Source : CDC Requirements for Immigrant Medical Examinations: COVID-19 Technical Instructions for Panel Physicians

Overview
The current pandemic of Coronavirus Disease 2019 (COVID-19) has been determined by the World Health Organization (WHO) to be a public health emergency of international concern (PHEIC) under the International Health Regulations. COVID-19 meets the definition of a quarantinable communicable disease under 42 USC 264 and Executive Order 13295, as amended by Executive Order 13375 and 13674. Specifically, COVID-19 meets the definition of severe acute respiratory syndromes as specified by Presidential Executive Order 13674external icon (issued July 31, 2014), thus making it a Class A Inadmissible Condition.

Applicants*, defined in these Technical Instructions as people applying for immigrant or refugee status, as well as non-immigrants (NIVs) who are required to have an overseas medical examination, are medically screened days or weeks prior to travel to the United States (US). Thus, a negative screening for COVID-19 at the time of the medical evaluation does not guarantee the applicant will not have COVID-19 at the time of immigration to the United States.

A combination of vaccination, strategic testing, and routine infection control practices will provide the best protection from COVID-19 for applicants and US communities. These instructions provide requirements for COVID-19 vaccination and testing for applicants. The Instructions in this document are to be followed for COVID-19 when assessing applicants from all countries. These Technical Instructions are effective from October 1, 2021 until the Centers for Disease Control and Prevention (CDC) determines these Technical Instructions are no longer needed to prevent the importation and spread of COVID-19.

Visit the Technical Instructions for Panel Physicians webpage for more information about the medical examination for applicants for US immigration.

*Refugees and NIVs, including K-visa applicants are not required to receive the COVID-19 vaccine as part of the immigration medical examination; however, the other components of these Technical Instructions do apply to all applicants.

Key Concepts
If a COVID-19 vaccine listed for emergency use by the World Health Organization (WHO) or licensed or authorized for emergency use by the US Food and Drug Administration (FDA) is available to the applicant in the country where the medical examination is conducted, the eligible applicant must complete the COVID-19 vaccine series in addition to all other necessary vaccines (see Figure 1 for proposed timeline).
All applicants with symptoms of COVID-19 should be tested for COVID-19 and must postpone the immigrant visa medical examination until they have met recovery criteria to end isolation.
Close contacts of persons with COVID-19 should also be tested and must postpone the medical examination until quarantine criteria have been met.
Screening testing of asymptomatic applicants for COVID-19 as part of the immigrant medical evaluation may be required at the discretion of the panel physician.
COVID-19 Vaccination Requirement
The US Advisory Committee on Immunization Practices (ACIP) has recommended COVID-19 vaccination for the age-appropriate, general US population. Therefore, COVID-19 vaccination now meets the criteria for required vaccinations and is a requirement for applicants.

The COVID-19 vaccines approved for use in these Technical Instructions, hereinafter referred to as “approved COVID-19 vaccines,” are those vaccines authorized for emergency use (EUA) by the US Food and Drug Administration (FDA)external icon or listed for emergency use (EUL) by the World Health Organization (WHO) (see “Status of COVID-19 Vaccines within WHO EUL/PQ evaluation process”).external icon If an FDA EUA vaccine becomes licensed for use in the United States, it will continue to be an approved COVID-19 vaccine. If an approved COVID-19 vaccine is available to the applicant in the country where the examination occurs, the applicant must complete the vaccine series and provide documentation to the panel physician in person before completion of the medical examination.

The COVID-19 vaccination requirement will differ from previous requirements in that the entire vaccine series (1 or 2 doses depending on formulation) must be completed in addition to the other routinely required vaccines. An example timeline for the Pfizer-BioNTech, Moderna, and Janssen (Johnson & Johnson) COVID-19 vaccines and other required vaccinations is illustrated in Figure 1.

Figure 1.

Day 0

Day 21

Day 21

First dose of Pfizer-BioNTech COVID-19 Vaccine

Second dose of Pfizer-BioNTech COVID-19 Vaccine

Other routine vaccinations

Although the vaccine schedules cannot be shortened, other components of the medical examination can be scheduled at the discretion of the applicant and panel physician. The panel physician must confirm in person documentation that the applicants received all doses of COVID-19 vaccine and, if applicants want to complete the remaining components of the exam after they are fully vaccinated against COVID-19, panel physicians should accommodate them.

The applicant should be vaccinated in accordance with the specific instructions for the formulation used in the country where the examination occurs. If a delay is required between COVID-19 vaccination and other routine vaccinations, panel physicians must take this into consideration when scheduling the examination so that all required vaccines can be administered.

Panel physicians are expected to remain informed about changing recommendations, such as expansion of recommendations to include younger children, and any new contraindications or precautions. Panel physicians must be aware of local availability of and eligibility criteria for COVID-19 vaccines so they can determine if their applicants are eligible for a waiver. As with all vaccinations, there are specific blanket waivers that cover reasons why an applicant did not receive the required vaccination. Given the special circumstances, the blanket waivers to be used for COVID-19 vaccination are further defined below to include information specific to this vaccination.

Blanket Waivers Applicable to COVID-19 vaccination:
Not age-appropriate
For COVID-19 vaccines, the age at which a particular vaccine can be administered differs by formulation. If the applicant is younger than the lowest age limit for the approved COVID-19 vaccine formulations in use, this blanket waiver should be documented. If, in the country where the exam is performed, there is an age restriction (for example, the vaccine is only being given to people over the age of 65 and the applicant is younger than 65), this blanket waiver should be documented.
Contraindication
If an applicant has a contraindication or precaution to the approved COVID-19 vaccine formulation available, the “Contraindicated” reason should be documented, and the vaccine should not be administered. If the applicant has had a severe reaction to the first dose that is considered a contraindication to receiving a second dose, the first dose should be documented in addition to the blanket waiver. Please refer to Interim Clinical Considerations for Use of COVID-19 Vaccines Currently Authorized in the United States or similar guidance for other vaccine formulations for information about contraindications and precautions.
Not routinely available
If none of the approved COVID-19 vaccines are routinely available in the country where the panel physician practices, the “Not routinely available” reason should be documented. If an approved COVID-19 vaccine is available to the applicant but limited supply would cause significant delay for the applicant to receive it, then this situation would also be considered “Not routinely available.”
Other reasons why an applicant might not complete a COVID-19 vaccine series:
Applicant may request a waiver based on religious or moral convictions
If an applicant objects to vaccination based on religious or moral convictions, it must be documented that the applicant is requesting an individual waiver based on religious or moral convictions. This is not a blanket waiver. The applicant will have to submit a waiver request to US Citizenship and Immigration Services (USCIS). USCIS will determine if this type of waiver is granted, not the panel physician or CDC.
Applicant refuses a COVID-19 vaccine series in part or entirety
If an applicant refuses one or more doses of an approved COVID-19 vaccine series that is medically appropriate for and available to the applicant, it should be documented that the vaccine requirements are not complete and that the applicant refuses vaccination. This applicant is Class A and is inadmissible to the United States.
Review of Vaccination Records
The panel physician should instruct the applicant to submit documentation of receiving a COVID-19 vaccine series. Acceptable vaccination documentation must come from a vaccination record, either a personal vaccination record or a copy of a medical chart with entries made by a physician or other appropriate medical provider. If COVID-19 vaccine is available to panel physicians, the panel physician may vaccinate applicants and document the doses.
Panel physicians must be familiar with the COVID-19 vaccination documentation used in their country and use their judgement to evaluate the validity of these documents. Only those records of vaccine doses that include the dates of receipt (month, day, and year) are acceptable. The name or manufacturer and lot number should be included if available. The document must not appear to have been altered, and dates of vaccinations should seem reasonable. Self-reported vaccine doses without written documentation are not acceptable.
Panel physicians must document all valid vaccination history on the DS-3025 Form, which will become the applicant’s permanent vaccination record. If the COVID-19 formulation is a two-dose series, both doses must be documented. In the eMedical USA system, panel physicians must document the COVID-19 vaccinations in the 951 Vaccinations form, in the fields designated for COVID-19 vaccines.
Laboratory confirmation of immunity
Laboratory tests for COVID-19 immunity must not be used for the panel physician examination. The applicant is required to receive the vaccine series regardless of evidence of immunity or COVID-19 infection. The duration of immunity due to natural infection is still being investigated and might not protect the applicant throughout the immigration process. Also, COVID-19 antibody tests are not reliable indicators of active infection.
COVID-19 Screening
Symptom Screening
COVID-19 is a respiratory illness caused by SARS-CoV-2 infection. Symptoms of COVID-19 are highly variable and include fever, chills, shortness of breath, fatigue, muscle and body aches, headache, new loss of taste or smell, sore throat, nasal congestion, runny nose, nausea, vomiting, and diarrhea. The clinical course of the disease ranges from asymptomatic to severe illness resulting in death; studies suggest that approximately half of those who test positive are asymptomatic. Although asymptomatic infection and mild illness can occur in all age and risk groups, advanced age is a significant risk factor for severe illness and death. In addition, people with certain health conditions are at increased risk of severe COVID-19 illness.

Panel physicians and their staff should ask about symptoms and contact history when scheduling appointments, at time of check-in, and at the beginning of the visit with the physician. Doing so will allow multiple opportunities to detect symptoms or identify contacts and reschedule the exam. Panel physicians must at a minimum screen for clinical signs and symptoms of COVID-19 and contact history and postpone the exam for those with a suspected or confirmed diagnosis until the criteria to end isolation have been met or post-exposure quarantine has been completed.

Applicants who arrive for the exam with clinical signs and symptoms of COVID-19 should receive a nucleic acid amplification test (NAAT) if possible. Antigen testing should not be used during the panel physician exam. Asymptomatic applicants who are contacts must be managed according to the Contacts section below. Applicants with symptoms of COVID-19 must complete the required isolation period before returning for the exam even if they receive a negative COVID-19 test result. Until the applicant has met the criteria to end isolation, the applicant will be Class A, Inadmissible for COVID-19. Panel physicians must report all applicants diagnosed with COVID-19 to local public health officials as per national guidelines and the consular section.

As vaccine coverage increases, the need for testing might decrease, and panel physicians should anticipate changes to these Technical Instructions.

Optional Laboratory Testing
In addition to symptom screening for COVID-19, panel physicians may choose to also require laboratory testing of all applicants 2 years of age and older to improve the safety of their clinics and the quality of the exam. It is recommended that this test be performed and results be available in the 24 hours prior to the panel physician examination. If testing is performed, the test must be performed within the 3 days prior to the examination. This will ensure the most accurate results are available for the exam, and patients who have positive test results can be rescheduled to complete their examination after recovery. Panel physicians must report all applicants diagnosed with COVID-19 and all contacts to local public health officials as per national guidelines. Negative test results do not definitively rule out infection at the time of the examination; appropriate precautions should still be taken.

Allowed Test Types
When COVID-19 testing is performed, panel sites must use a NAAT such as a reverse transcription polymerase chain reaction (RT-PCR) that has received an Emergency Use Authorization (EUA) by the US FDA or other national governing authority, and samples must be collected using nasopharyngeal (NP) swabs. Tests should be licensed for use in the country of the exam.

Other tests, such as antibody tests or antigen tests must not be used.

Panel physicians and testing laboratories should closely follow the manufacturer’s instructions in the product package insert to ensure the correct specimen is collected, stored, transported, and used by the laboratory as collection methods and specimen types may vary. Laboratories should handle all biological specimens using universal precautions and standard international biohazard practices. Refer to the WHO Laboratory Biosafety Manual pdf icon[PDF – 186 pages]external icon for additional guidance.

COVID-19 Screening Results and Travel Clearance
Lack of COVID-19 vaccination, exposure to COVID-19, or current COVID-19 infection would make an applicant Class A, Inadmissible. The medical exam must be postponed for applicants who have symptoms of COVID-19, recent exposure to COVID-19, or a positive laboratory test for COVID-19 until recovery criteria are met as defined by CDC. If COVID-19 testing is performed, results should be documented in the remarks section in eMedical or the DS forms. The panel physician should inform the consular section when applicant examinations are postponed because of COVID-19.

Applicants should be informed that all international air travelers to the United States aged 2 years or older must be tested within 3 days of the flight and show documentation of a negative COVID-19 result to the airline before boarding their flight. Applicants who have recovered from COVID-19 will not need to be retested for travel if they travel within 3 months of their positive test and can provide appropriate documentation. Any additional information about test availability and requirements that panel physicians can provide will be helpful to applicants. Also, all applicants who receive a positive test result for COVID-19 from the panel physician should be supplied with a copy of the positive test result as well as a medical clearance letter when they have completed isolation. More information about this requirement, including Frequently Asked Questions, is available on CDC’s website.

COVID-19 Treatment
Panel physicians are not expected to treat or manage COVID-19 in applicants and should refer all patients diagnosed with COVID-19 immediately to local public health officials per national guidance, as well as the applicant’s primary care provider. The panel physician should provide all applicants diagnosed with COVID-19 with guidance about when to seek medical attention and how to self-isolate at home. This information can be found on CDC’s web page What to Do if You Are Sick.

Patients with asymptomatic, mild, or moderate illness can frequently be managed with home isolation and supportive care; for more information visit CDC’s Care for Patients at Home.

Patients with risk factors for severe illness should be monitored closely for progression to severe disease, which most often occurs in the second week of illness. Additional information about COVID-19 treatment can be found in CDC’s Clinical Care Guidance.

Exposed Contacts
Close contacts of persons with laboratory-confirmed or probable COVID-19 are Class A for COVID-19 exposure until they complete 14 days of quarantine. A close contact is defined by CDC as any individual who has been within 6 feet of an infected person for a cumulative total of 15 minutes or more over a 24-hour period. Applicants who are close contacts should be rescheduled and not complete their exam until 14 days of quarantine are complete;

The 14 days should begin after the person’s last exposure to the person with COVID-19 or, if exposure continues, when that person has recovered.
If possible, the contact should be tested immediately and then tested again on day 12 of the quarantine period. The same tests described above (NAAT such as RT-PCR tests) should be used.
If the applicant develops symptoms of COVID-19 during this time or tests positive, they must meet criteria to end isolation before completing the medical examination.
All close contacts should be reported to the consular section and local health authorities according to national guidance.
Waivers
Applicants who have COVID-19 and COVID-19 contacts can apply for a Class A waiver
Waivers will not be needed after an applicant completes the required isolation or quarantine period
A provision exists that allows applicants with a Class A physical disorder to petition for a Class A waiver. The Application for Waiver of Grounds of Inadmissibility Form (I-601 or I-602 for immigrants or refugees, respectively) must be completed. These waivers are submitted to US Citizenship and Immigration Services (USCIS) on an individual basis. The CDC Division of Global Migration and Quarantine (DGMQ) also reviews the waivers and supporting medical documentation to provide an opinion regarding the case to the requesting entity (Department of State or USCIS). DGMQ’s review of the waiver and supporting medical examination documentation ensures that the applicant has been classified properly and that an appropriate US healthcare provider is identified for the applicant. USCIS has the final authority to adjudicate the waiver request. If granted a waiver, an applicant who has COVID-19 or is a close contact may only travel to the United States in accordance with Interim Guidance for Transporting or Arranging Transportation by Air into, from, or within the United States of People with COVID-19 or COVID-19 Exposure.

Glossary of Abbreviations
Acronym

Full Phrase

CDC

Centers for Disease Control and Prevention, United States

EUA

Emergency Use Authorization

FDA

United States Food and Drug Administration

DS

Department of State

Additional Information
Federal regulations at 42 CFR part 34, among other things, define communicable diseases of public health significance to include:

(1) communicable diseases as listed in a Presidential Executive Order, as provided for under 42 USC 264 ,

(2) communicable diseases that may pose a public health emergency of international concern as determined under the International Health Regulations, if the disease meets certain risked-based criteria and the CDC Director determined a threat exists for importation into the United States and the disease may potentially affect the health of the American public

(i) communicable diseases for which a single case requires notification to the World Health Organization (WHO),

(ii) communicable diseases which require notification to the WHO as an event that may constitute a public health emergency of international concern.

When HHS/CDC determines that additional medical screening and testing for examinations performed outside the United States are necessary, HHS/CDC must follow a risk-based approach for making that determination (§34.3). SARS-CoV-2 (COVID-19) is a quarantinable disease because it meets the definition in the Presidential Executive Order for Severe Acute Respiratory Syndrome (SARS), which is a disease associated with fever and signs and symptoms of pneumonia or other respiratory illness, is transmitted from person to person predominantly by the aerosolized or droplet route, and, if spread in the population, would have severe public health consequences. Per 42 CFR Part 34 (§34.3), CDC has undertaken a risk-based approach regarding infections caused by SARS-CoV-2 (COVID-19) and has determined that additional medical screening and testing for examinations performed outside the United States are necessary. COVID-19 Technical Instructions for panel physicians have thus been issued that must be followed by panel physicians when examining all applicants.