Abstract
Objectives. To compare the prevalence and characteristics of facility laws governing abortion provision specifically (targeted regulation of abortion providers [TRAP] laws); office-based surgeries, procedures, sedation or anesthesia (office interventions) generally (OBS laws); and other procedures specifically.
Methods. We conducted cross-sectional legal assessments of state facility laws for office interventions in effect as of August 1, 2016. We coded characteristics for each law and compared characteristics across categories of laws.
Results. TRAP laws (n = 55; in 34 states) were more prevalent than OBS laws (n = 25; in 25 states) or laws targeting other procedures (n = 1; in 1 state). TRAP laws often regulated facilities that would not be regulated under OBS laws (e.g., all TRAP laws, but only 2 OBS laws, applied regardless of sedation or anesthesia used). TRAP laws imposed more numerous and more stringent requirements than OBS laws.
Conclusions. Many states regulate abortion-providing facilities differently, and more stringently, than facilities providing other office interventions. The Supreme Court’s 2016 decision in Whole Woman’s Health v Hellerstedt casts doubt on the legitimacy of that differential treatment.
Approximately 1 million abortions are performed in the United States annually,1 either by procedure or by dispensing medication to the patient.2 Procedural abortions are often called “surgical,” but are more accurately categorized as procedural because they are performed through the cervix without incision.3 Like other procedures performed through an orifice naturally colonized with bacteria, procedural abortions need to be performed in “clean,” but not “sterile,” physical environments.4–6 Both medication and procedural abortions are very safe interventions, carrying lower complication risks than other common outpatient procedures.7–10
The vast majority of abortions in this country are provided in freestanding medical offices and clinics, where they have taken place since the Supreme Court recognized a constitutional right to abortion in 1973.1,11 Soon after the legalization of abortion, states began enacting laws governing facility licensing, accreditation, physical plant, and operations (facility laws) for facilities that provided abortions (TRAP laws, an acronym for the colloquial term “targeted regulation of abortion providers”).12 Proponents of TRAP laws claim that they promote women’s health by bringing abortion provision in line with accepted medical practice; opponents of TRAP laws argue that they impose burdensome requirements that differ from, and are more stringent than, requirements imposed on comparable health care providers.
The 1970s saw a variety of surgeries and medical procedures move out of hospitals, thanks to advancements in technology and the development of ambulatory surgery centers (ASCs).13–15 Further technological advances and growing concerns about health care costs subsequently moved some surgeries, procedures, and sedation and anesthesia use from ASCs to offices and clinics (office interventions; OBS).13,14 By 2000, an estimated 4.4 million office interventions occurred annually in the United States,15 and by 2005, that total more than doubled to an estimated 10 million.16 Current office interventions vary widely,10 ranging from “removal of a mole to breast augmentation/reduction, liposuction, hernia repairs or knee arthroscopies.”17 Unlike the early enactment of TRAP laws, states did not begin imposing facility laws on other office interventions until the mid-1990s. At that point, as office interventions increased and public attention was brought to potential safety concerns around office surgery (especially cosmetic surgery), some states began enacting facility laws governing office interventions generally (OBS laws).13,14
The constitutionality of TRAP laws has been called into question by the Supreme Court’s 2016 decision in Whole Woman’s Health v Hellerstedt, which struck down a Texas TRAP law requiring abortion facilities to be licensed as ASCs, and requiring abortion-providing physicians to hold local hospital admitting privileges.18 The Court held that laws regulating abortion provision by health care providers will only be upheld if the laws’ burdens are counterbalanced by proportional benefits, and the Court found that the challenged laws’ imposition of requirements only on abortion provision, rather than on a broader swath of procedures or providers, suggested that the requirements lacked benefits.18 The Whole Woman’s Health decision highlights the importance—to future research, policymaking, and jurisprudence—of understanding the extent to which TRAP laws regulate the provision of abortion similarly or differently from regulation of other office interventions. Existing literature documents some aspects of OBS laws13,16,19 and TRAP laws12,20,21 but does not provide a rigorous review or comparison of current facility laws regulating abortion and other office interventions. This study fills that gap, comprehensively comparing the ways and extent to which the states’ regulation of abortion-providing facilities differs from the states’ regulation of facilities providing other office interventions.
We used public health law research methods22 to conduct an in-depth, cross-sectional legal assessment of facility laws governing office interventions in the 50 states and District of Columbia (collectively, the states). This approach includes establishment of the legal framework and conceptual model, an iterative process of refining coding schemes and procedures, and rigorous quality control.22
After conducting preliminary legal research, we identified 3 categories of facility laws governing office interventions: OBS laws, TRAP laws, and laws governing specific procedures other than abortion (other specific procedure laws). We further identified 3 different types of TRAP laws: those requiring abortion-providing facilities to be licensed under a distinct abortion facility licensing scheme or meet state regulations specifically governing abortion facilities (abortion facility laws), those requiring abortion-providing facilities to be licensed as ASCs or to meet state ASC regulations (ASC laws), and those requiring that abortion-providing facilities be licensed as hospitals and meet state hospital regulations (hospital laws).23
Using standard public health law research methods, we sought to identify the laws in each category in each state, the applicability of each individual law (i.e., the conduct and facilities governed by the law), and the requirements imposed by each individual law. We excluded hospital laws from this last part of our study because requirements for hospitals are typically far more extensive than, and different in kind from, requirements for outpatient facilities.24
For each category of laws, we developed search strings and conducted keyword searches on Westlaw, a legal research database. We identified and recorded citations of relevant statutes and regulations in effect as of August 1, 2016, and reviewed the table of contents of relevant laws to determine if any surrounding laws were also relevant. In addition, we used Westlaw’s KeyCite feature to identify any court decision or attorney general opinion affecting the enforceability of relevant laws.
We excluded from our data sets TRAP laws that applied only to facilities providing abortions at or beyond “viability,” or 24 weeks gestation from last menstrual period. Few, if any, office and clinic settings provide abortions at this stage of pregnancy,1,2 and different constitutional standards apply to laws regulating postviability abortions.25 We employed the American Society of Anesthesiologists’ classification system for anesthesia and sedation levels,26 and we excluded laws that applied only to facilities that used general anesthesia because few, if any, office and clinic settings use general anesthesia in connection with abortion.27 Note that external third-party “guidelines” referenced by laws in the data set were not coded or included in the legal text (collecting and coding “guidelines” presents different challenges than laws: guidelines are not updated or published in a uniform manner, and state laws may reference different sections and versions of the same set of guidelines).
We then collected the relevant statutes and regulations from the state legislatures’ Web sites and created a final citation list for each category of laws (Appendix A, available as a supplement to the online version of this article at http://www.ajph.org).
On the basis of a review of a sample of facility laws, we developed a list of important features regarding applicability and requirements and subsequently converted these into coding questions.
With respect to applicability, we sought to identify limits on the laws’ application, including limits related to performing particular interventions or types of interventions, using a specified minimum level of sedation or anesthesia, or performing specific numbers or percentages of interventions.
With respect to requirements, we sought to identify facility licensing or accreditation requirements, physical plant specifications, required physician qualifications beyond licensing, requirements for nursing staff, required arrangements to facilitate patient transfers, other required policies and procedures, and penalties for noncompliance. For the “required transfer arrangements” measure, we coded the minimum arrangements necessary to satisfy each law by using the following scale from least onerous to most onerous: “plan or protocol” in place for patient transfers, formal “transfer agreement” between the facility and a local hospital or back-up physician, and “admitting privileges” at a local hospital held by 1 or more facility physicians.
Unlike traditional legal practice, which is based on interpretation of legal rules and precedent, our coding questions sought to identify and record only observable features of the laws; this helps ensure the validity and reliability of our data. We entered our coding questions into the LawAtlas Workbench,28 a Web-based software coding platform, and used it to create cross-sectional legal assessment mapping studies or legal data sets.
To ensure data quality, 2 researchers redundantly conducted each step of the research process (identification of laws, inclusion of relevant citations, and coding of requirements). We calculated our error rates by comparing all differences in coding between researchers and resolved divergences by reaching group consensus. As a final quality check, we also consulted publications of secondary sources29 to ensure all relevant citations were included.
We compared the prevalence and applicability of OBS, TRAP, and other specific procedure laws across the states. We compared the requirements of OBS, TRAP (abortion facility laws and ASC laws only), and other specific procedure laws in all states across measures. We used the number of laws, rather than the number of states, as our unit of comparison because we sought to comprehensively compare the regulation of abortion-providing facilities and of facilities providing other office interventions; using states as the unit of comparison would have required the exclusion of 1 or more TRAP laws in states with multiple TRAP laws.
We used the Fisher exact test to compare all categorical variables (P < .05) between the OBS and TRAP data sets. We excluded other specific procedure laws from our statistical tests as there was only 1 other specific procedure law.
A comprehensive description of our methods is in Appendix B (available as a supplement to the online version of this article at http://www.ajph.org).
Key results of the study follow; Tables A, B, and C (available as supplements to the online version of this article at http://www.ajph.org) present state-specific data.
US states had enacted 55 TRAP laws (25 abortion facility laws, 14 ASC laws, and 16 hospital laws) in 34 states, 25 OBS laws in 25 states, and 1 other specific procedure law in 1 state (Figure 1). Nineteen states had enacted both TRAP and OBS laws; 14 states had enacted TRAP laws but no OBS laws (1 state had both a TRAP law and a law targeting other specific procedures); and 6 states had enacted an OBS law but no TRAP law. Eleven states had enacted no TRAP, OBS, or other specific procedure laws.
FIGURE 1— Prevalence of State Facility Laws for Office Interventions Generally (OBS), Abortion Specifically (TRAP), and Other Specific Procedures, as of August 1, 2016: United States
Note. OBS laws = facility laws governing office interventions (office-based surgeries, procedures, sedation or anesthesia) generally; TRAP laws = facility laws governing abortion specifically. The number in parentheses indicates the number of TRAP laws in a state.
There existed significant variation between TRAP and OBS laws with respect to the types of interventions that subjected health care facilities to the laws (Table 1). All 55 TRAP laws applied to abortion-providing facilities regardless of the level of sedation or anesthesia they used. Furthermore, 80% of TRAP laws (n = 44/55) applied to abortion-providing facilities regardless of whether they provided any procedures or surgeries (TRAP laws typically treat procedural abortion as surgery). In addition, 51% of TRAP laws (n = 28/55; not shown) applied regardless of the stage of pregnancy at which the facility performed abortions.
TABLE 1— Applicability of State Facility Laws for Office Interventions Generally (OBS) and Abortion Specifically (TRAP), as of August 1, 2016: United States
| Law Applicability | OBS Laws (n = 25), % | TRAP Laws (n = 55), % | Pa |
| Law applies to following levels of sedation use | < .001 | ||
| Any | 8 | 100 | |
| ≤ minimal | 16 | 0 | |
| ≤ moderate | 68 | 0 | |
| ≤ deep | 8 | 0 | |
| Law applies to following types of interventions | < .001 | ||
| Surgical or procedural only | 88 | 20 | |
| Nonsurgical or procedural | 12 | 80 |
Note. OBS laws = facility laws governing office interventions (office-based surgeries, procedures, sedation or anesthesia) generally; TRAP laws = facility laws governing abortion specifically. Some OBS and TRAP laws apply only to facilities performing a certain number or percentage of office interventions.
aComparison between OBS and TRAP laws according to the Fisher exact test.
By contrast, 92% of OBS laws (n = 23/25) applied only to facilities that used a specified threshold level of sedation or anesthesia (note that 2 of 23 laws disregarded their sedation or anesthesia threshold for liposuction provision); just 2 OBS laws applied regardless of the level of sedation or anesthesia used. Four OBS laws (16%) applied to facilities that used minimal sedation or greater; 17 (68%) applied to facilities that used moderate sedation or greater; and 2 (8%) applied to facilities that used deep sedation or greater. Furthermore, 88% of OBS laws (n = 22/25) applied only to facilities that performed “surgeries,” “invasive procedures,” or “procedures”; the other 3 OBS laws (12%) applied solely on the basis of a sedation or anesthesia threshold. To see how the 23 laws that applied according to sedation level overlap with the 22 laws that applied according to type of intervention, see Table A.
The other specific procedure law applied similarly to OBS laws: it governed only facilities that provided cosmetic surgical services using moderate sedation or greater.
Characteristics of TRAP and OBS law requirements are shown in Table 2; requirements of the single other specific procedure law are described at the end of this section. Note that because we excluded hospital laws (n = 16) from our comparison of legal requirements (see Methods), we use “TRAP” in this section to refer to the 39 abortion facility and ASC laws enacted by 30 states. We conducted statistical significance tests for all reported measures.
TABLE 2— Requirements in State Facility Laws for Office Interventions Generally (OBS) and Abortion Specifically (TRAP), as of August 1, 2016: United States
| Requirement | OBS Laws (n = 25), % | Abortion Facility and ASC-Type TRAP Lawsa (n = 39), % | Pb |
| Facility licensing and accreditation | |||
| Facility accreditation only | 32 | 0 | < .001 |
| State licensing of facility only | 16 | 92 | < .001 |
| Both licensing and accreditation | 8 | 0 | .15 |
| Neither licensing nor accreditation specified | 44 | 8 | < .001 |
| Specialized roomsc | |||
| Operating room | 16 | 21 | .75 |
| Procedure room | 4 | 51 | < .001 |
| Separate recovery room | 16 | 51 | .007 |
| Separate instrument processing rooms | 12 | 33 | .08 |
| None of these rooms specified | 80 | 28 | < .001 |
| Physical plant specificationsc | |||
| Specific hallway and doorway widths | 8 | 36 | .017 |
| Emergency power beyond backup lighting | 24 | 36 | .41 |
| Specific ventilation and temperature | 8 | 21 | .29 |
| None of these features specified | 76 | 49 | .039 |
| Required physician qualifications | |||
| Must meet specific qualification(s) | 8 | 28 | .06 |
| May demonstrate competency by various means | 40 | 0 | < .001 |
| No physician qualifications specified | 52 | 72 | .12 |
| Requirements for specified levels of nursing staff | 28 | 74 | < .001 |
| Other required policies and procedures | |||
| Infection control | 72 | 85 | .34 |
| Quality assurance | 40 | 69 | .037 |
| Preventive maintenance | 48 | 62 | .31 |
| Disaster preparation | 32 | 74 | .002 |
| Peer review of physicians | 20 | 15 | .74 |
| Patient satisfaction assessment | 4 | 8 | > .99 |
| None of these policies and procedures specified | 12 | 10 | > .99 |
| Required arrangements to facilitate patient transfersd | |||
| Plan or protocol | 40 | 10 | .011 |
| Transfer agreement | 36 | 54 | .20 |
| Admitting privileges | 4 | 18 | .14 |
| Admitting privileges and transfer agreement | 0 | 15 | .07 |
| No arrangements for patient transfers specified | 20 | 3 | .030 |
| Penalties for noncompliance | |||
| Criminal | 12 | 41 | .023 |
| Fines | 20 | 67 | < .001 |
| Facility licensing sanctions | 24 | 90 | < .001 |
| No penalties specified | 72 | 5 | < .001 |
Note. ASC = ambulatory surgery center; OBS laws = facility laws governing office interventions (office-based surgeries, procedures, sedation or anesthesia) generally; TRAP laws = facility laws governing abortion specifically. See Tables B and C, available as supplements to the online version of this article at http://www.ajph.org, for additional information, including totals for each requirement.
aThis comparison of OBS and TRAP requirements includes only TRAP laws of the abortion facility and ASC types (n = 39); it excludes hospital laws.
bComparison between OBS and TRAP requirements according to Fisher exact test.
cIn some states, specialized room requirements and physical plant specifications were provided by external guidelines or standards; such requirements are not included in this table. For additional information, see Table C (Alaska ASC, Pennsylvania ASC, Utah abortion facility, Virginia abortion facility, and Virginia ASC).
dThe table reflects the most onerous of each law’s minimum requirements for patient transfer arrangements.
Some facility laws required regulated facilities to obtain a state license or accreditation from a third-party accrediting body. There were significant differences between TRAP and OBS laws in this regard. TRAP laws (92%; n = 36/39) were more likely than OBS laws (16%; n = 4/25) to require facility licensing (P < .001), whereas OBS laws (32%; n = 8/25) were more likely than TRAP laws (n = 0/39) to require accreditation (P < .001). Eight percent of OBS laws (n = 2/25) required licensing and accreditation.
Some TRAP laws required compliance with external physical plant specifications referenced by the laws; those external requirements are not included in our counts. Specialized rooms: Some facility laws permitted office interventions to be provided in examination rooms; other laws required a procedure room or operating room for that purpose. Procedure rooms are typically larger than examination rooms, and operating rooms are larger still and are usually specially equipped to maintain a sterile environment and accommodate more extensive equipment and additional personnel.30,31 Twenty-one percent of TRAP laws (n = 8/39) and 16% of OBS laws (n = 4/25) required an operating room (P = .751; 1 of the OBS requirements applied only to facilities using deep sedation). TRAP laws (51%; n = 20/39) were significantly more likely than OBS laws (4%; n = 1/25) to require a procedure room (P < .001) and were significantly less likely (28%; n = 11/39) than OBS laws (80%; n = 20/25) to require neither an operating room nor a procedure room (P < .001; not shown). Some facility laws permitted patients to recover in the room in which they received an office intervention; other facility laws required facilities to provide a separate recovery room. TRAP laws (51%; n = 20/39) were significantly more likely than OBS laws (16%; n = 4/25) to require a separate recovery room (P = .007; 1 of the OBS requirements applied only to facilities that used deep sedation). Some laws permitted facilities to clean and sterilize reusable surgical instruments in a single room with distinct “soiled” and “clean” areas and proper flow between them; other laws required separate rooms for soiled and clean instrument processing. Thirty-three percent of TRAP laws (n = 13/39) and 12% of OBS laws (n = 3/25) required such separate rooms (P = .077). Hallway and doorway widths: Some facility laws established specific minimum dimensions for the widths of facility hallways or doorways; other laws required that such openings be “adequate” for the purposes served, or imposed no requirements in this area. TRAP laws (36%; n = 14/39) were significantly more likely than OBS laws (8%; n = 2/25) to require facilities to meet specific minimum hallway or doorway widths (P = .017). Emergency power supply: Some facility laws required regulated facilities to be able to provide emergency power beyond emergency lighting for specified elements of the facility in case of a power failure. Thirty-six percent of TRAP laws (n = 14/39) and 24% of OBS laws (n = 6/25) included such a requirement (P = .411). Ventilation and temperature: Some facility laws imposed minimum specifications for air ventilation or temperature; other laws required “adequate” ventilation or temperature control for the purposes served or imposed no requirements in this area. Twenty-one percent of TRAP laws (n = 8/39) and 8% of OBS laws (n = 2/25) imposed specific minimum ventilation or temperature specifications (P = .292).
Some facility laws required physicians to “demonstrate competency” by meeting specific qualifications beyond physician licensing; other facility laws required physicians to demonstrate competency but allowed them to do so via 1 of various alternative means; still other facility laws imposed no requirements in this area. Twenty-eight percent of TRAP laws (n = 11/39) and 48% of OBS laws (n = 12/25) contained requirements for physician qualifications (P = .062). All TRAP requirements in this regard (28%; n = 11/39) required physicians to meet specific qualifications whereas only 8% of OBS laws contained such requirements (n = 2/25); the other OBS requirements in this area (40%; n = 10/25) allowed physicians to demonstrate competency via various means (P < .001).
Some facility laws required that regulated facilities use specified levels of nursing staff (most commonly registered nurses), either in a given number or ratio or to carry out certain tasks (e.g., supervise patient recovery). TRAP laws (74%; n = 29/39) were more likely than OBS laws (28%; n = 7/25) to contain such requirements (P < .001).
Some facility laws required that regulated facilities establish formal written policies and procedures governing specified areas of operation. The most frequent areas for required policies and procedures were infection control (85% [n = 33/39] TRAP laws and 72% [n = 18/25] OBS laws; P = .340), quality assurance (69% [n = 27/39] TRAP laws and 40% [n = 10/25] OBS laws; P = .037), preventive maintenance (62% [n = 24/39] TRAP laws and 48% [n = 12/25] OBS laws; P = .313), and disaster preparation (74% [n = 29/39] TRAP laws and 32% [n = 8/25] OBS laws; P = .002).
Some facility laws required the establishment of arrangements related to transferring a patient to the hospital if needed. Ninety-seven percent of TRAP laws (n = 38/39) and 80% of OBS laws (n = 20/25) required arrangements for patient transfers (P = .030). TRAP laws (10%; n = 4/39) were significantly less likely than OBS laws (40%; n = 10/25) to be satisfied simply by establishing a plan or protocol (P = .011). Fifty-four percent of the TRAP laws (n = 21/39) and 36% of the OBS laws (n = 9/25) required a hospital transfer agreement (P = .204); 18% of the TRAP laws (n = 7/39) and 4% of the OBS laws (n = 1/25) required 1 or more facility physicians to hold local admitting privileges (P = .135; the single OBS requirement applied only to facilities that used deep sedation); and 15% of the TRAP requirements (n = 6/39) and none of the OBS requirements (n = 0/20) mandated that the facility both hold a hospital transfer agreement and ensure that 1 or more facility physicians hold local admitting privileges (P = .074).
Considerable variation existed in the type and degree of penalties that facility laws authorized for noncompliance. TRAP laws (41%; n = 16/39) were significantly more likely than OBS laws (12%; n = 3/25) to authorize criminal penalties (P = .023; 1 of the 3 OBS requirements applied only to facilities that used deep sedation), fines (67% [n = 26/39] TRAP laws vs 20% [n = 5/25] OBS laws; P < .001; 1 of the 5 OBS requirements applied only to facilities that used deep sedation), and sanctions against a facility’s license (90% [n = 36/40] TRAP laws vs 24% [n = 6/25] OBS laws; P < .001).
The single other specific procedure law required both state licensing and third-party accreditation. It contained none of the requirements regarding physical plant, physician qualifications, nursing staff, or patient transfer arrangements that were found in some TRAP and OBS laws. The law authorized fines and facility license sanctions but not criminal penalties.
Our results led to 3 key findings that inform the current issues in this area. First, the states had frequently singled out abortion provision for targeted regulation, enacting more TRAP laws than OBS laws. At the same time, the states had virtually never singled out other office interventions for such separate legal treatment. Second, unlike OBS laws, many TRAP laws applied regardless of the level of sedation or anesthesia used, or the nature of the office intervention, applying in many cases to facilities that provided abortion only via medication. As a result, in many cases, an abortion-providing facility would be governed by its state’s TRAP law even though it would not be regulated under the state’s OBS law. Third, in many instances and areas, TRAP laws imposed more numerous and more stringent requirements than did OBS laws or the single law targeting specific procedures other than abortion.
These findings begin to provide answers to the question—raised both by the Whole Woman’s Health decision and policy debates about TRAP laws—of whether TRAP laws align abortion provision with existing health care standards or subject abortion provision to separate and different requirements. Our results indicated that TRAP laws, which regulate a small subset of office interventions with an established safety record, exceeded in their application and requirements both OBS laws, which governed a broader swath of varied office interventions, and the 1 state facility law that targeted particular procedures other than abortion, namely cosmetic surgery. Under the reasoning of Whole Woman’s Health, the singular treatment of abortion facilities by many TRAP laws suggests that these laws go beyond necessary and accepted standards of practice and fail to provide countervailing benefits. Accordingly, those laws may be vulnerable to legal challenge under Whole Woman’s Health.18 Additionally, existing literature indicates that TRAP laws make abortions less accessible to patients (especially poor and low-income patients)32 by reducing the number of facilities that provide abortion services.33,34 To the extent that TRAP laws reduce access to health care services in the absence of countervailing benefits, they threaten to undermine public health. The findings of this study, alongside the Whole Women’s Health decision, indicate that legislators and policymakers seeking to protect women’s health would be best served by addressing abortion provision within the context of comparable health care services rather than via separate and different requirements.
See also Galea and Vaughan, p.
ACKNOWLEDGMENTS
This study was funded by an anonymous private foundation.
We acknowledge Andrew Campbell, JD, and Adrienne Ghorashi, JD, from the Policy Surveillance Program at Temple University, who researched and coded the state laws and contributed to the drafting and review of the Methods section. We would also like to thank Lauren McCulloch who assisted with quality control processes. We would also like to acknowledge Nancy Berglas, DrPH, Sarah Roberts, DrPH, and Stephanie Toti, JD, for providing editorial review and commentary.
Note. The funder had no influence on the research, writing, or conclusions of the authors.
HUMAN PARTICIPANT PROTECTION
This research did not require protocol approval because it did not use human participants.
