The legal landscape for abortion is undeniably murky. Since the rollback of federal abortion protection, states have been tasked with defining the boundaries of reproductive rights. More than a dozen states have near-total abortion bans or lack available abortion care, with approximately 24 states anticipated to enact abortion bans or gestational limits on abortion procedures. The flurry of changes to state laws and uncertainty at the federal level over an abortion drug has produced fear and confusion amongst clinicians, some of whom feel duty-bound to their patients but face liability for noncompliance with state laws.
To enhance abortion access, companies have expressed interest in tele-prescribing abortion medication across state lines. As reproductive telehealth companies form and expand, some are relying on so-called abortion shield laws to protect their cross-border activity. These shield laws, however, have limits and may expose clinicians to legal risk depending on the jurisdiction(s) in which the clinician operates. Additionally, shield laws do not protect clinicians from noncompliance with scope of practice, business registration, and tele-prescribing rules in non-protected states. Understanding the interconnectedness of these laws is crucial for mitigating legal risk while providing reproductive health services.
With the Rise of AI, What IP Disputes in Healthcare Are Likely to Emerge?
Munck Wilson Mandala Partner Greg Howison shared his perspective on some of the legal ramifications around AI, IP, connected devices and the data they generate, in response to emailed questions.
Regulating the practice of medicine
The regulation of healthcare, including telehealth, is complex and, depending on the aspect of healthcare being regulated, may be governed by either (or both) the federal or state governments. States are the primary regulators of the practice of medicine – a power granted to them through the Tenth Amendment, which reserves certain non-delegated powers to the states.
Most healthcare companies are familiar with this state-driven model of regulation for the practice of medicine. State medical boards have long governed the admission and licensure of clinicians within their borders and have established disciplinary procedures for violations of state standards. Each state also has unique laws for the establishment of a physician-patient relationship and pre-requisites to prescribing medication and controlled substances. Since the Covid-19 pandemic, a significant number of states have also adopted or amended their telehealth laws and licensing requirements to facilitate the cross-border practice of medicine.
Clinicians must comply with all tele-prescribing pre-requisites in each applicable state (which may include establishment of a physician-patient relationship) before prescribing medication, including abortion pills. Some states expressly prohibit clinicians from tele-prescribing abortion medication. If a clinician practices medicine or prescribes abortion medication in a state where the clinician is not licensed, that clinician may be subject to unauthorized practice of medicine charges. Additionally, if a clinician does not comply with all prescribing pre-requisites, that clinician may be investigated and disciplined for failure to adhere to the appropriate standard of care. Such disciplinary actions fall solely within the purview of each state.
A Personalized Approach to Medication Nonadherence
At the Abarca Forward conference earlier this year, George Van Antwerp, managing director at Deloitte, discussed how social determinants of health and a personalized member experience can improve medication adherence and health outcomes.
According, clinicians must know and understand the rules of medical practice in each jurisdiction where they provide services. Longstanding telehealth policies and standards of care state that patients are governed by the law of the state where they are located. Providers who practice medicine in a state but fail to follow that state’s licensing and tele-prescribing requirements risk civil liability, fines, license revocation, and other penalties.
Registering and doing business in a state
In addition, states generally require that businesses be properly registered if they are doing business within that state. “Doing business” means that an individual/company is carrying out normal business activities in a state on a regular basis or that the individual/company has substantial contacts with that state. Providing healthcare services in a state is often sufficient to satisfy this threshold.
Depending on the state, companies that conduct business but fail to register will often be liable for fees, taxes, and penalties. States and localities may also charge back taxes (including interest) if they discover an entity operated without proper registration. Certain states may allow the attorney general or another person (such as a competitor) to bring an action to restrain the company from transacting business in that jurisdiction going forward. California will even authorize the voiding of contracts that a business entered while it was out of compliance with registration laws.
The risks associated with failing to register a business go beyond state sanctions. When businesses enter contracts, they must often attest to representations and warranties. These representations and warranties frequently state that the company (including its employees) maintains proper licensure and is in good standing in the states in which it operates. Violating representations and warranties can have negative implications and may result in a material breach of the agreement. Material breaches may also need to be reported to other partners and vendors, depending on the contractual language. Further, in the event of a merger or acquisition (M&A), the purchasing party will want to confirm that the company is properly registered and licensed to do business in all applicable states. Failure to register may jeopardize future M&A activity. Thus, telehealth companies must ensure they are properly registered in all states where they serve patients.
Abortion shield law protections
Given the shifting abortion landscape, telehealth companies are increasingly turning to abortion shield laws to protect their medical activities. Providers and telehealth companies, however, are often unsure about the scope of protection afforded by shield laws, and whether these laws negate licensure and registration requirements.
At least seven states have passed abortion shield laws, with several others considering similar legislation. Among the states that have passed shield laws are California, Connecticut, Delaware, Illinois, Massachusetts, New Jersey, and New York. The types of protection offered by each state’s shield law vary, though most shield laws include some of the following protections:
- Counter lawsuit. Ability for clinicians and entities to counter sue if a lawsuit is brought against them for participating in an abortion that is legal in the protected state.
- No adverse medical board action. Inability of the licensing board in the protected state to deny a medical license, certificate, or other registration based on a clinician’s discipline in another state for performing abortion services.
- Insurance protection. Inability of insurance carriers in the protected state to raise the medical malpractice insurance premiums for clinicians with disciplinary action or lawsuits against them for performing abortion services.
- No cooperation with out of state investigators. Refusal of public officials to cooperate with out-of-state investigators if the investigation relates to reproductive health services that are lawful in the protected state.
- No data sharing. Refusal to share abortion data with out-of-state officials.
- Limits on extradition. Exceptions to extradition requirements if the request is based on a reproductive health offense that is legal in the protected state.
- No adverse actions by healthcare institutions. Inability of healthcare institutions to rescind privileges or take negative actions against clinicians who perform reproductive health services or are subject to out-of-state investigations for their performance of abortion services.
While abortion shield laws are intended to protect clinicians who provide reproductive healthcare services in protected states, the limits of these laws are commonly misconstrued. These laws only protect clinicians while they are physically located in the protected state. Travel out of the protected state places the provider at risk of extradition while physically located in another territory. When deciding to rely on abortion shield law protections, providers should consider their travel plans carefully and ensure they are not opening themselves up to liability if they leave the protected state.
Moreover, abortion shield laws do not protect clinicians from non-reproductive healthcare activities. If a clinician provides abortion services in a state where the clinician is not licensed, that state may prosecute the clinician for the unlicensed practice of medicine. As written, most shield laws would not protect providers from this type of violation, as each state is allowed to regulate the practice of medicine in their borders. States that charge providers with the unlicensed practice of medicine are not charging providers with any reproductive health related crime, likely exempting such charges from the shield law protections.
Further, while shield laws may protect clinicians from adverse medical board action related to reproductive health services, such laws cannot protect providers’ medical licenses in other states. States not subject to the shield law may suspend a provider’s license or take other adverse action against the provider. It is unclear how a protected state’s medical board would view and respond to out-of-state disciplinary action for the unlicensed practice of medicine, given that such charge is not inherently a reproductive healthcare offense. Similarly, shield laws would not protect telehealth companies from state registration violations. Thus, as written, most shield laws do not protect against the unauthorized practice of medicine in another state or state registration violations.
An interesting scenario is emerging in states like New York that are contemplating legislation to allow clinicians to prescribe abortion pills to patients located in abortion-restricted states. Such legislation will likely face significant legal challenges because it impinges on other states’ ability to regulate the practice of medicine within their borders. As noted, the practice of medicine is dictated by the law of the state where the patient is located. Legislation like the type proposed in New York contravenes the default location of care principle, which could produce consequences for the entire healthcare industry. Such laws could easily undermine comity between states and create a breakdown of state-to-state relations, rippling to other areas of law and policy.
Conclusion
The uncertainty and murkiness of abortion shield laws means that providers seeking protection will likely be on the front lines of litigation challenging the scope and legality of these protections. As telehealth providers navigate the ever-evolving abortion terrain, it is important that they evaluate all avenues for potential exposure and risk. While shield laws can protect clinicians in certain instances, they cannot shield clinicians from the unauthorized practice of medicine, corporate deficiencies, and other conduct unrelated to reproductive healthcare. Informed decision making is crucial, and each clinician must act according to their risk tolerance. For these reasons, it is important for providers and telehealth abortion companies to harmonize their approach to the practice of medicine to ensure they are complying with all applicable laws while maximizing the advantages of the abortion shield protections.
Photo: Fokusiert, Getty Images
Bethany Corbin is a recognized thought-leader at the intersection of law and women’s health technology (femtech). She empowers pioneering femtech and healthcare innovation companies to revolutionize care delivery with well-crafted legal counsel and strategic guidance. In particular, Bethany partners with emerging health technology companies at the forefront of healthcare transformation to ensure they are building robust, scalable, and legally compliant health solutions that are ready to lead the industry. Bethany’s strategic guidance and insights have been featured in top news outlets and she has been recognized as a trailblazer in women’s health. Bethany is also the host of the Legally Femtech Podcast, which provides practical, ethical, and legal insights to women’s health startup founders.
