Part V - Opening New Pathways for Health Care Delivery and Access

Introduction

Katherine L. Kraschel

The chapters that follow in Part V of this volume illustrate how COVID-19’s disruptive pressure on health care delivery and access served as a catalyst for change. These chapters show that the analogy to a catalyst in a chemical reaction is apropos, demonstrating how COVID-19:

(1) sped up but did not create novel modalities of health care delivery and treatment; (2) created new pathways to care through various legal and policy changes; and (3) ushered in changes that may or may not have sustained impact.

First, in chemistry, a catalyst speeds up a reaction but does not create one itself. Each of the chapters in Part V describes an innovation in delivery or pathway around barriers to access that existed prior to COVID-19 but whose uptake was sped up in the face of the pressures of COVID-19. In Chapter 18, “Telehealth Transformation in COVID-19,” Ryan Knox, Laura Hoffman, Asees Bhasin, and Abbe Gluck emphasize that telehealth has existed for more than seventy years and describe the long-standing barriers to embracing it – from payment to licensing, prescribing, and privacy laws, and more. In Chapter 19, “Changes in the Provision of Take-Home Methadone for People with Opioid Use Disorder During the COVID-19 Pandemic: Implications for Future Policymaking,” Dr. Zoe Adams, Taleed El-Sabawi, Dr. William Coe, Hannah Batchelor, Janan Wyatt, Mona Gandhi, Dr. Ida Santana, and Dr. Ayana Jordan point to evidence supporting the safety and effectiveness of methadone to treat opioid use disorder (OUD) that predate the pandemic. In Chapter 20, “Reproductive Justice After the Pandemic: How ‘Personal Responsibility’ Entrenches Disparities and Limits Autonomy,” Rachel Zacharias, Elizabeth Dietz, Kimberly Mutcherson, and Josephine Johnston describe the pre-pandemic consensus that in-person requirements for medication abortion provision were unnecessary. Similarly, in Chapter 21, “Abortion At-Home and At-Law During a Pandemic,” Joanna Erdman describes the unrealized revolutionary potential of medication abortion that has been lying in wait since its first uses in the 1980s.

The first three chapters in Part V point to problematic sources of regulatory barriers to access. As Dr. Adams and her coauthors state, “[r]ooted in racialized understandings of criminality, methadone has been regulated for protection of ‘the public,’ rather than for the safety, efficacy, and treatment of people with OUD.” In addition, Zacharias, Dietz, Mutcherson, and Johnston depict the entrenched notions of personal responsibility and blameworthiness that took a backseat in the name of reducing the risk of viral spread and uncover readily available, reproductive justice-enhancing alternatives.

Second, a catalyst speeds up a reaction by creating lower energy pathways to the end state of the reaction. The chapters in Part V show where the system was before COVID-19, including the legal, regulatory, and political structures in place, and how racism and sexism manifest as barriers to effective care. They also detail how government responses elicited by COVID-19 shepherded changes, creating new pathways. Knox and his coauthors detail the rapid change to both state and federal laws that allowed the unprecedented growth of telehealth, largely in a synergistic way between federal law, governing issues such as Medicare reimbursement and privacy, and state laws, governing licensure. The other three chapters in Part V tell a slightly different story of how state and federal laws can work against one another – one looking to maintain the status quo, the other forging a new pathway to access. They show us how COVID-19 acted as a catalyst to motivate government actors to open new pathways to an end state that mitigates some of the pitfalls of the system at the outset and provides a roadmap for similar models in the future.

Finally, a catalyst’s effect depends upon whether the reaction is reversible or irreversible. If it is irreversible, the catalyst speeds up the reaction and results in newly formed substances that cannot react with one another to return to the pre-reaction state. If the reaction is reversible, the catalyst serves to move the reaction along more quickly, but to an equilibrium in which some of the new products react to return to the original state. Taken collectively, the chapters in Part V tell a story of accelerated uptake of forward-looking models of care. Some show how COVID-19 expedited the demolition of barriers to care that were largely unsupported by evidence and based in racism and sexism. They also illustrate the precariousness of their longevity and the complexities of laws governing health care. Knox and his coauthors note that the Centers for Medicare and Medicaid Services have made some changes permanent by adding several telehealth services to the list of covered services, while noting that many other changes have sunsetted or are slated to sunset. They also discuss the remaining challenges for telehealth, including perpetuating disparities in accessing care and fraud, and call for continued research and regulatory innovation. Dr. Adams and her research team summarize the growing body of peer-reviewed literature and share their own study that provides concrete evidence of the safety and patient satisfaction of take-home doses of methadone for patients with OUD. Zacharias and her coauthors argue for the reproductive justice-enhancing changes

COVID-19 facilitated to serve as proof of concept for further, long-lasting reforms. Finally, Erdman describes how COVID-19 brought abortion into the home and contemplates the feedback loop that will continue between abortion at-home and laws that govern its provision.

What these chapters make abundantly clear is that no one law, no one body – legislative, regulatory, executive, or judicial – can work in isolation to maintain the gains realized during the pressures of the pandemic. Similarly, no entity alone can ensure lasting improvements or that the barriers removed during COVID-19 are not reconstructed. Time will tell whether COVID-19’s catalytic power to reform health care delivery and remove barriers to access will be a lasting legacy of change or a brief snapshot in time.

18 Telehealth Transformation in COVID-19

Ryan P. Knox , Laura C. Hoffman , Asees Bhasin , and Abbe R. Gluck

I Introduction

Telehealth surged to the forefront of health care delivery during the COVID-19 pandemic. Though it has existed for years, telehealth has long faced legal, regulatory, and economic barriers to widespread adoption in the United States. The COVID-19 pandemic forced the health care system to rapidly adapt to overcome significant challenges, including those relating to reimbursement rules, regulation of online prescribing, privacy laws, and licensing requirements.

The policy changes implemented during the pandemic allowed for the adoption of telehealth at lightning speed and are in many ways unlikely to be rolled back even after the pandemic concludes. Yet while this natural experiment with telehealth demonstrated its overall effectiveness and received high patient satisfaction, concerns remain regarding telehealth’s appropriateness in some health care contexts, its cost-effectiveness, its potential for exacerbating existing health disparities, and its risks of fraud and abuse. Further, many of the policy changes implemented during the pandemic were temporary; failure to make changes permanent will limit telehealth’s future success.

This chapter engages with the transformation of telehealth use and regulation during the COVID-19 pandemic. After examining the historical and current barriers to telehealth adoption, we detail the explosive growth of telehealth during the pandemic, as well as the challenges that remain for the field’s future success.

II Background

Telehealth, sometimes referred to as telemedicine, is the provision of medical, public health, and health education services remotely – when a patient and provider are in different locations – using technology. Telehealth may involve real-time communications with a provider using audio-video or audio-only devices, the transmission of health information manually or through a medical device, or data tracking using a mobile health application.

Telehealth has existed in some form for more than seventy years and has grown significantly in recent decades. Radiological images were first sent by telephone in 1948, from West Chester, Pennsylvania to Philadelphia. In 1959, the Nebraska Psychiatry Institute began providing psychiatric consultations by videoconference. The National Aeronautics and Space Administration started telehealth projects in the 1970s, providing telehealth to rural patients in at least six states. Many large telehealth companies formed in the 2000s, providing services to patients directly or through partnerships with insurers or health systems.

Despite its long history and growth before the COVID-19 pandemic, telehealth’s role in the US health care system was limited. Telehealth use was increasing by 30–50 percent per year prior to the pandemic, but adoption rates were still very low.¹ Only 0.25 percent of Medicare beneficiaries had used a telehealth service in 2016, and only 840,000 Medicare fee-for-service telehealth visits occurred in 2019.² For large employer plans, only 0.8 percent of beneficiaries in 2016 and 2.4 percent of beneficiaries in 2018 had used a telehealth service.³ In February 2020, fewer than six services per 1,000 Medicaid and Children’s Health Insurance Program beneficiaries were delivered via telehealth.⁴

Many factors contributed to telehealth’s limited success. First, limited telehealth coverage and reimbursement by payers, or even a complete lack thereof, as well as lower rates of reimbursement as compared to in-person visits, deterred patient and provider adoption. Second, licensing laws have traditionally been barriers to telehealth adoption, as most states and Medicare require providers be licensed in the state where the patient is located. Third, state laws and federal health regulations restricting the creation of a doctor–patient relationship via telehealth, often requiring an initial in-person encounter, have prevented or discouraged telehealth adoption. Fourth, telehealth prescribing of certain medications was restricted by federal laws and regulations prohibiting prescribing without an in-person evaluation or requiring in-person dispensing. Last, health privacy laws have limited the technologies that can be used for telehealth, prohibiting the most commonly used and easily accessible platforms, such as Zoom or FaceTime.

III Changes to Telehealth Regulation in COVID-19

The COVID-19 pandemic demanded rapid changes virtually overnight. Medical providers suspended non-essential in-person appointments and procedures to curb the spread of the virus and to reduce the burden on a medical system under unprecedented pressure. Both government and health care stakeholders across the country implemented new laws and policies to resolve many barriers to the use of telehealth.

A Coverage Parity

Government and private payers moved quickly to increase telehealth coverage and reimbursement. Historically, Medicare covered telehealth only if the patient was in a rural area, and even then required patients to go to an “originating site” to receive the care (typically a provider’s office).⁵ In March 2020, the Department of Health and Human Services (HHS) used its authority under Section 1135 of the Social Security Act to issue a waiver lifting this restriction by permitting non-rural patients to receive telehealth services and the patient’s home to be an “originating site” of care.⁶ Medicare also had previously required telehealth be delivered in real time using both audio and video technologies. While this requirement largely remained, the Centers for Medicare and Medicaid Services (CMS) issued a rule allowing reimbursement for behavioral health and patient education services provided via telehealth when patients only have audio-only phones.⁷ CMS also added 144 additional telehealth services to its covered services list.⁸ Many of these services were temporarily covered through the duration of the public health emergency. CMS extended permanent coverage to many behavioral telehealth services, including audio-only telehealth services, and temporary coverage to several other telehealth services through December 31, 2024, allowing the agency additional time to evaluate whether to cover those services permanently.⁹ States and private health plans also removed many telehealth coverage restrictions. Medicaid programs in all fifty states and the District of Columbia covered some telehealth services prior to the pandemic, but only nineteen states permitted beneficiaries to receive services at home and very few covered audio-only services.¹⁰ During the pandemic, the majority of states issued emergency policies expanding Medicaid telehealth coverage, most permitting beneficiaries to access telehealth in their home and some audio-only telehealth visits. More than forty states already had laws regulating telehealth coverage, though only about half of them required private insurers to cover telehealth services to the same extent as in-person visits (i.e., coverage parity).¹¹ During the pandemic, at least six additional states required coverage parity, with another dozen states requiring some level of expanded telehealth coverage.¹² Many states also took steps to expand access to audio-only telehealth services for individuals with private insurance, with only three states requiring plans to cover audio-only services prior to the pandemic and an additional eighteen states requiring private plan coverage of audio-only services permanently or temporarily during the pandemic.¹³

B Payment Parity

In addition to expanding coverage, payers also increased reimbursement rates for telehealth services. Medicare reimbursed all audio-video telehealth services and most audio-only telehealth services at the same rate as in-person visits (i.e., payment parity).¹⁴ This was extended and is set to expire at the end of 2023.¹⁵ In at least forty-five states, Medicaid adopted payment parity for audio-video and audio-only telehealth visits – reimbursing both in-person and telehealth service at the same or comparable rates.¹⁶ At least eighteen states also adopted policies temporarily requiring telehealth payment parity for private health plans.¹⁷ Several states have since made these changes permanent.¹⁸

C Licensing

Regulators temporarily eliminated state licensing requirements preventing telehealth adoption. For most states and Medicare, providers must be licensed in the state where the patient is located. CMS used its waiver authority to waive licensing requirements, permitting providers with out-of-state licenses to practice via telehealth if they met certain requirements.¹⁹ All fifty states and the District of Columbia also waived certain licensing requirements during the pandemic, with some offering a fast track licensure pathway for out-of-state providers.²⁰ Some of these waivers applied only to doctors, while many others also included nurses, nurse practitioners, physical therapists, other mental health professionals, or inactive or retired licensees.²¹ Most of these waivers were temporary, with about thirty state waivers having expired at the end of 2021 and only three remaining in place in April 2023. States have taken further action, however, to ease telehealth licensing requirements, including temporary practice laws, interstate licensing compacts, and telehealth practice licensure (https://telehealth.hhs.gov/licensure/licensing-across-state-lines.).

D Doctor–Patient Relationships

While many states permitted the creation of a doctor–patient relationship via telehealth before the pandemic, some required an in-person examination or an existing doctor–patient relationship before allowing the provision of telehealth services. During the pandemic, some states suspended laws requiring a doctor–patient relationship to be formed through an in-person visit.²² Similarly, Medicare previously required that a telehealth provider had an existing relationship with the patient and had treated the patient in-person within the past three years.²³ CMS waived these requirements for the duration of the COVID-19 public health emergency.²⁴ Medicare requirements for in-person visits within six months of the first behavioral health encounter and annually thereafter were also waived through December 31, 2024.²⁵

E Prescribing

Historically, federal laws have prohibited telehealth prescribing of certain controlled substances without an in-person evaluation. Prior to the pandemic, most states required a patient–provider relationship before certain drugs (the list of drugs varies by state) could be prescribed remotely, and in at least fifteen states a physical exam would be required – in person, by live video, or by a referring physician.²⁶ During the pandemic, however, at least fifteen states issued emergency orders removing such in-person requirements. The Secretary of HHS and the Drug Enforcement Administration (DEA) invoked the “telemedicine exception” of the Controlled Substances Act, which permits health care providers to prescribe controlled substances, including opioids, via a real-time video telehealth visit without a prior in-person visit. The DEA also exercised enforcement discretion to permit prescribing of buprenorphine, an opioid use disorder treatment, over the phone without an in-person or video consultation.²⁷ While the in-person evaluation requirement remained for new patients being treated with methadone, Opioid Treatment Programs were permitted to dispense both buprenorphine and methadone based on a telehealth evaluation, including an audio-only evaluation. Congress since eased telehealth prescribing of buprenorphine by passing the Mainstream Addiction Treatment Act in 2022.²⁸ The DEA took further steps, announcing proposed permanent rules that would permit telehealth prescribing of buprenorphine and non-narcotic Schedule III, IV, and V controlled substances under certain circumstances, in some cases without an in-person evaluation.²⁹

Similarly, Food and Drug Administration (FDA) regulations requiring in-person visits or laboratory tests for the dispensation of certain medications have historically restricted telehealth prescribing. During the pandemic, the FDA exercised enforcement discretion over in-person testing and dispensing requirements for certain medications, but controversially did not initially waive in-person dispensing requirements for mifepristone, part of a medication abortion regimen.³⁰ While a Maryland federal court issued two injunctions prohibiting the FDA from enforcing in-person requirements for mifepristone, the Supreme Court stayed enforcement of the Court’s decision in January 2021, allowing the FDA to continue enforcing the requirements.³¹ The FDA under the Biden Administration later lifted these restrictions, first temporarily in April 2021 and then permanently in January 2023, thereby permitting online prescribing of mifepristone as well.³² The policy change remains controversial, with an ongoing court battle challenging FDA’s approval of and safety requirements for mifepristone.³³ This controversy is exacerbated by the Supreme Court’s decision in Dobbs v. Women’s Whole Health Organization and states’ efforts to both protect and restrict access to abortion. While some states permit telehealth to access medication abortions, other states have required in-person visits or in-person dispensing to limit access.³⁴

F Privacy

The Health Insurance Portability and Accountability Act (HIPAA), which sets privacy and security requirements for health care providers and certain other entities handling health information, prohibits providers from communicating with patients or transmitting patient information over most commonly used platforms. In March 2020, HHS announced that during the pandemic it would “exercise enforcement discretion and … waive potential penalties for HIPAA violations against health care providers” delivering telehealth services over common platforms, including FaceTime and Zoom, as long as they were not public-facing.³⁵ Many states also provided guidance on state health privacy laws for telehealth providers. HHS announced that the discretionary enforcement for HIPAA violations related to telehealth will conclude at the end of the public health emergency, with a 90-day transition period for entities to become compliant.³⁶

IV Data on Telehealth Adoption During the Pandemic

These changes and reforms to telehealth regulation, and many others, permitted a massive surge in telehealth adoption during the COVID-19 pandemic. While the week before the pandemic saw only 13,000 Medicare telehealth visits, the last week in April 2020 saw 1.7 million.³⁷ By the end of 2020, there were 52.7 million Medicare fee-for-service telehealth visits, a sixty-three-fold increase compared to 2019.³⁸ Medicaid and Children’s Health Insurance Program beneficiaries saw a twenty-fold increase in telehealth visits, from six telehealth visits per 1,000 beneficiaries in February 2020 to over 150 telehealth visits per 1,000 beneficiaries in April 2020.³⁹ From April 2019 to April 2020, private insurance claims for telehealth increased by more than 8,000 percent.⁴⁰

Telehealth provided access to many health care services, making possible treatment that would have otherwise been delayed or prevented by the pandemic. Providers met virtually with patients, over the phone or by videoconference, to provide non-urgent care visits or other routine consultations to manage medical and psychiatric conditions. Among medical specialties, gastroenterology, neurology, endocrinology, and psychiatry saw the greatest telehealth adoption during the pandemic, while obstetrics/gynecology, oncology, ophthalmology, physical therapy, and orthopedics saw the least.⁴¹ More than half of endocrinologists, gastroenterologists, neurologists, pain management physicians, and psychiatrists used telehealth at least once during the COVID-19 pandemic between March and June 2020.⁴² Telehealth in pediatrics varied by location and type of provider, with many visits for endocrine, nutritional, and metabolic diseases, and mental and neurodevelopmental disorders.⁴³

Telehealth utilization rates varied widely across the country. One study found that between May 20, 2020 and June 16, 2020, 47.6 percent of visits in Massachusetts were via telehealth, compared to only 8.4 percent in South Dakota.⁴⁴ The Assistant Secretary for Planning and Evaluation similarly reported that between January and December 2020, the highest use of telehealth by Medicare beneficiaries was in Massachusetts, Vermont, Rhode Island, New Hampshire, and Connecticut, while the least use was in Tennessee, Nebraska, Kansas, North Dakota, and Wyoming.⁴⁵ There was also greater telehealth adoption in urban areas, counties with low poverty rates, and areas with a higher COVID-19 prevalence between March and June 2020.⁴⁶

These explosive telehealth utilization rates decreased as the pandemic wore on, but stayed significantly above pre-pandemic levels. After quarantine ended for most people in early May 2020, telehealth use decreased, though it was still about thirty-eight times above the pre-pandemic level.⁴⁷ These telehealth rates leveled out during the summer of 2020, plateauing at about 17 percent of all outpatient visits. Some specialties saw significantly higher continued telehealth use, in particular psychiatry and substance use treatment, maintaining telehealth rates at about 50 percent and 30 percent, respectively. Neurology, family medicine, and internal medicine also sustained higher rates of telehealth video visits through March 2021.⁴⁸ Other specialties, especially surgical specialties, largely returned to in-person visits.⁴⁹

Despite the decrease in telehealth utilization, the changed landscape endured. Patients and providers alike indicated high satisfaction with telehealth and a desire to continue using telehealth after the pandemic. A May 2020 Press Ganey survey found that 96.3 percent of patients were likely to recommend a telehealth visit with their provider to others.⁵⁰ Providers have also reported positive experiences with telehealth. One survey of a large health care system found that clinicians “feel that they are able to not only provide equal quality of care in a video visit and an in-person visit, but also to establish rapport to the same extent via either type of visit.”⁵¹

V Telehealth Risks and Limitations

While the COVID-19 pandemic highlighted telehealth’s potential, it also raised several risks and limitations associated with telehealth use, in addition to the challenges discussed above.

A Disparities in Telehealth Access and Use

Telehealth aims to improve access to health care, but the experience during the pandemic made it plain that access is not equitable. A major disparity related to telehealth is the “digital divide” – the gap in access to technology, access to Internet coverage, and digital literacy. Lack of access to technology prevents many populations from accessing telehealth. People without a smartphone, computer, or tablet may not be able to use telehealth or may only be able to use audio-only services, which providers largely view as inferior. Older adults, people of color, and low-income populations are less likely to have the technology at home needed for telehealth access.⁵² The technology necessary for telehealth, and in some cases the website accessibility of the telehealth platform, pose further challenges for some populations, as many platforms are not accessible for people with disabilities, particularly visual, hearing, or speech impairments, or cognitive disabilities.⁵³ Many telehealth platforms are only in English, are primarily designed for English speakers, or have limited access to interpreters, preventing effective use for patients with limited English proficiency or who are non-English speaking.⁵⁴ The design of telehealth technologies is frequently not made with the specific needs of various populations in mind.⁵⁵ Access to Internet coverage is also necessary for telehealth. Half of low-income Americans and a third of rural Americans lack broadband access at home.⁵⁶ Digital literacy, or the ability of people to use technologies, also contributes to disparities in telehealth. Older adults in particular have less digital literacy, hindering their ability to use telehealth.⁵⁷ Without addressing the digital divide, telehealth may leave certain populations behind, including those already experiencing health disparities.

Consistent with these barriers, studies have shown that people in rural areas, older adults, people with Medicaid, and patients whose preferred language was not English had lower rates of telehealth adoption during the COVID-19 pandemic.⁵⁸ Relatedly, older age, Black race, Latinx ethnicity, Medicaid insurance, and lower income were associated with decreased use of telehealth with video and increased use of audio-only telehealth services. While telehealth seeks to promote access to health care, it may be exacerbating existing health disparities.

B Telehealth Appropriateness and Effectiveness Across Health Care Contexts

There are also concerns about telehealth’s appropriateness and effectiveness in different health care contexts. Some benefits of telehealth are broadly accepted, including “refilling prescriptions, treating low-severity symptoms, and counseling for mental health.”⁵⁹ Telestroke care has been used for decades and is an effective, life-saving tool.⁶⁰ A systematic review indicated that outcomes of telemental health relating to assessment and treatment of mental health conditions were not significantly different when compared with in-person care.⁶¹ The same review found that care delivered by telerehabilitation was generally equivalent to or yielded better outcomes than in-person care. Telehealth has also been effective in detecting post-operative complications related to appendectomies and colorectal surgeries.⁶² Additionally, a study also found that in the obstetric field, telehealth interventions improved outcomes related to smoking cessation and breastfeeding, and decreased the need for high-risk obstetric monitoring office visits while maintaining maternal and fetal outcomes.⁶³ Telehealth was also found likely to yield clinical improvements in nutrition management for older adults living at home when compared to usual care or no intervention.⁶⁴

Alongside the benefits of telehealth, there also exist some drawbacks to using it as an delivery method. Naturally, there are limitations in which tests, assessments, and examinations can be accomplished during a telehealth visit without a patient having additional medical technologies at their disposal. For example, assessments of blood pressure and cholesterol during telehealth primary care visits decreased during the COVID-19 pandemic.⁶⁵ Further, many types of care, even if they can be initiated over telehealth, necessitate subsequent in-person visits. Between 10 and 20 percent of patients require an in-person biopsy after a telehealth dermatology visit and 38 percent of patients receiving a diabetic retinopathy screening via telehealth require an in-person follow-up.⁶⁶ Another study showed that patients using direct-to-consumer telemedicine for diagnosis of acute respiratory infections were more likely to have a repeat related visit within seven days than similar patients who visited their providers in person.⁶⁷ Patients may be seeking this follow-up care because they were directed to, due to a worsening of their symptoms, or due to concerns about the inability to conduct a physical examination or the quality of care provided by a telemedicine visit. These issues of proximity may also have impacts on the accuracy of diagnosis and consequently on the quality of treatment. For example, a study reported that in-person dermatology performed better for diagnostic accuracy than teledermatology; within this, a higher diagnostic concordance was found between in-person dermatology and live video as compared to asynchronous communications (submitting data for review by a provider at a later time).⁶⁸ A 2018 study examining patients seeking care for a sore throat found that telemedicine exhibited poor agreement with the in-person physical examination on the primary outcome of tonsil size, but exhibited moderate agreement on coloration of the palate and cervical lymphadenopathy, and suggested that physical examination likely remained an important part of the diagnostic process.⁶⁹

While telehealth has been seen to be successful during the pandemic overall, it is not effective or appropriate in all health care contexts. Further research is required to determine how the efficiency of telehealth can be maximized to discern those specialties and services for which telehealth is suited and those for which it is not ideal. Research comparing the impact of in-person visits and telehealth visits on health outcomes will also prove very valuable.

C Telehealth Utilization and Spending

Furthermore, there has been debate as to whether increased telehealth coverage in the long term will drive up health care utilization and, in turn, health care spending. The convenience of telehealth may promote excessive, unnecessary utilization; as such, some studies have indicated that telehealth coverage expansions would increase overall health spending.⁷⁰ There is conflicting evidence as to whether this has been the case in practice. One study of ambulatory visits between October 1, 2019 and April 30, 2021 at a large New England health care system found that adopting telehealth did not increase the overall volume of visits and that most telehealth visits were substitutive, not additive.⁷¹ This evidence must be considered in light of the fact that such care was sought during an ongoing pandemic, and it is unclear where telehealth services will be substitutive or additive in the absence of these circumstances. For example, a study of Blue Cross Blue Shield of Michigan patients between 2011 and 2017 found telehealth visits for all conditions except mental health were associated with a higher rate of subsequent visits and increased health care utilization.⁷²

D Telehealth Fraud

From the beginning of the pandemic, HHS recognized the potential for health care fraud in telehealth, especially as its use increased. To mitigate provider risk and incentivize telehealth adoption, HHS allowed providers to reduce or waive patient copayments for telehealth services during the COVID-19 pandemic, which typically would violate the Anti-Kickback Statute.⁷³ While this eased the quick transition to telehealth, it did not prevent fraud and abuse in the growing telehealth market. The relaxed regulatory environment increased the risk of upcoding (billing for more expensive services or more time than was spent with the patient), misrepresenting the services provided, and billing for services not rendered. Studying telehealth use during the first year of the pandemic, the HHS Office of the Inspector General found 1,714 providers – receiving $127.7 million in Medicare fee-for-service payments – that posed a high risk of fraud, waste, or abuse of telehealth services.⁷⁴ Some large telehealth fraud schemes have involved telehealth providers billing for consultations that did not occur and receiving bribes to order unnecessary testing, durable medical equipment, and pain medications, sometimes with no or limited patient interaction. Two such cases brought by the Department of Justice in 2020 and 2021 alleged $4.5 billion and $1.1 billion in losses to Medicare, respectively.⁷⁵

VI The Future of Telehealth

Steps have already been taken to secure telehealth’s future place in the US health care system. Some reforms have already been implemented, while many other proposals at the federal and state levels remain pending.

A Federal and State Reforms and Proposals

Many of the changes implemented during the pandemic have been made permanent. In 2021, CMS permanently added several telehealth services to its list of Medicare-covered services, including group psychotherapy and psychological and neuropsychological testing.⁷⁶ In 2022, CMS authorized Medicare payments for telehealth services furnished “for purposes of diagnosis, evaluation or treatment of a mental health disorder” on a permanent basis. CMS also expanded the ability of Opioid Treatment Programs to provide counseling and therapy services using audio-only telehealth, while Substance Abuse Mental Health Services Administration extended the rules permitting telehealth prescribing of methadone by Opioid Treatment Programs.⁷⁷ The FDA permanently removed mifepristone’s in-person dispensing requirements in January 2023.⁷⁸ Since March 2021, at least 25 states have passed laws expanding access to telehealth, including allowing telephone visits and requiring telehealth services be accessible for people with disabilities, older adults, and people with limited English proficiency.⁷⁹ Twenty-one states have adopted payment parity as of May 2023, with an additional seven states having conditional payment parity.⁸⁰ Arkansas passed legislation allowing providers to establish a relationship and treat patients in an audio-video or audio-only telehealth visit and to prescribe non-controlled substances.⁸¹ At least nine states have permanently allowed for audio-only telehealth visits in Medicaid.⁸² Five new states joined the Interstate Medical Licensure Compact, easing licensing barriers for telehealth providers in those states.⁸³

Other changes have not yet been made permanent, although several telehealth policy proposals have been made at the federal and state levels. Multiple bills have been introduced in Congress to remove Medicare’s geographic restrictions on telehealth coverage.⁸⁴ Other bills have sought to expand access to telehealth for specific types of health care services. The Women’s Health Protection Act of 2023 would protect providers’ ability to deliver and patients’ ability to access telehealth medication abortion services.⁸⁵ The Expanding Access to Mental Health Services Act would allow Medicare to permanently cover behavioral health counseling services provided via audio-only telehealth.⁸⁶ Many states have also proposed legislation to expand coverage of audio-only telehealth services, to require coverage parity and payment parity for telehealth services, and to provide the cross-border provision of telehealth services. Other states have let their temporary waivers expire or actively sought to reel back their telehealth expansions; for example, a New Hampshire bill was introduced seeking to end audio-only coverage and telehealth payment parity.⁸⁷

Still other changes implemented during the pandemic have gone unaddressed. No reforms have been made to HIPAA to expand technologies that can be used for telehealth. Although there has been an increase in telehealth fraud enforcement, no changes have been made to the current regulatory scheme to prevent telehealth fraud in the first place.

B Uniform Law Commission Draft Legislation

The Uniform Law Commission, the largest state law-drafting organization in the country, approved the Uniform Telehealth Act in July 2022 to aid states in developing their own telehealth legislation.⁸⁸ The November 18, 2021 draft of the Telehealth Act explained that the Committee sought to capture two broad goals with the model legislation: to emphasize parallels between the delivery of telehealth services and in-person traditional services; and to establish a registration system for out-of-state practitioners to reduce existing licensing barriers. As approved, the Act sets forth the circumstances under which a practitioner may provide telehealth services in a state. It does not, however, engage with the critical questions of coverage parity or payment parity. Further, passed in the wake of Dobbs v. Women’s Whole Health Organization, the Act poses potential obstacles for the telehealth consultation and prescribing across state lines on matters relating to reproductive choice. This has led some former supporters of the idea of uniform telehealth legislation to object to the finalized version without further amendment. The future of the Uniform Telehealth Act remains uncertain and thus far no states have enacted it.

VII Conclusion

The telehealth landscape has been permanently transformed by the COVID-19 pandemic. Providers are expanding their telehealth services. Companies and health systems are experimenting with new telehealth innovations, from using artificial intelligence to remotely adjust a patient’s insulin dose to using drones with cameras to consult with patients in their home while delivering medications or medical supplies. The telehealth market is growing, with non-traditional companies such as Walmart entering the telehealth space.

But for telehealth’s success to continue in the future, regulatory reforms are needed. The changes implemented to permit telehealth adoption are largely temporary, with some having already expired and others set to expire at the end of the declared COVID-19 public health emergency. Further, there are risks and limitations with telehealth, resulting in greater health disparities and potential fraud and abuse. Several telehealth policy proposals have already been made at the federal and state levels, considering issues from coverage and payment parity to cross-border provision of care to expanding the locations where Medicare and Medicaid patients can receive telehealth services. Additional reforms should take into account the challenges observed during the COVID-19 pandemic and seek to promote telehealth’s future success, and continued research is needed to determine the proper role of telehealth in the US health care system.

Going forward, the lessons from the pandemic should inform future policymaking so telehealth can continue to thrive and promote access to health care for all.

19 Changes in Methadone Regulation During COVID-19

Zoe M. Adams , Taleed El-Sabawi , William H. Coe , Hannah Batchelor , Janan Wyatt , Mona Gandhi , Ida Santana , and Ayana Jordan *

I Introduction

The COVID-19 pandemic has created a natural experiment for the treatment of opioid use disorder (OUD) that decades of advocacy could not achieve. Evidence-based treatment for OUD currently exists in the form of medications for opioid use disorder (MOUD), including buprenorphine, naltrexone, and methadone. Methadone, a long-acting, synthetic opioid used to treat OUD that is approved by the Food and Drug Administration (FDA), is the oldest MOUD and has a significant body of evidence to demonstrate its safety and efficacy. Despite this, access to methadone is significantly limited in the United States due to federal regulations that place unique restrictions on its use to treat OUD. Unlike any other medication in the United States, patients must initially report to an opioid treatment program (OTP) daily to receive their methadone dose. It takes at least one year for a patient to receive a fourteen-day supply of take-home doses (THDs) and two years for a twenty-eight-day supply.¹ The justifications for these stringent regulations have included fears that the medication would be diverted for recreational use; however, as we demonstrate in this chapter, much of the motivation for such strict regulation also derived from racist sentiment by regulators.

Since the federal regulations governing methadone were introduced in 1972, advocates of methadone treatment for OUD have suggested that THD policies should be relaxed to increase access to it.² Until the COVID-19 pandemic, however, methadone continued to be more strenuously regulated due to the lack of political power among those prescribed methadone (a higher proportion of Black, Indigenous, and People of Color);³ competing financial incentives of OTPs, where THDs can minimize financial return;⁴ and the lack of pharmaceutical lobbying efforts to support the deregulation of this generic medication.

During the pandemic, the Substance (Ab)use and Mental Health Services Administration (SAMHSA) relaxed regulations surrounding THDs, along with the Drug Enforcement Agency (DEA), which authorized OTP employees, law enforcement, and the National Guard to allow for methadone doorstep delivery to limit viral spread. Prior to the pandemic, people were required to attend OTPs in person to obtain their medication up to six times a week taking one to two years to be deemed eligible for fourteen- or twenty-eight-day THDs, respectively; this was widely viewed as a major barrier to methadone access.⁵ We focus on the federal SAMHSA waiver, released in March 2020, which allowed “clinically stable” patients enrolled in OTPs to immediately receive either fourteen or twenty-eight days of THDs, regardless of time enrolled in treatment.⁶ This chapter tells a larger story about methadone regulations in the United States and how COVID-19 prompted a historic change in the way the medication is dispensed. We begin with a history of the 1972 federal methadone regulations and the sociopolitical context that informed this legislation, paying specific attention to what motivated the initial restrictions on THDs. We next describe SAMHSA’s March 2020 waiver and pertinent results from research studies conducted in the United States and internationally on how increases in THDs during COVID-19 affected overdose rates, diversion, and patient preferences. We then conclude with our preliminary survey data, contextualized within this growing body of scholarship, which assess patient experiences with increased THDs due to COVID-19 at a for-profit OTP located in Nashville, Tennessee.

II Background

A The Base of Evidence for Methadone

Methadone has been shown to decrease opioid overdose deaths and all-cause mortality, while also increasing adherence to substance use disorder treatment and decreasing the rates of infectious diseases associated with intravenous substance use.⁷ It is correlated with improved health-related quality of life, physical, and mental health outcomes,⁸ as well as with higher rates of employment and metrics of “social stability.”⁹ Methadone is more effective than readily available behavioral health treatment modalities that emphasize an abstinence-only approach.¹⁰

Notwithstanding these benefits, THDs of methadone have been stringently regulated. Accidental overdose or co-ingestion – particularly in patients who are unable to store their medication in a locked box – as well as non-prescribed and illicit use of opioids are ongoing fears that currently guide the strict regulation of methadone. However, while diversion exists, there is evidence to support the conclusion that increasing access to this medication reduces hospital admissions and otherwise promotes recovery.¹¹ Countries with more flexible THD guidelines do not report increased levels of overdose deaths,¹² and several randomized controlled trials have found no difference in treatment retention or diversion in patients receiving daily supervised dosing versus THDs with contingency management.¹³ Thus, allowing for more flexible THDs would permit easier access to this lifesaving medication, yet such reforms are hindered by the sociopolitical history of methadone regulation.

B The Sociopolitical History of Methadone Regulations

The sociopolitical history of methadone regulation in the United States is rooted in racist theories of criminality and social deviance that motivated early regulation of narcotics, and these same racialized constructions continue to inform where and how methadone is dispensed.¹⁴ During the mid-1960s, methadone maintenance treatment began to be accepted as effective medical treatment. Physician-researchers began framing methadone as a treatment geared toward criminals who used drugs, namely young Black men.¹⁵ Black people who used drugs in the early 1970s were depicted as threats to “community” safety, rather than people suffering from the sequelae of structural violence.¹⁶ This fit squarely with President Nixon’s desire to disrupt Black communities, by associating Black persons with heroin and then heavily criminalizing it. By expanding methadone, President Nixon could also make good on his campaign promise to be “tough on crime.” By the early 1970s, he began a nationwide expansion of methadone maintenance treatment and created the Special Action Office of Drug Abuse and Prevention, which was instrumental in the establishment of the FDA’s 1972 regulations.

Many private, for-profit methadone clinics closed because they no longer met the FDA’s standards and were soon replaced by federal, state, and city-funded methadone clinics that served growing Black and Latinx populations who could now afford this treatment. Many rapidly gentrifying neighborhoods in urban cities did not want methadone maintenance treatment programs on their city blocks, which pushed methadone clinics into what physician-anthropologist Helena Hansen and historian Samuel Roberts have called “geographically marginalized” spaces where “local opposition is less organized, such as low income and Black or Latinx neighborhoods.”¹⁷ In line with the narrative that methadone was being used to treat criminals, the 1972 regulations required urine reports and mandated behavioral therapy, mimicking carceral procedures and solidifying methadone’s place in a larger structure of racialized surveillance.¹⁸ This history continues to fuel structural inequalities in opioid treatment access, where methadone is dispensed in OTPs and remains highly regulated.

In contrast, the pharmaceutical company that originally developed buprenorphine – Reckitt and Colman – played a significant role in paving the way for new legislation that would make that medication increasingly accessible and profitable. In the 1990s, company representatives used their lobbying power to convince members of Congress to allow physicians to prescribe “certain FDA[-]approved opioids without being subject to the current regulations,” in other words, the regulations surrounding methadone.¹⁹ Reckitt and Colman also founded a non-profit organization that launched advertising campaigns casting buprenorphine as a solution to the opioid addiction experienced by White suburban communities.²⁰ These lobbying efforts, coupled with Reckitt and Colman’s racialized framing,²¹ resulted in the Drug Addiction Treatment Act of 2000, which allows buprenorphine to be prescribed in office-based settings by physicians who have undergone an eight-hour course,²² and leaves the methadone regulations unchanged. Governmental agencies justified the continued and much more stringent regulation of methadone because they considered the medication, when compared to buprenorphine, to be a more potent opioid agonist with higher “abuse” potential. Access to buprenorphine is concentrated in predominantly White neighborhoods, and Black patients are less likely to receive this less regulated MOUD compared to White patients.²³ Rooted in racialized understandings of criminality, methadone has been regulated for the protection of “the public,” rather than for the safety, efficacy, and treatment of people with OUD.

C OTPs and Restrictions on Take-Home Methadone

At present, methadone is regulated by three federal agencies – the FDA, DEA, and SAMHSA – making methadone the most regulated pharmaceutical medication in the United States.²⁴ The FDA monitors the safety and efficacy of methadone and has approved the medication for specific medical uses, including the treatment of chronic pain and OUD. Because methadone is considered a controlled substance, it is also regulated by the DEA. The 1971 Controlled Substances Act gives the DEA and the FDA joint authority over the scheduling of drugs that have potential for misuse. However, unlike other controlled prescription medications, methadone is subject to a third layer of regulatory control by SAMHSA if it is being prescribed to treat OUD. Only OTPs are permitted to dispense methadone for the treatment of OUD, and methadone is subjected to restriction on THDs.²⁵

SAMHSA sets the accreditation standards for OTPs and promulgates guidelines that govern the frequency, dosage, and dispensing of methadone by OTPs.²⁶ If methadone is being prescribed for pain management, it can be prescribed by office-based practices, and offices need not comply with the SAMHSA regulations.²⁷ There is no base of evidence to justify this distinction.

Perhaps the defining features of methadone regulations are the location limitations, namely that patients are not allowed to take the medication home with them and that it must be dispensed in an OTP. Since 1972, federal regulations surrounding THDs have mandated that patients receiving methadone for the treatment of OUD must travel to OTPs almost daily to receive their medication under directly observed therapy for at least the first ninety days of treatment, and often for longer periods of time.²⁸ Directly observed therapy means that health care providers must, according to SAMHSA, watch patients “drink and speak after dosing” to ensure medication adherence and diversion control, treating patients as if they have “done something wrong” and are involved in the carceral system.²⁹

Per SAMHSA guidelines, OTPs may gradually increase the number of THDs by one THD per week every ninety days until one year, when patients are eligible to receive a fourteen-day supply, or two years, when patients may receive a twenty-eight-day supply.³⁰ Even though the guidelines allow for a twenty-eight-day supply after two years of treatment, many OTPs across the country continue to require that patients come in more frequently. The laws of individual states also vary widely in terms of when patients are able to qualify for increased THDs. Some states do not even allow any THDs to be given to patients.³¹

SAMHSA’s current regulatory scheme actively disincentivizes OTPs from issuing THDs based on varying types of reimbursement.³² For instance, some private, for-profit OTPs can bill for the number of times patients physically present to the clinic – a major source of financial revenue. In some instances, even if a patient is “clinically stable,” financial incentives are prioritized over maximizing quality of life and patient care for people with OUD.³³ Furthermore, patients who are allowed a twenty-eight-day supply continue to be scrutinized by OTPs. For instance, despite attaining the maximum number of THDs, many patients are still required to present to a clinic weekly for urine toxicology screens and random bottle counts, often traveling long distances with little notice.³⁴

Under the SAMHSA guidelines, OTP leadership can evaluate a patient’s eligibility for THD privileges based on “regularity of clinic attendance,” absence of recent substance use and criminal activity, and the “stability of the patient’s home environment.”³⁵ Such subjective determinations invite bias, particularly against Black, Indigenous, and People of Color, and against persons living in rural or economically disadvantaged communities. Many OTPs also establish their own internal guidelines, including prohibiting patients from receiving increased THDs for cannabis-positive urine toxicology reports, even if they have been consistently adherent to methadone treatment.³⁶

D The Disruptive Nature of Daily Methadone Dosing

Traveling to an OTP daily to receive methadone is extremely disruptive to the lives of people with OUD. The SAMHSA regulations about THDs prior to COVID-19 require patients to take time away from childcare, school, and work to access methadone. Employment security, which promotes treatment adherence, has also been shown to be compromised, given the need to accommodate the demand of daily medical appointments.³⁷ Moreover, the cost and time of travel to OTPs, particularly for rural populations, can be prohibitive.³⁸ Further, there are privacy and stigma concerns for patients at OTPs, which often require patients to line up outside to receive medication. This contrasts with buprenorphine, which can be prescribed inside providers’ offices and does not require directly observed therapy. Many grassroots organizations, including the Drug Policy Alliance, medical societies such as the National Academy of Medicine and the American Society of Addiction Medicine, and directly-impacted groups, like the Urban Survivors Union, have called for sweeping changes in the regulations surrounding methadone and the provision of THDs.³⁹

III A Waiver for Take-Home Methadone During COVID-19

SAMHSA’s federal waiver during COVID-19 addressed some of these barriers. In line with social distancing protocols put in place to reduce the spread of COVID-19, SAMHSA’s March 2020 waiver granted exemptions to the regulations on THDs.⁴⁰ Under the waiver, which remained in effect in some states through 2021, patients deemed “clinically stable” by OTP leadership can receive a fourteen- or twenty-eight-day supply regardless of their time at the OTP. As a result, thousands of patients have received increased THDs, a historic shift in care for people with OUD.⁴¹ However, OTPs are not uniformly funded (e.g., for-profit, city-funded, or state-funded). Coupled with variable clinical discretion about which patients receive increases in THDs, there has been immense heterogeneity in how OTPs enforced the SAMHSA waiver. Furthermore, there is no centralized data collection system that tracks how many OTPs across the United States adopted SAMHSA’s waiver and how many patients received increases in THD after March 2020.

Since SAMHSA issued the waiver, research groups across the United States, Europe, and Asia have examined the effect of increased THDs during COVID-19 on patient preferences and experiences with treatment, diversion, and fatal and non-fatal overdose rates. To further substantiate our survey results in the context of other studies conducted during COVID-19, our team conducted a literature search. On September 9, 2021, a search on the following databases was conducted: MEDLINE, Embase, and APA PsycInfo on the Ovid platform and Web of Science Core Collection (Clarivate). Search terms included both controlled vocabulary terms and keywords for the concepts of “opioid treatment” and “take-home medication.” The search was limited to articles published between March 2020 and September 9, 2021 on the effects of COVID-19 on take-home medication use for opioid treatment. The database search was supplemented by a focused Google search for unpublished literature.

Most studies had multiple outcomes related to changes in OTP services during COVID-19, but we only included measures related to methadone THDs. A summary of key findings is included in Table 19A.1, which can be found in the Appendix (published online).⁴² Overall, these findings demonstrate three key points: (1) most OTPs in the United States and internationally significantly increased the number of THDs in response to COVID-19;⁴³ (2) diversion and overdose rates did not significantly increase as a result of increased THDs;⁴⁴ and (3) most OTP providers wanted increases in THDs to become a permanent fixture of methadone dispensing.⁴⁵

A Patients’ Lived Experiences with Increased THD During COVID-19: Lessons from an OTP in Nashville, Tennessee

Contextualized by findings from other studies in Table 19A.1, our survey data sought to understand how THDs during COVID-19 impacted patients’ quality of life, perceived stigma, lived experience, and OUD treatment outcomes at a for-profit OTP in Nashville, Tennessee.

1 Methods

To understand the impact of these changes on patients with OUD, our research team obtained informed consent and conducted telephone surveys of eligible patients at a for-profit OTP in Nashville about their experiences receiving increased THDs during COVID-19. The survey instrument consists of twenty-four questions, with free text boxes to capture patients’ direct comments. The survey was administered from June to August 2020, with demographic questions (including race and gender) incorporated in July, after seven participants had already completed the survey. Due to the negative impact that THDs had on this for-profit OTP’s financial status, this OTP decided to no longer provide twenty-eight-day supplies of THDs, thus ending our data collection prematurely. After collection, the open-ended responses were analyzed to identify common themes and narratives using qualitative methods. Because of the small sample size, this chapter presents the results of the qualitative analysis, with frequency statistics provided only for context. Note that this is one partner site in an ongoing multi-site (six nationwide OTP) trial.

Light gray points indicate the number of THDs per week given to an individual participant prior to the exemption, and the corresponding dark gray points represent the number of THDs per week given to the same participant after the exemption was issued.

2 Results

Demographic data are available for twenty-two of the thirty-four participants. Eleven identified as women and eleven identified as men (n = 22). One identified as American Indian or Alaska Native, one as Black, African, or African American, nineteen as Caucasian, and one as Other: Caucasian/American Indian (n = 22) (Table 19.1). Prior to COVID-19, more than half, eighteen of thirty-four participants (52.9 percent), were not receiving THDs, five were receiving one THD per week (14.7 percent), and two were receiving two THDs per week (5.9 percent). After the COVID-19 exemption, THDs ranged from one to twenty-eight THDs per week among this population (Figure 19.1). The following is a summary of the salient themes that emerged from the analysis.

Figure 19.1 Number of THDs per participant pre- and post-COVID-19 exemption

Table 19.1 Demographics of research participants from Nashville OTP

The second column indicates gender and race/ethnicity options read aloud to patients. The third column indicates the number of participants with the corresponding percentages that chose each option.

Demographics (n = 22)*
Gender	Woman	11 (50%)
	Man	11 (50%)
	Non-Binary	0
	Other	0
Race/ethnicity	American Indian or Alaska Native	1 (4.5%)
	Asian or Asian American	0
	Black, African, or African American	1 (4.5%)
	Caucasian	19 (86.4%)
	Hawaiian Native or Pacific Islander	0
	Non-Caucasian Hispanic or Latinx	0
	Other: Caucasian/American Indian	1 (4.5%)

* Demographic questions were incorporated into the survey at a later date and therefore represent 22 of the 34 total participants.

Participants reported taking great care with storing their THDs to prevent diversion. All participants indicated their THDs were locked (n = 34), with thirty-one out of thirty-four participants (91.2 percent) storing THDs in a lockbox, two out of thirty-four participants (5.9 percent) storing THDs in a cupboard or cabinet, and one out of thirty-four participants (2.9 percent) storing THDs under the bed (Table 19.2). Furthermore, no participants stated that they had shared, given away, or sold their THDs or had any THDs stolen since the change in their THDs during COVID-19.

Table 19.2 Safety measure quantitative responses

The first column represents an abbreviated description of the question asked to each participant (see Section III.A.1 for full-length survey questions). The second column indicates the options read aloud for participants. The third column indicates the number of participants who chose each option.

Safety Measures (n = 34)
Storage location of THD	Lockbox	31 (91.2%)
	Bookbag/purse	0
	Cupboard/cabinet	2 (5.9%)
	Other: under bed	1 (2.9%)
Locked	Yes	34 (100%)
	No	0
Missed THD	Yes	3 (8.8%)
	No	31 (91.2%)
Taken more THD than prescribed	Yes	3 (8.8%)
	No	31 (91.2%)
Overdosed from opioids	Yes	0
	No	34 (100%)
Shared, given away, or hold THD or had THD stolen	Yes	0
	No	34 (100%)

Three out of thirty-four participants (8.8 percent) took THDs in greater amounts than prescribed, citing under-dosing or the need to self-medicate to manage symptoms as motivating factors (Table 19.2). For example, one participant stated: “One time because my dosage wasn’t enough, … I needed to take more to make myself not be sick, and therefore I needed to take more. Now that I’m on the right dosage I do not need to.” Another participant identified “stress” and “anxiety” specifically related to his health during the pandemic as his reason for taking more than prescribed. No participants reported they had overdosed on opioids since their recent increase. Barriers to treatment adherence prior to the COVID-19 regulation, which allowed for increased THDs, were related to transportation difficulties, causing missed OTP appointments. For example, one participant said that “[it was] hard getting back and forth,” because he lived an hour away from the clinic. Similarly, another participant said that he lived forty minutes away from the clinic and did not have enough money for gas to make it to his appointment.

Thirty-two out of thirty-four participants (94.1 percent) overwhelmingly preferred THDs to dosing at the OTP in part because the burden caused by frequent commuting to an OTP to receive a dose was at least partially relieved (Table 19.3). Participants reported living 35 to 120 minutes away from their OTP and described travel to the OTP as a “huge inconvenience” and “burden … [as there is] no other closer clinic.” Some participants reported that, prior to the increase in THDs, the frequent commute to the OTP interfered with their work duties and cited the childcare difficulties that commuting created. One woman stated, “it’s better to have take homes just because of work and I have a daughter and am starting to work again, so it’s inconvenient to come [to the clinic] multiple times a week.” One participant described her new dosing schedule as “a lot easier and less stressful” because previously she was often “running late to work.” Another stated that they had “been able to hold down a job” due to the increase in THDs. Other participants explained that the financial difficulties of travel were barriers to treatment. For example, one participant stated “sometimes [I] would miss going to clinic due to financial reasons” such as not having enough gas money or bus fare.

Table 19.3 Patient preference quantitative responses

The first column represents an abbreviated description of the question asked to each participant (see methods for full-length survey questions). The second column indicates the options read aloud for participants. The third column indicates the number of participants who chose each option.

Patient Preferences (n = 34)
Dosing preference	Taking it with me	32 (94.1%)
	Coming into clinic	0
	No preference	2 (5.9%)
	Positive	31 (91.2%)
Impact on quality of life	Negative	1 (2.9%)
	No Impact	2 (5.9%)

Thirty-one out of thirty-four participants (91.2 percent) reported that THDs contributed to improvements in their overall well-being. “It’s been life changing to have my medicine with me,” confided one participant. Another stated, “I wake up … my first thought is that I don’t have to wake up and worry about feeling bad. I can wake up clear minded. I can live a full happy life, and not be stuck chasing dope or feeling sick.” One participant stated that due to the need to frequently report to the OTP, he “wasn’t able to travel for six years, missing family vacations and stuff. It was a whole lot. Mentally.” Some participants said that increased THDs provided more time for family obligations. One woman stated, “I help take care of my in-laws and not having to run to the clinic every day is quite helpful.” Another reported, “because I have 2 kids, and I have to get them ready for school, but [now] I don’t have to run out there every day to get my dose. Anything is better than every day.” Other participants reported reduced stress and hassle of presenting to the clinic as frequently. “I mean it’s less stressful, I live in [town] so it’s far to drive all the way to the clinic just to get a dose and come all the way back.” Another participant said that she doesn’t “freak out if there is an accident and doesn’t make it” to the clinic, resulting in a missed dose. Another reported, “It’s [THDs] helping me tremendously … and I’m not so stressed.”

Participants stated that increased THDs contributed to a greater sense of stability and accomplishment in treatment. “[It] feels like you’ve accomplished a lot more not having to go as often. Before it was so long to get increased take-homes,” one participant explained. She further expressed feeling more “successful” with the program now compared to before when she had to come in every day. Another participant described his increase in THDs as: “Definitely a positive reinforcement to stay clean.”

Participants also reported that THDs decreased the stigma they felt from being in methadone treatment. One participant described daily dosing as a “dehumanizing process” as the strict guidelines often make patients feel as though they are being “treated like criminals.” Another participant commented that since an increase in THDs, he felt like he was “living a more normal life” and that he was “no longer concerned about how friends at work feel about [him] going to a methadone clinic every day.”

Some participants reported that the increase in THDs provided a sense of safety during the pandemic. One stated, “I’ve got a two-year-old who is immunocompromised and an 88-year-old father who is at risk. [I] cannot afford to come in during COVID.” No participants felt the increase in THDs had a negative impact on their quality of life. “I would definitely be on board with take-homes after this,” one participant concluded. “It has been a definite improvement in my life, and I hope it continues.”

IV Discussion and Recommendations for Future Policymaking

COVID-19 produced a natural experiment to study how increased THDs impact patient experiences, preferences, diversion, and overdose rates. As found in studies conducted during COVID-19 across the United States,⁴⁶ as well as internationally,⁴⁷ none of our participants reported diversion or overdoses since the increase in THDs, and approximately 94 percent of our participants stated they preferred increased THDs, saying that being able to take their medication home with them improved their quality of life. Our findings add to the growing body of evidence demonstrating that increased THDs can eliminate unnecessary barriers to methadone treatment, while simultaneously decreasing the burdens shouldered by patients in treatment. Our study and others provide the data needed to aid policymakers in creating more patient-centered, evidence-informed substance use disorder policies that counter unfounded narratives that have prevented access to more just methadone treatment.

Our study does have limitations that must be taken into consideration. First, we are presenting one site of a larger trial, thereby resulting in a smaller sample size, with a majority White cohort, and a lack of experimental design. These findings will need to be validated by a larger sample size, one more representative of the diverse population of people in methadone treatment. Nevertheless, the narratives that emerged from the data remain useful as a testament to how increased THDs had a positive impact on employment, family life, and feelings of self-worth, bolstering the case for regulatory reform. Moreover, because of institutional racism, which fueled the heavy regulation of methadone, such stringent methadone policies disproportionately affect Black and Latinx communities, who are also less likely to have access to less heavily regulated medications for OUD, such as buprenorphine.⁴⁸ Therefore, policies that decrease access to THDs are not only an issue of access to care, but also a racial justice issue that involves health equity. As such, methadone THD policy reform requires immediate action.

Given our results, in concert with other domestic and international studies (Table 19A.1) showing an overall positive trend with increased THDs, SAMHSA’s COVID-19 waiver, should be extended indefinitely. However, there must be additional federal support and legislation, as individual states currently have the authority to not enforce the exemptions on THDs. For instance, even though increases in THDs have not been shown to increase overdoses or diversion, on September 30, 2021, OTPs in Pennsylvania were ordered to scale back their increases in THDs and reverted to the pre-COVID-19 restrictions.⁴⁹ With a record 93,000 overdose deaths in 2020, removing barriers to methadone access is paramount: increased THDs must be prioritized in order to prevent unnecessary deaths.⁵⁰

Furthermore, as written, the relaxed guidelines give OTPs permission to increase THDs when certain treatment milestones are met, but OTPs are not incentivized financially to do so. Like other health care providers, some OTPs are financed through fee-for-service arrangements, which allow them to bill for daily medication provision and drug testing. If OTPs provide THDs, they can no longer bill for the daily clinic visit, thus resulting in decreases in financial revenue for the clinic. Therefore, the increase in THDs must be accompanied by payment reforms that incentivize THDs. Such reforms can take many forms, including bundled payments and quality-based payments. Second, the language in SAMHSA’s waiver regarding “clinical stability” is problematic and invites OTP clinicians to make subjective determinations that are likely informed by bias, particularly against racial and ethnic minorities and persons living in rural and/or economically disadvantaged communities. As such, SAMHSA should commission a taskforce to assist it in defining “clinical stability” and issue guidelines based on their findings.

COVID-19 has demonstrated that federal regulatory agencies must be proactive about increasing access to methadone treatment. Participants in our study frequently reported that the distances they had to travel to reach an OTP were a major barrier to care. Increasing the number of THDs permitted helps address the barriers to showing up daily to the facility, but it does not address the number of OTPs, which has remained largely stagnant over the past fifteen years.⁵¹ Studies such as ours, and others in Table 19.A.1,⁵² have demonstrated that there is little risk of diversion or overdose deaths due to increases in THDs, suggesting that fears of diversion are likely exaggerated. Thus, the United States should revisit new models of methadone dispensing, such as pharmacist-administered dosing or prescriptions by primary care providers, as in Canada, the United Kingdom, and Australia.⁵³ Integrating methadone treatment into our health care system would decrease the carceral overtones of addiction treatment, and patients would likely feel less stigma toward their OUD diagnosis.

20 Reproductive Justice after the Pandemic How “Personal Responsibility” Entrenches Disparities and Limits Autonomy

Rachel L. Zacharias , Elizabeth A. Dietz , Kimberly Mutcherson , and Josephine Johnston *

I Introduction

COVID-19 laid bare the responsibility that American laws, policies, and society have long placed on individuals to ensure their own health and well-being. Policies guided by an ethic of “personal responsibility” particularly restrict reproductive justice (RJ),¹ a framework and set of objectives first defined by Black women as the human rights to have children, not have children, and parent children in safe, healthy, and sustainable communities.² RJ goes beyond an articulation of reproductive rights; it is an analytic and movement-building tool that describes how people are inseparable from the systems that they are in,³ and how those systems make their choices possible (or not).⁴ As we will make clear, the RJ framework is relevant not only to issues of reproduction and family, but also to understanding the social conditions in which individuals create families with children.

American laws and policies obstruct RJ when they ascribe blame to Black and Brown people for not meeting societal standards of family, health, and flourishing. These polices presuppose that there are certain normatively correct family structures and ways to be in the world, which are largely defined by racist, classist, and sexist ideals.⁵ Personal responsibility policies attribute harms – including reproductive and other health inequities, environmental exposures, poverty, and food and housing insecurity – to individuals’ choices, rather than to the social, economic, historical, or political conditions that shape those choices. These policies additively punish marginalized people who already experience structural forms of injustice, concentrating their force on Black people, other people of color, and trans people, instead of creating conditions to foster RJ.

Overall, COVID-19 policy under the Trump Administration relied heavily on an ethic of personal responsibility, as illustrated by those lawmakers who called for people to wear masks and socially distance without creating policy mechanisms that would require them to do so.⁶ Yet certain responses to COVID-19 resulted in a small number of long-standing barriers to RJ falling away. For instance, some laws, policies, court orders, and procedures catalyzed by COVID-19 temporarily increased access to reproductive health care for some and allowed workers paid and protected time off from work to care for themselves and their family members.⁷ These responses employed personal responsibility in a way that was empowering rather than controlling, facilitating recognition of reproductive autonomy by removing barriers to it and entrusting individuals to manage their own care needs.

Enacting RJ-enhancing policies should not require a pandemic. In this chapter, we call for more laws and policies that equitably enable personal power consistent with RJ. These laws and policies see people as worthy and capable of making decisions about their own and their family’s health, and therefore remove barriers to, and provide the underlying support for, personal decisions. We begin by outlining how the ideology of personal responsibility has been woven into the fabric of US policy, consistently holding marginalized people accountable for maintaining prescribed standards of family, health, and well-being, while simultaneously neglecting structural conditions that impact many marginalized communities and exacting heavy tolls for non-compliance. Then, we identify three examples of RJ-enhancing policy changes enabled by the COVID-19 pandemic. While states and the federal government continued to invoke personal responsibility during the pandemic, certain policy changes recognized individuals’ personal power and removed barriers to reproductive autonomy.

Although these RJ-enhancing, COVID-19-based policies were in some cases time-limited and predominantly benefited people who already had means, they provide a kind of “proof-of-concept” for further RJ-enhancing changes to law and policy. To be truly consistent with RJ, future such measures must exist outside an ideology that conditions deservingness on blamelessness. Instead, conditions must exist which make such enhancements available to and possible for everyone. We conclude that RJ, as a goal and a framework, should undergird all US reproductive and social policy.

II Responsibility in US Reproductive and Social Policy

COVID-19 did not inaugurate policies structured by personal responsibility. The ethics of personal responsibility and individual autonomy have been deeply engrained in US culture since the country’s founding.⁸ In the twentieth century, Republican and Democratic administrations alike promulgated policies demanding personal responsibility, particularly reproductive, health, family, welfare, and housing policies – some of the realms most critical to RJ.⁹ Two national Democratic-administration initiatives – the Moynihan Report and Clinton-era welfare reforms – offer incomplete but instructive historical insight into the logic of personal responsibility and its opposition to RJ. These initiatives promoted the shifting of care for families from governments to individuals, while determining that individuals’ worthiness of social assistance (needed for said family care) depended on their ability to care for themselves. They created a punitive regime that conditioned financial assistance on satisfying bureaucratic requirements of correct family structure, vastly reducing the aid available directly to individuals and families.

In the 1965 report The Negro Family: The Case for National Action, the assistant secretary of labor to the Johnson Administration, Daniel Patrick Moynihan, argued that Black families’ matriarchal structures would slow the progress of Black men, and, in turn, that of Black women.¹⁰ The report articulated the racial injustice that Black families experience in terms of individual failings that could be acted on through government policy.¹¹ It did so through a focus on what it called the “pathology” of “broken homes,” which, it concluded, are too often headed by women dependent on welfare.¹² These supposed indictments helped to explain why, in Moynihan’s words, “the circumstances of the Negro American community in recent years has probably been getting worse, not better.”¹³ The report and its policy proposals are then framed as an act of care: attending to racial inequity and proposing interventions. But the mechanisms through which it understood that inequity, and therefore the interventions that it proposed, framed individuals and the ways that they behave and engage in family-making as the source of their own difficulties. In an analysis of the Moynihan Report, Professor Grace Hong notes that “[i]n the neoliberal moment, ‘care’ becomes the conduit for violence.”¹⁴ Government abrogates responsibility for injustice in favor of punishing Black people, and particularly Black women, for making what it sees as the “wrong” choices.

The Personal Responsibility and Work Opportunity Reconciliation Act of 1996 (PRWORA),¹⁵ signed by President Clinton, formed part of the set of Congressional Republican-led “Contract with America” reforms that sought to streamline government and require work.¹⁶ The Act is a defining moment in the history of personal responsibility-based US policy. Its advocates promised that PRWORA would reduce the number of people on welfare and create self-sufficiency through employment by imposing limits on the number of years that people could receive cash assistance and the work requirements for that assistance.¹⁷ PRWORA also sought to use welfare eligibility rules to bring about “proper” families (i.e., those with two married parents);¹⁸ it did this by imposing work requirements on people with past-due child support payments,¹⁹ and by seeking to prevent teen pregnancy through abstinence-only sex education.²⁰ The law substantially reduced the number of people who received assistance, though it did so largely through cuts to benefits,²¹ and through imposing sanctions (disproportionately for people of color) that made those in need ineligible for benefits – not by lifting people out of poverty.²² White people were also able to leave welfare rolls for jobs (a key goal of the Act) in greater proportions than racial minorities, in part due to employer preferences for White employees.²³ In effect, the Act required personal responsibility, but did not create the conditions for equitably realizing and supporting it.²⁴

Like other invocations of personal responsibility, PRWORA is inextricable from its racial context, including the erroneous and racist suppositions that Black people are lazy and need to be coerced into work.²⁵ PRWORA imagined a kind of undesirable Black family (headed by a poor single mother intent on gaming the system) that could be improved through legislation tethering work to notions of stronger and better families.²⁶ Sexist notions of White womanhood that praised stay-at-home parenting for women with young children did not extend to Black women, who were expected to find and pay for substitute care for their children while engaging in low-wage work.²⁷ Accordingly, some state welfare systems, afforded more discretion to administer cash assistance under the Act,²⁸ conditioned families’ receipt of cash assistance on whether their family structure and practices were acceptable to the state. Some states enacted caps on cash assistance based on family size,²⁹ thereby casting family size as a privilege of the wealthy and as a sign of irresponsibility in the low-income community. Poor children were presumed to be both a drain on taxpayer dollars and an impediment to their mothers’ transition from welfare to work. Welfare caps sought to both control Black and other low-income individuals’ reproductive and familial choices and make Black women “available” to engage in more low-wage work.

Dangerous rhetoric about personal responsibility was also a hallmark of the Obama presidency. In the wake of the 2008 financial collapse, President Obama declared that “[w]hat is required of us now is a new era of responsibility – a recognition on the part of every American that we have duties to ourselves, our nation[,] and the world.”³⁰ That speech, which did not talk meaningfully about race, asked Americans to make then-unspecified hard choices, anchored by values of “honesty and hard work” – the bedrocks of personal responsibility. Yet even cursory scrutiny of the causes of the 2008 recession makes clear that catastrophic losses of housing, savings, and jobs were not a failure of hard work but the result of predatory lending and poor government oversight.³¹ Solutions to the recession did not lie in individual people making better choices, but in better industry practices and stronger government policies.

The kind of personal responsibility in reproductive matters called for in the Moynihan Report, enacted into the Clinton welfare reforms, and invoked by President Obama demands that everyone take responsibility for their own actions and individually contribute toward a common goal, with both the goal and the means to effectuate it limited by racist notions of deservingness and what constitutes “good” families. This is manifest in the punitive regime PRWORA created: (1) a set of requirements to work, undergirded by notions of proper family structures, in order to receive assistance; (2) the lack of an attendant guarantee of jobs; and (3) a social system that makes job acquisition more difficult for those already marginalized and where much available work does not pay a living wage. RJ stands in ideological opposition to this regime of personal responsibility. Where personal responsibility forecloses structural explanations for people’s personal struggles (while creating the conditions for many of those struggles), the RJ framework is an explicit invitation to analyze structures and develop solutions that acknowledge interdependence. As our federal policy examples illustrate, when applied to reproduction and families, the ideology of personal responsibility generates policies that control individuals’ choices about reproduction and family form. Myriad examples also exist in state and local policy; for instance, some states condition the receipt of public health insurance on individuals’ perceived self-sufficiency and deservingness, choosing not to expand their Medicaid programs under the Affordable Care Act,³² or to enact work requirements to access Medicaid.³³ RJ instead insists that people can and ought to be considered instead as autonomous, capable of acting in the best interests of themselves and their communities, and, perhaps most importantly, of making their own calculations about what it means to be responsible. To enhance RJ, reproductive and social policies must not merely recognize individuals’ reproductive autonomy and personal power, but must also create the conditions to enable them.

III The Disparate Impacts of Personal Responsibility in COVID-19

Personal responsibility, long an ideological lodestar in US policy, was easy to adopt for the pandemic response, especially given the role that individual behavior has in public health efforts to prevent viral transmission.³⁴ In lieu of robust and uniform policy actions and social support, the United States, led by an Administration sorely lacking public health expertise or the basics of good government, left people to personally manage their COVID-19 prevention and care. The federal government issued no stay-at-home mandates and provided sparse funding for protective equipment, testing, treatment, and, initially, vaccines.³⁵ Aside from a $1,200 stimulus check in April 2020 and another $600 check in January 2021, as well as a temporary top-up to unemployment benefits, individuals have received very little financial assistance from the federal government, particularly when compared with other developed nations, many of which were less hard hit but provided more financial assistance to individuals, families, and small businesses.³⁶

The federal government left vulnerable Americans to navigate their own financial solvency, including the cost of health care and other necessities, even while millions of jobs were lost and poverty rates rose.³⁷ States and localities varied widely in terms of whether or not they considered lack of federal pandemic support to be a problem. Some states considered individual choice – afforded by ideologies of personal responsibility – to be a moral necessity, while others saw relegations to individual choice as critically endangering their most vulnerable residents.

Once again, the individual was the wrong object of responsibility. COVID-19 does not merely infect and affect individuals: people live, work, travel, and commune with others – some because they want to, many others because their jobs or families require it.³⁸ Essential health care and other workers are disproportionately women and people of color.³⁹ They are most likely to be exposed to COVID-19 through their labor; their exposure risk is compounded by the improper mask wearing, lack of vaccination, and other risky behaviors of those they encounter.⁴⁰ Research shows that racial and ethnic minorities across all ages, and particularly those aged between twenty-five and fifty-four years, have experienced significantly higher COVID-19 mortality than White people.⁴¹ Once exposed, these same people were more vulnerable to morbidity and mortality from the virus.⁴² Treating risk as an individual responsibility ignores the ways that an individual’s risk is affected by the actions of others. Once again, personal responsibility fails by imagining that people will voluntarily do the work of accounting for one another without requiring them to do so.

Given this, it is surprising that the emergency conditions surrounding COVID-19 also catalyzed some long-needed reforms, which move toward RJ by reframing notions of responsibility. Here, we provide three examples of RJ-enhancing policy changes prompted by the pandemic: (1) telemedicine-supported abortion access; (2) remote access to judicial bypass hearings; and (3) paid family and medical leave. Their immediate justification was health, specifically the reduction of risk of viral spread due to in-person contact. But their impact was to remove the presumption that people are blameworthy for the social conditions in which they find themselves; that they are at fault for their own need. The fact that these changes were possible, but politically feasible only with the catalyst of a pandemic, makes manifest that often policies are conditioned on the idea that deserving help requires that a person be deemed blameless for their need.

A Telemedicine-Supported Abortion Access

Telemedicine allows physicians to supervise patients remotely accessing abortion care. Allowing individuals to remotely access medication abortions increases access to abortion care, especially for people of color, people with disabilities, people living in rural areas, and low-income people.⁴³

At the beginning of the pandemic, policy changes by both public and private actors supported the near-instant adoption and implementation of telemedicine care, which included reproductive health care services, such as contraception prescriptions and some preventative, screening, and routine care.⁴⁴ Initially, telemedicine implementations could not include medication abortion due to a Food and Drug Administration (FDA) “Risk Evaluation and Mitigation Strategy” (REMS) policy, which bars the distribution of mifepristone, the first of two medications used in medication abortion, at pharmacies and limits it to registered providers at clinics and hospitals, on the pretextual basis of safety.⁴⁵ But in 2020, litigation brought by the American College of Obstetrics and Gynecology, with the RJ collective SisterSong as one of the co-plaintiffs, successfully enjoined the REMS policy nationwide for several months to enable medication abortion by telemedicine during the COVID-19 pandemic.⁴⁶ The plaintiffs’ American Civil Liberties Union lawyers particularly framed the legal issue in terms of the disproportionate impact of the FDA policy on low-income people of color.⁴⁷

Even with the FDA’s policy enjoined, a number of state regulations continue to forbid telemedicine exclusively for abortion care.⁴⁸ And, in January 2021, the Supreme Court stayed the federal district court’s injunction order, reinstating the FDA REMS policy and again singling out abortion care for unnecessary and harmful burdens to treatment.⁴⁹ In her dissent, Justice Sonia Sotomayor reiterated the particular RJ concerns, noting that the FDA allowed many other drugs, including some controlled substances, to be dispensed without in-person visits, and questioning why a similar approach could not be taken to abortion medications, especially given the disparities in prevalence, morbidity, and mortality from COVID-19 for Black and Brown communities.⁵⁰

Despite existing state bans and the Supreme Court’s ruling on the REMS policy, the conditions of the pandemic may yet catalyze lasting change for remote abortion access. At the time of writing, the Biden Administration’s FDA is “exercising enforcement discretion” of its REMS policy for mifepristone and reviewing the policy more broadly.⁵¹ If this review leads to policy change, it will be long overdue – multiple administrations have failed to take on board RJ-centered advocacy and lawyering highlighting the harmful effects of FDA’s REMS policy, particularly on marginalized people.⁵² However, the pandemic’s conditions laid bare these harms for policymakers and made clear that RJ-centered abortion care is possible and necessary. What has been missing is the will of federal and state governments to adopt policies centering on the collective, rather than the individual.

B Remote Access to Judicial Bypass Hearings

Following the Supreme Court’s affirmation of laws requiring parental consent for abortion on the basis of minors’ safety in Bellotti v. Baird and Planned Parenthood v. Casey, more states have required that minor patients seeking abortion obtain parental consent.⁵³ In these jurisdictions, minors who are not able to get parental consent for any reason may receive an abortion only if they receive a “judicial bypass” order from a judge. It is well documented that judicial bypass requirements pose particular barriers to low-income and disabled young people, people who live in rural communities, and young people who became pregnant as the result of violence from accessing safe and legal abortion.⁵⁴ Accessing abortion through judicial bypass is further known to be a humiliating and traumatic experience for many young people.⁵⁵

During COVID-19, court proceedings in some jurisdictions were moved to remote venues, a change that anecdotally increased young peoples’ access to abortion by alleviating the logistical and emotional barriers of judicial bypass hearings.⁵⁶ With remote hearings, young people did not have to miss school, pay for or arrange travel to court, or experience acutely daunting or traumatic in-person hearings in courtrooms or judicial chambers discussing their reproductive decisions. Although we believe that the underlying laws should be fully repealed, we note that this small policy change inches toward RJ. If made permanent, it could be especially impactful to young people for whom travel, missed school, or the in-person hearing represent even greater hardships or trauma.

C Paid Family and Medical Leave

The pandemic has made obvious the interconnectedness of America’s underpaid workforces. The pandemic catalyzed Congress to pass temporary paid family and medical leave,⁵⁷ for which Americans have advocated for decades. Paid medical, family, and sick leave is essential for people to have time, funds, and for many within America’s current structure of health coverage, insurance to care for their own health needs as well as those of their dependents. Paid leave, as well as pay for family home care, are also critical to people’s financial stability,⁵⁸ and is thus especially critical for marginalized people who are more likely to work in jobs that most expose them to the pandemic. Economic stability has lifesaving importance for many, including victims of domestic violence who are separating from and leaving abusive partners.⁵⁹

Unfortunately, mandatory COVID-19 paid leave, already limited to employees at large companies, health care employers, and otherwise,⁶⁰ expired on December 31, 2020 and was only replaced by a voluntary tax credit for employers through March 2021.⁶¹ However, like remote abortion care, the pandemic’s conditions catalyzed long-requested conversations about the necessity for paid leave. At the time of writing, Congress is considering including some form of paid leave in its 2021 domestic social policy bill.⁶²

These changes are particularly laudable because they model policy that is materially beneficial without conditioning access on blamelessness. But, as already noted, the three examples of long-overdue, RJ-enhancing policy changes described above are or were temporary and limited in scope. More problematically, even these temporary advances best serve those who already have means: people who have legal, financial, and logistical access to telehealth providers to manage abortion and people in employment positions from which paid leave can be taken.⁶³ Thus, while these COVID-19-stimulated policy changes were laudable, some were not only ineffectual for marginalized individuals (for whom they were most needed), but in practice further entrenched harms to them by requiring them alone to continue to work when they or their family members were sick and to overcome numerous barriers to seek reproductive care in person. Despite these limitations, the three examples provide proof-of-concept for more robust future changes.

Centering the RJ framework in future policies is critical to remedying inequity. Mainstream reproductive rights discourse, which has been largely controlled by White middle and upper-class women and from which COVID-19 telemedicine abortion and paid leave changes stemmed, is rooted in the neoliberal conceptions of choice that “locate[] individual rights at [their] core, and treat[] the individual’s control over her body as central to liberty and freedom.”⁶⁴ While this conception of reproductive rights is distinct from the personal responsibility policies discussed that seek to explicitly punish individuals for non-compliance with social standards, any policy focused on individual choice “obscures the social context in which individuals make choices, and discounts the ways in which the state regulates populations, disciplines individual bodies, and exercises control over sexuality, gender, and reproduction.”⁶⁵

In contrast, as we have shown, an RJ approach rejects conceptions of blameworthiness and addresses the ways that economic and institutional constraints on women of color and other marginalized people can restrict their choices.

IV A Call for Responsibility Compatible with and Enabling RJ

In her dissent from the Court’s decision to reinstate FDA’s REMS program, Justice Sotomayor made plain the intersectional implications of requiring pregnant people to risk exposure to COVID-19 to receive a prescription for medication abortion. First, she explained that COVID-19 makes pregnant people more susceptible to bad outcomes.⁶⁶ Then, she noted that:

[M]ore than half of women who have abortions are women of color, and COVID-19’s mortality rate is three times higher for Black and Hispanic individuals than non-Hispanic White individuals. On top of that, three-quarters of abortion patients have low incomes, making them more likely to rely on public transportation to get to a clinic to pick up their medication. Such patients must bear further risk of exposure while they travel, sometimes for several hours each way, to clinics often located far from their homes. Finally, minority and low-income populations are more likely to live in intergenerational housing, so patients risk infecting not just themselves, but also elderly parents and grandparents. These risks alone are significant deterrents for women seeking a medication abortion that requires in-person pickup.⁶⁷

Justice Sotomayor’s dissent, which Justice Elena Kagan joined, focuses not on those who are most able to move forward with abortion care despite the in-person requirement, but on those for whom this rule creates an undue burden to accessing care. In true RJ fashion, Sotomayor centers those most vulnerable people who are affected by the outcome of this case – women of color and women who are low-income – and finds that the policy imposes an “unnecessary, unjustifiable, irrational, and undue burden” on the constitutionally protected right to abortion. Unfortunately, Sotomayor’s RJ-informed approach did not convince the majority of Supreme Court justices, who saw no reason to interfere with the FDA’s assessment that, even in a pandemic, in-person prescription of abortion medications should be required. As Justice Sotomayor points out, the majority maintained this view despite the failure of the FDA to provide any reasons “explaining why the Government believes women must continue to pick up mifepristone in person, even though it has exempted many other drugs from such a requirement given the health risks of COVID-19.”⁶⁸ The majority’s refusal to require reasons from the FDA and lack of interest in the real-world impact of the FDA’s policy is consistent with an approach to personal responsibility that understands financial and logistical (and in this case, even health-related) barriers to accessing abortion care as the responsibility of the individual rather than as facts about American society that American regulators have a responsibility to consider when making policy. In this way, the majority upheld and affirmed an atomistic and hands-off conception of responsibility – and, through it, of individual autonomy – rather than an understanding that seeks to empower individuals so that they can choose how to care for themselves and their families. Though people seeking abortions received no relief from the Supreme Court, the FDA did finally relent under the continued weight of advocacy and evidence that its rule inhibited access to needed care without creating safety benefits to those seeking medication abortions. On December 16, 2021, the agency reversed course by announcing that it would jettison the unnecessary in-person dispensing requirement for mifepristone – thus easing a burden that had persisted for far too long.⁶⁹

This expression of personal responsibility has long structured reproductive policy in the United States, bolstered by a sense that it is an uncontroversial and bipartisan appeal to an individualism highly prized by Americans. But it rests on an impoverished and often unrealistic notion of individual autonomy that foregrounds the idea of individual choice while failing to support the necessary conditions to enable all, or even most, individuals to actually make choices consistent with their own values and interests. The COVID-19 pandemic has further exposed the failure of this conceptualization of autonomy by making clear the profound ways in which individual flourishing is not an individual matter.

Recognizing a fuller understanding of autonomy has driven this move in reproductive ethics from a negative to a positive rights approach – an approach led by the RJ movement. In the RJ approach, responsibility is not eliminated. Rather, RJ calls for policies that enable and promote personal power, simultaneously recognizing interdependence and facilitating autonomy. Such policies are even more necessary in light of state laws, including those in Texas, Mississippi, and up to twenty other states, that imminently challenge the constitutional right to abortion.⁷⁰

The pandemic catalyzed limited expressions of RJ-centered policymaking, in changes permitting remote management of reproductive care and remote judicial bypass of laws requiring parental consent for minors’ abortions, as well as policies expanding access to paid family leave. These policies reflected the reality of our interconnected existence, if obliquely. They removed barriers to people making personal decisions, if temporarily. They illustrate that RJ-consistent policy is possible in the United States. Adopting an RJ approach in future policy allows us to recognize our society’s interdependence. Doing so is necessary for all our health and flourishing.⁷¹

21 Abortion At-Home and At-Law During a Pandemic

Joanna N. Erdman

I Introduction

Abortion law has long been preoccupied with place, that is, where an abortion happens. In the nineteenth century, growing commercial markets in so-called “ladies’ remedies” justified stricter criminal laws, which confined legal abortion to the medical clinic.¹ Abortion law today continues to authorize certain places of care and to outlaw others, unfairly restricting supply and frustrating access. During the COVID-19 pandemic, clinic-based restrictions on abortion access became the targets of advocacy, leading to authorizations for the remote provision and local delivery of abortion pills. People could now access abortion without leaving their homes: abortion at-home.

Homes are built structures, but they are also inventions.² Abortion law creates the places that it regulates and thus shapes the experience of abortion within them.³ Yet homes are also imbued with meaning by the people who live there. The law may thus anticipate abortion at-home, but its practice within the home will also come to shape the law that authorizes it. Rooted in this relationship of law and place, this chapter explores abortion at-home during the COVID-19 pandemic. After an introduction to abortion pills and abortion law in Section II, Section III examines features of COVID-19 authorizations for abortion at-home in Europe and the United States. Despite differences among them, all the authorizations reflect a crisis management discourse, designed to conserve access to care during the pandemic, but conserving much more in the continued clinical control of abortion and the social norms of abortion law. Against this conservative view, in an alternative legacy, Section IV speculates on how abortion at-home, normalized within the everyday tasks, products, and people of home life, may lead to a radical change in its practice, especially during a time when people have formed new relationships to their home and invested new meaning in it. This chapter concludes by imagining a future for abortion law born of the pandemic but radicalized in the home.

II Abortion Pills and Abortion Law

A common regimen of early abortion with pills involves a person swallowing one tablet of mifepristone to block the hormone progesterone needed to sustain a pregnancy, and twenty-four to forty-eight hours later, inserting four tablets of misoprostol between the gums and cheeks to induce contractions.⁴ The abortion takes place over a period of days with cramping and bleeding stronger than a usual menstrual period and similar to an early miscarriage.

The science behind abortion pills was revolutionary, but their effect in the world was not. In 1988, after French authorities approved mifepristone, the company that developed the drug Roussel-Uclaf abandoned distribution because of a social backlash.⁵ The minister of health intervened, declared mifepristone the “moral property of women,” and returned it to market, but Hoescht Marion Roussel proceeded cautiously thereafter. Global registration was slow, and regulatory agencies adopted strict prescription and dispensing controls on the drug.⁶

In 2000, when mifepristone was approved in the United States, the cover of Time magazine heralded, “The Little White Bombshell: This Pill Will Change Everything.”⁷ It did not. The Food and Drug Administration (FDA) imposed strict distribution controls, including a ban on retail pharmacy access,⁸ and later subjected mifepristone to a Risk Evaluation and Mitigation Strategy (REMS), requiring that people both access and take the drug in-clinic.⁹ Many countries imposed similar controls on misoprostol, especially after a campaign by its manufacturer to dissuade its off-label use for abortion, but misoprostol has not been similarly restricted in Europe or the United States.¹⁰ Many of the controls on mifepristone remain to this day, including unique prescriber registration, restricted in-clinic distribution, and/or the supervised taking of the pill.

Rather than any revolution, abortion pills were folded into abortion law and made subject to its norms and conceits. Abortion law, even the most liberal variant, follows a logic of control. Abortion is lawful within the provisions of the law, and any act taken outside of them with the intent to end a pregnancy – including to prescribe, administer, or supply any drug – is prohibited.¹¹ Legal abortion is a place-bound practice, figuratively and literally. Abortion must be practiced within the provisions of the law, which often authorizes the physical places of care.

Place-based control of abortion can be tracked to the mid-nineteenth century in Europe and the United States, when the medical profession campaigned for stricter criminalization.¹² These campaigns were premised on the moral wrong of abortion and its unsafe practice, although abortion early in pregnancy was relatively safe. Rather, historians identify professional self-interest and social control as the primary motivations. The medical establishment was concerned with a growing and profitable market in home-use abortifacients, which reflected the frequency of abortion in White, middle-class homes. The professional self-interest in quashing this market coincided with a patriarchal and nativist fear that women within these homes were abandoning their familial duties, leading to declining birth rates among this social class. To stem this threat, criminalization, as an act of medical and social control, took abortion from the home and confined it to the clinic.

The clinic is therefore not only a physical place but an institution of control, and by raising the prospect of a “post-clinic abortion,” abortion with pills thus threatens the control of the law.¹³ For this reason, even in relatively liberal contexts and despite decades of advocacy, abortion at-home remained but an idea prior to COVID-19. In the United Kingdom, the home use of misoprostol was allowed by executive orders, but a criminal statute, the Abortion Act 1967, mandated in-clinic prescription and administration of mifepristone.¹⁴ French law similarly did not allow telemedical abortion, requiring that mifepristone be administered in-clinic in the presence of a physician or midwife.¹⁵ In the United States, despite a relaxation of the REMS that allowed the pills to be taken at home, federal law still required that mifepristone be dispensed in a clinical setting, and so prohibited its distribution by mail, pharmacy, or online.¹⁶ Moreover, some state laws prohibited abortion at-home by bans on telemedical abortion or remote provision regardless of federal drug regulation.¹⁷

Abortion law before COVID-19 required some “touch” to a clinical setting, however formal or perfunctory. The fact that people already consumed abortion pills at home and ended their pregnancies at home proved of little persuasion in changing the law. This is because the in-clinic requirements of abortion law have always been as much discursive as real. They maintain the social control of the law. During COVID-19, when clinics shuttered and hospitals overfilled, and any safety pretense for these restrictions strained the most common of sense, abortion with pills found its revolutionary context – or perhaps not.

III Abortion At-Home as Crisis Management

There is a popular notion that crises create an opportunity to reform the status quo by threatening the structures that underlie it.¹⁸ Yet, in the thick of crisis, reform is often not a priority. In conventional crisis management, the imperative is to “bring things back to normal.” Reform comes only from the desire to change something so that everything else can stay the same. COVID-19 authorizations for abortion at-home in Europe and the United States reflect this idea.

In 2020, five European countries (Ireland, England, Wales, Scotland, and France) introduced executive orders or other measures that authorized abortion at-home by allowing for patient consultations by video or phone (remote provision), designating the home as a site of abortion care, and/or permitting the online purchase, home delivery, or local pharmacy pick-up of abortion pills.¹⁹ In the same year, authorization in the United States came via litigation. The FDA refused to suspend the in-clinic distribution requirement for mifepristone despite doing so for other drugs. The American Civil Liberties Union filed a lawsuit challenging this requirement for mifepristone and found early success when a federal district court judge ordered the FDA to suspend its enforcement during the pandemic.²⁰

These authorizations were all designed to ensure access to abortion during the pandemic, limit exposure to the virus, and conserve health system resources.²¹ They achieved these aims, but they also conserved certain social norms of abortion law. This section explores these conservative features of the COVID-19 authorizations.

First, the authorizations often framed abortion at-home as a mere practice innovation under the law to ensure continued access to care – that is, doing the same thing a different way. The Irish minister of health explicitly introduced remote provision as a revised model of abortion care to emphasize that it required no reform of abortion law.²² In Ireland, the Health (Regulation of Termination of Pregnancy) Act 2018 requires that a medical practitioner “examine the pregnant woman” to stay within the law and avoid criminal sanction.²³ According to the minister, this requirement did not preclude clinical examination by phone or video.

Continued clinical control was the most emphasized feature of the authorizations. “No touch protocols” promised that medical practitioners could and would do everything they ever did to administer abortions at-home.²⁴ The English order promised that the “medical practitioner” would carry out the “treatment” (abortion) as authorized by law, which restricts provision to “nine weeks and six days” on the day “mifepristone is taken.”²⁵ The Scottish order required practitioners to continue to file the green approval and yellow reporting forms under the law.²⁶ When the Christian Legal Centre challenged the UK authorization as ultra vires of the Abortion Act 1967 because abortion at-home would not be “carried out” by practitioners, but by patients, the Court of Appeal denied the review by emphasizing the control of the doctor, who “remains in charge [of the abortion] … even if they do not perform every part of it.”²⁷ Medical organizations led the charge for abortion at-home in every country.²⁸ In April 2021, after the US elections, when the FDA announced that it would not enforce the in-clinic distribution requirement for mifepristone, it did so by letter to the American College of Obstetrics and Gynecologists, the lead plaintiff in the American Civil Liberties Union lawsuit.²⁹ Even after the FDA permanently removed the in-person requirement, the REMS still required that a certified provider pledge they can date pregnancies accurately and will remain in control of the abortion throughout.³⁰

Rather than disrupt the status quo – abortion as a clinically controlled practice – abortion at-home conserved it. Virtual examinations are still medical examinations, telemedicine is still medicine, and the home is no different, and, most importantly, not inferior to the clinic. This conception of non-inferiority reflects a convention of abortion research and was central to all the authorizations, which cited evidence showing that abortion at-home was not unacceptably less safe or resulted in substantially worse outcomes than the status quo.³¹ The routine citation of this research softened any radical edge to abortion at-home, specifically because research is always revisable with new evidence, and thus so too, the authorizations premised upon it. With the UK orders set to expire within a month, the government continued to consider “all the evidence” before deciding whether to make abortion at-home a permanent feature of the law.³²

This is a second conservative feature of the authorizations, their temporary status, born and time-bound to a historic state of emergency. Sunset clauses were attached to the orders in Ireland and Wales, which meant they were to be automatically revoked with the end of emergency COVID-19 legislation.³³ In England, the secretary of state for health and social care reissued its order because this clause was mistakenly left out.³⁴ In Scotland, an accompanying letter explained the order’s temporary status with the stated intention to return to the status quo when abortion at-home was “no longer necessary in relation to the pandemic response,” that is, when “there was no longer a serious and imminent threat to public health posed by the … coronavirus in Scotland.”³⁵

This temporary status reflected an effort to allow abortion at-home with as little change to existing law as possible. This is a third conservative feature of the authorizations. In the United Kingdom, the Abortion Act 1967 authorizes a medical practitioner to carry out an abortion in a hospital or other approved place.³⁶ Abortion in any other place is a criminal offense. The English and Welsh orders both temporarily approved the “home” as a “class of place” for abortion under the Act. The Scottish order was more restrictive, approving the home only where a medical practitioner “considers that it is not advisable or not possible for the [patient] … to attend a clinic.”³⁷ The approval of abortion at-home, in other words, was entirely consistent with the aims of a criminal statute, and more so, with the nineteenth-century physician-led campaign for its enactment, given that telemedical abortion was justified as necessary to protect against a growing online market in abortion pills.³⁸ Indeed, before COVID-19, the FDA in the United States acted similarly to shut down this online supply for breach of the REMS.³⁹ The intended effect of approving abortion at-home was to channel all abortion into a single controlled system. The UK orders thus did not challenge the control logic of abortion law but traded on it.

In France and the United States, authorizations for abortion at-home were also anchored in existing abortion law, albeit constitutional rather than criminal. When French authorities justified the legality of the order authorizing teleconsultation and direct pharmacy pick-up of abortion pills, they referenced the constitutional status of abortion rights, declaring that the “[COVID-19] health crisis must not call into question our most fundamental values: those of the emancipation of women and their right to their bodies.”⁴⁰ Constitutional abortion rights doctrine also anchored the US authorization and then undid it. In 2020, the US federal district judge who suspended the in-clinic requirement reasoned that it posed an undue burden on the right to abortion, namely by increasing the risk of COVID-19 infection for oneself or family.⁴¹ When the Supreme Court later reinstated the requirement on an emergency motion, it reasoned from the same constitutional doctrine and against a strong dissent that emphasized the undue burden of the requirement, especially for people of color and from low-income communities, who faced greater risk.⁴² For those outside the United States, its constitutional doctrine on abortion rights is indeed “strangely disorienting … a sort of fascistic madness,”⁴³ especially when it proves futile to keep people safe during a pandemic. Moreover, abortion at-home challenges basic ideas in US abortion law, for example, altering the path to an abortion and so too the opportunity for substantial obstacle, yet any radical implications of the post-clinic abortion were held off in constitutional argument, which proceeded by established doctrine.⁴⁴ When the FDA eventually changed course to allow abortion at-home, it cited no constitutional right but rather the evidence of the safety of the practice.

Together these conservative features of the COVID-19 authorizations reflect the paradox of a crisis management discourse. Crisis creates an opportunity to reform the status quo, as much as it supports the status quo as solace in a risk-filled world. In these authorizations, abortion at-home conserved the clinical control and social norms of abortion law. The home was merely a temporary place to weather the storm.

IV Abortion At-Home in Radical Speculation

In the COVID-19 authorizations, whether court judgments or administrative orders, the home itself received little attention. In the English order, for example, the home was described simply as a permanent address or usual residence.⁴⁵ Yet the home is so much more. Indeed, there is a long tradition in creating meaning from the empty abstractions of law. This part speculates on the ways abortion at-home, as authorized by law, but normalized in the home, may lead to a radical change in its practice. In challenge to a conservative view of these authorizations, this part asks: What if everything does not stay the same? What if abortion at-home does more than remove access barriers and otherwise leave everything else the same?

When nineteenth-century criminal statutes took abortion from the home and the market, and relocated care to the clinical setting, it not only restricted access to abortion, but also changed the people and practices of abortion, the experiences, and even the nature of it. In the United States, criminalization outlawed domestic practice by midwives, many Black and Indigenous women, suppressing the knowledge and norms of their practice.⁴⁶ These included beliefs about abortion rooted in people’s perceptions and experiences of their bodies, including beliefs in their acts as no abortion at all but as the bringing back of the menses and health.⁴⁷ By giving the medical profession authority over abortion, the law displaced these ways of knowing and doing abortion.⁴⁸

With abortion at-home, this history may reverse as the medical practitioner is invited into the home, a place of experience that reflects the person who lives there and over which they have greater control. In many ways, the practice innovations of abortion at-home reflect this shift of control.⁴⁹ Ultrasounds to date pregnancy are replaced by “LMP,” an acronym for last menstrual period, something medical practitioners know from their patients. Routine clinic follow-ups are replaced by self-administered pregnancy tests to assess the success of an abortion. Most importantly, step-by-step instructions are shared on dosage and routes of administration, how many pills to take and how to take them, and how to care for the patient (yourself) throughout the process. There is a know-how quality to this information, which reflects not simple instruction, but a belief and trust in people and their bodily experiences of abortion. Medical practitioners may instruct, but the purpose of their instruction is to support people to have abortions on their own and ultimately to let go of control.⁵⁰

At home, people know things and do things that a medical practitioner cannot. At home, people may improvise or improve on standard practice – or create new practices. The off-label use of misoprostol for abortion came from such tinkering.⁵¹ In-clinic restrictions, even requirements that abortion pills be picked up from a clinic rather than a local pharmacy or mailed by post, affect the experience of them. When people must face the world outside in leaving their home, or the comforts of home life, there is a sense of the observation of others, the clinic staff and other patients, and an attention to some external environment, the path to the clinic, the world around it, and the clinic itself.⁵² Being in these places imprints on the experience of abortion, by marking the pills as controlled objects and the abortion itself as clinical care. Abortion at-home originates in a different place, within the material cultures and social relations of the home.⁵³

The home is also a place of multiple influences, which makes it difficult for the law to keep its promise of control. Today, an ever-growing suite of social media platforms, such as YouTube, Reddit, and Facebook, as well as abortion apps (one affectionately nicknamed, the abortion siri) and popular magazines (e.g., Teen Vogue, Self), promise everything anyone ever needed or wanted to know about managing abortion at-home.⁵⁴ In contrast to a (tele)medical consultation, within these information networks, people speak in their own voice and narrate their own experiences apart from the scripts of the law. Moreover, people not only share information on abortion, but also produce new knowledge about abortion based on the practice of it.⁵⁵ Such information gains authority by its usefulness, not its legal authorization.

The association of abortion at-home with a commodity (pills), rather than a service, may also change the social relations around it, including by patients reidentifying as consumers in the navigation of abortion markets.⁵⁶ The very term “abortion pills” signals this change, a deliberate denotation that questions the status of mifepristone and misoprostol as medicines, and thus the prescription and other controls on their distribution. When abortion pills are mail-ordered, home-delivered, and picked up in local retail pharmacies, they circulate in ways more common to other household products of need and leisure. Home abortion paraphernalia, such as pregnancy tests, ibuprofen, and soothing teas, can already be added to an Amazon cart. This materiality of abortion at-home may augment other features of it. The telemedical consultation may start to resemble more of a checkout counter than a doctor’s visit, leading people to question the need for a prescription at all, but also the more general belief that only regulated systems of medical control can guarantee abortion safety.⁵⁷

Abortion services in Europe and the United States have always functioned as a market, even if highly regulated, but abortion is rarely seen or talked about as such.⁵⁸ These markets have been dominated by a small set of organizations, strongly aligned with the medical establishment, and at least in Europe, with state provision. The markets in abortion pills, however, are much more diverse, involving more people and connections between them. Authorizations for abortion at-home were motivated in part by a desire to extinguish these markets or protect people from them, and while they may have had this effect in the short term, over time this effect may diminish, especially as the abortion markets themselves, the regulated versus unregulated, become harder to distinguish. In the United States, for example, many start-up abortion clinics began to advertise services during the pandemic and online pharmacies began shipping pills directly to patients.⁵⁹ People themselves may also come to feel differently about these markets. As abortion at-home becomes a more mundane affair, the medical controls of regulated access may also become more burden than protection. People may become comfortable with forms of consumer protection familiar to small-scale community distribution and online commerce in securing a safe supply of abortion pills.⁶⁰ Despite the expiry dates on its authorization, abortion at-home, once a habitual practice, may thus prove a more permanent feature of home life.

Speculating on abortion at-home as commodity and consumption also invites reflection on the social and cultural norms around it, including the inequalities of relying on private markets to fulfill constitutional rights. This lesson came early for abortion with pills when mifepristone was pulled from the French market for fear of commercial boycott and lost profits. As against the commercial context of abortion pills, however, the normalizing of abortion within the intimate and interior spaces of the home may also change the sociality of it. Abortion may become less a solitary act of the body than an act of home life, taken to support the social and economic well-being of a household. Support for abortion at-home during the pandemic, for example, centered on the home and life within it: loss of household incomes or housing itself, the care burdens of young children in the home, and violence that makes it difficult for people to leave their homes.⁶¹ In the end, these contradictions of the home as a place of care and consumption, protection and risk, freedom and control may prove the most radical element of abortion at-home and confound the control of the law.

V Conclusion

In 1990, when the UK Abortion Act 1967 was reformed to allow the health secretary to designate a “class of place,” the amendment was criticized as a backdoor to abortion at-home, or worse yet, do-it-yourself (DIY) abortion.⁶² Thirty years later, during the COVID-19 pandemic, “DIY abortion” remains a pejorative term used by critics to denounce abortion at-home as a dangerous practice, one set outside the law and showing contempt for its social norms.⁶³ This critique might explain why the authorizations for abortion at-home reflected a crisis management discourse, one designed to conserve access to abortion care during the pandemic, but conserving much more in the continued clinical control of abortion and the social norms of abortion law. Since their advent, abortion pills have been folded into abortion law and made subject to its control, namely by restrictions requiring some touch to a clinical setting. While place-based abortion law has long been justified as a measure of safety, social control was always a primary motivation. The clinic was never only a physical place, and always an institution of control. On a conservative view, the COVID-19 authorizations brought clinical control into the home during a historic but time-bound state of emergency to conserve the social norms and thus the status quo of abortion law. On an alternative view, by returning abortion to the home, the authorizations may have a radical legacy. The home, after all, is an inhabited space shaped by the people who live there. At home, within the material cultures and social relations of home life, people will learn and create new ways of knowing and doing abortion. Abortion at-home will change what it means to have an abortion, but then again, the law has always known this truth. Every revolution starts at home.