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Slow and Steady and Right on Time:

An Evaluation of the MAHEC Postpartum LARC Pilot Project

By

Lydia Russell-Roy

A Master’s Paper submitted to the faculty of the University of North Carolina at Chapel Hill in partial fulfilment of the requirements for the degree of Master of Public Health in the Public

Health Leadership Program Chapel Hill

2016

, Advisor and First Reader

7 July 2016

Date

Second Reader

7 July 2016

(2)

ABSTRACT

Research Question:How can a community hospital implement an optimal postpartum long acting reversible contraception (LARC) distribution program in North Carolina?

Importance: Many states are starting to cover early postpartum LARC and hospitals need guidance on how to implement these programs effectively.

Specific Aims: This study will evaluate a quality improvement project at Mission Hospital to increase access to postpartum contraception in order to improve other hospitals’ efforts at implementation in the future.

Methods: The triangulation of in-depth interviews with project stakeholders and observations of quality improvement efforts at Mission Hospital with reports of other successful implementation strategies from a systematic review will be used to evaluate the progress and approach of the MAHEC postpartum LARC pilot project.

(3)

Acknowledgements

Blake Fagan for his enthusiasm

Kellett Letson for his vision

Sue Tolleson-Rinehart for her keen eye

(4)

TABLE OF CONTENTS

Abstract……….i

Acknowledgements….……….ii

Table of Contents………iii

Introduction………..1

Background and Significance………...….……….……….2

Methods………....8

Findings and Discussion………...………...9

Conclusion……….17

References……….19

(5)

Introduction

In 2011, forty-five percent of pregnancies in the United States were unintended or

mistimed.1 One way that women’s health providers are trying to improve family planning is

increasing access to long-acting reversible contraception (LARC) devices in the postpartum

period. Instead of waiting until the outpatient postpartum clinic visit 6 weeks after delivery,

physicians can insert LARC devices before women, who want this form of contraception, are

discharged from their delivery hospitalization. Although moving the clinical location of the

insertion seems like a simple shift, significant changes need to be made in billing policies,

protocols, and provider comfort before such a program can be implemented successfully. This

paper will evaluate one hospital’s experience trying to implement an early postpartum LARC

distribution program.

Early postpartum LARC (EPLARC*) is not currently provided in North Carolina because

of billing arrangements and financial hurdles. Most health insurance plans, including Medicaid,

pay for the delivery hospitalization in one bundled payment. LARC devices are too expensive to

be lumped into that reimbursement. Medicaid programs in other states have created separate

codes to allow billing for the device and the procedure in the hospital.2 North Carolina Medicaid

is in the process of developing codes, but some providers are impatient.

Physicians at the Mountain Health Area Health Education Center (MAHEC) in Asheville,

North Carolina, are eager to provide LARC to their patients. A pilot project is underway, starting

the implementation process in anticipation of changes in reimbursement. MAHEC providers plan

(6)

during three pilot procedures, making implementation faster when Medicaid allows billing.

Despite provider enthusiasm, no pilot insertion has occurred in eight months.

The goal of this paper is to evaluate the MAHEC EPLARC pilot project. I will discuss

the origins of the MAHEC quality improvement project, accomplishments and hurdles, and next

steps through the lens of quality improvement and implementation science. Specifically, I will

focus on answering why little progress has been made in eight months, whether this quality

improvement project’s reproductive health focus make progress more vulnerable to slow downs,

and how the next steps can be taken effectively and thoughtfully.

Background and Significance The Need for Early Postpartum LARC

LARC devices are preferred by women and providers because they provide highly

effective birth control for several years that does not require patient upkeep. LARC is the broad

term for several contraception devices: subdermal hormonal devices like Nexplanon™ and

intrauterine devices like Paraguard™ and Mirena™. All LARC methods are more than 99%

effective at preventing pregnancy.3 The Contraceptive CHOICE Project confirmed LARC’s

desirability and patients’ satisfaction with it: 75% of the 9,000 women in the study chose LARC.

After 24 months, 77% of the women who chose LARC were still using it, while only 41% of

women who chose other contraception were continuing.4 Part of what made the CHOICE project

so successful in distributing LARC, was that they provided the IUD or implant on the same day

as counseling.4

Giving women easy access to contraception is essential for reducing unintended

(7)

occur in women who have already given birth.5 Half of those pregnancies occur within 2 years of

a previous birth.5 Getting to appointments can be difficult for patients at any time, and having a

newborn can increase the challenge of making and keeping doctor’s appointments. In California,

only 41% of women who delivered with Medicaid coverage had a claim for contraception in the

90 days postpartum.6 In a UNC survey of 324 women who wanted LARC at discharge, 65% did

not have it 6-8 weeks postpartum.7 Those women who did not get LARC were more likely to

have multiple children and to miss their postpartum appointment. The reasons women gave for

not getting LARC were having to come back for a separate insertion visit (45%) or missing the

postpartum appointment (26%).7 Improving women’s access to these methods postpartum is

important for improving quality of health care delivery and improving health outcomes.

The known risks to mothers and infants of inadequate birth spacing create a strong

mandate to provide postpartum patients access to their preferred form of contraception

immediately after delivery. Women who have short interpregnancy intervals, defined as

pregnancy less than two years after a delivery, face increased risks of obesity and gestational

diabetes.8 If the repeat pregnancy occurs within 5 months, the risks of third trimester bleeding,

endometritis, and maternal death increase.8 In addition, the child of that short interval pregnancy

is at higher risk for pre-term birth and low birth weight.9,10 Offering LARC in the hospital is an

important way to reduce short interpregnancy intervals, improve maternal and fetal health

outcomes, and increase efficiency in preventive care.

Providing LARC to women in the hospital is an effective way of lowering the number of

short interpregnacy interval deliveries because women have access to effective contraceptive

(8)

reproductive goals.11 With regular prenatal appointments, women have time to discuss family

planning options and make an informed decision. However, women cannot initiate any

contraceptive method until after delivery. Providing LARC in the hospital enables women to

access contraception in the overlap between contraceptive intention and physiological capability.

Providing LARC in the hospital prior to discharge is a safe, convenient way to ensure that

women get the contraception they desire (see Figure 1).

History of Medicaid Coverage of Inpatient LARC Distribution

In order to address the public health issues of preterm birth and unintended pregnancy,

Medicaid programs around the country are trying to facilitate EPLARC by changing

reimbursement codes for deliveries. Medicaid programs create new codes which provide larger

reimbursement to cover the cost of the LARC device and the procedure fees.2 The number of

Medicaid programs covering this service is growing rapidly: the most recent estimate is nineteen

states.12 Although the practice of EPLARC placement is spreading around the country, the

impetus, approach to implementation, and rate of practice uptake vary around the country.

South Carolina’s Medicaid program was the first to cover inpatient postpartum LARC

placement in 2012.13 This developed out of The South Carolina Birth Outcomes Initiative, a

coalition that addresses poor birth outcomes and teen pregnancy.14 Part of what made this effort

successful is that a statewide coalition was in place to coordinate advocacy and implementation.

In addition, Medicaid covers 60% of all births and 85% of teen births in South Carolina.13 The

state program benefits from any cost savings this policy produces. This coalition was helpful in

getting the political support for new billing codes, but other states’ policies developed from the

(9)

New Mexico was the second state to extend Medicaid coverage to EPLARC. Three

Obstetrician/Gynecologists lobbied the Department of Health and Human Services (DHHS) with

evidence of the burden of unintended pregnancies in New Mexico.15 Medicaid covers 70% of the

births in New Mexico, mostly in rural areas, and rurality influences access to contraception.13 But

although the state’s DHHS was willing to provide a supplemental code, the University of New

Mexico Hospital was the only one providing this service after 2 years.15 In contrast to South

Carolina which had a statewide initiative to help promote this policy, New Mexico’s few

advocates have not been able to convince other providers in the state, despite the opportunity for

reimbursement. The reluctance of some New Mexico providers might arise from the number of

undocumented women whose delivery will be covered by Emergency Medicaid, but whose

LARC cannot be added on using the new codes.13 New Mexico illustrates the myriad of ways

demographics, culture, political atmosphere, and motivations of state providers and DHHS all

play a role in if and how quickly EPLARC distribution can be established in a state.

Since 2012, the number of states covering, or in negotiations to cover, EPLARC has

grown substantially.2 North Carolina falls into the latter category; it has been considering

EPLARC coverage for over a year and is in the process of negotiating with the Hospital

Association to formalize a process for hospitals to provide and bill for inpatient LARC

insertion.16 Advocates can offer financial and social justification for Medicaid coverage: 46% of

births in North Carolina are paid for by Medicaid.17,18 In 2014, 10% of those women who

delivered with Medicaid coverage were pregnant again within 12 months.17 In addition, North

Carolina is above the national average for pre-term births and infant mortality: 9.7% of births

(10)

The public health justification, however, has apparently not yet stimulated a functional method

of inpatient LARC insertion reimbursement in North Carolina.

Providers at MAHEC and Mission Hospital in Asheville, North Carolina, are eager to

provide LARC in the hospital and are unwilling to wait for Medicaid to start the implementation

process. MAHEC is comprised of family medicine and Ob/Gyn clinics and residency programs.

A team of MAHEC family medicine providers is piloting the inpatient procedure using a

potential coverage work-around. The goal is to optimize the procedure protocol through three

pilot insertions. This pilot project will serve two purposes: starting the implementation process to

ensure easy transition when codes are available, and testing a potential method for providing and

getting paid for this service within the current billing restraints. This project was initiated in

October 2015, and as of the writing of this paper in June 2016, not one insertion has yet

occurred. The motivation and justification seem to be in line, however, even a small pilot project

apparently cannot get underway in North Carolina. This slow process will be the case study for

looking at the disconnect between enthusiasm for quality improvement efforts and the

practicalities of completing projects.

Justification for Quality Improvement Evaluation

Quality improvement (QI) is now virtually a paradigm in the medical community: it is

included in the Patient Protection and Affordable Care Act, mandated as part of graduate medical

education, required for recertification for at least 4 major specialties, and part of health systems’

public and private insurance contracts. However, many health professionals feel ill-equipped to

instigate or manage such projects. The MAHEC pilot project exemplifies some QI and

implementation science methods that have functioned well, and also shows why integrating QI

(11)

The push for QI comes out of a desire for health care to reach the triple aim of improving

population health and the patient experience of care while lowering costs. Approaches to

reaching this aim focus on payment models, care delivery, and cutting out waste. This is

approached on the systems level through initiatives like Accountable Care Organizations and

Medicare reforms, but also on a clinic or hospital level through local QI projects.21 A QI project

is now a requirement of all physicians during residency training.22 The principles of QI are

straightforward, but using them effectively can be difficult.

QI and Implementation Science are fields that examine how people and organizations

attempt change, and provide frameworks and tools to approach change in a systematic and

effective manner. Numerous resources describe techniques for improving a process or instigating

meaningful change in a clinical setting. These resources are often intuitive, so learning about

them prior to a project can be tedious. However, many people are not using these tools

effectively once their projects begin. Despite efforts in medical education and health care

systems to promote the use of these tools, they are perceived to be hard to incorporate and people

often feel they do not have the time to use them. 23

Providing inpatient postpartum LARC is a way of increasing value for patients: it is

aimed at improving population health and patient satisfaction. Because the MAHEC EPLARC

project is aimed at optimizing a process to improve implementation, this evaluation will

approach it using some of the frameworks and tools of QI and implementation science. Although

I am not an expert in either, I will attempt to determine if the slow progress of this project could

have been improved with more focus on QI tools, and how principles of implementation science

(12)

Methods

This MAHEC pilot project is being evaluated as a quality improvement project in the

context of the nationwide push to increase women’s access to LARC devices postpartum. The

goal is to compare this project to similar programs in other states, as well as to consider whether

the project could have been improved with more QI or implementation science tools. This will be

done by triangulating observations of the project’s process, interviews with project planners and

stakeholders, and literature reviews of existing EPLARC programs.

The MAHEC project was initiated by enthusiastic women’s health providers in October

2015. The project instigator and leader is Julia Oat-Judge, a family medicine physician. The

project is being done by MAHEC, in order to bring EPLARC distribution to women who deliver

at Mission Hospital, in Asheville, North Carolina. I, a medical and public health student at the

University of North Carolina at Chapel Hill, am both a team member and an evaluator.

I collected information about other EPLARC programs by conducting a limited

systematic review of the literature (Appendix A). I supplemented the information in published

peer-reviewed articles with the directive resources that were referenced in the articles, and

personal communications with other women’s health providers and state Medicaid officials.

I conducted interviews with key informants in May and June 2016 using the attached

interview guide (Appendix B). Interviews were recorded and written notes were taken during and

immediately following the interviews. Participants were given the option of remaining

anonymous. This project was granted IRB exemption from UNC (reference number: 160757)

(13)

Findings and Discussion Project Origins and Accomplishments

Although the MAHEC EPLARC pilot project has not reached its primary goal of

inserting subdermal LARC, the progress thus far will inform and improve the full project. The

focus of the project over the past 8 months has been to get all involved departments comfortable

with the project, the procedure, and clearing all the hurdles to smooth the path for pilot

insertions. Ideally, this process of familiarization might have proceeded quickly, but with

conflicting clinical priorities and without a start date for Medicaid codes, there is little

motivation to move quickly. The project has moved slowly, but this strong foundation may lead

to faster and better implementation in the future.

The push for EPLARC in North Carolina has arisen from a mix of Medicaid Program

championing and provider enthusiasm. Unlike New Mexico’s EPLARC program which was

developed by a few physicians or South Carolina’s statewide coalition, North Carolina has both a

strong network of provider support and Medicaid promotion.13,16 Although there are no public

comments about the slow progress towards reimbursement codes, the problem seems to be in the

politics of state budget-making in a unique context of Medicaid reform battles. North Carolina is

in discussions to privatize Medicaid, and there has been little space for conversations about

smaller changes.

Representatives from the Medicaid office have promoted EPLARC by positing that it is

possible to do the procedure and the hospital will get paid through budget reconciliation at the

end of the year, a process that hospitals are unwilling to accept. The other reimbursement

(14)

insertion regardless of where the procedure takes place. This latter concept is what opened up the

possibility of a pilot project.

MAHEC has been interested in EPLARC for several years, but the project truly took

shape when Julia Oat-Judge returned to Asheville. She is a family medicine physician who

completed an Obstetrics fellowship in Rhode Island where inserting IUDs and Nexplanons™

postpartum was a common practice. Another MAHEC physician had been thinking about

EPLARC for women with substance use disorders, and Dr. Oat-Judge’s arrival and comfort with

EPLARC moved this from an idea to a project.24 Initially she set the aim at offering all forms of

LARC, to all postpartum patients. Although that is still the long-term goal, without a proven

process for ordering and getting paid for the device, Mission Hospital requested a more limited

pilot project. With Medicaid reimbursement codes rumored to be forthcoming, the project’s

scope was trimmed down to piloting subdermal implant insertion for three high-risk patients, but

with the aim to use expertise gained in the pilot project to streamline implementation on a larger

scale after the Medicaid reimbursement codes arrived.

The specific aim of the pilot process is to create a protocol for Nexplanon™ insertion on

the postpartum floor that is optimized for the patient, physician, nurse, and pharmacy and billing

departments. The plan is to do this through three PDSA cycles. Specifically, the project team will

develop a protocol with input from hospital staff and administrators, perform this protocol on a

patient, study the process through observations and interviews, and then revise the protocol for

the next patient. To be a true PDSA cycle, there needs to be a specific measureable outcome

which this project has not yet identified.25 However, the MAHEC pilot project already has a clear

(15)

projects. With that goal in mind, the project team set out to get stakeholder buy-in, create the

initial protocol, and get hospital approval for the pilot project, which has taken eight months.

Although taking the time to establish connections with each involved department was

slow, the project will ultimately benefit from this careful implementation strategy. The limited

systematic review makes clear that the most successful EPALRC programs were ones that had

focused on educating all people and departments involved in the procedure (Appendix A). The

Learning Community, which brought together the administrators and providers from the six

states that first provided EPLARC, found that places that spent time educating providers, billing

staff, pharmacists, and administrators, were ultimately more successful. In those places the plan

was clear from the outset, and people knew who to turn to if there was a problem.26 The

MAHEC project was deliberate in approaching all departments that might be touched by a

Nexplanon™ insertion: nursing, physicians, pharmacy, billing, lactation consultants. Although

there were patients who were appropriate candidates for the service along the way, the choice

was made to move slowly and get everyone comfortable with the procedure, to ensure against

any misunderstanding that might prevent future insertions.

Involving all the departments, educating them, and opening lines of communication are

important steps in careful implementation. The National Implementation Research Network lays

out 4 stages of implementation: exploration, installation, initial implementation, and full

implementation.27 The exploration and installation stages include identifying champions who are

proponents of the change, and opening lines of communication for feedback.27 The 4 stages of

implementation are estimated to take 2-4 years. The MAHEC project has been working through

(16)

Project Timing: Appropriate Progress or Politically Slowed?

For the people working on the MAHEC pilot project, the progress has seemed

frustratingly delayed. One potential cause of the pace is political discomfort with the project’s

focus. The pilot project is working to increase women’s access to contraception, which can be

controversial and sensitive. However, at the local level, the hurdles have been about resource

utilization and workflow logistics, not disapproval of the service.

Julia Oat-Judge, the MAHEC project leader denies political push-back at Mission

Hospital. She said, “It was more that the hospital is trying to protect it employees from

overwork.”24 The hospital’s concern with EPLARC focused on whether the hospital will get

reimbursed, how disruptive this project will be for the billing and pharmacy department, and

what this procedure will add to the postpartum nurses’ workflow. Their concerns were

appropriate, since without Medicaid codes, the hospital has to donate time and resources to make

this pilot project work.24 Kellett Letson, the Vice President for Women’s Health at Mission

Health System, echoed this sentiment commenting that the pilot project would provide the

hospital quantifiable costs of this procedure. Knowing the monetary effects will allow the

hospital to make an educated decision about whether to donate resources toward this cause.28

This donation of pro-bono service will end when there are state-wide Medicaid codes.

The potential political slowdown is not directly from Mission Hospital employees, but

from the lack of statewide Medicaid codes. A set date when the Medicaid codes were going into

effect, might create an incentive for the hospital to optimize the protocol. As it stands, there is

interest in providing this service, but there is little motivation to invest time and money into its

development. Julia Oat-Judge confirmed this: “I don’t think we experienced any of the direct,

(17)

potential political questions are outside Mission Health System.”28 At the state level, there is

political discomfort with the whole arena of women’s reproductive health, which includes

LARC. When EPLARC was discussed in a state senate subcommittee meeting, some legislators

reacted by considering imposing a 30-day waiting period for LARC postpartum.16 About

Mission Hospital, Dr. Oat-Judge said, “I have not heard that paranoid thinking or people trying

to restrict women’s options here.”24 Even though there were no strong political opponents in

Asheville, this process could have moved more quickly had the motivation come from within the

hospital.

Change, especially change that requires practice shifts, needs a champion. Dr. Oat-Judge

feels like this champion is most effective when she or he is a part of the organization that needs

to change.24 This pilot project would likely have moved more quickly if it had grown organically

at Mission Hospital. Instead MAHEC, an intimately connected but separate organization, has

come in asking them to do more work and donate time.24 Her point requires us to ask whether

this project would have occurred at Mission Hospital without MAHEC instigation: who is

responsible for improving women’s access to contraception and clinical quality improvement?

Where Should Quality Improvement Projects Come From?

Physicians, clinics, and hospitals are increasingly pressured to meet the triple aim,

measured through clinical quality improvement projects. Dr. Oat-Judge feels the ethos of QI has

always existed at MAHEC, but with ACA and certification requirements, the focus of the

projects and desired outcomes have changed.24 Instead of being inspired by frustrations with

inefficient systems, the desired outcomes now seem to be directed by outside organizations.

(18)

Preventive care, like family planning, is not traditionally the role of the hospital. In the

past, the hospital was a place for acute care and the outpatient providers were responsible for

preventive care. The triple aim is changing this narrative. Now, everyone is responsible for

population health. Dr. Letson described his role this way: “My job is to think of ways to help the

women of the 18 counties of Western North Carolina to be well, get well, and stay well.”28 Under

that definition, he wants to increase women’s access to contraception. However, the

reimbursement models have not yet caught up with a population health perspective. He said,

“While this is changing, our nation’s health care system continues to have financial incentives

for hospitals to fill themselves up with the sickest patients with the best possible insurance.”28 In

addition, even if they were paid for preventive services like contraception, this might not be the

best use of hospital resources: “The assumption is always that if you are providing a service at a

high cost location like the hospital that you could be providing at a lower cost location like an

office, it is not as responsible, you are spending more of our precious resources to do something

in the hospital.”28 As payment models change and value-based care is reimbursed, improving

population health still needs to be balanced with lowering costs. When the responsibility of

population health is shared between hospitals and outpatient clinics, decisions need to be made

about how to allocate resources to meet that newly shared goal.

If high value care and quality improvement are everyone’s responsibility, projects need to

come both from the visionary leaders and practitioners in the clinical environment daily. Dr.

Letson placed the responsibility in everyone’s hands: “As a larger system of providers in the

state, that would include Medicaid, government agencies, hospital and providers, we collectively

are definitely responsible for providing access to contraception to any and everybody that wants

(19)

Oat-Judge pointed out that the vision, the broader goals, need to come from people like Dr. Letson,

whose job it is to think about the health of women across western North Carolina.24 To achieve

that, Dr. Letson feels he needs information from practitioners who are on the front lines; the

nurses and physicians who are in clinical practice every day have the best opportunity to identify

places for improvement. These responses seem to show how important open channels of

communication are to achieving change. The most effective change will most likely come from

organizations that set clear and widely understood goals for addressing population health and

provide clinicians the tools they need to attempt QI projects.

Although the EPLARC pilot project might have moved more quickly had it originated at

Mission Hospital, this collaboration between outpatient providers and the hospital might be the

new standard, as the broader health care system shifts its focus to population health. Although

outpatient clinics and hospitals are historically separate organizations, new arrangements, like

Accountable Care Organizations, are changing how these entities interact. Moving forward,

projects like this EPLARC example at MAHEC and Mission Hospital might be the norm.

To get a project like this off the ground in the hospital takes communication and

education; the hospital employees need to see the value of the project, why their location is the

most appropriate for this service, and see a clear justification that the benefits of the service

outweigh the effort and financial costs they entail. Now that the MAHEC project has

successfully got the approval and interest of the hospital, piloting the procedure will provide the

quantifiable evidence needed to make an informed decision about continuing this project toward

(20)

Considerations for Next Steps

As the MAHEC EPLARC project moves forward and potentially expands, careful

consideration should be given to informed consent and who is eligible for inpatient LARC

placement. As Dr. Letson mentioned, LARC is more expensive in the hospital and should be

done only for patients who are at risk for missing their postpartum appointment.28 However,

predicting who is going to miss an appointment is hard to do. MAHEC needs to be careful not to

make assumptions about patients’ reproductive desires and ability to keep appointments.

Descriptions of other EPLARC programs around the country have not provided clear direction

for making the right choices about identifying patients for whom EPLARC is the highest quality

of care (Appendix A). Certain life circumstances like not having transportation might be good

indications that keeping a postpartum appointment will be challenging. However, the desire to

increase these women’s access to contraception needs to be balanced with their desire for birth

control. Although leading with the inpatient option would be enticing, providers should start the

contraception conversation by talking about all the methods, and only present the inpatient

insertion if the patient is interested in LARC and the provider feels the woman is a good

candidate. As the project expands and payment from public and private insurers is confirmed,

this service can eventually be offered to all postpartum women. Until that time, providers and

administrators need to be careful about how they are determining who is high-risk, and how

these women are consenting to inpatient placement.

Breastfeeding is another important consideration in informed consent. Although the

WHO and CDC confirm that the theoretical harms of LARC while breastfeeding are outweighed

by the benefits, there is still concern in the lactation community about EPLARC.29,30

(21)

careful inclusion of a breastfeeding goals discussion in informed consent. Outpatient providers

are going to discuss the importance of breastfeeding and birth spacing, and let patients decide

which would be more devastating: not being able to breastfeed or getting pregnant again in the

next few months. This is another moment when providers need to be aware of their assumptions

and truly listen to their patients’ desires. The ultimate goal of the EPLARC project is to remove

barriers between women and the services they want.

The MAHEC pilot project hopes to move toward the goal of improving women’s access

to family planning services in two ways. Ideally the project will provide sufficient evidence that

the benefits of these procedures outweigh the hospital’s costs, and help to convince the North

Carolina Hospital Association and Medicaid Program to join the nationwide trend and create

reimbursement codes. Alternatively, the MAHEC pilot project might be a model for how this

service can be provided in North Carolina within the current financial restrictions. The pilot

insertions will be billed to Medicaid through the outpatient provider, for whom reimbursement

theoretically will be paid without question, since Medicaid already covers such services in the

outpatient clinic. The MAHEC project is the first in the state to test this process. The results,

positive or negative, will be shared with women’s health providers around the state. It could

allow hospitals to start offering EPLARC in North Carolina in advance of Medicaid codes.

However, even if this process fails, this project will provide valuable information to the North

Carolina medial community.

Conclusion

(22)

and created a protocol that fits their needs. The team secured a method for purchasing and billing

for these devices. The hospital has approved the project. The next step is to find a patient who

wants the subdermal implant and is at risk for short interpregnancy interval. These are

accomplishments and have most likely occurred at the fastest rate possible given the disruption

of hospital workflow and lack of financial incentive.

Even with a potentially controversial procedure, the largest local hold-ups to

implementation are logistical and financial. Innovation is welcome at hospitals like Mission, but

change is disruptive and administrators are appropriately worried about the effects on workflow

and reimbursement. There is a call for all parts of the health system to address population health,

but the financing side of health care has not caught up. Despite the present lack of financial

incentive, hospitals like Mission nonetheless seem to evince genuine vision for population

health.

As hospitals and clinics shift their aims to include population health, QI projects will

develop more naturally. In the current environment, providers feel stretched between doing their

clinical duties and meeting their QI benchmarks. As the culture shifts toward population health,

the clinical and QI goals may better align, and physicians’ interest in and ability to take on QI

projects will grow. As this happens, visionary leaders should support employees by providing QI

and implementation science resources. Although many providers have probably been “trained” in

QI, refreshing understanding of the use of QI tools during a project gives QI principles

immediate relevance. In the example of this EPLARC project, examining QI and implementation

science tools helped to reset expectations for progress.

This is evaluation is limited by my own participation in the project. I have been both

(23)

and to be critical of my own advocacy. I do believe that hospitals in North Carolina will find a

way to provide inpatient postpartum LARC. Implementing these programs will improve with

careful consideration of implementation science and QI principles, as will most health care

innovations in the future.

References

1. Guttmacher Institute. Unintended Pregnancy in the United States. Guttmacher Inst. 2016;(March). http://www.guttmacher.org/pubs/FB-Unintended-Pregnancy-US.html.

2. Moniz MH, Dalton VK, Davis MM, et al. Characterization of Medicaid policy for immediate postpartum contraception. Contraception. 2015. doi:10.1016/j.contraception.2015.09.014.

3. Committee on Gynecologic Practice Long-Acting Reversible Contraception Working Group. Increasing Access to Contraceptive Implants and Intrauterine Devices to Reduce Unintended Pregnancy.

2015;125(618):268-273.

4. Secura GM, Allsworth JE, Madden T, Mullersman JL, Peipert JF. The Contraceptive CHOICE Project: reducing barriers to long-acting reversible contraception. Am J Obstet Gynecol. 2010;203(2):115.e1-e115.e7. doi:10.1016/j.ajog.2010.04.017.

5. Potter JE, Hopkins K, Aiken AR a., et al. Unmet demand for highly effective postpartum contraception in Texas. Contraception. 2014;90(5):488-495. doi:10.1016/j.contraception.2014.06.039.

6. Thiel de Bocanegra H, Chang R, Menz M, Howell M, Darney P. Postpartum contraception in publicly-funded programs and interpregnancy intervals. Obstet Gynecol. 2013;122(2 Pt 1):296-303.

doi:10.1097/AOG.0b013e3182991db6.

7. Zerden ML, Tang JH, Stuart GS, Norton DR, Verbiest SB, Brody S. Barriers to Receiving Long-acting Reversible Contraception in the Postpartum Period. Women’s Heal Issues. 2015:1-6.

doi:10.1016/j.whi.2015.06.004.

8. Rousso D, Panidis D, Gkoutzioulis F, Kourtis A, Mavromatidis G, Kalahanis I. Effect of the interval between pregnancies on the health of mother and child. Eur J Obstet Gynecol Reprod Biol. 2002;105(1):4-6. doi:10.1016/S0301-2115(02)00077-5.

9. Lassi ZS, Mansoor T, Salam RA, Das JK, Bhutta ZA. Essential pre-pregnancy and pregnancy interventions for improved maternal, newborn and child health. Reprod Health. 2014;11 Suppl 1(Suppl 1):S2.

doi:10.1186/1742-4755-11-S1-S2.

10. Conde-Agudelo A, Rosas-Bermúdez A, Kafury-Goeta AC. Birth Spacing and Risk of Adverse Perinatal Outcomes. JAMA J Am Med Assoc. 2006;295(26):1809-1823. doi:10.1001/jama.295.15.1809.

11. Baldwin MK, Edelman AB. The effect of long-acting reversible contraception on rapid repeat pregnancy in adolescents: A review. J Adolesc Heal. 2013;52(4 SUPPL.):S47-S53. doi:10.1016/j.jadohealth.2012.10.278. 12. Moniz MH, Chang T, Davis MM, Forman J, Landgraf J, Dalton VK. Medicaid Administrator Experiences

with the Implementation of Immediate Postpartum Long-Acting Reversible Contraception. Women’s Heal Issues. 2016:1-8. doi:10.1016/j.whi.2016.01.005.

13. Association of State and Territorial Health Officials. Long Acting Reversible Contraception ( LARC ) Learning Community Launch Report. 2014.

http://www.astho.org/Programs/Maternal-and-Child-Health/Long-Acting-Reversible-Contraception-LARC/. 14. Health Management Associates. Medicaid Reimbursement for Immediate Post-Partum LARC. 2013:1-3.

https://www.acog.org/~/media/Departments/LARC/HMAPostpartumReimbursmentResource.pdf. 15. Rodriguez MI, Evans M, Espey E. Advocating for immediate postpartum LARC: increasing access,

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18. Osterman MJK, Martin JA, Curtin SC, et al. Newly Released Data From the Revised U.S. Birth Certificate, 2011. Natl Vital Stat Reports. 2013;62(4):1-22.

19. Matthews TJ, MacDorman MF, Thoma ME. Infant Mortality Statistics From the 2013 Period Linked Birth/Infant Death Data Set. Natl Vital Stat Rep. 2015;64(9):1-30.

http://www.ncbi.nlm.nih.gov/pubmed/26270610.

20. The Kaiser Family Foundation. Preterm Births as a Percent of All Births by Race/Ethnicity.

http://kff.org/other/state-indicator/preterm-births-by-raceethnicity/. Published 2014. Accessed June 20, 2016.

21. Pines JM, Farmer S a., Akman JS. “Innovation” Institutes in Academic Health Centers. Acad Med. 2014;89(9):1204-1206. doi:10.1097/ACM.0000000000000419.

22. Mate KS, Johnson MB. Designing for the Future: Quality and Safety Education at US Teaching Hospitals. J Grad Med Educ. 2015;7(2):158-159. doi:10.4300/JGME-D-14-00199.1.

23. Rosenbluth G, Tabas JA, Baron RB. What’s in It for Me? Maintenance of Certification as an Incentive for Faculty Supervision of Resident Quality Improvement Projects. Acad Med. 2015;XX(X):1-4.

doi:10.1097/ACM.0000000000000797. 24. Oat-Judge J. Key Informant Interview. 2016.

25. Institute for Healthcare Improvement. Science of Improvement: How to Improve.

http://www.ihi.org/resources/Pages/HowtoImprove/ScienceofImprovementHowtoImprove.aspx. Accessed June 20, 2016.

26. Kroelinger CD, Waddell LF, Goodman DA, et al. Working with State Health Departments on Emerging Issues in Maternal and Child Health: Immediate Postpartum Long-Acting Reversible Contraceptives. J Women’s Heal. 2015;24(9):693-701. doi:10.1089/jwh.2015.5401.

27. Ward C. Putting Innovations into Prenatal Care Practice. 2016. 28. Letson K. Key Informant Interview. 2016.

29. Teeper NK, Curtis KM, Jamieson DJ. Update to CDC’s U.S. Medical Eligibility Criteria for Contraceptice Use, 2010: Revised Recommendations fo the use of contraceptive methods in the postpartum period.

MMWR. 2011;60(26):878-883. http://www.cdc.gov/mmwr/preview/mmwrhtml/mm6026a3.htm#tab3. 30. World Health Organization. Medical eligibility criteria for contraceptive use Fifth edition 2015 Executive

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FIGURES

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APPENDIX A

Limited Systematic Review Introduction

About half of pregnancies in the United States are unintended or mistimed.1 In order to

address this, women’s health providers around the country are focusing on improving access to

long-acting reversible contraception (LARC). LARC are birth control devices that are

highly-effective for at least 3 years without patient maintenance. Many women are interested in getting

LARC devices in the postpartum period, however, only about 60% of those who state interest

prenatally have the devices in the twelve weeks after they deliver.2 To improve access to LARC

postpartum more and more hospitals around the country are providing LARC to women early

postpartum, prior to discharge from their delivery hospitalization. This is not yet universal

because reimbursement for the delivery does not cover the high cost of the device and insertion.

Medicaid in nineteen states has created a new reimbursement scheme to encourage hospitals and

providers to offer LARC immediately postpartum.3 The North Carolina Department of Health

and Human Services is in negotiation with the Hospital Association to create reimbursement

codes, but until codes are established, there is no clear way to be reimbursed for this service.

To prepare for the anticipated Medicaid codes, physicians at the Mountain Area Health

Education Center (MAHEC) are hoping to pilot the process of early postpartum LARC

distribution to optimize the protocol before full Medicaid implementation. An upside to North

Carolina being late in initiating early postpartum LARC (EPLARC) programs, are the lessons

other states have learned in establishing their programs. The project coordinators turned to the

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This limited systematic review seeks to answer the following questions:

1. What makes an early postpartum LARC program successful?

2. How many states’ Medicaid programs cover this service in the hospital? How many hospitals in those states have implemented programs?

3. How were programs implemented successfully? How did programs fail?

Methods

MAHEC project coordinators searched several databases hoping to identify reports of

programs, analysis of Medicaid policies, and opinions on the value of or problems covering

EPLARC. In each case, search results were screened for eligibility and relevance. The eligibility

criteria included English language, being about EPLARC programs, or Medicaid coverage of

EPLARC. Relevance was determined first by title, then by reviewing abstracts. All searches

were conducted on May 16, 2016.

A Medline search for “Postpartum LARC” AND Medicaid retrieved 3 articles. The

search was expanded by omitting Medicaid. The search “postpartum LARC” retrieved 8 English

language articles. The same search term was used in SCOPUS, International Bibliography of the

Social Sciences, LexisNexis, and JSTOR.

An additional article was included at the author’s discretion as a result of

“hand-searching” for articles by a certain author. The article was written by one of the authors of

another included article. When I broadened the search further, to encompass this article, I

returned the titles of 73 additional results. Review of these additional 73 articles did not uncover

other relevant articles; the additional article turned out to be only the article that had been missed

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Results

The Medline and SCOPUS searches both retrieved the same eight articles. The search

was repeated in the International Bibliography of the Social Sciences, which gave no results.

LexisNexis produced five, irrelevant articles. JSTOR identifies nine articles, but none were

appropriate for inclusion. Those excluded articles were often about either family planning too

broadly or environmental health. The eight articles from SCOPUS and Medline, plus the article

included at the author’s discretion became the data for this systematic review.

Of the nine articles reviewed in depth, three provided interesting background information

and justification for EPLARC programs, however, they did not fully meet inclusion criteria. Six

articles did meet all the inclusion criteria and they provide answers to the 3 outlined questions.

One article is a literature review on the efficacy of EPLARC, one is an opinion piece, two are

about an Association of State and Territorial Health Officials (ASTHO) Learning Community,

and two are from one qualitative study of Medicaid programs’ approaches to EPLARC (Table 1).

Table 1. Articles in the systematic review.

Authors Title Year Type Quality

Goldthwait e and Shaw

Immediate Postpartum Provision of Highly Effective Reversible Contraception

2015 Review Poor

Rodriguez et al.

Advocating for Immediate Postpartum LARc 2014 Commentary Good

Kroelinger et al.

Working with State Health Departments on Emerging Issues in Maternal and Child Health: Immediate Postpartum Long-Acting Reversible Contraceptives

2015 Program Report

Good

Moniz et al. Characterization of Medicaid Policy for Immediate Postpartum Contraception

2015 Cross-Sectional

Good

Moniz et al. Medicaid Administrators Experiences with the Implementation of IPLARC

2016 Semi-Structured Interviews Good Rankin et al.

Application of Implementation Science Methodology to Immediate Postpartum LARC

2016 Program Evaluation

Fair

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description. This was not a systematic review, but a selective discussion of articles that support

the authors’ view that EPLARC should be the standard of practice. However, if the article is read

with an understanding that this is the authors’ agenda, this is a helpful review of the evidence

that supports the use of LARC while breastfeeding, the safety, efficacy, and cost-effectiveness of

providing LARC in the early postpartum period, and the systemic barriers that need to be

overcome to make this a widespread practice.

A commentary by Rodriguez et al. from 2014 was not shy about the fact that it was an

opinion piece: “advocating” is in the title. Although this article has a clear agenda, it does

describe the three states who were the earliest to adopt EPLARC, explaining their approach,

challenges, and adjustments. This is the oldest article in this limited systematic review, and was

an early way to get information out to providers and hospitals who were considering starting

EPLARC.

Another way that information is being shared about EPLARC programs without true

program evaluations is through descriptions of The Learning Community, a committee run by

ASTHO to get early EPLARC adopters together to discuss strategies. Kroelinger et al. published

a program report on The Learning Community that described the group, the structure of their

meeting, and their topics for continued discussion and communication.5 By describing how The

Learning Community functions, the authors are also able to describe the major themes that have

emerged about EPLARC programs around the country.

Similarly, Rankin et al. wrote a paper about EPLARC by evaluating The Learning

Community using an implementation science framework.6 The authors introduce The

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review well because it is about EPARC and the process of quality improvement. Although this

article can provide information both about EPLARC and implementation science, for readers

without a thorough understanding of CFIR, the authors seem to be describing the domains with

the same examples that they are evaluating. This approach does not allow a reader without

background knowledge in CFIR to apply this framework to The Learning Community, instead

the reader has to trust the authors’ interpretation. Both of the papers about The Learning

Community are masterful in their ability to describe the details of EPLARC programs while

focusing on the process of the Learning Community. However, what is most interesting to see is

true evaluation of EPLARC programs.

Michelle Moniz and her team provide more systematic research on the number of

EPLARC programs through two articles.3,7 The authors contacted Medicaid programs in all fifty

states to assess whether they covered inpatient LARC distribution or were considering changing

their policies. Using semi-structured interviews, they explored some of the experiences of those

Medicaid offices attempting to promote EPLARC. The methods are well described and

thorough: each office was contacted on 4 occasions, interviews were recorded and transcribed, or

notes were taken immediately following the call, and all transcripts were coded and analyzed

using qualitative analysis software. Unlike the ASTHO Learning Community which only

involved 6 states, this study attempted to capture the prevalence of EPLARC programs around

the country. They also are able to describe the success and surprising hurdles that emerged as

themes in the interviews with program implementers. These two articles had the highest quality

because they systematic in their interview and analysis, and provide some clear answers to our

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Although the body of literature is limited on this topic, these articles started to address the

three questions.

1. What makes an early postpartum LARC program successful?

The most successful programs seem to be ones where there are clear protocols that ensure

that payment is made quickly and efficiently. The six states who participated in the ASTHO

Learning Community found that the most successful programs were ones that had developed

protocols and policies that laid out a clear administrative structure and had champions who lead

the implementation.5 These were places where the Medicaid programs had addressed what

Moniz and her colleagues found to be the biggest roadblocks for Medicaid officials trying to

decide whether to cover EPLARC. There were logistical issues: the health effects on Medicaid

beneficiaries, financial implications, and competing demands in the policy environment. 3 There

were also public health concerns: about breastfeeding on LARC, that LARC devices are

abortifactants and the health effect on adolescents.7

2. How many states’ Medicaid programs cover this service in the hospital? How many hospitals in those states have implemented programs?

The most recent estimate is that 19 states’ Medicaid programs cover inpatient LARC

insertion.7 However, this estimate is changing quickly as more states cover EPLARC. Between

the publication of the two Moniz et al. pieces in October 2015 and April 2016, the estimate

increased from 15 to 19 states.3,7 This number will most likely continue to grow. However, there

is no clear estimate of how many hospitals within those states are providing EPLARC.

Rodriguez et al, in the review of the three earliest states, found that in New Mexico only one

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3. How were programs implemented successfully? How did programs fail? Why?

The most successful programs were ones that had done a lot of educating: teaching providers

about the benefits of EPLARC and training them to perform the procedure, talking to the billing

staff about the new protocols and when to update Medicaid about cost changes, and making all

the hospital staff affected by this new procedure comfortable with the protocol prior to

implementation.7 Several successful programs achieved this by piloting the procedure before full

implementation.7

The programs are so new that none can truly be called failures yet. The most common way

EPLARC programs struggled was in efficient and adequate reimbursement. Momentum can slow

down quickly when payment does not come. In addition to pay streams, investigators have

identified hurdles with ordering and stocking the devices.5

Colorado and New Mexico are two extreme examples of implementation, which can help

guide other states. In New Mexico, providers were the champions of EPLARC, and successfully

lobbied to get Medicaid coverage. However, there was no focus on state-wide implementation

and the practice has not spread. Colorado, on the other hand, was a state-level program change

that covered all LARC devices. This was implemented broadly and demonstrated the

cost-effectiveness, which has been a helpful tool in convincing other states to cover EPLARC.8

Colorado has been more successful in increasing access to EPLARC, but New Mexico provides

another model for states where there is less systematic enthusiasm. Neither is truly a failure, but

both could be improved.

Discussion and Concluding Suggestions

The push to provide EPLARC is still a relatively new movement; South Carolina was the

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program evaluations because EPLARC programs are still too new for systematic program

evaluations to discern outcomes. In the meantime, members of the Learning Community are

creatively disseminating preliminary information through descriptions of their meetings and

assessing program commencement using implementation science techniques.

Kroelinger et al.’s program report included a table of the topics they discussed, with links

to all of the Powerpoints and handouts. This was a tactic to get these resources distributed to

more people, to publicize the work and resources that other states can use.5 The information that

we, as project coordinators, were looking for, is found more in the supplemental resources they

mention and not in the article itself. The downside to this approach is that the results, the

information that readers most want, is interspersed with the discussion of the meeting structure,

and not clearly laid out.5

There is so much interest in EPLARC that descriptions and preliminary results would be

helpful. There is information on the ASTHO website, which these published articles help guide

people to, but more information would be helpful.5 Moniz and her colleagues have started to

answer these questions by interviewing the Medicaid administrators, but more studies,

particularly from the provider or hospital administrator perspective would be helpful.3,7 In

addition, the articles mostly discussed places where EPLARC coverage was being implemented.

Although it is helpful to learn about successes and overcoming challenges in places where the

programs have begun, it might also be helpful to know more about places that have not been able

to gain momentum.

Without thorough program descriptions, certain nuances associated with EPLARC are

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informed consent is critical, and the current published literature does not do this topic justice.

The ASTHO Learning Community included consent as one of their main discussion points, but

in order to learn more, readers have to track down the resources associated with that session.5

People are eager for this service to be widely available, but it is important to implement it with

careful thought.

References

1. Guttmacher Institute. Unintended Pregnancy in the United States. Guttmacher Inst. 2016;(March). http://www.guttmacher.org/pubs/FB-Unintended-Pregnancy-US.html.

2. Zerden ML, Tang JH, Stuart GS, Norton DR, Verbiest SB, Brody S. Barriers to Receiving Long-acting Reversible Contraception in the Postpartum Period. Women’s Heal Issues. 2015:1-6.

doi:10.1016/j.whi.2015.06.004.

3. Moniz MH, Dalton VK, Davis MM, et al. Characterization of Medicaid policy for immediate postpartum contraception. Contraception. 2015. doi:10.1016/j.contraception.2015.09.014.

4. Goldthwaite LM, Shaw KA. Immediate postpartum provision of highly effective reversible contraception.

Curr Opin Obstet Gynecol. 2015;27(6):460-464. doi:10.1111/1471-0528.13306.

5. Kroelinger CD, Waddell LF, Goodman DA, et al. Working with State Health Departments on Emerging Issues in Maternal and Child Health: Immediate Postpartum Long-Acting Reversible Contraceptives. J Women’s Heal. 2015;24(9):693-701. doi:10.1089/jwh.2015.5401.

6. Rankin KM, Kroelinger CD, DeSisto CL, et al. Application of Implementation Science Methodology to Immediate Postpartum Long-Acting Reversible Contraception Policy Roll-Out Across States. Matern Child Health J. 2016. doi:10.1007/s10995-016-2002-4.

7. Moniz MH, Chang T, Davis MM, Forman J, Landgraf J, Dalton VK. Medicaid Administrator Experiences with the Implementation of Immediate Postpartum Long-Acting Reversible Contraception. Women’s Heal Issues. 2016:1-8. doi:10.1016/j.whi.2016.01.005.

8. Rodriguez MI, Evans M, Espey E. Advocating for immediate postpartum LARC: increasing access, improving outcomes, and decreasing cost. Contraception. 2014;90(5):468-471.

doi:10.1016/j.contraception.2014.07.001.

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APPENDIX B

Interview Guide for Key Informants

Aim: To assess attitudes towards the QI project, perceptions about barriers and potential success, and sense of QI projects more broadly at Mission

Background Information

What is your role at the hospital?

What have you heard about plans to distribute LARC at Mission?

What is your role in the pilot project?

Project Specific Questions

How did you first get involved in the project?

How do you feel this project will affect your departments work flow? - What will the costs be?

- How much time will you spend on it?

How does piloting the project improve the plan for implementation?

How would you most like postpartum LARC be brought to Mission?

What do you think are the biggest barriers to providing LARC on MomBaby?

What issues do you think this type of project poses?

Quality Improvement Efforts

What do you think are the biggest barriers to protocol changes at the hospital? - What administrative steps stand in the way

- How much does cost play a role?

- Who is responsible for promoting change?

What are the departmental policies that promote quality improvement projects? - What about deter?

Attitudes Towards Contraception

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Interview Guide for Follow –Up to Pilot Tests

Aim: To review each participants’ experience with Nexplanon™ insertion procedure in order to revise the protocol for the next pilot insertion.

Procedure

How much time did the Nexplanon™ insertion and documentation take you?

What would you have been doing during that time?

How comfortable were you with the duties assigned to you?

Did you feel like you had adequate training to perform your tasks?

Attitudes

Do you think the procedure ran smoothly?

What would improve your experience participating in this procedure?

Were you uncomfortable with any part of the procedure?

What would you change about the procedure protocol?

Figure

Figure 1. How inpatient LARC placement captures the overlap between women’s contraceptive  intention toward and physiological ability to get LARC.

References

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