IntroductionFootnote 1
In 2017, 39% of all abortions in the United States were medication abortions, a safe and effective option for those seeking abortions through up to ten weeks of pregnancy.Footnote 2 The United States Food and Drug Administration (FDA) approved medication abortion, composed of a combination of mifepristone and misoprostol, in 2000, making the method available for the first time.Footnote 3 The FDA’s choice to approve medication abortion gave abortion activists hope that abortion would be more readily accessible.Footnote 4 One of the many barriers to abortion is the social outing one must undertake when visiting a doctor’s office to obtain the procedure—visits often accompanied by protestors outside those offices shouting at the patient. Medication abortion allows for patients to essentially perform their abortions privately, in their own homes, without suffering that social condemnation.Footnote 5
However, starting in 2004, numerous states began restricting access to medication abortion.Footnote 6 Many states require that medication abortion only be prescribed and administeredFootnote 7 by a physician who is in the same room as the patient, which essentially prevents physician assistants or advanced practice nurses from prescribing the medication, and any clinician from prescribing and administering the medication via telemedicine.Footnote 8 These restrictions became problematic during the COVID-19 pandemic when doctors’ offices were either closed or dangerous places to visit for people with certain health conditions.Footnote 9
Part I of this paper briefly explains the medication abortion process, as well as the history of medication abortion and its FDA approval. Part II illustrates the three most common ways that states have tried to limit access to, and use of, medication abortion since its FDA approval in 2000. Part III provides an analysis of how COVID-19 affected medication abortion access. Part III also introduces the first of three experimental models for providing medication abortion services during our time in a pandemic and in the future. Part IV first argues that medication abortion has the potential to improve access and safety to abortion care in the United States. Next, Part IV illustrates how many states are already allowing the use of telemedicine to prescribe medication abortions and argues that the rest of the states should allow the use of telemedicine to prescribe medication abortions. Additionally, Part IV describes and promotes the use of the other two experimental models for providing medication abortion services. Finally, Part IV concludes that states should not continue their patterns of limiting access to medication abortion, especially considering the potential for another global pandemic or crisis during which in-person access to healthcare/abortion is severely limited. Banning medication abortion will not help preserve healthcare resources.Footnote 10 The healthcare system is already strained;Footnote 11 clinician limitations should not be required; and the physical presence requirement is unnecessary and onerous.Footnote 12
Medication abortion and the fda
A vacuum aspiration, also known as a surgical abortion, is the most common procedure for the early termination of a pregnancy.Footnote 13 But more and more abortions in the United States are being achieved via medication.Footnote 14 Medication abortion involves taking two medications, mifepristone (also known by the original brand name Mifeprex) and misoprostol.Footnote 15 Mifepristone “halts the pregnancy by initiating the breakdown of the endometrium.”Footnote 16 Misoprostol “leads to contractions and the emptying of the uterus.”Footnote 17 Medication abortion under the FDA protocol is effective and safe.Footnote 18 If the medication is ingested at nine weeks of gestational age or less, there is a 99.6% chance of successfully terminating the pregnancy and a 0.4% chance of major complications, with an associated mortality rate of 0.00064%.Footnote 19
The FDA first approved the combination of mifepristone and misoprostol in 2000.Footnote 20 In 2016, the FDA updated its protocol to a regimen that is “just as effective but uses less medication, has fewer side effects, has a longer time span for use…and requires fewer visits to the provider.”Footnote 21 This protocol includes the following steps (1) the patient takes 200 milligrams of mifepristone by mouth on day one; (2) twenty-four to forty-eight hours after taking the mifepristone, the patient takes 800 micrograms of misoprostol buccally, or in the cheek pouch, “at a location appropriate for the client”; and (3) one to two weeks after taking the misoprostol, the patient follows up with the healthcare provider.Footnote 22 This process will end a pregnancy up to 70 days after the first day of the patient’s last menstrual period.Footnote 23 Under the original 2016 protocol, only one physician visit was required for the patient to obtain the pills and then the patient could take the misoprostol pill anywhere, including at home.Footnote 24 The patient could then follow up by phone one to two weeks after taking the medication.Footnote 25 By the time the FDA protocol was updated in 2016, the regimen was already in widespread use among providers.Footnote 26 Currently, use of medication abortion is FDA-approved for up to ten weeks of gestational age.Footnote 27
In 2019, the FDA approved a Risk Evaluation and Mitigation Strategy (REMS) which limited patients’ access to medication abortion.Footnote 28 Under the 2019 REMS, only certified providers were allowed to dispense the medication in specified settings; pharmacies were not allowed to dispense the medications; physicians could not mail their patients the medication; and physicians had to obtain a signed Patient Agreement Form before prescribing the medication.Footnote 29 Additionally, when an abortion provider preordered and stocked the medication ahead of time, that provider was added to the drug manufacturer’s record of certified providers.Footnote 30 Due to the history of harassment against abortion providers, many providers were hesitant to stock the medication because they would be added to that record of certified providers.Footnote 31
In 2021, the FDA undertook a full review of the 2019 Mifepristone REMS.Footnote 32 At that time, the FDA modified the REMS to keep most of the components of the 2019 REMS but removed the restriction that the medication can only be dispensed in clinics, medical offices and hospitals.Footnote 33 Given that pharmacies can now stock and dispense the medication, the 2021 REMS requires pharmacies to be certified to dispense mifepristone.Footnote 34 This REMS modification also modified the 2016 protocol to remove the in-person physician visit to obtain the pills.Footnote 35
History of medication abortion state statute restrictions
The United States Supreme Court ruled in Roe v. Wade that women possess the constitutional right to decide whether or not to terminate a pregnancy, and that this right could only be limited by the trimester within which the decision was made.Footnote 36 Up until June 24, 2022, after years of litigation and Supreme Court cases, the legal standard when analyzing whether a state could pass any law which limited access to abortion was whether the law imposed a substantial obstacle to a woman seeking an abortion.Footnote 37 If the obstacle was substantial, it would constitute an undue burden on the right to an abortion.Footnote 38 Whole Woman’s Health v. Hellerstedt confirmed Planned Parenthood of Southeast Pennsylvania v. Casey’s finding that “a statute which, while furthering [a] valid state interest, has the effect of placing a substantial obstacle in the path of a woman’s choice cannot be considered a permissible means of serving its legitimate ends,” and “[u]nnecessary health regulations that have the purpose or effect of presenting a substantial obstacle to a woman seeking an abortion impose an undue burden on the right.”Footnote 39 More recently, the Court in June Medical Services v. Russo emphasized that if a law creates a substantial obstacle in the path of womenFootnote 40 seeking an abortion and there is no health-related benefit, the law imposes an undue burden and is therefore unconstitutional.Footnote 41 States often argue as a justification, or legitimate end, for restrictions on abortion that they protect women’s health.Footnote 42
Although banning abortion outright was unconstitutional prior to June 24, 2022, many states consistently enacted legislation substantially restricting abortion and access to abortions and some courts upheld those statutes as constitutional. Footnote 43 Medication abortion was no exception. In 2014, the Fifth Circuit accepted the “women’s health” justification in the case of restricting medication abortion and noted that it had “no reason to examine the state’s factual support for a health-justified restriction on abortion” because a state’s “rational speculation” that the statute’s legitimate end is women’s health was all a state had to present for the law to remain valid.Footnote 44
The current Supreme Court has faced the question of whether abortion restrictions impose an undue burden on women seeking to end their pregnancies.Footnote 45 In December of 2021, the Supreme Court ruled in Whole Woman’s Health v. Jackson that a Texas law which effectively bans abortions after six weeks of gestational age could take effect.Footnote 46 The law, known commonly as S. B. 8, not only bans abortions after the detection of a fetal heartbeat, which typically occurs at six weeks of pregnancy, but also criminalizes anyone who aids or abets any abortion after six weeks and allows any private citizen to file a lawsuit for damages against any “aider” or “abettor.”Footnote 47 The Court focused on the procedural issues with challenges against S. B. 8 and did not address whether the law places an undue burden on a woman seeking an abortion according to Hellerstedt. Footnote 48 Although this case does not specifically target medication abortion, medication abortion is directly affected by S. B. 8 as it is currently designated for proper use through ten weeks of gestational age.
Finally, and devastatingly, on June 24, 2022, the Supreme Court explicitly overruled Roe v. Wade and Planned Parenthood v. Casey in Dobbs v. Jackson Women’s Health Organization. Footnote 49 Dobbs concerned Mississippi’s Gestational Age Act, which prohibits abortions after fifteen weeks of gestational age except in medical emergencies or in the case of severe fetal abnormality.Footnote 50 In his majority opinion, Justice Alito wrote that the Constitution does not reference abortion and the right to abortion is not implicitly protected in any Constitutional provision.Footnote 51 Therefore, the Court decided that the issue of abortion should be left to the states to decide.Footnote 52 However, as noted above, states have continuously assaulted abortion access, including access to medication abortions. Therefore, this decision severely impacts access to a legal and safe abortion for a large proportion of United States citizens.
State restrictions on medication abortion come in three main forms.Footnote 53 First, some states require the clinicians who prescribe medication abortions to be physicians.Footnote 54 Second, some states require the clinician prescribing the medication abortion to be physically present when the medication is administered.Footnote 55 Third, some states require the clinician to share with patients the medically unsupported claim that the medication abortion process can be reversed.Footnote 56
Clinician requirements
In addressing questions and answers about medication abortion, the FDA observes that some states allow health care providers other than physicians to prescribe the medication for a medication abortion, but that the discretion to do so belongs to the states.Footnote 57 Currently, twenty-nine states limit certified providers solely to physicians, even though the World Health Organization, the National Academies of Science, Engineering, and Medicine, and the National Abortion Federation found that “midlevel providers, such as physician assistants and advanced practice nurses, can safely provide medication abortion.”Footnote 58 Certified nurse midwives also fall into the “midlevel provider” category and can safely provide medication abortions.Footnote 59
Physicians and activist groups in some states have fought this requirement in court.Footnote 60 For example, in 2019, a family planning clinic, a physician, and others brought a claim challenging the constitutionality of an Arkansas statute which required a physician to be board-certified or board-eligible in obstetrics and gynecology to be able to perform both surgical and medication abortions.Footnote 61 The United States district court in Arkansas held that this board-certification requirement would give little, if any, benefit to the health of women in Arkansas.Footnote 62 It found instead that the OB-GYN requirement, together with the other requirements of the statute, created an undue burden on women seeking abortion care.Footnote 63 The court in its analysis noted the evidence brought by the clinic that if the law was put into effect, it would prevent 53% to 70% of the women who annually sought abortions in Arkansas from obtaining them.Footnote 64 On appeal, the Eighth Circuit Court of Appeals found the issue moot because by the time it got to the court, the clinic had hired a board-certified OB-GYN physician.Footnote 65
Physical presence
As of August 1, 2022, nineteen states require the clinician prescribing the medication abortion to be physically present when the medication is administered, which prohibits the use of telemedicine to prescribe the medication remotely.Footnote 66 Nine states ban telemedicine abortion through “legislation that exempts abortion from any permitted telemedicine.”Footnote 67
Telemedicine refers to the delivery of health-related information and services through the use of telecommunication technologies.Footnote 68 It has long been deemed a way to expand health care to rural and otherwise underserved communities.Footnote 69 According to the Guttmacher Institute, a leading research and policy organization which produces a wide range of resources on topics pertaining to sexual and reproductive health, half of counties in the United States counties lacked an obstetrician-gynecologist, with more than ten million women living in those mainly rural counties as of 2017.Footnote 70 That same year, 38% of women in the United States between the ages of 15 and 44 lived in a county that had no abortion clinic.Footnote 71 As such, states that limit or remove access to telemedicine abortion threaten to severely limit their citizens’ access to abortion more generally.
In Part III, I explore a recent Supreme Court case which analyzed this in-person requirement.Footnote 72 In short, the Court ruled that the in-person requirement was constitutional and based its decision on deference to the FDA.Footnote 73
Medically unsupported claims
Finally, at least nine states require clinicians to share the medically unsupported claim that the medication abortion process can be reversed by taking a high dose of progesterone after taking the mifepristone with patients.Footnote 74 No medical evidence exists to support the claim that progesterone can reverse the medication abortion process and there is no data on the safety of this “unproven treatment.”Footnote 75 In fact, the American College of Obstetricians and Gynecologists (ACOG) specifically does not support the use of progesterone to “stop” or reverse a medication abortion, because the treatment does not meet clinical standards and is not based on scientific evidence.Footnote 76
Moreover, the FDA has not assessed the potential reversal of a medication abortion.Footnote 77 The same expert panel discussed above, assembled by the National Academies of Sciences, Engineering and Medicine, concluded that requiring abortion providers to give patients inaccurate and misleading information interferes with a patient’s ability to make informed medical decisions, which diminishes the quality of health care.Footnote 78
There have been challenges in court to this requirement as well.Footnote 79 In American Medical Association v. Stenehjem, the American Medical Association sought to prevent the enforcement of a North Dakota statute that required providers to inform patients seeking both surgical and medication abortions that it might be possible to reverse a medication abortion.Footnote 80 The court issued an injunction on the enforcement of the North Dakota statute, finding “North Dakota may not violate the First Amendment rights of physicians by compelling them to espouse the State’s ideology.” The court went on to say that the “law also clearly interfere[d] with the doctor-patient relationship; force[d] the attending physician to convey to his/her patient a state-mandated message that is devoid of credible scientific evidence; misinform[ed] and misle[d] the patient; undermin[d] informed consent and the standard of care; and [was] arguably unethical.”Footnote 81
Medication abortion and COVID-19
The world as we knew it changed on January 21, 2020, when the first COVID-19 case was detected in the United States.Footnote 82 As of August 22, 2022, there have been over ninety-three million cases of COVID-19 and over 1,036,000 COVID-19-related deaths in the United States alone.Footnote 83 The COVID-19 pandemic has had detrimental effects on public health in general, but has also affected every facet of care offered in the American healthcare system.Footnote 84 When COVID-19 cases first began to rise in the United States in early 2020, hospital systems and clinics prepared to meet increased demand for the care of COVID-19 patients and created strategies to reduce the spread of the virus.Footnote 85 One of these strategies, recommended by the Centers for Disease Control and Prevention (CDC), was for hospital and medical offices to cancel elective and non-urgent procedures.Footnote 86 In some states, this meant that access to surgical and medication abortion was severely limited.Footnote 87
Surgical abortion
Using the CDC’s recommendation, some states targeted surgical abortion care, placing it in the same category as elective and non-urgent healthcare services.Footnote 88 In August 2020, when over 20,000 people had died from COVID-19, one report found that “[w]hile every state has taken action to declare a public health emergency to mitigate the spread of COVID-19, several states have made public health emergency declarations to specifically define abortion as non-essential or elective health procedures and banned abortions until the end of the emergency.”Footnote 89 Many states justified the banning of surgical abortion care to conserve personal protective equipment.Footnote 90 The ACOG released a statement “defining abortion as a time sensitive and an ‘essential component of comprehensive health care’ and [warning] that delay, even days, ‘may increase the risks or potentially make it completely inaccessible.’”Footnote 91 Most courts were persuaded by the challenges brought by reproductive rights advocates and abortion provider groups and blocked these restrictions by a court order.Footnote 92
Medication abortion
As mentioned previously, nineteen states currently require the clinician prescribing the medication abortion to be physically present when the medication is administered, prohibiting the use of telemedicine to prescribe the medication remotely.Footnote 93 Without an option for telemedicine, these restrictions required and continue to require women to travel long distances, perhaps with overnight stays, at a high cost, all in the middle of a pandemic.Footnote 94 Access was further challenged by the risk of exposure to COVID-19, the uncertain future of the pandemic, the additional costs related to waiting periods and other delays, the loss of jobs, and the difficulties of traveling when a stay-at-home order is in effect.Footnote 95 For communities facing barriers to accessing care, “which are exacerbated during the COVID-19 pandemic, telemedicine provision of abortion is essential in addressing health inequities.”Footnote 96
During the COVID-19 pandemic, many states tried to institute more medication abortion restrictions.Footnote 97 For example, Arkansas required patients to have one negative COVID-19 Nucleic Acid Amplification Test in the 48 hours prior to the clinician visit.Footnote 98 The requirement has since been rescinded by the Arkansas Department of Health, but for a period of approximately fourth months, patients in Arkansas had the additional responsibility of receiving a negative COVID test in order to receive necessary care.Footnote 99
Furthermore, Texas tried to wholly shut down abortion care in the state, claiming the need to preserve personal protective equipment and using its emergency state authority during a public health crisis.Footnote 100 And in April of 2020, the Fifth Circuit found that Texas could ban medication abortions in response to COVID-19.Footnote 101 In its opinion, the court stated that states have the authority to craft emergency health measures and that medication abortion is not exempt from the state’s emergency rules requiring healthcare professionals and facilities to postpone non-essential procedures to preserve personal protective equipment during the COVID-19 pandemic.Footnote 102 Shutting down legal abortion care in Texas increased the average one-way driving distance to an abortion clinic for a woman of reproductive age from 12 miles to 243 miles: a 1,925% increase.Footnote 103 On January 25, 2021, the Supreme Court granted certiorari and vacated the Fifth Circuit’s judgment with instructions to dismiss the case as moot because the executive order ended in the summer of 2020.Footnote 104
In another fight for access to medication abortion during COVID-19, the ACOG and other groups sued the Federal Drug Administration to suspend the physician presence requirement in light of the pandemic.Footnote 105 They argued that no good reason existed to support the requirement that patients visit physicians’ offices to receive the drug when it was prescribed via telemedicine, and when the drug could be delivered or mailed.Footnote 106 Despite research that concludes that medication abortion can safely and effectively be administered outside of a physician’s office, on January 12, 2021, the Supreme Court in Food and Drug Administration v. American College of Obstetricians and Gynecologists “reinstated a federal requirement that women seeking to end their pregnancies using medications pick up a pill in person from a hospital or medical office.”Footnote 107 The Court justified its opinion based on deference to the legislature and the FDA, and Chief Justice Roberts stated that the question before the Court was not whether the requirement imposed “an undue burden on a woman’s right to an abortion as a general matter” but “whether a federal judge should have second-guessed the Food and Drug Administration” based on “the Court’s own evaluation of the impact of the Covid-19 pandemic.”Footnote 108 Chief Justice Roberts wrote that “courts owe significant deference to the politically accountable entities with the ‘background, competence and expertise to assess public health.’”Footnote 109
In her strongly worded dissent, Justice Sonia Sotomayor noted how the country’s laws have isolated abortion from other medical procedures that carry similar or greater risks.Footnote 110 She also noted how the country’s laws have isolated mifepristone from the other 20,000 FDA-approved drugs.Footnote 111 She drew attention to the fact that the FDA and the Secretary of Health and Human Services waived in-person requirements for several other drugs during COVID-19, including powerful opioids, but refused to waive the requirement for mifepristone.Footnote 112 She stated that “like many of those laws, maintaining the FDA’s in-person requirements” for picking up the drug from a physician’s office “during the pandemic not only treats abortion exceptionally, it imposes an unnecessary, irrational and unjustifiable undue burden on women seeking to exercise their right to choose.”Footnote 113
This case was the first abortion case decided by the Supreme Court since Justice Amy Coney Barrett joined the Court in 2020, and perhaps was predictive of how abortion cases would be treated by this Court.Footnote 114 Julia Kaye, a lawyer for the American Civil Liberties Union, commented that the Court took an extraordinary step and rejected “science, compassion and decades of legal precedent in service of the Trump administration’s anti-abortion agenda.”Footnote 115 She added: “It is mind-boggling that the Trump administration’s top priority on its way out the door is to needlessly endanger even more people during this dark pandemic winter—and chilling that the Supreme Court allowed it.”Footnote 116
The fight for the lifting of the in-person dispensing requirement, especially during COVID-19, continued when on February 9, 2021, Congresswoman Carolyn Maloney (D-NY), along with ten other female congresswomen, wrote a letter to Dr. Janet Woodcock, the acting commissioner for the FDA, urging her to eliminate the in-person requirement for dispensing mifepristone.Footnote 117 The letter cited Justice Sotomayor’s dissent in Food and Drug Administration v. American College of Obstetricians and Gynecologists and used many of her same arguments.Footnote 118 Previously, in September of 2020, a group of conservative senators wrote a letter to the preceding FDA Commissioner, Dr. Stephen Hahn, urging him to keep the REMS in-person requirements in place during the pandemic.Footnote 119 In their letter, the senators called mifepristone a “deadly pill,” said that “the abortion industry and its allies…have wanted an unregulated and demedicalized abortion pill since…2000,” and encouraged the FDA to “resist this opportunistic ploy to expand access to abortion under the fallacy that the REMS imposes an undue burden on women’s rights.”Footnote 120
Fortunately, the letter Congresswoman Maloney spearheaded was successful, and on December 16, 2021, the FDA announced that as a result of its full review of the Mifepristone REMS, it was removing the REMS that required that the medication be dispensed in clinics, medical offices and hospitals.Footnote 121 Removing this in-person requirement opens the door to using telemedicine in the practice of abortion care.
Not only did the group of conservative senators urge the FDA to keep the in-person requirement in its letter, but the senators also condemned the “TelAbortion” project conducted by Gynuity Health Project and approved by the FDA.Footnote 122 In order to allow clinicians to provide abortion services while protecting both patients and providers from COVID-19, Gynuity Health Projects, Advancing New Standards in Reproductive Health at the University of California San Francisco, and the Society of Family Planning, with special approval from the FDA, developed a “Telehealth for Medication Abortion Care” protocol for providing medication abortion during the COVID-19 pandemic.Footnote 123 “This method enables patients to obtain their abortions safely without the traditional need for in-person pregnancy testing, pelvic examination, ultrasounds, or labs.”Footnote 124 According to the protocol, clinicians determine their patients’ eligibility for this service based on their health and gestational age via a telemedicine appointment.Footnote 125 If the clinician determines that the patient is eligible, the patient retrieves the medication curbside from the medical office and takes the pills at home.Footnote 126 The patient and clinician then schedule a follow-up appointment via telemedicine.Footnote 127 This model could only be legally implemented in 22 states due to regulations restricting telemedicine appointments for access to medication abortion.Footnote 128 In those 22 states, however, the Telehealth for Medication Abortion Care protocol could “preserve abortion access and maintain patient and provider safety during the COVID-19 pandemic.”Footnote 129
Recommendations for the future of medication abortion
The use of medication abortion has the potential to improve access to safe abortion care in the United States because it can be safely offered in diverse settings and by a range of health care providers.Footnote 130 Medication abortions are a safe and effective means to terminate a pregnancy.Footnote 131 In fact, the complication rate for medication abortion is less than 0.5% whether it is provided in-person or by telemedicine.Footnote 132 Medication abortion has the potential to improve access and safety to abortion care in the United States through utilizing telemedicine. However, we cannot look to the current Supreme Court to protect medication abortion from state regulations. Therefore, both federal and state governments should prioritize increasing access to medication abortion and, at a minimum, should not continue their patterns of limiting access to medication abortion, especially considering the potential for another global pandemic which would severely limit in-person access to healthcare/abortion.
Medication abortion improves access to abortion care through telemedicine
Medication abortions have the potential to expand care immensely if telemedicine prescription is allowed to continue.Footnote 133 The rapid growth in the use of telemedicine in diverse health care settings has confirmed its effectiveness as for expanding access to care, reducing health care costs and improving health outcomes.Footnote 134 Generally, telemedicine renders medical care more accessible, and lowers the cost of provision by reducing or eliminating the time and costs associated with provider visits.Footnote 135 The American Medical Association supports the use of telemedicine as a means of improving the quality of health care delivered to patients.Footnote 136 For the same reasons telemedicine is used in other areas of health care, telemedicine should be permitted to prescribe medication abortion. Although some states are already utilizing telemedicine in their abortion services, all states should eschew their restrictions which disallow providers to prescribe medication abortions via telemedicine.
Telemedicine is currently being used to prescribe medication abortions in some states
In 2008, Planned Parenthood of the Heartland in Iowa began using telemedicine in its clinics, which were not regularly staffed by an abortion-providing clinician.Footnote 137 Today, Planned Parenthood health centers offer telabortions in at least ten states.Footnote 138 Many independent abortion providers also integrated telemedicine into their abortion practices.Footnote 139 Under the traditional approach of prescribing medication abortions via telemedicine (coined “telabortion”), patients must visit a health clinic for a consultation and screening with on-site staff.Footnote 140 Then, eligible patients who opt for medication abortion is connected to an abortion provider at another health center by videocall.Footnote 141 During this appointment, the clinician reviews the patient’s medical records, answers questions, and remotely authorizes the medication.Footnote 142
The use of telemedicine to prescribe medication abortions should expand to more states
Access to telabortion would be especially helpful for the ten million U.S. citizens who live in counties that lack an obstetrician-gynecologist and/or abortion clinic.Footnote 143 Mitigating the need to travel could reduce delays in receiving care, which in turn could enable patients to obtain an abortion earlier than if they had to travel far away from their home.Footnote 144 The earlier a patient gets an abortion, the safer the process is; delaying care thus increases the risks and costs of abortion.Footnote 145 Providing medication abortion through telemedicine has proven to increase access to abortion care, reduce second-trimester abortion rates, and improve patient-centered care.Footnote 146 Furthermore, because the Supreme Court’s overruling of Roe and Casey has spurred states to limit and/or ban access to abortion care, telabortion is becoming all the more crucial.
Research shows that being prescribed medication abortion via telemedicine is safe, effective, and convenient for patients.Footnote 147 In 2019, the largest United States study focusing on the efficacy of telabortions found that patients who received medication abortion by mail had similar health outcomes as those who received it at the doctor’s office or abortion clinic.Footnote 148 The study also found that patients reported high levels of satisfaction with the service.Footnote 149 Medication abortion can provide patients with more flexibility and greater access to abortion care when clinicians are able to prescribe the medication via telemedicine and the patient can self-administer the medication at home without a physician present.Footnote 150 “While abortion is an incredibly safe procedure, improving access to care at earlier gestational ages through telemedicine decreases the risk of complications and reduces patient costs.”Footnote 151 During the COVID-19 pandemic, clinicians could prescribe medication abortion via telemedicine, thereby providing abortion services while protecting both patients and providers from the disease.Footnote 152
Use of telemedicine for medication abortion can improve access to abortion outside of the pandemic context, especially in rural areas where patients may have difficulty traveling to a health facility.Footnote 153 In 2017, 38% of women between the ages of fifteen and forty-four lived in a county that had no abortion clinic.Footnote 154 Women who lived in those counties had to travel long distances to reach their nearest abortion clinic in order to receive the care they need. In states like Missouri, where 97% of counties had no abortion clinics in 2017, traveling may cause delays in receiving care.Footnote 155 Earlier access to abortion care is safer and telemedicine visits could be a solution to travel delays.Footnote 156
Abortion providers have expressed concern that if they cannot obtain access to abortion care in a timely fashion, “women will try to self-manage abortions in ways that are not safe, putting their own health at risk.”Footnote 157 The ACOG found that “where abortion is illegal or highly restricted, women resort to unsafe means to end unwanted pregnancies, including self-inflicted abdominal and bodily trauma, ingestion of dangerous chemicals, self-medication with a variety of drugs, and reliance on unqualified abortion providers.”Footnote 158 If telemedicine is unavailable in certain states, patients must travel to a health center far from home, and when travel becomes expensive or dangerous due to the health risks associated with a global pandemic, patients may be deterred from seeking the necessary care and instead take matters into their own hands.Footnote 159
A significant barrier to medication abortion access in states where telemedicine is not utilized was the FDA REMS in-person requirements.Footnote 160 However, under the Biden-Harris administration, the FDA removed this requirementFootnote 161 after many activists pushed the Biden-Harris administration to keep to its promise to advance reproductive justice and remove the requirements.Footnote 162 For example, Monica Simpson, executive director of SisterSong Women of Color Reproductive Justice Collective, asserted that it was “up to the Biden-Harris administration to not only undo this damage they [inherited], but also take bold affirmative action to advance reproductive justice.”Footnote 163 Removing the in-person REMS requirement expanded access to medication abortion across the country. This allowed the medication prescribed via telemedicine to be shipped directly to the patient, or to be picked up by the patient at a local pharmacy.Footnote 164
Another way in which the Biden-Harris administration endeavored to advance reproductive justice was to advance the Women’s Health Protection Act of 2021. The Act, among other things, specifies that the government may not limit an abortion provider’s ability to prescribe and administer medication abortions, offer telabortions, or provide abortion services when a delay would risk the patient’s health.Footnote 165 The bill was passed by the House of Representatives on September 24, 2021, and is now awaiting a Senate vote.Footnote 166 If this bill becomes law, access to abortion care—including via telemedicine—would expand exponentially.
Experimental models for providing medication abortion services via telemedicine
As mentioned above, Gynuity Health Projects, Advancing New Standards in Reproductive Health at the University of California San Francisco, and the Society of Family Planning, with special approval from the FDA, are currently piloting and studying various new telemedicine abortion model, including the “Telehealth for Medication Abortion Care” protocol used during the COVID-19 pandemic. Footnote 167 The other two models that the groups are studying are the “Direct-to Patient Model,” and the “Site-to-Site Model.”Footnote 168 All three of these models could be utilized to increase access to medication abortions both within and outside of a pandemic context and should be implemented across the country.
Under the Direct-to-Patient Model, a patient seeking abortion care does not need to physically visit a health clinic.Footnote 169 Instead, the patient consults with the certified abortion provider via videoconference from any location.Footnote 170 Any required tests, like blood work or an ultrasound, are completed at a local health care facility or laboratory and the pills are mailed directly from the certified abortion provider to the patient.Footnote 171 After taking the medication, the patient completes follow-up testing at their local health care facility or laboratory and then has another videoconference with the certified abortion provider.Footnote 172 This model has been implemented so far in four states: Hawaii, New York, Oregon, and Washington.Footnote 173 Data from these four states suggest this model is feasible and safe for patients.Footnote 174
Under the Site-to-Site Model, a patient goes to a participating clinic for an intake appointment and an ultrasound.Footnote 175 At the clinic, a patient then connects with a remote provider and that provider determines the patient’s eligibility for receiving a medication abortion.Footnote 176 If the patient is found to be eligible, the provider remotely unlocks a medication drawer in the patient’s room and the patient takes the mifepristone in the clinic.Footnote 177 The patient takes the misoprostol home and takes it there.Footnote 178 Finally, the patient has a follow up appointment in person at the clinic.Footnote 179 The Site-to-Site Model is safe and effective, and research indicates that both patients and providers find use of the model to be a positive experience.Footnote 180
These three models would increase access to abortion care and provide a variety of avenues for patients to receive medication abortions. These models could expand access in all areas of the country and could be one solution to the problem of there being so few abortion clinics in many areas the country. While there are multiple barriers to these methods being implemented in actuality but these barriers seem to have relatively simple solutions.Footnote 181
First, mifepristone is currently subject to REMS restrictions by the FDA, which are “for certain medications with serious safety concerns to help ensure the benefits of the medication outweigh its risks.”Footnote 182 The REMS restrictions are not necessary for mifepristone, a drug which has proven to be very safe for over twenty years. In fact, both the American Medical Association and the ACOG have argued mifepristone should be free from REMS restrictions.Footnote 183 The most stringent and restricting REMS was the in-person requirement. The Biden-Harris administration removed the REMS requirement for in-person disbursement of the medication and the removal expands access to abortion care exponentially.Footnote 184 The removal of the in-person requirement allows for the three above models of care to function properly. However, the other REMS, including the clinician requirements, may prove to be burdensome and unnecessary as the American Medical Association and the ACOG have argued.Footnote 185 If the Biden-Harris administration removes the remaining REMS restrictions in place, patients will have even greater access to medication abortions.
Second, clinician licensing, insurance reimbursement, and other patient protections differ among states, making it difficult for telemedicine to cross state-lines.Footnote 186 One response to these issues is for physicians “to enter into multi-state compacts, which allow a provider licensed in one state to receive reciprocity or expedited licensing in the other states participating in the agreement.”Footnote 187 States can work together in a similar way and adopt uniform laws to help facilitate the ease of insurance reimbursement, ensure malpractice laws in various states are predictable, and make certain patients are protected appropriately.Footnote 188
Third, it would take considerable funds to implement these models and incorporate telemedicine into the existing abortion care system.Footnote 189 “Due to the segregation of abortion services from other health care, some of the standard ways health care providers access new funds and technology—such as through hospital networks or incentives from insurers—already exclude many abortion providers.”Footnote 190 One way to ensure abortion providers are able to implement these models in practice is making sure their clinics are not excluded from government telehealth resources, like public grants.Footnote 191
Fourth, Congress passed the Hyde Amendment in 1977, which forbids the use of federal funds for abortion care except if the mother’s life is endangered or if the pregnancy resulted from rape or incest.Footnote 192 The Hyde Amendment makes abortion the only medical procedure exempted from federal Medicaid funding.Footnote 193 Although telehealth reduces healthcare costs generally, for these models to truly expand access, they need to expand access for everyone, including low-income and otherwise marginalized patients. In order for these patients to get the care they need, the Hyde Amendment and other financial government barriers to abortion must be repealed. Thankfully, this may be on the to-do list for the Biden-Harris administration.Footnote 194 In a memorandum written by President Joe Biden, he stated that “undue restrictions on the use of Federal funds have made it harder for women to obtain necessary healthcare” and he ordered the Secretary of Health and Human Services to review the restrictions on the use of Federal funds for abortion care.Footnote 195
Finally, all three models require the nineteen states that currently mandate physical presence of the prescribing physician to remove the physical-presence requirement.Footnote 196 Unfortunately, due to the politicized nature of abortion, this may be the most difficult barrier to overcome. Perhaps as abortion care becomes more connected with healthcare generally, more widespread acceptance of its place in healthcare will allow for the issue to be less politicized. Additionally, because the Biden-Harris administration took federal steps through the removal of the FDA REMS in-person requirement, perhaps states will follow suit.
States must stop their patterns of limiting access to medication abortion
States should not continue to limit access to medication abortion, especially in light of the potential for another global pandemic during which in-person access to healthcare would be severely limited. The world is already dealing with “one of the most dangerous challenges this world has faced in our lifetime” with the COVID-19 pandemic.Footnote 197 Moreover, pandemics are inevitable and are likely to recur.Footnote 198 It is essential that abortion care does not get left behind in the next pandemic as it did in this one.
There are three main reasons why I argue that especially during a pandemic, medication abortion restrictions should be removed. First, banning medication abortion will not help preserve healthcare resources.Footnote 199 Second, the healthcare system is already strainedFootnote 200 and, therefore, the clinician limitations should not be required. Finally, the physical presence requirement is unnecessary and onerous.Footnote 201
Banning medication abortion will not help preserve healthcare resources
At the beginning of the COVID-19 pandemic, many states ordered elective and non-urgent procedures to be postponed and included medication abortion in those elective and non-urgent procedures.Footnote 202 One justification for these orders was to preserve healthcare resources, such as personal protective equipment (PPE).Footnote 203 However, medication abortions ordinarily do not require PPE, such as gowns, gloves, eyewear, or masks.Footnote 204 Additionally, medication abortion is often not administered in a physician’s office or hospital, but rather in a standalone reproductive health clinic.Footnote 205
Furthermore, if medication abortions were allowed to be administered via telemedicine, there would be no strain on healthcare resources at all because physicians could prescribe medication from anywhere, including their own homes, and patients could likewise be prescribed their medication from home. Therefore, these concerns about preserving healthcare resources are unfounded.
In fact, banning medication abortion may actually strain healthcare resources because patients who cannot access abortion services close to their homes will travel to other states where they can access abortion services, or, in the alternative, patients will carry their pregnancies to term and then will require assistance in prenatal care and childbirth.Footnote 206 Accordingly, states should not ban medication abortions because banning medication abortions will not help preserve healthcare resources, both during and not during global pandemics.
Clinician limitations should not be required
In the United States, whether or not we are in the middle of a global pandemic, the healthcare system is strained.Footnote 207 During COVID-19, the approach for staffing has been “all-hands-on-deck.”Footnote 208 Yet, currently twenty-nine states limit certified providers who may prescribe medication abortion solely to physicians.Footnote 209 Especially during a global pandemic, but also during normal times, licensed physicians should not need to be the sole healthcare workers able to prescribe medication abortions when other healthcare professionals are just as capable.Footnote 210
Allowing nurse practitioners, physician assistants, or nurse midwives to prescribe medication abortions would result in a more evenly distributed workload for reproductive healthcare professionals. With a more evenly distributed workload and more professionals being able to provide medication abortions, providers will have availability to meet with more patients and patients will have more options for providers, increasing access. Specifically, wait times will likely decrease if more providers are able to prescribe medication abortions, which is important since abortion care is incredibly time sensitive.Footnote 211
Clinician limitations for medication abortions are not only onerous for physicians because the healthcare system is strained and demand is high for medication abortions but are also onerous for patients who have to wait for a physician to be available to prescribe the medication. This can be especially difficult for patients who do not live near clinics with multiple providers or do not live near clinics at all. In states like Missouri, with only one abortion provider remaining, and with the law that only a licensed physician can prescribe the medication, access is extremely diminished.Footnote 212
The physical presence limitation is unnecessary and onerous
As discussed above, nineteen states currently require the clinician prescribing the medication abortion to be physically present when the medication is administered, which in turn prohibits the use of telemedicine to prescribe the medication remotely.Footnote 213 However, research has shown that “there is overwhelming evidence that the safety and effectiveness of medication abortion is the same whether it is provided via telemedicine or through in-person provision, as shown by a seven-year cohort study with tens of thousands of patients, systematic reviews, and an evaluation of a telemedicine abortion service across five states.”Footnote 214 Additionally, the National Academies of Science, Engineering and Medicine issued an independent report confirming that “[t]here is no evidence that the dispensing or taking of [medication abortion pills] requires the physical presence of a clinician.”Footnote 215 Therefore, there is no medically necessary reason to require a patient to be in the same room as the clinician when the medication is being administered.
Not only is there no medical necessity in requiring a patient to be in the same room as the clinician when the clinician prescribes and gives to the patient the medication, but the physical presence requirement also burdens patients and can put them at risk, especially during a global pandemic.Footnote 216 Until Roe and Casey were overruled in Dobbs, the constitutional test for evaluating restrictions on abortion was if the regulation imposed an undue burden on the right to obtaining an abortion.Footnote 217 Although Roe and Casey were overruled, and the constitutional test is no longer applicable, the in-person requirement nonetheless creates a substantial obstacle to a woman seeking an abortion in the context of a pandemic and therefore is harmful. The requirement notably burdens those patients who are unemployed or work essential jobs, lack transportation, have lost health insurance, and live in multi-generational homes.Footnote 218 Leaving work, finding childcare, and transportation are just a few of the burdens that are exacerbated during a pandemic. Another large burden is also the potential for additional exposure to COVID-19. Low-income individuals and people of color disproportionately suffer during a pandemic.Footnote 219 These individuals are more likely to get the virus, to have inadequate resources to respond to the virus, and to have worse health outcomes as a result of health inequalities.Footnote 220 These burdens will surely be present in future pandemics.
These burdens are also present for patients living in rural communities in America. With over ten million women living in rural communities without an obstetrician or gynecologist, these burdens are prevalent whether or not there is a pandemic. Poverty is more prevalent in rural areas compared to urban areas. Further, in areas of poverty, “time away from work, lost wages and the added costs and challenges of securing child care, lodging, and adequate and accessible transportation” are especially burdensome.Footnote 221 Furthermore, because the Supreme Court removed the undue burden test in Dobbs, the regulation of abortion is now subject to the more relaxed and deferential rational basis of review accorded to socioeconomic legislation.Footnote 222 If any future abortion case reaches the Court, under a rational basis of review method, the Court will defer to state rationales and will rarely invalidate any state abortion law unless it is blatantly unconstitutional, essentially allowing states to have free range to limit or eliminate access to abortions in their states. Although the Mississippi law in Dobbs prohibits all abortions after fifteen weeks of gestational age, and medication abortion can be accomplished at ten weeks of gestational age or earlier, states can now target abortion at earlier and earlier stages in a pregnancy, which already has, can, and will affect medication abortion in the future.
Conclusion
Since its FDA approval in 2000, states have restricted access to abortion in three main ways: (1) requiring the clinicians who prescribe medication abortions to be physicians;Footnote 223 (2) requiring the clinician prescribing the medication abortion to be physically present when the medication is administered;Footnote 224 and (3) requiring the clinician to share with patients the medically unsupported claim that the medication abortion process can be reversed.Footnote 225
The COVID-19 pandemic provided unique challenges on top of the restrictions states already had in place, which in turn diminished access to medication abortion.Footnote 226 While many states have worked to inhibit access to abortion care, medication abortions have the potential to improve access and safety to abortion care in the United States because they can be safely offered in diverse settings and by a range of health care professionals.Footnote 227 Medication abortions can particularly improve access if they can be offered via telemedicine.Footnote 228 With the danger that if abortions are not accessible, women will try to self-manage abortions in ways that are not safe,Footnote 229 states must stop their patterns of limiting access to medication abortion, especially considering the likelihood of another global pandemic, during which in-person access to healthcare is severely limited. Moreover, the Biden-Harris administration must continue advancing reproductive justice by removing the Hyde Amendment and all REMS restrictions on medication abortion usage, and by moving the Women’s Health Protection Act of 2021 forward through Congress. If the federal government legalizes access to abortions for all United States citizens, the Dobbs decision or any other future abortion case before the Supreme Court will cease to have such dire consequences.
