UPDATE: On March 23, North Carolina’s State Health Director issued a new temporary order requiring physicians to report suspected or confirmed deaths from novel coronavirus infections within 24 hours. Infections that do not cause death are still reportable under the rulemaking actions described in this post–the new order did not alter that requirement, but added a new reporting obligation to assure that deaths from novel coronaviruses are captured in public health data, even if the infections were undetected prior to death. New rulemaking is underway to make permanent the requirement to report deaths from novel coronavirus infections.
COVID-19 is a respiratory disease caused by a novel coronavirus that was first detected in China in late 2019. The disease has since spread to several other countries, including the United States.
From the outset, North Carolina public health officials have been monitoring the virus and preparing for the possibility of cases in our state. Local health departments are the lead local agencies for responding to COVID-19 in North Carolina. The local departments work closely with the state’s Communicable Disease Branch, within the N.C. Division of Public Health. These agencies will be the key first responders when a case of the disease is detected within the state—but how will they know?
North Carolina has laws that require health care professionals (and sometimes others) to notify public health officials when they know or suspect that a patient has a condition or disease that has been designated “reportable.” COVID-19 is now reportable in North Carolina. Health care providers who have patients with suspected or confirmed COVID-19 should notify their local health department or the NC Division of Public Health’s Communicable Disease Branch immediately.
This post reviews the North Carolina laws that address communicable disease reporting. Because the situation is rapidly evolving, I have not attempted to provide an update on the spread of the disease, travel restrictions, or other matters that may be of interest to readers. Instead, I have provided a list of resources for updated information at the conclusion of the post.
Requirement to Report COVID-19
North Carolina physicians and laboratories are required to make an immediate report to public health officials when they confirm or reasonably suspect a novel coronavirus infection, a category that includes the virus that causes COVID-19. Physicians must report to the local health department for the county where the patient resides. The local health director must then report the case to the state Division of Public Health. Laboratories must make their reports directly to the state agency.
State public health officials have issued guidance memoranda to explain how clinicians should identify patients who must be reported for further investigation to determine if they have COVID-19. A February 28, 2020 memo set out the present criteria for determining which patients should be investigated further–certain respiratory symptoms plus one of the following: a history of exposure to a person with known COVID-19, travel to an affected geographic area, or hospitalization for severe symptoms without an alternative explanatory diagnosis. The public health agencies that receive reports will assist health care providers with risk assessments, laboratory testing if indicated, and assuring the appropriate disease control measures for infected and exposed individuals.
The criteria for case identification and investigation may change as the situation develops. Physicians and laboratories should keep abreast of communications from their local health departments and the Division of Public Health.
Sources of Law for the Novel Coronavirus Reporting Requirement
State Health Director’s Temporary Order
On February 3, Dr. Elizabeth Cuervo Tilson, the State Health Director, issued an order setting out the new reporting requirements for physicians and laboratories. The order is authorized by G.S. 130A-141.1, which permits the State Health Director to issue a temporary order requiring health care providers to report symptoms, diseases, conditions, trends in the use of health care services, or other health-related information that may indicate the existence of a communicable disease that threatens the public health.
The State Health Director’s order is described as temporary, and the statute provides that such an order may not exceed 90 days. If a longer period of time is needed, the North Carolina Commission for Public Health may adopt rules to continue the reporting requirement.
Rulemaking: Emergency, Temporary, and Permanent Rules
The North Carolina Commission for Public Health is the principal agency responsible for making statewide administrative rules for public health in North Carolina. G.S. 130A-134 directs the Commission to use its rulemaking authority to establish a list of communicable diseases and conditions that must be reported to public health officials. The rule establishing the list is published in the North Carolina Administrative Code, at 10A N.C.A.C. 41A .0101. Additional statutes require physicians, laboratories, and certain others to make the reports required by the Commission’s rule. G.S. 130A-135 through 130A-141.
The Commission has begun the process of adding novel coronavirus infection to the list of reportable communicable diseases and conditions, so that reporting may continue after the State Health Director’s temporary order expires.
Rulemaking is governed by the North Carolina Administrative Procedure Act, G.S. Ch. 150B, Art. 2A, which sets out procedures that generally include giving the public notice of rulemaking, allowing the public to comment on rules, and review by various bodies before a rule becomes final. However, the Act allows an agency to adopt an emergency rule without prior notice if the agency finds that adherence to the usual notice and hearing requirements would be contrary to the public interest, and that immediate adoption of a rule is required by a serious and unforeseen threat to the public health or safety. G.S. 150B-21.1A.
On February 5, the Commission adopted an emergency rule requiring physicians to immediately report novel coronavirus infection, and requiring laboratories to report findings of novel human coronavirus strains. The emergency rule was published in the North Carolina Register on March 2, 2020. An emergency rule becomes effective when it is entered in the North Carolina Administrative Code by the Codifier of Rules, G.S. 150B-21.3(a), and expires no later than 60 days after its publication in the North Carolina Register, unless a temporary rule to replace the emergency rule has been submitted to the state Rules Review Commission during that timeframe.
In the case of novel coronaviruses, including the one that causes COVID-19, a temporary rule to replace the emergency rule has been proposed. The Administrative Procedure Act permits an agency to adopt a temporary rule when it finds that immediate adoption is required for one of several reasons, including a serious and unforeseen threat to the public health, safety or welfare. G.S. 150B-21.1. A temporary rule requires notification of interested parties, a public hearing, and a public comment period, during which members of the public may submit written comments.
The timeline for the temporary rule governing novel coronavirus reporting is:
- The rule was proposed and notice to interested parties was provided on February 5, 2020.
- A public hearing was held on February 24, 2020.
- A public comment period opened on February 5 and will close on March 5, 2020.
- After the close of the comment period, the Commission for Public Health may adopt the temporary rule and submit it to the Rules Review Commission.
- The Rules Review Commission must approve the rule within 15 days if it determines the criteria for temporary rulemaking are met.
Assuming approval by the Rules Review Commission, the temporary rule will go into effect. A temporary rule may remain in effect for up to 270 days, or longer if a permanent rule has been proposed in the meantime. I anticipate that permanent rulemaking will occur, to assure that novel coronaviruses remain reportable in North Carolina.
Throughout this process, the new requirement to report novel coronaviruses will be in effect. The underlying legal authority will shift as it moves from the State Health Director’s temporary order to the final permanent rule, but the reporting requirement should remain the same.
The process of making a new disease reportable in North Carolina has multiple steps and may be confusing, but these are the bottom lines:
- Physicians and laboratories must report novel coronavirus infections to public health officials immediately.
- Clinicians and laboratories should monitor communications from public health officials that provide information about how to identify a reportable case, recognizing that the criteria for case identification—and thus for reporting—may change over time.
Readers who would like a general overview of communicable disease law in North Carolina may be interested in my 2017 book, North Carolina Communicable Disease Law. You can purchase it here. All proceeds go to the UNC School of Government.