This notice is intended: to serve as both a notice of emergency adoption and a notice of proposed rule making. The emergency rule will expire May 5, 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
Data, views or arguments may be submitted to: Same as above.
Public comment will be received until: 60 days after publication of this notice.
This rule was not under consideration at the time this agency submitted its Regulatory Agenda for publication in the Register.
Regulatory Impact Statement
Statutory Authority:
Section 225 of the Public Health Law (“PHL”) authorizes the Public Health and Health Planning Council (PHHPC), subject to the approval of the Commissioner of Health (Commissioner) to establish and amend State Sanitary Code 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 authorizing PHHPC, with the approval of the Commissioner, to designate communicable diseases, thereby permitting enhanced disease monitoring and authorizing isolation and quarantine measures, if necessary, to prevent further transmission.
Needs and Benefits:
The 2019 Novel Coronavirus (2019-nCoV) is a virus that was found to be the cause of an outbreak of respiratory illness in Wuhan, Hubei Province, China in December 2019. It is associated with mild to severe respiratory illness including symptoms of fever, cough, and difficulty breathing. People infected with the virus have had symptoms ranging from those that are mild (like a common cold) to severe pneumonia that requires medical care in a hospital and may be fatal.
As of February 3, 2020, 17,391 confirmed cases of 2019-nCoV were reported to the World Health Organization from 23 countries, including Canada and the United States, with 362 deaths reported.
On January 30, 2020 the World Health Organization designated the 2019-nCoV outbreak as a Public Health Emergency of International Concern, advising that further cases may appear in any country. On January 31, 2020, the Secretary of Health and Human Services determined that as a result of confirmed cases of 2019-nCoV in the United States, a public health emergency exists and has existed since January 27, 2020, nationwide.
If 2019-nCoV spreads in the general population, there could be severe public health consequences. On February 1, 2020, the New York State Commissioner of Health determined that 2019-nCoV is communicable, rapidly emergent and a significant threat to the public health, and designated 2019-nCoV as a communicable disease under 10 NYCRR Section 2.1. This designation will expire at the next scheduled meeting of the Public Health and Health Planning Council on February 6, 2020. Adding “severe or novel coronavirus” to the reportable disease list will confirm the Commissioner's designation and permit 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.
The regulation will also permit the Department to monitor and respond to other severe or novel coronavirus cases that may arise, including Middle East Respiratory Syndrome (MERS).
Costs:
Costs to Regulated Parties:
As 2019-nCoV is a newly emerging disease, it is not possible to accurately predict the extent of the outbreak or potential costs. In the event of the occurrence of 2019-nCoV cases, however, it is imperative to the public health that they be reported immediately and investigated thoroughly to curtail additional exposure and potential morbidity and mortality and to protect the public health.
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 2019-nCoV 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 2019-nCoV, however, could be significant. Control efforts may include isolation or quarantine. Close contacts of individuals diagnosed with 2019-nCoV may need to be closely monitored with daily follow-up by local health departments for up to two weeks post-exposure. These intensive efforts are critical to minimize the spread of this disease.
However, by potentially decreasing the spread of 2019-nCoV, this regulation may reduce costs associated with public health control activities, morbidity, treatment and premature death.
Costs to the Department of Health:
As 2019-nCoV 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 2019nCoV, 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 2019-nCoV, 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 2019nCoV 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 2019nCoV.
Compliance Schedule:
Reporting of 2019-nCoV is currently mandated, pursuant to the authority vested in the Commissioner of Health by 10 NYCRR Section 2.1(a). This mandate will be extended upon filing of a Notice of Emergency Adoption of this regulation with the Secretary of State and made permanent by publication of a Notice of Adoption of this regulation in the New York State Register.
Regulatory Flexibility Analysis
Effect on Small Business and Local Government:
This rule will apply to physicians, hospitals, nursing homes, diagnostic and treatment centers and clinical laboratories. There are approximately 76,500 licensed and registered physicians in New York State; it is not known how many of them practice in small businesses. Five hospitals, 130 nursing homes, 311 diagnostic and treatment centers, and 150 clinical laboratories employ less than 100 persons and qualify as small businesses.
Implementation will require reporting of 2019-nCoV in all 57 counties of the State outside of New York City. New York City has already adopted regulations identifying severe or novel coronavirus as a reportable, communicable disease.
Compliance Requirements:
Hospitals, clinics, physicians, nursing homes, and clinical laboratories that are small businesses and local governments will utilize revised Department of Health reporting forms and existing laboratory referral forms.
Local health officers receiving reports from physicians in attendance on persons with or suspected of being affected with 2019-nCoV, will be required to immediately forward such reports to the State Health Commissioner and to investigate and monitor the cases reported. Local health officers may also need to isolate or quarantine individuals to stop the spread of disease.
Professional Services:
No additional professional services will be required since providers are expected to be able to utilize existing staff to report occurrences of 2019nCoV and to order laboratory tests.
Compliance Costs:
No initial capital costs of compliance are anticipated. Annual compliance costs will depend upon the number of 2019-nCoV cases. The reporting of 2019-nCoV should have a negligible to modest effect on the estimated cost of disease reporting by hospitals, but the exact cost cannot be estimated. The cost would be less for physicians and other small businesses.
As 2019-nCoV is a newly emerging disease, it is not possible to accurately predict the extent of the outbreak or potential costs for local governments. Costs to local governments associated with investigating and implementing control strategies to curtail the spread of 2019-nCoV, however, could be significant. Control efforts may include isolation or quarantine. Close contacts of individuals diagnosed with 2019-nCoV may need to be closely monitored with daily follow-up by local health departments for up to two weeks post-exposure. These intensive efforts are critical to minimize the spread of this disease.
However, by potentially decreasing the spread of 2019-nCoV, this regulation may reduce costs associated with public health control activities, morbidity, treatment and premature death.
Economic and Technological Feasibility:
There are no economic or technological impediments to the rule changes.
Minimizing Adverse Impact:
There are no alternatives to the reporting requirement. Adverse impacts have been minimized since revised forms and reporting staff will be utilized by regulated parties. Electronic reporting will save time and expense.
Small Business and Local Government Participation:
Local governments have been consulted in the process through ongoing communication on this issue with local health departments and the New York State Association of County Health Officers (NYSACHO).
Rural Area Flexibility Analysis
Types and Estimated Numbers of Rural Areas:
This rule applies uniformly throughout the state, including rural areas. Rural areas are defined as counties with a population less than 200,000 and counties with a population of 200,000 or greater that have towns with population densities of 150 persons or fewer per square mile. The following 43 counties have a population of less than 200,000 based upon the United States Census estimated county populations for 2010 (https:// www.census.gov/quickfacts/).
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Allegany County |
Greene County |
Schoharie County |
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Cattaraugus County |
Hamilton County |
Schuyler County |
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Cayuga County |
Herkimer County |
Seneca County |
|
Chautauqua County |
Jefferson County |
St. Lawrence County |
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Chemung County |
Lewis County |
Steuben County |
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Chenango County |
Livingston County |
Sullivan County |
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Clinton County |
Madison County |
Tioga County |
|
Columbia County |
Montgomery County |
Tompkins County |
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Cortland County |
Ontario County |
Ulster County |
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Delaware County |
Orleans County |
Warren County |
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Essex County |
Oswego County |
Washington County |
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Franklin County |
Otsego County |
Wayne County |
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Fulton County |
Putnam County |
Wyoming County |
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Genesee County |
Rensselaer County |
Yates County |
|
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Schenectady County |
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The following counties have a population of 200,000 or greater and towns with population densities of 150 persons or fewer per square mile. Data is based upon the United States Census estimated county populations for 2010.
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Albany County |
Monroe County |
Orange County |
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Broome County |
Niagara County |
Saratoga County |
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Dutchess County |
Oneida County |
Suffolk County |
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Erie County |
Onondaga County |
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Compliance Requirements:
Hospitals, clinics, physicians, nursing homes, and clinical laboratories that are located in rural areas will utilize revised Department of Health reporting forms and existing laboratory referral forms.
Local health officers in rural areas receiving reports from physicians in attendance on persons with or suspected of being affected with 2019nCoV, will be required to immediately forward such reports to the State Health Commissioner and to investigate and monitor the cases reported. Local health officers may also need to isolate or quarantine individuals to stop the spread of disease.
Professional Services:
No additional professional services will be required. Rural providers are expected to use existing staff to comply with the requirements of this regulation.
Compliance Costs:
No initial capital costs of compliance are anticipated. Annual compliance costs will depend upon the number of 2019-nCoV cases. The reporting of 2019-nCoV should have a negligible to modest effect on the estimated cost of disease reporting by hospitals in rural areas, but the exact cost cannot be estimated. The cost would be less for physicians and other small businesses.
As 2019-nCoV is a newly emerging disease, it is not possible to accurately predict the extent of the outbreak or potential costs for local governments in rural areas. Costs to local governments associated with investigating and implementing control strategies to curtail the spread of 2019-nCoV, however, could be significant. Control efforts may include isolation or quarantine. Close contacts of individuals diagnosed with 2019nCoV may need to be closely monitored with daily follow-up by local health departments for up to two weeks post-exposure. These intensive efforts are critical to minimize the spread of this disease.
However, by potentially decreasing the spread of 2019-nCoV, this regulation may reduce costs associated with public health control activities, morbidity, treatment and premature death.
Minimizing Adverse Impact:
No alternative to the reporting requirements were considered due to the obvious need to prevent the spread of nCoV. Adverse impacts have been minimized since familiar forms and reporting staff will be utilized by regulated parties.
Rural Area Input:
The New York State Association of County Health Officers, including representatives of rural counties, has been informed about of this rule change and supports the need for it.
Job Impact Statement
The Department of Health has determined that this regulatory change will not have a substantial adverse impact on jobs and employment, based upon its nature and purpose.