Variation in the interpretation and application of the Medicaid sterilization consent form among Medicaid officials

Abstract

Objective:

The Medicaid consent policy has been identified as a major barrier to desired permanent contraception, particularly for low-income communities and communities of color. As each state may modify their state Medicaid sterilization consent form, variation in the form has been reported. This study aims to characterize state-level variation in Medicaid Title XIX consent form interpretation and application.

Study design:

We aimed to collect primary data from Medicaid officials in all 50 United States from January to May 2020 via a 25-question electronic survey regarding state-level consent form implementation. Questions targeted consent form details and definitions, insurance and billing, clinician correspondence, and administrative processes. We used Qualtrics XM to collect survey responses. We performed descriptive statistics on the survey responses. There were no exclusion criteria.

Results:

We had 41 responses from 36/50 states (72% participation rate). Heterogeneity existed in the key definitions of “Premature Delivery” and “Emergency Abdominal Surgery.” One in five respondents reported the consent form was only available in English. Variation among Current Procedural Terminology codes covered in each state’s sterilization policy were noted. Nearly a quarter of respondents did not know how Medicaid informed healthcare providers of consent form denials. Most participants (90%) were unaware of differences between state sterilization policies.

Conclusion:

This study demonstrates variation in terms of consent form definitions, procedures covered, correspondence with clinicians, and administrative review processes among state Medicaid offices regarding the sterilization consent form. Greater transparency is necessary in order to reduce administrative barriers to desired permanent contraception.

1. Introduction

The Medicaid Title XIX Sterilization Consent policy, established in 1974 by the Department of Health, Education, and Welfare, was initially enacted as a protective measure to address the United States’ (U.S.) history of involuntary sterilizations among racial minority and low-income patients [1–2]. For those with Medicaid insurance, the policy mandates a sterilization consent form with a 30-day waiting period between patient signature and sterilization procedure. Currently, the form expires 180 days after it is signed. Despite new medical technologies, the passage of the Affordable Care Act, which broadly increased insurance coverage, and a growing and diversifying patient population since the 1970s, the Medicaid sterilization policy and consent form remain largely unmodified.

While there are numerous obstacles to permanent contraception completion, the Medicaid consent form is a major barrier to fulfillment of permanent contraception requests [3–14]. Approximately half of female Medicaid recipients who request postpartum permanent contraception undergo the procedure [5,6]. The form includes key terms such as “preterm delivery” and “emergency abdominal surgery” that, when applicable, reduce the mandatory waiting period from the standard 30 days to 72 hours between signature and procedure. However, these critical terms are not defined by federal statute, thereby leaving room for variation in interpretation between states [8]. One study demonstrated both inter-and intra-state variation in definitions for “premature delivery,” leading to concerns regarding unnecessarily restrictive contraceptive practices and hospital policies that are entirely dependent on geography [15].

The primary objective of this analysis is to describe how individual states implement Medicaid sterilization policy, specifically variation in consent form details and key definitions, insurance and billing discrepancies, correspondence and information given to clinicians, and differences in administrative review. We hypothesize that variation between states permeates all aspects of the consent form, from definitions to determinations of which procedures are covered under the policy.

2. Material and methods

From January to May 2020, we sent a 25-question electronic survey using Qualtrics XM to 50 U.S. Medicaid Directors, or the most appropriate official as ascertained from each state’s Medicaid website (e.g., Family Planning, Maternal and Child Health Director). We obtained a list of Medicaid director contact information from the publicly available National Association of Medicaid Directors website and other women’s health list-serves [16]. For states that did not list a Medicaid director email or did not respond to our initial outreach, we utilized all publicly available contact information through women’s health organizations. We contacted each Medicaid official by email and phone.

The survey instrument included a voluntary participation agreement with options to accept and proceed to the survey or decline and conclude the survey. We provided an information sheet containing study details with the participation invitation. The survey included questions regarding consent form details and definitions, insurance and billing considerations, information for and correspondence with clinicians, and administrative review details. We crafted survey questions based on our clinical experience and literature in the field, including a prior survey of OBGYNs and a prior qualitative study of Medicaid administrators [15,17]. Answers were formatted as multiple-choice, fill-in-the-blank, or Likert-scales with the availability for non-response options. Some questions were presented as adaptive questions, meaning further questions either were or were not presented depending on the initial response (i.e., answering “Yes” would prompt additional questions, whereas “No” would not). All questionnaires were complete, and responses were automatically stored on a secure database. We analyzed all responses, including multiple responses for a single state as we were unable to verify which response was the most correct. We reported in aggregate de-identified data, limiting granularity to U.S. census regions (Northeast, South, Midwest, West) to maintain respondent confidentiality. We calculated descriptive statistics using frequencies and Fischer-exact tests for regional associations. We used a p -value of 0.05 to define statistical significance for the Fischer-exact tests. We aimed for a greater than 60% state participation rate goal (more than 30 states) to minimize participation bias. The Institutional Review Board viewed this study as exempt from review as the study did not involve the use or collection of protected health information.

3. Results

We received 41 responses from 36 states out of the 50 contacted for a 72% participation rate. Of the 41 responses, 14 responses were from 11 of the 13 states in the West, 10 responses were from nine of the 12 states in the Midwest, 11 responses were from 10 of the 16 states in the South, and six responses were from six of the nine states in the Northeast, as determined by U.S. census regions. Four states had multiple, non-duplicated responses.

3.1. Consent form details and definitions

Table 1 displays the responses regarding form details and key term definitions. For “Premature Delivery”, the selected response ‘Other’ included write-in answers such as “No definition, review of medical records,” “Provider Discretion,” and “Unknown”. For “Emergency Abdominal Surgery”, the selected response ‘Other’ included write-in responses such as “Any emergency abdominal surgery,” “There is no state definition of emergency abdominal surgery,” “Case by case basis,” and “Unknown.” There were no statistically significant differences between regional groups for each individual definition.

Table 1.

Responses by state Medicaid officials in the United States of America by geographical region regarding definitions, applicability, and updates to the sterilization consent form policy in 2020

	West (n = 14)	Midwest (n = 10)	South (n = 11)	Northeast (n = 6)	Total (n = 41)
Definition of premature delivery
Any time before the EDD	2 (14%)	0 (0%)	1 (9%)	0 (0%)	3 (7%)
Any time before the EDD as long as the form was filled out 30 days prior to the EDD	1 (7%)	1 (10%)	4 (36%)	3 (50%)	9 (22%)
Before 39 wk gestation	0 (0%)	1 (10%)	1 (9%)	2 (33%)	2 (5%)
Before 37 wk gestation	6 (43%)	7 (70%)	2 (18%)	2 (33%)	17 (41%)
Before 34 wk gestation	0 (0%)	0 (0%)	1 (9%)	0 (0%)	1 (2%)
Other	5 (36%)	1 (10%)	2 (18%)	1 (17%)	9 (22%)
Definition of emergency abdominal surgery
Unscheduled cesarean section	4 (29%)	3 (30%)	5 (45%)	2 (33%)	14 (34%)
Emergency cesarean section	6 (43%)	4 (40%)	6 (55%)	4 (67%)	20 (49%)
Ovarian torsion	6 (43%)	3 (30%)	6 (45%)	3 (50%)	17 (41%)
Ectopic pregnancy	6 (43%)	4 (40%)	4 (36%)	2 (33%)	16 (39%)
Non-obstetrical abdominal surgery	6 (43%)	4 (40%)	2 (18%)	2 (33%)	14 (34%)
Physician judgment	5 (36%)	2 (20%)	4 (36%)	2 (33%)	13 (32%)
Other	7 (50%)	4 (40%)	5 (45%)	2 (33%)	18 (44%)
Necessity of sterilization consent form if sterilization not primary intent
Needed	6 (43%)	6 (60%)	5 (45%)	3 (50%)	20 (49%)
Not Needed	4 (29%)	3 (30%)	4 (36%)	3 (50%)	14 (34%)
Unknown	4 (29%)	1 (10%)	2 (18%)	0 (0%)	7 (17%)
Last update to sterilization consent form
Last year	1 (7%)	0 (0%)	3 (27%)	1 (17%)	5 (12%)
Last 5 y	5 (36%)	4 (40%)	2 (18%)	1 (17%)	12 (29%)
Unsure	5 (36%)	4 (40%)	4 (36%)	0 (0%)	13 (32%)
No updates	0 (0%)	1 (10%)	2 (18%)	1 (17%)	4 (10%)
Other	3 (21%)	1 (10%)	0 (0%)	3 (50%)	7 (17%)

Numbers presented as n (%)

There were no statistically significant differences between regional groups for each individual definition.

EDD = estimated date of delivery

Within the survey, we asked participants in an open-ended question if the consent form is required for procedures even if contraception is not the primary intent of the procedure (Table 1). For example, a situation like this may arise when a patient who previously had one fallopian tube removed, such as with a previous ectopic pregnancy, then undergoes removal of the second tube for a non-contraceptive reason, such as treatment of hydrosalpinx or ectopic pregnancy, thereby constituting permanent sterilization. Nearly half of respondents (20, 49%) stated the form was needed, while seven respondents (17%) did not know if it was needed (Table 1).

Five respondents (12%) indicated that they were aware of procedures other than permanent contraception procedures that require a waiting period, reporting “hysterectomy,” “prior authorization requirements,” and “vasectomy.” Over half of respondents (21, 51%) indicated that they were not aware of other procedures requiring a waiting period, and 15 respondents (37%) selected “Unknown.”

We inquired regarding timing and nature of the last consent form update (Table 1). Reasons for updating the form included updating language, shifting the minimum consenting age, changing the form expiration date, including gender diverse individuals, increasing font size, including a blank space for provider office use, transitioning to electronic forms, updating the department name, restructuring the interpreter’s statement, and clarifying medically necessary abdominal surgeries.

Almost two-thirds of participants (26, 63%) reported that their state’s form was available in a language other than English, of which Spanish was the most reported language (96%), and one participant (4%) reported Vietnamese. Eight respondents (20%) reported that their state’s form was only available in English, and seven respondents (17%) reported “Unknown.”

Most participants (36, 88%) reported that they were not aware of differences between their and other states’ consent forms. The five respondents (12%) who noted differences specified perceived consent form differences as “definitions of premature delivery,” “age of consent,” “process of denying sterilization consent form,” and “terminology.”

3.2. Insurance and billing

Thirty respondents (73%) reported that their state had Managed Care Organizations (MCOs), while eight respondents (20%) reported no MCOs, and three respondents (7%) did not know. Of the states with MCOs, nearly all respondents (29, 97%) indicated that MCOs required the consent form to bill for sterilization, and one respondent (3%) did not know. Most respondents (36, 88%) reported that there was no associated copay for permanent contraception procedures for Medicaid recipients, one respondent (2%) reported that there was a copay, and four respondents (10%) did not know if there was a copay. Specifically, for private health insurance companies, six respondents (15%) indicated that the form was required, 14 respondents (34%) reported the form was not required, and half of respondents (21, 51%) did not know whether these non-Medicaid insurances required a consent form.

Respondents identified the Current Procedural Terminology (CPT) codes that are specifically included under their state’s sterilization policy from a predetermined list of 16 procedures (Table 2). Over a quarter of respondents (12, 29%) did not know which CPT codes qualify under their state’s sterilization policy. There were no statistically significant differences between regional groups for each CPT code.

Table 2.

Sterilization consent form current procedural terminology (CPT) codes in the United States of America in 2020

CPT code	CPT code description	Respondents, n (%)
58150–58152, 58200, 58570–58573, 58180, 58541–58544, 58260–58294, 58550–58554	Hysterectomy	9 (22%)
58565	Hysteroscopy, surgical; with bilateral Fallopian tube cannulation to induce occlusion by placement of permanent implants	18 (44%)
58600	Ligation or transection of the Fallopian tube(s), abdominal or vaginal approach, unilateral or bilateral	26 (63%)
58605	Ligation or transection of Fallopian tube(s), abdominal or vaginal approach, postpartum, unilateral or bilateral during the same hospitalization (separate procedure)	22 (54%)
+58611	Ligation or transection of Fallopian tube(s) when done at the time of cesarean delivery or intra-abdominal surgery [not a separate procedure]. This is an add on code.	22 (54%)
58615	Occlusion of Fallopian tube(s) by device [e.g., band, clip, Falope ring] vaginal or suprapubic approach	24 (59%)
58661	Laparoscopy, surgical, removal of tubes and/or ovaries	19 (46%)
58662	Laparoscopy, surgical, removal of lesions/cysts of ovaries and pelvis	8 (20%)
58670	Laparoscopy, surgical; with fulguration of oviducts [with or without transection]	22 (54%)
58671	Laparoscopy, surgical; with occlusion of oviducts by device [e.g., band, clip, or Falope rings]	22 (54%)
58700	Salpingectomy, complete or partial, unilateral or bilateral	15 (37%)
58720	Salpingo-Oophorectomy, partial or total, unilateral or bilateral	15 (37%)
58925	Ovarian cystectomy, unilateral or bilateral	4 (10%)
58940	Oophorectomy, partial or total, unilateral or bilateral	10 (24%)
59151, 59121	Treatment of Ectopic w/ Salpingectomy and/or Oophorectomy	6 (15%)
+59525	Subtotal or total hysterectomy after cesarean delivery. This is an add on code.	8 (20%)
Other	Option for respondents to fill in their own answer, which included responses such as “vasectomy”.	7 (17%)
Unknown	Unknown	12 (29%)

Numbers presented as n (%)

“+” indicates an add on code, which is added to another procedure code.

Table 2 displays each CPT code that requires the sterilization consent form as well as the total number and percentage of Medicaid official respondents for each code.

3.3. Clinician information and correspondence

Respondents reviewed the state-specific resources available for clinician questions regarding their state’s Medicaid consent form and approval process. The majority (36, 88%) indicated that information could be found online. Over half of respondents (23, 56%) indicated that healthcare providers could call the state Medicaid office directly, nine respondents (22%) noted a Medicaid provided brochure or handout, six respondents (15%) indicated an in-person meeting or workshop, two respondents (5%) stated that there were no methods to find information on the consent form, and one respondent (2%) did not know if there were any resources.

Respondents indicated the legal methods for providers to submit a signed consent form to Medicaid. Over half of respondents (23, 56%) selected an electronic method such as email, about half selected mail (21, 51%) or fax (20, 49%), nine respondents (22%) did not know of the legal method(s), and six respondents (22%) selected “Other,” which included “Hand delivery.” When asked for the legal and valid methods by which Medicaid informs healthcare providers of form denials, majority of respondents (29, 71%) indicated “Mail”. Over half of respondents (25, 61%) selected an electronic format (email), six respondents (15%) indicated fax, four respondents (10%) selected telephone, and two respondents (5%) selected “Other,” writing in that contacting providers was “handled through MCO and tied to payment.” Nearly a quarter of respondents (10, 24%) did not know how Medicaid informed providers of form denials.

3.4. Administrative review

We asked participants to identify the official individual responsible for the final decision regarding consent form acceptance or rejection. Five respondents (12%) designated their state’s Medicaid Office Director, 10 respondents (24%) reported “Unknown,” and one respondent (2%) selected “Any Medicaid officer or staff.” The majority of respondents (35, 85%) indicated “Other position,” which included answers such as “Claims unit staff/reviewer,” “Medical Director,” “Fiscal Agent,” “Sterilization Policy Expert,” “Office Administrative Legal services,” “Provider Relations,” and “It depends.”

4. Discussion

This study demonstrates that there is variation between state Medicaid offices in terms of consent form details and definitions, insurance and billing considerations, correspondence with and information for clinicians, and administrative review processes. This study bolsters previous findings that individual state interpretation of the sterilization policy is varied [15,17–19]. Greater transparency is necessary regarding this variation so that administrative barriers are lessened. In addition, the range of interpretation and major differences depending on the location in the U.S. creates unequal access to care for Medicaid recipients, raising questions of ethics and the necessity of policy reform.

These findings demonstrate a lack of clarity regarding insurance and billing guidelines pertaining to the consent form, including whether MCOs require the form, whether permanent contraception carries associated copays, and whether private insurances require a consent form. We also report discordance regarding which CPT codes may be used for permanent contraception, further highlighting the lack of clarity surrounding sterilization policies. We compared the responses between U.S. regions for CPT codes and terminology definitions, and though there were no statistically significant differences, we observed wide variations in responses. While it has been previously noted that Southern states have higher rates of postpartum sterilization compared to the rest of the U.S., we did not find regional variations in implementation and administration of the Medicaid sterilization policy. Rather, the level of variation remains at the state- rather than region-level [20].

Though the lack of knowledge of state Medicaid officials who self-reported as most knowledgeable about the policy is concerning, more importantly, this ambiguity leads to a decreased ability to adequately counsel clinicians regarding proper processes and payment rejection for procedures [15]. Prophylactic salpingectomies for the prevention of epithelial ovarian cancer further complicates elective permanent contraception payment coding, given the potential benefit for fallopian tube removal beyond desired permanent contraception [21].

Despite the negative impact of the Medicaid sterilization policy on permanent contraception fulfillment rates and opportunities to improve the consent form, Medicare officials and clinicians understand that there is a need for the policy [17,22,23]. Prior qualitative work of patients, physicians, and Medicaid state employees note the necessity for a consent process that must acknowledge historical reproductive coercion and balance patient autonomy [22–24].

The recent COVID-19 pandemic has not only served as a colossal barrier for routine healthcare administration but has created further barriers for those seeking permanent contraception. Some Medicaid offices have determined permanent contraception as “elective” procedures, curtailing these operations during the COVID-19 surges [25]. This raises the question of whether contraceptive procedures are truly elective, given the increased maternal morbidity with unintended, especially short-interval, pregnancies. Furthermore, the increase of telemedicine visits has limited the ability to physically sign consent forms, posing another barrier for successful form completion [25].

This study highlights areas of the current sterilization policy that would be amenable to revision and clarification. One of the most notable findings is the variation in definitions of “Premature Delivery” and “Emergency Abdominal Surgery.” These definitions are critical as they legally stipulate when the mandatory 30-day waiting period may be shortened to the 72-hour waiting period. It is evident by the numerous interpretations that the existing statement is ambiguous. Second, the lack of non-English translations is problematic as language barriers, especially for informed consent, result in lack of access for vulnerable populations [1,8,23,24]. Ideally, revisions should be consistent across states given the federal nature of the policy and ensure equal accessibility to permanent contraception regardless of geographical location. Therefore, we encourage state Medicaid offices to follow the example of states like Massachusetts to publish clear guidance regarding the details of their policy in order to aid clinicians in correctly completing the consent form and minimizing rejections [26–28]. Furthermore, as physician perceptions and practices of the form vary, greater education is necessary to ensure standardization of availability of permanent contraception [22,29].

There are several limitations to this study. By nature of a self-reported survey, the quality of the responses is based on the respondent’s knowledge and subject to misinterpretation or incorrect selections. Four states submitted multiple responses, limiting our interpretation to survey respondents rather than the expected single response per state. However, the variation within these responses exemplifies the problematic nature of Medicaid sterilization policy variability, indicating a lack of internal consistency at the state level. This phenomenon of multiple non-similar responses has been previously described in similar studies [15].

These data contribute to the growing body of evidence that call for standardization of the permanent contraception consent process within and across states. Inconsistent interpretation creates administrative barriers to care and leads to unnecessarily denying patients the contraceptive option of their choice. However, given the historical backdrop and ongoing structural racism, a protective mechanism against coercion of marginalized communities remains necessary. Therefore, permanent contraception policies should have the dual goals of preserving reproductive autonomy and effectively protecting vulnerable populations. Ensuring greater transparency and consistency in the Title XIX sterilization consent process within and between states is a key first step to striking this balance.

Implications.

Inconsistent interpretation poses an administrative barrier to care, raises concern regarding appropriate clinician reimbursement, and can potentially lead to unnecessarily denying patients the contraceptive option of their choice. Permanent contraception policies should be equitable no matter insurance status, preserve reproductive autonomy and effectively protect vulnerable populations.