0.001

In-hospital mortality

4.0 (82,498)

4.1 (310,451)

<0.001

Acute respiratory distress syndrome (ARDS)

0.4 (9291)

3.6 (84,710)

<0.001

Renal failure

0.4 (10,148)

1.6 (37,158)

<0.001

Surgical site infection

0.4 (9164)

1.4 (33,503)

<0.001

0.160

Stroke/cerebrovascular accident

0.4 (2760)

1.4 (33,503)

<0.001

Urinary tract infection

0.6 (13,490)

2.4 (55,140)

<0.001

Venous thromboembolism

0.9 (21,400)

3.0 (69,605)

<0.001

Any complication

0.7 (72,249)

3.3 (318,875)

<0.001

taghavi et al  aca in penetrating trauma patients

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Table 3 e Disposition in pre-ACS versus post-ACS. Disposition location Home w/o services Home w/services

Pre-ACA (n ¼ 2,053,501) % (n)

Post-ACA (n ¼ 7,660,970) % (n)

P Value

55.7 (1,144,097)

57.8 (4,427,405)

<0.001

5.7 (117,462)

5.1 (390,186)

<0.001

10.6 (217,199)

11.7 (894,612)

<0.001

Long-term acute care (LTAC)

0.9 (18,607)

0.2 (12,902)

<0.001

Skilled nursing facility (SNF)

4.8 (98,333)

4.5 (347,222)

<0.001

Psychiatric facility

0.8 (17,009)

0.2 (15,545)

<0.001

Other

2.7 (55,809)

2.4 (182,910)

<0.001

Against medical advice

1.2 (24,219)

1.0 (74,866)

<0.001

Jail

0.9 (18,369)

0.2 (13,997)

<0.001

Rehabilitation facility

Hospice

0.16 (3282)

0.15 (11,738)

<0.001

Not known/recorded

12.5 (256,617)

12.8 (978,795)

<0.001

P < 0.001), but less likely to be discharged to a long-term acute care (0.9% versus 0.2%, P < 0.001) or skilled nursing facility (4.8% versus 4.5%, P < 0.001).

Survival Logistic regression was carried out to examine variables associated with mortality as shown in Table 4. On multiple variable analysis, the pre-ACA era was associated with mortality risk (OR: 1.02, 95% CI: 1.01-1.04, P ¼ 0.004). Other variables associated with mortality included increasing age (OR: 1.03, 95% CI: 1.03-1.03, P < 0.001), male gender (OR: 1.16, 95% CI: 1.14-1.17, P < 0.001), increasing ISS (OR: 1.05, 95% CI: 1.051.05, P < 0.001), Asian race (OR: 1.36, 95% CI: 1.31-1.36,

P < 0.001), black race (OR: 1.34, 95% CI: 1.31-1.36, P < 0.001), other insurance (OR: 1.24, 95% CI: 1.15-1.35, P < 0.001), being uninsured (OR: 1.89, 9% CI: 1.87-1.92, P < 0.001), having Medicaid (OR: 1.02, 95% CI: 1.00-1.03, P ¼ 0.049), or Medicare (OR: 1.60, 95% CI: 1.56-1.63, P < 0.001). Variables associated with survival included higher presenting SBP (OR: 0.99, 95% CI: 0.99-0.99, P < 0.001), higher GCS (OR: 0.84, 95% CI: 0.84-0.84, P < 0.001), American-Indian ethnicity (OR: 0.78, 95% CI: 0.730.78, P < 0.001), and Hispanic ethnicity (OR: 0.86, 95% CI: 0.840.88, P < 0.001). Logistic regression using the same covariates was carried out to examine mortality among minorities in the pre-ACA era only. Hispanic ethnicity (OR: 0.89, 95% CI: 0.85-0.94, P < 0.001) was associated with survival. Being Asian (OR: 1.26, 95% CI:

Table 4 e Logistic regression examining variables associated with mortality. Variable

Odds ratio

95% confidence interval

Pre-ACA era

1.02

1.01-1.04

P Value 0.004

Age

1.03

1.03-1.03

<0.001

Male

1.16

1.14-1.17

<0.001

Injury severity score

1.05

1.05-1.05

<0.001

Presenting systolic blood pressure

0.99

0.99-0.99

<0.001

0.84

0.84-0.84

Presenting Glasgow Coma Scale White

Reference

Reference

<0.001 Reference

American-Indian

0.78

0.73-0.82

<0.001

Asian

1.36

1.31-1.42

<0.001

Black

1.34

1.31-1.36

<0.001

Hawaiian/Pacific Islander

1.09

0.99-1.20

0.07

Other race

1.00

0.99-1.21

0.68

0.86

0.84-0.88

Hispanic Private insurance Other insurance

Reference 1.24

Reference 1.15-1.35

<0.001 Reference <0.001

Other government insurance

0.99

0.96-1.03

0.63

Uninsured

1.89

1.87-1.92

<0.001

Medicaid

1.02

1.00-1.03

0.049

Medicare

1.60

1.56-1.63

<0.001

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Table 5 e Payer status for patients in the dependent care provision age group. Payer

Total cohort (n ¼ 1,958,697) % (n)

Pre-ACA (n ¼ 403,726)

Post-ACA (n ¼ 1,554,971)

P Value

Commercial/private

52.4 (211,333)

50.7 (33,195)

52.7 (178,138)

<0.001

Medicaid

17.8 (71,825)

25.8 (16,860)

16.3 (54,965)

<0.001

Medicare

0.8 (3011)

0.7 (486)

0.8 (2525)

<0.001

Other government

5.3 (21,527)

4.6 (3036)

5.5 (18,491)

<0.001

23.1 (92,997)

17.6 (11,528)

24.1 (81,469)

<0.001

0.7 (2359)

<0.001

Self-pay Not known/billed

0.7 (2694)

0.5 (335)

1.13-1.39, P < 0.001) or black (OR: 1:28, 95% CI: 1.24-1.33) was associated with mortality. When looking at the post-ACA era only, Hispanic ethnicity was still associated with survival (OR: 0.84, 95% CI: 0.82-0.87, P < 0.001), whereas being Asian (OR: 1.44, 95% CI: 1.37-1.51, P < 0.001) or black (OR: 1.34, 95% CI: 1.32-1.37, P < 0.001) was more associated with mortality than in the pre-ACA era.

Dependent care provision group A comparison of payer status in the DCP age group is shown in Table 5. Patients in this age group were more likely to have private insurance (50.7% versus 52.7%, P < 0.001), Medicare (0.7% versus 0.8%, P < 0.001), other government insurance (4.6% versus 5.5%, P < 0.001), or be self-insured (17.6% versus 24.1%, P < 0.001) in the post-ACA era. Patients in the DCP age group were less likely to be on Medicaid (25.8% versus 16.3%, P < 0.001) in the post-ACA era. Logistic regression examining the relationship between the DCP and mortality is shown in Table 6. The pre-ACA era was not associated with mortality (OR: 1.03, 95% CI: 0.99-1.06, P ¼ 0.20).

Covariates associated with mortality included male sex (OR: 1.32, 95% CI: 1.27-1.36, P < 0.001), increasing ISS (OR: 1.05, 95% CI: 1.051.05, P < 0.001), Asian race (OR: 1.71, 95% CI: 1.55-1.89, P < 0.001), black race (OR: 1.72, 95% CI: 1.66-1.78, P < 0.001), Hawaiian/Pacific Islander (OR: 1.39, OR: 1.12-1.72, P < 0.001), other race (OR: 1.14, 95% CI: 1.09-1.19, P < 0.001), other insurance (OR: 2.10, 95% CI: 2.32-2.48, P < 0.001), being uninsured (OR: 2.61, 95% CI: 2.24-3.06, P < 0.001), and Medicare (OR: 2.61, 95% CI: 2.24-3.06, P < 0.001). Covariates associated with survival in the 19- to 25-year-old age group included increasing age (OR: 0.98, 95% CI: 0.98-0.99, P < 0.001), increasing presenting SBP (OR: 0.99, 95% CI: 0.99-0.99, P < 0.001), increasing GCS (OR: 0.81, 95% CI: 0.81-0.81, P < 0.001), and other government insurance (OR: 0.82, 95% CI: 0.94-1.02, P < 0.001).

Discussion Penetrating trauma patients represent a vulnerable population as they are more likely to be uninsured and living in

Table 6 e Logistic regression examining mortality in patients eligible for dependent care provision. Variable Pre-ACA era

Odds ratio 1.03

95% Confidence interval 0.99-1.06

P Value 0.20

Age

0.98

0.98-0.99

<0.001

Male

1.32

1.27-1.36

<0.001

Injury severity score

1.05

1.05-1.05

<0.001

Presenting systolic blood pressure

0.99

0.99-0.99

<0.001

0.81

0.81-0.81

Presenting Glasgow Coma Scale White

Reference

<0.001 Reference

Reference

American Indian

0.98

0.85-1.14

0.42

Asian

1.71

1.55-1.89

<0.001

Black

1.72

1.66-1.78

<0.001

Hawaiian/Pacific Islander

1.39

1.12-1.72

0.003

Other race

1.14

1.09-1.19

<0.001

0.91

0.79-3.09

Hispanic Private insurance Other insurance

Reference 2.10

0.34 Reference

1.79-2.47

Reference <0.001

Other government insurance

0.82

0.75-0.88

<0.001

Uninsured

2.40

2.32-2.48

<0.001

Medicaid

0.98

0.94-1.02

0.26

Medicare

2.61

2.24-3.06

<0.001

taghavi et al  aca in penetrating trauma patients

poverty.17 Although the ACA has been shown to improve outcomes in trauma patients,11,12 how it specifically affected the penetrating trauma population needs further investigation. In this study, penetrating trauma patients from the preACA era were compared with those in the post-ACA era. We found that being in the post-ACA era was associated with improved outcomes. However, this did not appear to be related to increased insurance coverage as penetrating trauma patients in the post-ACA era did not have increased insurance coverage. Patients aged 19-25 y who were eligible for the DCP were not more likely to have insurance coverage after the ACA. Although the ACA provided coverage to over 20 million uninsured people, it also improved the quality of care in the U.S. health care system. This has been demonstrated in several different specialties, including behavioral health, chronic medical conditions, and for cancer care.18-21 This improvement in quality has also been shown in care for the traumatically injured.3,11 The present study demonstrated that these findings have extended to victims of penetrating trauma that are hospitalized. The reason for the improved outcomes seen after the ACA, both in this study and in others, needs further investigation as it does not seem to be attributable, at least in full, to increased access to care. Several measures were included in the bill that set out to improve quality of health care. This included transitioning payment for health care away from volume and toward quality. For example, the Centers for Medicare and Medicaid Services implemented the HospitalAcquired Condition Reduction Program, which measured select measures, such as central line associated blood stream infections and catheter-related urinary tract infections.8 Other measures were taken with the ACA to shift away from fee for service that are beyond the scope of this discussion, such as the adoption of bundled payment and development of Accountable Care Organizations.8 How these various aspects of the ACA affected the quality of care for penetrating trauma patients needs further study. Interestingly, penetrating trauma patients do not appear to be more likely to have insurance after the ACA. Between 2010 and 2012, six states moved to expand Medicaid and in 2014, 19 more states also followed suit.22 Because the post-ACA era in this study consisted of 2011-2014, most states that expanded Medicaid had not done so yet, which may explain these findings in part. However, the fact that penetrating trauma patients were more likely to be self-insured after the ACA indicates that victims of penetrating trauma have not been reached by the health care bill. This represents an opportunity for a public health intervention when penetrating trauma patients who are uninsured are admitted to the hospital. In states where Medicaid expansion has occurred, case managers and social workers can target these individuals to help them enroll in insurance when they are eligible. This may help improve access to care for a population that is often times from impoverished neighborhoods and dealing with the traumatic effects of violence. The ACA improved the financial well-being of trauma centers that often serve as a safety net for impoverished communities by providing health care for individuals regardless of insurance status.9,10 Although association does not equal causation, the ACA appears to have decreased

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disparities among minority trauma patients.11,12 The present study examined this among penetrating trauma patients and did not demonstrate a decrease in disparities among minorities. Hispanic patients were found to have improved survival on multivariate analysis, a finding that has been corroborated in prior studies.23 However, mortality risk was higher in the post-ACA era among Asian and black victims of penetrating trauma. Further studies are needed to determine how the ACA influenced minority populations. Prior work has shown that the DCP leads to a decrease in uninsured rates among young trauma patients in the 19- to 25-year age group, although this relative reduction was not as robust in minority populations.12,24 Although the present study showed a small increase in patients with commercial/ private insurance (50.7% versus 52.7% P < 0.001) with the DCP, overall, the number of self-insured increased (17.6% versus 23.1%, P < 0.001). This suggests that the DCP has not increased insurance coverage for the penetrating trauma population. The reasons for this finding are unclear and need further investigation. Gun violence is known to affect people from economically depressed areas25 and this may simply lead to more and more uninsured people becoming victims of penetrating trauma. More studies are needed to examine this finding and patients in this age group may benefit from targeted interventions to identify those eligible for the DCP when they are admitted to the hospital. Furthermore, the post-ACA era did not have a survival advantage in the DCP age group, further suggesting that the DCP did not improve health care for penetrating trauma patients. This study was not without limitations, including those related to retrospective analysis of large, administrative databases. Such large data sets rely on accurate reporting and coding. Although we cannot confirm that the data are devoid of coding errors, any such errors are likely random and unlikely to create bias with such a large sample size. In addition, information on mortality is limited to the initial hospitalization, which prevents any long-term survival analysis. In addition, resuscitation strategies have changed over the course of the study period26 and this could have partly influenced the results. The NTDB does not have detailed information on resuscitation, and we could not adjust for this variable. Finally, most states did not expand Medicaid until 2014 and while the database has some regional data, it does not allow us to separate states that expanded Medicaid during the study period. In conclusion, the ACA appears to have improved the quality of care among penetrating trauma patients. However, it does not appear to have increased insurance coverage among this vulnerable population, and hospitalization due to penetrating trauma may represent an opportunity to enroll patients in insurance coverage offered by the ACA. Finally, the DCP did not improve outcomes or decrease the number of uninsured patients in the penetrating trauma population.

Acknowledgment Authors’ contributions: S.T. contributed to conception and design, data analysis, and writing of the manuscript; S.S.

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contributed to data analysis and editing the manuscript; D.T. contributed to design, writing, and editing the manuscript, A.S. contributed to design and editing of the manuscript; C.G., P.M., C.H., and R.S. contributed to drafting and editing the manuscript; J.D. contributed to conception and design, data analysis, and writing of the manuscript.

Disclosure The authors have no disclosures or funding sources to report.

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