Antibody Testing - COVID-19

[LOGO] North Dakota Insurance Department Jon Godfread, Commissioner # BULLETIN 2020-10 TO: Insurance Carriers offering Health Benefit Plans and Self-Funded Plans FROM: Jon Godfread, Commissioner DATE: May 18, 2020 SUBJECT: Antibody Testing – COVID-19 JCH In response to the Executive Order 2020-03 issued by Governor Doug Burgum declaring a state of emergency in North Dakota in response to the public health crisis resulting from COVID-19, the North Dakota Insurance Department issues this Bulletin regarding COVID-19 testing. Recognizing that members of the public may seek a variety of laboratory tests for COVID-19, this Bulletin addresses coverage for COVID-19 testing that is medically necessary to diagnose or treat COVID-19 or other covered health conditions. # The COVID-19 Risk The public health and societal consequences of the spread of the COVID-19 have dramatic impacts in the State. It is essential that government and business leaders take all appropriate steps to safeguard the general public and well-being of the citizens of North Dakota. Health insurance coverage plays a critical role in the public's actual and perceived access to and affordability of health care services. COVID-19 may impose unique risks to our insurance market that North Dakota has not faced for at least a generation. Therefore, the Department is notifying North Dakota Carriers of the expectation to take all necessary steps to enable their covered members to obtain medically necessary and appropriate testing and treatment that will fight the spread of this disease. As stated in Bulletin 2020-1.1 the Department requests Carriers remove barriers to testing and treatment of COVID-19. Consistent with recommended methods of removing barriers to testing and treatment as stated in Bulletin 2020-1.1, carriers should provide information, and easy access to information, regarding prevention, testing and treatment options to covered persons in accordance and consistent with Governor Burgum's Executive Order 2020-14, guidelines from the North Dakota's State Health Officer, the North Dakota Department of Health, the Centers for Disease Control and Prevention ("CDC") and the Centers for Medicare & Medicaid Services ("CMS"). To effectively remove barriers to testing and treatment of COVID-19, the Department recommends that Carriers: - Establish dedicated help lines to respond to all calls about COVID-19 and keep covered members aware of providers who test/treat the virus, members' available benefits, and phone numbers that members can call for additional help. - Relax prior approval requirements and procedures for medically necessary testing or treatment so that members with COVID-19 and members at risk of contracting COVID-19 may receive timely testing and treatment. - Relax out-of-network requirements and procedures when access to urgent testing or treatment, is unavailable from in-network providers. Bulletin 2020-10 page 1 of 2 - Forego any cost-sharing (copayments, deductibles, or coinsurance) for medically necessary COVID-19 diagnostic testing, including influenza testing or other respiratory testing done in conjunction with COVID-19 testing, counseling and vaccinations at in-network doctors' offices, urgent care centers, or emergency rooms; and at out-of-network doctors' offices, urgent care centers, or emergency rooms when access to urgent testing or treatment is unavailable from in-network providers. ## COVID-19 PCR, Antigen and Antibody Testing At present, the Department is aware that there are three types of COVID-19 tests. - PCR (Polymerase Chain Reaction) tests look for the presence of the unique DNA of COVID-19 in a patient. - Antigen tests look for a unique part of COVID-19, such as a specific protein on one of the unique COVID-19 spikes. - Antibody tests (also known as serology tests) look for presence of antibodies in a patient's immune system that may fight off the COVID-19. Please be aware that the Department expects Carriers to cover PCR and antigen tests designed to detect the presence of COVID-19 when a patient's symptoms indicate the medical need to conduct a test. Regarding antibody tests, the Department expects Carriers to cover FDA-authorized antibody tests. This includes tests approved for patient use through premarket approval or emergency use pathways, and tests that are developed and administered in accordance with FDA specifications or through state regulatory approval. The Department expects Carriers to cover these antibody tests, but only when such tests are medically necessary and ordered by an appropriate treating medical professional who is tracking the symptoms, diagnosis, and prognosis of the patient in order to support diagnosis or treatment for COVID-19 or for treatment of another disease when information about COVID-19 antibodies may impact the future outcome of that treatment for a particular person. It is not considered medically necessary if a COVID-19 antibody test is to be used as part of "return-to-work" programs, public health surveillance testing or any efforts not associated with disease diagnosis or treatment. ## Carriers Acting As Administrators- Self Funded Plans Due to the public health crisis caused by COVID-19, when Carriers are acting as administrators for employment-sponsored self-funded health benefit plans, the Department expects Carriers to encourage plan sponsors to take steps that are consistent with the provisions of Bulletins 2020-01.1 and this Bulletin. Plan sponsors should be made aware of the public health risks to all North Dakota residents, and Carriers should do all they can to encourage plan sponsors to take steps to remove barriers to accessing medically necessary testing, diagnosis, counseling, and treatment of COVID-19. If you have any questions about this Bulletin, please contact the North Dakota Insurance Department at 701-328-2440. Bulletin 2020-10 page 2 of 2