H1N1 and Privacy
Concerning Privacy and the H1N1 Virus
H1N1 influenza (commonly referred to as “swine flu”) is a virus resembling the seasonal flu, which causes illness in humans. Symptoms vary, but may include fever (consistent temperature above 98.6 degrees Fahrenheit or 37 degrees Celsius), chills, headache, upper respiratory tract symptoms (cough, sore throat, shortness of breath), muscle or joint pain, fatigue, vomiting, and diarrhea.
The first cases of the virus in the United States were documented on April 17, 2009. At that time, the Senate had not yet confirmed Kathleen Sebelius as Secretary of the Department of Health Human Services (“Secretary”), who would have had oversight and coordination responsibilities for a disease outbreak of this nature. Rather, the Obama Administration turned to Department of Homeland Security Secretary Janet Napolitano to lead the nation’s response to the H1N1 influenza until Sebelius’s confirmation on April 28, 2009.
On June 11, 2009, due to the rapid spread of the H1N1 virus, World Health Organization (“WHO”) Director-General Dr. Margaret Chan declared a “phase six” pandemic. This phase, which marks the beginning of a pandemic, is characterized by person-to-person spread of the virus into more than one country in one WHO region, and “community level outbreaks in at least one other country in a different WHO region.”
On April 26, 2009, in response to the rising number of H1N1-related illnesses in the United States, then Acting Secretary Charles E. Johnson declared a public health emergency, pursuant to section 319 of the Public Health Service Act. This declaration enabled the Food and Drug Administration (FDA) emergency use authorization of drugs, devices, and medical tests in certain circumstances, facilitating proper preparation and mobilization to combat the H1N1 pandemic. The Secretary has since renewed this declaration two times, once on July 24, 2009, and again on October 1, 2009.
On October 24, 2009, President Obama signed a proclamation, pursuant to his authority under the National Emergency Act, declaring the H1N1 pandemic a national emergency, which would allow the waiver of certain statutory federal requirements for medical treatment facilities. [what kinds of decisions would they be allowed to make] [What is the National Emergency Act]. This proclamation would provide the Department of Health and Human Services (“HHS”) with the power to waive legal requirements that may otherwise limit the health care system’s ability to respond to the high volume of patients infected with the H1N1 influenza virus.
Under Section 1135 of the Social Security Act, the Secretary may, in response to an emergency, waive certain listed requirements for healthcare facilities relating to the following:
Medicare, Medicaid, and the Children’s Health Insurance Program (CHIP):
- Requirements that physicians or other health care professionals hold licenses in the State in which they provide services, if they have an equivalent license from another State (and are not affirmatively barred from practice in that State or any State a part of which is included in the emergency area).
- Certain conditions of participation, certification requirements, program participation or similar requirements for individual health care providers or types of health care providers, including as applicable, a hospital or other provider of services, a physician or other health care practitioner or professional, a health care facility, or a supplier of health care items or services, and pre-approval requirements.
- Sanctions under section 1877(g) (relating to limitations on physician referral) under such conditions and in such circumstances as the Centers for Medicare & Medicaid Services determines appropriate.
- Limitations on payments under section 1851(i) of the Act for health care items and services furnished to individuals enrolled in a Medicare Advantage plan by health care professionals or facilities not included in the plan’s network.
- Actions under section 1867 of the Act (the Emergency Medical Treatment and Labor Act, or EMTALA) for the direction or relocation of an individual to another location to receive medical screening pursuant to an appropriate state emergency preparedness plan or a state pandemic preparedness plan or for the transfer of an individual who has not been stabilized if the transfer is necessitated by the circumstances of the declared public health emergency for the 2009-H1N1 influenza pandemic.
- Requirements to obtain a patient’s agreement to speak with family members or friends or to honor a patient’s request to opt out of the facility directory (as set forth in 45 C.F.R. § 164.510)
- The requirement to distribute a notice of privacy practices (as set forth in 45 C.F.R. § 164.520); and
- The patient’s right to request privacy restrictions or confidential communications (as set forth in 45 C.F.R. § 164.522); but in each case, only with respect to hospitals in the designated geographic area that have hospital disaster protocols in operation during the time the waiver is in effect.
In other words, healthcare facilities receiving 1135 waivers are permitted to continue providing patient care even though they may be out of compliance with statutory requirements of CHIP, EMTLA, and HIPAA. The Secretary has the authority to issue such waivers only after the Secretary has declared a public health emergency and the President has declared an emergency or major disaster through a Stafford Act declaration or National Emergencies Act declaration. A Stafford Act declaration authorizes the Federal Emergency Management Agency to coordinate government-wide efforts to provide financial and physical relief during times of emergency.
As of November 2009, more than 42 million doses of the H1N1 vaccine have been allocated for distribution across the country. However, demand for the vaccine still exceeds the supply received from manufacturers. As a result, the Advisory Committee on Immunization Practices identified the groups most vulnerable to H1N1 influenza and thus most in need of the vaccination:
- Pregnant women;
- Caretakers of infants less than 6 months of age;
- Health care workers;
- Children and adults with health conditions such as asthma or diabetes; and
- People under the age of 25.
Not everyone who contracts the H1N1 virus needs to be examined by a healthcare provider or must be admitted to the emergency room. Most patients affected by H1N1 will recover without complications within a few days. Those infected or suspected to be infected with H1N1 should contact their medical provider. Within the physician’s discretion, patients may be prescribed an antiviral medication, such as Tamiflu or Relenza.
Certain patients are at high risk for complications associated with H1N1 influenza and thus should seek medical care if they are suspected of being infected with the H1N1 virus. The Center for Disease Control and Prevention identified these high-risk groups as:
- Children less than 5 years old;
- Persons aged 65 years or older;
- Children and adolescents (less than 18 years) who are receiving long-term aspirin therapy and who might be at risk for experiencing Reye syndrome after influenza virus infection;
- Pregnant women;
- Adults and children who have chronic pulmonary, cardiovascular, hepatic, hematological, neurologic, neuromuscular, or metabolic disorders;
- Adults and children who have immunosuppression (including immunosuppression caused by medications or by HIV); and
- Residents of nursing homes and other chronic-care facilities.
According to the CDC, the United States is not currently screening travelers who arrive from other countries or depart to other countries.
U.S. Government Pandemic Policy for Americans Abroad
Because the H1N1 influenza is rapidly spreading across the globe, the United States Government is concerned with the possibility that a severe influenza pandemic will result, which may affect Americans abroad. In the event that the WHO announces a severe pandemic, American citizens traveling or living abroad should return to the United States while commercial travel options still exist. HHS and CDC will allow American citizens to re-enter the United States, although ill travelers may be quarantined or isolated. The United States Department of State cannot provide private American citizens who are abroad with medical supplies or treatment, should a pandemic occur. Returning to the United States will allow Americans greater access to necessary medications and vaccines.
Privacy Rights of International Travelers and H1N1
Many countries are conducting health screenings for arriving passengers. The United States Department of State does not have the power to interfere with the rights of other countries to screen international travelers entering or exiting their countries. Passengers may be asked to:
- Pass through a scanning device that checks your temperature;
- Have your temperature taken with an oral or ear thermometer;
- Fill out a health questionnaire;
- Review information about the symptoms of H1N1 influenza;
- Give your address, phone number, or other contact information;
- Be quarantined for a short period of time if it is found that a passenger suffers from symptoms associated with H1N1 influenza; or
- Contact health authorities in the country to let them know you are ill.
During a pandemic, employees are still protected under the Americans with Disability Act (“ADA”), which regulates medical examinations and employer handling of confidential health information. The United States Equal Employment Opportunity Commission (“EEOC”) released Pandemic Preparedness in the Workplace Guidelines, which provides information on how employers may maintain compliance with the ADA.
The ADA prohibits an employer from making disability-related inquiries or conducting medical examinations unless they are job-related and consistent with business necessity. A business necessity arises when an employer has a reasonable belief, based on objective evidence, that the employee’s ability to perform significant and central job functions will be impaired by a medical condition, or an employee’s medical condition poses a significant risk of substantial harm to the health and safety of others. If such inquiries or examinations are made, all information about employees must be kept confidential and maintained in separate medical files.
During a pandemic, employers may send employees home when they display symptoms associated with the H1N1 influenza. ADA-covered employers may also ask employees whether they are suffering from influenza-related symptoms, but must maintain all information about the employee’s illness in a confidential medical file. Although generally, measuring an employee’s body temperature is considered a medical examination, if pandemic influenza symptoms become severe, employers may measure employees’ body temperature, but must keep this information confidential. If an employee does not exhibit influenza symptoms, employers may not ask employees to disclose medical conditions that may make them vulnerable to influenza complications. However, if an employee chooses to disclose this information, the employer must keep this information confidential.
Employers can require employees to abide by infection-control practices, which may include washing hands, wearing face masks, or following proper tissue usage and disposal etiquette. While employers cannot require their employees to be vaccinated against the H1N1 virus, they may encourage employees to do so.