In a March 24, 2020, letter, Secretary of Health and Human Services Alex Azar asked state governors to take immediate action to modify state law and regulations to extend the capacity of the healthcare workforce to address the Coronavirus (COVID-19) pandemic. Notwithstanding this call for a “whole-America response” to the crisis, states are pursuing their own approaches to modifying their healthcare laws and regulations.
In a letter dated March 24, 2020 (the Letter), Secretary of Health and Human Services Alex Azar has asked the governors of the United States to “take immediate action” to modify state law and regulation and take other actions “to extend the capacity of the health care workforce to address the [Coronavirus (COVID-19)] pandemic.” Noting that healthcare providers are at risk of infection and “some may be unable to treat patients due to quarantine,” the secretary asks the governors for help to “ensure health professionals maximize their scopes of practice and are able to travel across state lines or provide telemedicine to communities where they are needed most.”
Secretary Azar makes eight recommendations to modify regulatory and legal requirements around licensure, standard of care, scope of practice, supervision requirements, licensure and certification requirements, student practice and malpractice insurance in an attempt to free up resources. These recommendations are also specified and further explained in an attached document, “Guidance to States: Lifting Restrictions to Extend the Capacity of the Health Care Workforce during the COVID-19 National Emergency” (the Guidance).
Among other things, the Letter may put to rest any speculation on the implications of Vice President Pence’s statement at a Wednesday, March 18, 2020, White House press briefing that:
“[W]ith regard to medical personnel, at the President’s direction, the [Department of Health and Human Services] is issuing a regulation today that will allow all doctors and medical professionals to practice across state lines to meet the needs of hospitals that may arise in adjoining areas.”
While the Vice President’s comments raised the perhaps-enticing possibility of a temporary federalization of physician licensure, Secretary Azar’s Letter points in another direction. In fact, the Guidance indicates that, at least at present, the secretary does not have the authority to override state law. In the Guidance, the secretary notes that while he may waive requirements related to Medicare, Medicaid and CHIP Program reimbursement, “health care providers must still comply with various state laws and requirements.” Alternatively, the secretary may simply have determined that taking such a dramatic step would have been counterproductive in the effort to marshal resources to address the pandemic.
Regardless of reason, the secretary calls on the states to take action relative to the eight recommendations:
1. Modify Provider Licensure Requirements to Facilitate Cross-Border Practice
The secretary’s Guidance recommends that states temporarily waive restrictions on providers licensed in other states and consider ways to process rapidly the waivers. The secretary notes that some states may already have flexibility to allow licensure exceptions during periods of emergency and others may have laws triggered by emergency declarations to allow for temporary licenses, and he urges these states to activate such laws. The secretary’s Guidance also urges states to encourage licensing boards to establish enforcement moratoria related to licensure violations.
The Letter’s description of this action item notes specifically that the loosening of licensure requirements should allow professionals to practice “through telemedicine.” The secretary also identifies retired healthcare professionals as potential additions to the healthcare workforce. In addition, the Letter, a more informal document than the Guidance, reflects an urgency not reflected in the Guidance:
“I ask your assistance to immediately activate these and other health care professional licensure exceptions to the fullest extent appropriate, and to waive any state licensure or certification fees, in order to extend the capacity of health care professionals to fully assist in responding to the COVID-19 emergency.”
This urgency may also be reflected in the secretary’s suggestion that if the governors do not have the present authority to take these steps then they should “consider working with their legislatures to enact such mechanisms.”
Most states have already taken action to relieve licensure requirements for healthcare workers. Each state’s regime is different, however, and not all states have taken action; the waivers range from being broad and self-implementing (as in Connecticut) to limited waivers that only apply in specific instances (as in the District of Columbia, where licensure is only waived for professionals providing services for a healthcare facility or an existing patient located in the district). Ultimately, the country remains a patchwork of conflicting and distinct regulations, even though many have been liberalized to allow for easier cross-border practice.
2. Waive Restrictive Telemedicine Regulations
The Guidance recommends waivers of statutes and regulations that mandate specific telehealth modalities and practices necessary to establish the patient-provider relationship and to support diagnosis and treatment recommendations. The secretary does not describe or discuss this recommendation in much detail in either the Letter or the Guidance, but it does include some “hedge” language that does not appear in any of the other recommendations related to patient care.
Specifically, in the Guidance, the recommendation to loosen telemedicine regulations is qualified “[t]o the extent permissible.” Similarly, the Letter recommends waiving statutory and regulatory standards that are “not necessary for the applicable standards of care” to establish a patient-provider relationship. The secretary does not specifically describe or discuss these qualifications in either the Letter or the Guidance, leaving individual states with enormous discretion to determine their meaning for themselves.
Many states have already taken steps to modify their telemedicine laws to provide for greater utilization. Indeed, the licensure actions taken by many states have alleviated, at least temporarily, a significant burden for multi-state telemedicine programs. States have been far less likely to modify requirements around telemedicine in the context of the standard of care, however, which are much more nuanced than the licensure requirements. Nonetheless, states have acted. In Maine, for example, the Department of Health and Human Services changed rules to allow for prescribing via telehealth, and in New Hampshire providers have been temporarily allowed to provide telehealth services through all modes, including audio-only modalities.
3/4. Waiver of Other Scope of Practice Requirements/Waive Geographic Restrictions Relative to Supervision
The third and fourth recommendations are presented as alternatives and represent perhaps the boldest and most sweeping recommendations. In his Letter, the secretary asks that governors “[r]elax scope of practice requirements for healthcare professionals, including allowing professionals to practice in all settings of care.” The potential breadth is clearly intended as both the Letter and Guidance describe a wide array of waivers and modifications involving:
Written supervision or collaboration agreements.
Limitations on the number of non-physician healthcare professionals a physician may supervise.
Restrictions on the types of nurse practitioners (NPs), other registered nurses, physicians and other caregivers that can furnish care in the home or other settings.
Expanding allowable activities of non-physician health professionals, including emergency medical technicians and paramedics.
In addition, the Guidance recommends that the states encourage the applicable licensing boards to adopt enforcement moratoria with respect to these substantive areas.
Alternatively, the Guidance and Letter suggest lifting geographic limitations on physician supervision of NPs and physician assistants (Pas). The Guidance and Letter specifically contemplate physician supervision of these professionals via telemedicine services or other electronic means.
These recommendations, if adopted, could upend carefully constructed operating models based on professional evaluations of qualification, and are so sweeping that we would not be surprised if states took a more cautious approach.
Nonetheless, some states are already taking some of these actions in order to expand access to healthcare resources. For example, by executive order in Michigan, non-nursing assistants are empowered to help feed or transport a patient consistent with a care plan.
5. Rapid Licensure/Certification and Relicensure/Recertification
The secretary recommends easing the administrative burden for licensure and certification and reducing its cost through fee waivers. Some states have already taken these actions.
6. Alleviate Malpractice Liability
Recognizing that healthcare professionals may have liability concerns and face real liability risk, the secretary’s recommendations include making public all of the different liability protection mechanisms that may exist within a state. In addition, the secretary suggests that governors work with their state insurance commissioners to nullify malpractice policy provisions that would prevent insurance coverage for healthcare professionals responding to COVID-19.
7. Utilize Medical Students
The secretary recommends that legal and regulatory constraints to allowing medical students to treat patients under the supervision of a licensed physician be lifted.
8. Signature-Less Pharmaceutical Deliveries
Finally, the secretary recommends allowing signature-less deliveries of pharmaceuticals to assist in adhering to social distancing standards. This is another area that states have been actively monitoring and on which they have provided guidance (the Ohio Board of Pharmacy, for example, has highlighted that existing law does not require a signature for picking up prescriptions).
The secretary’s recommendations are intended to broadly apply to and address all healthcare services delivered within the scope of the practitioner’s license, and not just for COVID-19 related cases. This is a different approach than that taken by many states, which have pursued a more conservative approach to various modifications. California and Texas, for example, both waived licensure requirements, but both require an in-state sponsor to qualify. In the case of California, the sponsor must be a medical facility or staffing agency (and the care must be provided for that entity), while in Texas, individual physicians can sponsor an out-of-state practitioner.
Notwithstanding the secretary’s goal to “carry out a whole-America response,” his call to action is unlikely to untangle the legal and regulatory webs underlying our healthcare industry. It may, however, spur state action to permit more robust utilization of healthcare resources, even if within a complicated regulatory regime.