This notice is intended to serve only as a notice of emergency adoption. This agency intends to adopt the provisions of this emergency rule as a permanent rule, having previously submitted to the Department of State a notice of proposed rule making, I.D. No. HLT-08-20-00001-P, Issue of February 26, 2020. The emergency rule will expire July 4, 2020.
Text of rule and any required statements and analyses may be obtained from: Katherine Ceroalo, DOH, Bureau of Program Counsel, Reg. Affairs Unit, Room 2438, ESP Tower Building, Albany, NY 12237, (518) 4737488, email: regsqna@health.ny.gov
Regulatory Impact Statement
Statutory Authority:
Executive Order No. 202, signed by Governor Cuomo on March 7, 2020, and continued by Executive Order No. 202.14, signed on April 7, 2020, modified Section 225 of the Public Health Law (“PHL”) to authorize the Commissioner of Health (Commissioner) to promulgate emergency regulations to establish and amend the State Sanitary Code, including those provisions relating to the designation of communicable diseases which are dangerous to public health, designation of diseases for which specimens shall be submitted for laboratory examination, and the nature of information required to be furnished by physicians in each case of communicable disease.
Legislative Objectives:
The legislative objective of PHL § 225 is, in part, to protect the public health by designating communicable diseases, thereby permitting enhanced disease monitoring and authorizing isolation and quarantine measures, if necessary, to prevent further transmission.
Needs and Benefits:
The 2019 Coronavirus (COVID-19) is a disease that causes mild to severe respiratory symptoms, including fever, cough, and difficulty breathing. People infected with Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2), which is the virus that causes the disease COVID-19, have had symptoms ranging from those that are mild (like a common cold) to severe pneumonia that requires medical care in a hospital and can be fatal. According to Johns Hopkins' Coronavirus Resource Center, to date, there have been over 3.6 million cases and 258,085 deaths worldwide, with a disproportionate risk of severe illness for older adults and/or those who have serious underlying medical health conditions.
COVID-19 was found to be the cause of an outbreak of illness in Wuhan, Hubei Province, China in December 2019. Since then, the situation has rapidly evolved throughout the world, with many countries, including the United States, quickly progressing from the identification of travel-associated cases to person-to-person transmission among close contacts of travel-associated cases, and finally to widespread community transmission of COVID-19.
On January 30, 2020, the World Health Organization (WHO) designated the COVID-19 outbreak as a Public Health Emergency of International Concern. On a national level, the Secretary of Health and Human Services determined on January 31, 2020 that as a result of confirmed cases of COVID-19 in the United States, a public health emergency existed and had existed since January 27, 2020, nationwide. Subsequently, on March 13, 2020, President Donald J. Trump declared a national emergency in response to COVID-19, pursuant to Section 501(b) of the Robert T. Stafford Disaster Relief and Emergency Assistance Act.
On February 1, 2020, the New York State Commissioner of Health determined that SARS-CoV-2 is communicable, rapidly emergent and a significant threat to the public health and designated it as a communicable disease under 10 NYCRR Section 2.1. On February 6, 2020, the Public Health and Health Planning Council (PHHPC) adopted emergency regulations, which confirmed the Commissioner's designation by adding “severe or novel coronavirus” to the reportable disease list in Part 2. This amendment also permits the Department of Health (Department) to systematically monitor for the disease and permit decisions about isolation or quarantine of suspect or confirmed cases to be made on a timely basis. Additionally, this regulation makes it possible for the Department to monitor and respond to other severe or novel coronavirus cases that may arise, including Middle East Respiratory Syndrome (MERS).
Since these emergency regulations were first adopted by PHHPC, New York State has rapidly become the national epicenter of the outbreak. Case were first identified in New York State on March 1, 2020. On March 7, 2020, with widespread transmission rapidly increasing within certain areas of the state, Governor Andrew M. Cuomo issued an Executive Order declaring a state disaster emergency to aid in addressing the threat COVID-19 poses to the health and welfare of New York State residents and visitors. With 321,192 confirmed cases and 19,645 deaths, New York State continues to be the most impacted state in the nation.
Based on the foregoing, and pursuant to the Executive Order issued on March 7, 2020, which permits the Commissioner to promulgate emergency regulations and to amend the State Sanitary Code, the Department has made the determination that it is necessary to renew this emergency regulation.
Costs:
Costs to Regulated Parties:
As COVID-19 is a newly emerging disease, it is not possible to accurately predict the extent of the outbreak or potential costs. It is imperative to public health, however, that COVID-19 cases be reported immediately and investigated thoroughly to curtail additional exposure and potential morbidity and mortality.
The costs associated with implementing the reporting of this disease are lessened as reporting processes and forms already exist. Hospitals, practitioners and clinical laboratories are accustomed to reporting communicable disease to public health authorities.
Costs to Local and State Governments:
As COVID-19 is a newly emerging disease, it is not possible to accurately predict the extent of the outbreak or potential costs.
Costs to local or state governments associated with investigating and implementing control strategies to curtail the spread of COVID-19, however, could be significant. Control efforts have included and may continue to include isolation and quarantine. These intensive efforts are critical to minimize the spread of this disease.
However, by potentially decreasing the spread of COVID-19, this regulation may reduce costs associated with public health control activities, morbidity, treatment and premature death.
Costs to the Department of Health:
As COVID-19 is a newly emerging disease, it is not possible to accurately predict the extent of the outbreak or potential costs. Costs to the Department associated with assisting local health departments investigating and implementing control strategies to curtail the spread of COVID19, however, could be significant.
Paperwork:
The existing general communicable disease reporting form (DOH-389) will be revised. This form is familiar to and is already used by regulated parties.
Local Government Mandates:
Under Part 2 of the State Sanitary Code (10 NYCRR Part 2), the city, county or district health officer receiving reports from physicians in attendance on persons with or suspected of being affected with COVID-19, will be required to immediately forward such reports to the State Health Commissioner and to investigate and monitor the cases reported.
Duplication:
There is no duplication of this initiative in existing State or federal law.
Alternatives:
No other alternatives are available, because reporting of cases of COVID-19 is of critical importance to public health. There is an urgent need to conduct surveillance, identify human cases in a timely manner, and reduce the potential for further exposure to contacts.
Federal Standards:
Currently there are no federal standards requiring the reporting of COVID-19.
Compliance Schedule:
Reporting of COVID-19 is currently mandated, pursuant to the emergency regulation adopted by PHHPC on February 6, 2020.