Recent actions by the federal government are designed to ensure full access to abortion medication across the country, but it remains unclear whether these medications can be prescribed to and legally obtained by patients in states that have banned or limited abortions.
Some observers say clarity surrounding the conflict between state laws and federal policies restricting medication abortions may have to come from the U.S. Supreme Court, and litigation has already been filed.
Employers and plan sponsors that cover or are considering covering these drugs in their health plans should be aware of and continue to monitor these developments. Telehealth offerings could also be affected.
Here are the latest developments surrounding abortion medication.
- On January 3, the Food and Drug Administration (FDA) approved a protocol for pharmacies that have been certified by the manufacturers of the “abortion pill” mifepristone to dispense the drug directly to patients. The approval follows a change that the agency made in late 2021 to remove the in-person dispensing requirement for mifepristone and expand the distribution to include certified pharmacies in addition to certified clinicians. The change meant that a patient no longer had to visit a health care provider to receive the drug and could obtain it from a certified pharmacy.
- Also on January 3, the U.S. Department of Justice ruled that the U.S. Postal Service can deliver prescription abortion medications despite the U.S. Supreme Court’s ruling in Dobbs v. Jackson Women’s Health Organization, which allows states to regulate or prohibit abortions.
- On January 22, President Biden signed a presidential memorandum related to abortion medications that directs the Secretary of Health and Human Services (HHS), in consultation with the Attorney General and the Secretary of Homeland Security (DHS), to consider new guidance and actions that would support patients, providers and pharmacies in accessing reproductive care, including medication abortion and to do so within 60 days. A fact sheet does not specify what the new guidance or actions may be.
- Two lawsuits were filed on January 25 in federal district courts in North Carolina and West Virginia, arguing that federal policies should supersede state laws when it comes to abortion medication.
What are medication abortions?
Kaiser Family Foundation (KFF) reports that by 2021, more than half of abortions in the U.S. were medication abortions, and many are self-paid.
Most use the following two drugs:
*Mifepristone, which is sold under the brand name Mifeprex as well as in generic form.
*Misoprostol, which is taken 24 to 48 hours after mifepristone. This drug was already available from mail-order and retail pharmacies. Misoprostol also can be used alone for a medication abortion.
Prior to 2020, patients could only access mifepristone by visiting certain health care settings such as clinics, medical offices and hospitals. FDA temporarily relaxed this in-person dispensing requirement during the pandemic and, in late December 2021, announced that it would modify its mifepristone risk evaluation and mitigation strategy (REMS) program to remove the in-person requirement as well as require that pharmacies that dispense the drug be certified by the manufacturer.
The January 3 FDA action was an approval of a certification plan submitted by Danco Laboratories and GenBioPro, which are the brand-name and generic manufacturers of the pill, Bloomberg Law reported.
According to the FDA, any pharmacy that meets the requirements of the mifepristone program would be eligible for certification. That could include retail pharmacies. Bloomberg Law News reported that the online pharmacy, HoneyBee Health, has been certified. National retail drugstore chains Walgreens and CVS said they both plan to become certified to dispense the drugs, Axios reported, although the drug may not be available at all locations.
The drug is not available over the counter, but online services have been providing abortion medications to addresses in states where abortion is legal.
The other abortion medication, Misopristol, did not have an in-person dispensing requirement and was easier to obtain. KFF lists the prescriber requirements as “by or under the supervision of a prescriber that has been certified by the manufacturer.”
How do state abortion laws affect the availability of these drugs?
This issue remains unclear and is likely to be decided by the courts.
Abortion in all forms, including medication, is banned in 13 states. As of November 22, 17 additional states required medication abortions to be provided only by a physician. Six states required the physical presence of a prescribing clinician or had an explicit ban on the use of telemedicine, which is an appointment conducted via online video or telephone, for medication abortion.
A telemedicine appointment typically involves a review of the patient’s medical history as well as confirmation of the patient’s eligibility for medication abortion. Patients seeking a telehealth abortion have to be physically present in a state where telemedicine abortion is legal and must provide a mailing address in a state where abortion is legal, NPR reported. The provider must also be licensed and physically present in a state where telemedicine abortion is legal.
The KFF website states that it is unknown whether future litigation will clarify whether the FDA’s authority to regulate mifepristone preempts states’ authority to regulate abortion.
FDA says it is “coordinating with the Department of Justice and others across the government on these legal issues,” including what happens if a state refused to allow mifepristone to be prescribed for medical termination of pregnancy.
Lawsuits have already been filed. A North Carolina physician filed a lawsuit challenging North Carolina law, which requires in-person dispensing of abortion medications by a physician in a certified surgical facility, as well as a 72-hour waiting period and counseling session. The West Virginia lawsuit—filed by manufacturer GenBioPro—contends that the state’s abortion ban is preempted by the FDA’s regulations on medication.
As of January 25, no litigation had been filed opposing the FDA’s latest move, but 20 Republican attorneys general wrote a letter to the agency calling the FDA’s decision “illegal and dangerous.” In addition, there are also legal challenges pending to FDA’s 2000 approval of mifepristone. Officials in some states, including Florida and South Dakota, have issued warnings that pharmacists who dispense or procure abortion medication would be subject to criminal prosecution.
Stat News quoted an official from the National Community Pharmacists Association, saying that it has advised its members to follow state law, and quoted an attorney who said that the question of “state versus FDA authority would likely go to the Supreme Court.”
In the telehealth arena, a law has been proposed in New York State that would “allow licensed clinicians to provide telemedicine abortion services to patients located in states banning or severely restricting medication abortion.” Massachusetts passed a law in July that would protect Massachusetts providers who provide abortion services to patients living outside the state, even if abortion is illegal in the patient’s home state.
What do employers and plan sponsors need to know?
In an International Foundation webcast on post-Dobbs implications for employers and plan sponsors, attorneys Roberta Chevlowe and Neal Schelberg recommended that plan sponsors review their plans to determine what abortion medications the plan covers.
For plans considering covering medications or other abortion-related services, a key question is whether the health plan is self-funded or fully insured.
If the plan is self-funded: The plan may continue to cover abortions and other reproductive care, assuming that the procedure or medication is legal where it is obtained. This means that the plan can cover abortion services legally provided in another state, even if the participant works in a state where abortion is not legal. This is because self-funded plans are regulated by the Employee Retirement Income Security Act (ERISA), which preempts state laws that “relate to” employee benefit plans.
However, plan sponsors should consider risks that may be created by state “aiding and abetting” laws. While ERISA generally preempts state civil laws, it does not preempt “generally applicable” state criminal laws. Some employers may question whether they could face legal trouble for covering abortion medication in a state where it was illegal.
Third-party administrators (TPAs) and pharmacy benefit managers (PBMs) also may place limitations on abortion coverage.
If the plan is fully insured: Plan sponsors need to know which state laws apply to the plan. State insurance laws are not preempted by ERISA for these plans, and states prohibiting or limiting abortion will likely require that insurance policies written in their state exclude or limit coverage for abortion or other reproductive care.
The question of whether PBMs can deliver abortion-related drugs to states through mail order where abortion is illegal remains unclear, as previously mentioned. PBMs are licensed by states, and states enact laws that impact PBM, so they may be affected by the bans on abortion medication.
“The bottom line is . . . gather as much information as possible from your insurer, your claims administrator and pharmacy drug manager. Talk through what the benefits are, what you want them to be, and also talk with counsel about the potential risks of any changes you might be considering,” Chevlowe said.
This is a rapidly developing issue. Visit www.ifebp.org/Resources/Pages/dobbs-decision.aspx to keep tabs on future developments.