Compliance Considerations For Telehealth Abortion Services | Blogs | Health Care Law Today
In light of the U.S. Supreme Court’s recent decision in Dobbs v. Jackson Women’s Health Organization, which returned the right to enact laws regarding reproductive health care to the states, many health care providers are navigating available ways to provide abortion services to patients, including by utilizing innovative telemedicine care modalities.
Health care providers must comply with multiple and sometimes conflicting state laws when providing abortion-related services utilizing telemedicine. This article will address several issues that health care providers should consider relating to prescribing abortion-inducing medication utilizing telemedicine.
This article was excerpted from Medication Abortion, Telemedicine, and Dobbs — Key Considerations for Healthcare Providers. For a summary of abortion laws in each of the 50 states and the District of Columbia, see State Abortion Laws Tracker After Dobbs v. Jackson Women’s Health Organization.
Federal Regulation of Abortion Medications
While there is no federal law affirming a right to an abortion, federal agencies have nonetheless approved the use of abortion-inducing drugs. These agency approvals, and their regulatory underpinnings, are an essential part of the consideration a provider must undertake when delivering medication abortion services.
The U.S. Food and Drug Administration has approved a two-medication regimen of mifepristone and misoprostol to end a pregnancy through 70 days gestation — i.e., 70 days or less since the first day of the woman’s last menstrual period.1
When this regimen was first approved, the FDA adopted a risk evaluation and mitigation strategy, or REMS, for mifepristone that, among other things, limited dispensing of mifepristone to patients in certain health care settings — clinics, medical offices and hospitals — under the supervision of a certified prescriber.2
On Dec. 16, 2021, the FDA issued modifications to the mifepristone REMS that removed the in-person dispensing requirement, and added provisions allowing mifepristone to be dispensed by certified pharmacies and through the mail. These changes will take effect after the medication’s manufacturers submit proposals to FDA regarding how to implement the REMS modifications, and FDA reviews and approves those submissions.
Although the in-person dispensing requirements have ostensibly been lifted, the FDA still limits prescribing and dispensing authority to certified prescribers and pharmacies. As discussed in more detail below, health care providers must comply with applicable state laws relating to dispensing and prescribing abortion-inducing drugs. There are unsettled questions as to whether those state laws are preempted by the FDA’s approved REMS for this medication.
To ensure compliance with federal law, health care providers interested in prescribing abortion-inducing drugs must be certified by one of the two mifepristone drug manufacturers. In addition, the providers will need to consider several aspects of state law pertaining to abortion services.
Compliance With State Telemedicine Laws
When telehealth technology is used for a patient exchange, the care is considered to be rendered in the state where the patient is located. This means that, in most cases, an individual provider needs to be licensed in the state where the patient is located in order to provide care to that patient. Similarly, the laws of the state where the patient is located will govern the informed consent process, the standard of care for the encounter, and any telemedicine-specific laws that a state may have adopted.
Definitions of Abortion
Health care providers will need to know the state laws that apply to abortions in the state where the patient is located. Most state laws define an abortion to include prescribing a medication with the intent of terminating a pregnancy. For example, North Carolina defines an abortion in part to include the use or prescription of any “instrument, medicine, drug, or other substance or device” to terminate a woman’s pregnancy.3
Prohibitions on Abortion
If a provider is interested in prescribing an abortion-inducing drug, it is important to know whether an abortion can generally be performed in the state. In the wake of Dobbs, the legal status of abortion care in several states is in flux.
Multiple states have so-called trigger laws prohibiting or significantly restricting abortion that have gone, or will go, into effect following the Dobbs decision. Other states have laws that prohibited abortion prior to the Supreme Court’s 1973 decision in Roe v. Wade — sometimes referred to as zombie laws.
During the period of time when Roe and the 1992 Supreme Court case Parenthood v. Casey were in effect, states could not enforce their pre-Roe laws universally prohibiting abortion in the state.
Many states did not formally repeal those unenforceable laws from state statutes, however, and with the Dobbs decision, those state laws are now potentially enforceable. In addition, abortion laws in several states are temporarily enjoined by court order, or state actors are exercising enforcement discretion and adopting policies on how the law will be applied in the state.
It is important for health care providers to confirm that an abortion may be provided to a patient in a particular state in general, prior to exploring the option for prescribing an abortion-inducing drug to the patient.
Limitations on Medication Abortions
Assuming that abortions can legally be provided in the state, health care providers will then need to consider whether there are limitations to the modality that can be utilized to provide abortion-inducing medication. This is particularly important for providers using telemedicine to engage with patients, as there are several state laws that could limit this modality for abortion care. The limitations on utilizing telemedicine to prescribe abortion medication may appear in a variety of state laws.
Some states, such as Kansas, explicitly prohibit the use of telemedicine modalities to provide abortion services. Other states, such as Wisconsin, implicitly prohibit or restrict use of telemedicine modalities by requiring an initial dose of mifepristone or other abortion-inducing drug to be administered to the patient in the same room and in the physical presence of the physician who prescribed the medication.
Additionally, many states require an ultrasound be performed prior to an abortion or require in-person components to the abortion informed consent process. For example, Arizona requires both a pre-abortion ultrasound and that the provider meet in person with the pregnant woman to explain the procedure before the abortion can be performed.
These types of state laws also serve as de facto limitations on utilizing telemedicine to prescribe abortion-inducing medication, because they require some level of service or care to be provided in person.
Additional Restrictions on Patients and Prescribers
Providers must also take into account whether the laws in a particular state place other restrictions on abortion-inducing medication that impact care delivery. Many states only allow a physician to prescribe an abortion-inducing drug, even though other allied health professionals may be authorized to prescribe medication in the state.
For example, Nebraska only allows physicians to prescribe an abortion-inducing drug, even though Nebraska allows physician assistants and nurse practitioners to prescribe medication in other contexts. This means that if a health care provider utilizes allied health professionals as part of routine care, those providers could not prescribe medication for abortions, and patients would need to have an appointment with a physician for this service.
Since abortions are usually defined to include prescribing medication to cause a pregnancy termination, providers also must comply with the detailed informed consent requirements for obtaining an abortion in the state. These informed consent requirements can include waiting periods, an obligation to provide information about the physical and psychological risks of an abortion, and information about child support options.
Some state laws require providers to give patients specific information about abortion-inducing medication, including the possibility of reversing the effects of mifepristone.
Conclusion — Staying Apprised of Changes to State Laws
In summary, there are many considerations that health care providers must assess and comply with when providing medication abortion services using telemedicine modalities. State laws restricting abortion in general and medication abortions in particular may have been in place prior to the Dobbs decision.
After Dobbs, providers desiring to enter into this space will not only have to consider existing state law restrictions on this service, but they will also have to regularly keep track of whether abortions can be obtained in the state.
Although there may be some uncertainty as to how this will develop, in the meantime health care providers in this space will need to be extremely cognizant of the legal requirements for abortion care in the state or states in which they are operating.
This article originally appeared in Law360 on September 1, 2022, and is republished with permission.
1 https://www.fda.gov/drugs/postmarket-drug-safety-information-patients-and-providers/mifeprex-mifepristone-information.
2 https://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/020687Orig1s020RemsR.pdf.
3 North Carolina General Statutes Chapter 90. Medicine and Allied Occupations § 90-21.81.
