PURSUANT TO THE PROVISIONS OF THE State Administrative Procedure Act, NOTICE is hereby given of the following action:
Action taken:
Amendment of section 66-1.2 of Title 10 NYCRR.
Statutory authority:
Public Health Law, section 2168
Subject:
Immunization Registry.
Purpose:
Establishment of a statewide immunization registry.
Substance of final rule:
Effective January 1, 2008, Section 2168 of the Public Health Law requires that a statewide immunization registry be implemented. In order to define requirements for establishment of this statewide immunization registry, including rules for submission of immunization information by health care providers and methods by which providers and others can access needed information, a revised Section 66-1.2 is proposed for Title 10 of the Official Compilation of Codes, Rules and Regulations of the State of New York. This section will allow physicians and designated others to generate a child's immunization record in place of the nonspecific requirement previously in Section 66-1.2 for physicians or other authorized persons to prepare "certificates of immunization."
Section 66-1.2 will have the following subsections:
66-1.2 (a) Definitions, including statewide immunization registry (which will be the reporting vehicle for all health care providers practicing outside of New York City (NYC)), Citywide Immunization Registry (the pre-existing NYC registry that these regulations will affect only minimally), health care providers, schools, registrants (the patients whose immunizations are reported to the system), authorized users and timely reporting.
66-1.2 (b) Mandated reporting. Mandated reporters are health care providers ordering immunizations, and their designees.
66-1.2 (c) Information required to be reported to the statewide system. Such information includes the minimum data requirements for immunization registries, with the addition of patient address in order to allow for geographic tracking of immunization patterns in response to disease outbreaks and vaccine recall events.
66-1.2 (d) Levels of access and authorized uses of the New York State Immunization Information System ("NYSIIS") data. Such levels and uses vary by types of authorized users, with health care providers ordering immunizations allocated sole responsibility for submitting information, although they may in turn designate staff to submit information on their behalf. However, health care providers also receive significant benefits from use of the system, including the ability to print immunization histories for patients on demand, print reminder and recall notices and use the system to help with vaccine inventory. Other types of users will have read-only access, and only for registrants who fall under their administrative or clinical responsibilities.
66-1.2 (e) Methods of accessing NYSIIS data will be primarily electronic. Authorized users will be required to submit an application for access to the system, and have this application accepted, in order to log on to the system. These regulations will only permit users to access data for registrants within their scope of responsibility.
66-1.2 (f) Maintenance of security and confidentiality. This will be assured by following standard Department of Health security and confidentiality procedures for electronic data, requiring all individuals accessing the system to have pre-approved applications for access, with distinct passwords and system IDs that conform to the latest industry standards, and with level and type of access tied to the type of user, as defined in the regulations. All users will submit an attestation to maintain confidentiality, and will be required to update application information on an ongoing basis, as needed.
66-1.2 (g) Provision of NYSIIS information to registrant's family/guardian. All mandated reporters must provide the parent or legal guardian of each registrant with a copy of the appropriate department of health's informational brochure or letter at the time of each registrant's initial entry into the system.
Final rule as compared with last published rule:
Nonsubstantive changes were made in section 66-1.2(c)(2)(iii), (3)(i) and (4).
Text of rule and any required statements and analyses may be obtained from:
Katherine Ceroalo, DOH, Bureau of House Counsel, Regulatory Affairs Unit, Room 2438, ESP, Tower Building, Albany, NY 12237, (518) 473-7488, email: regsqna@health.state.ny.us
Revised Regulatory Impact Statement
Statutory Authority:
In 2006, Public Health Law section 2168 was enacted. This new law required the development and implementation of a statewide immunization registry by January 1, 2008. Public Health Law section 2168, subsection 13 specifically authorizes the commissioner to promulgate regulations as necessary to effectuate the provisions of Public Health Law section 2168. The regulations proposed set forth procedures and protocols assisting providers and consumers in utilizing the statewide system.
Legislative Objectives:
This section establishes a statewide immunization registry as required by Public Health Law section 2168. Physicians and others may now systematically generate a child's immunization record as needed by parents, schools, etc. The immunization information system permits population-based review and tracking of immunizations; critical markers of well-child care. A statewide system will also allow health care providers to track timeliness and receipt of important and potentially life-saving immunizations. It facilitates vaccine recall letters and allows the state to monitor patterns of immunizations related to infectious disease outbreaks.
Needs and Benefits:
The Centers for Disease Control and Prevention (CDC) cite the reduction of infectious diseases resulting from the use of vaccines as the greatest success story in public health. The virtual eradication of smallpox from the globe, near elimination of the wild polio virus, and the reduction of preventable infectious diseases to an all-time low are among the accomplishments of immunizations. However, CDC also cites the fact that vaccines are not 100 percent safe or effective as yet, that different immune systems react differently to different vaccines and, on rare occasions, side effects occur. For these reasons, CDC strongly advocates that all states collect and maintain immunization information. Immunization registries provide states with the ability to track administration of vaccines to children for public health purposes, monitor effectiveness and side effects of these vaccines, and respond quickly and effectively in case of outbreaks.
The system will be able to track which children have received immunizations, the vaccine manufacturer, and lot number. Previously, if it were discovered that a particular batch of vaccine was ineffective, tracking recipients of that lot would have been slow at best and incomplete at worst, leaving some children vulnerable to the disease the immunization was designed to prevent. With NYSIIS, recipients of ineffective vaccines could be quickly notified via their providers of the need for re-immunization to occur. The immunization information will also be used by schools, HMOs, local health departments, local districts of social services, the Office of Children and Family Services, and other entities responsible for providing services to children.
COSTS:
Costs to Private Regulated Parties:
The costs to regulated parties for the implementation of and continuing compliance with the rule are expected to be negligible, except in the initial implementation period. The system is expected to generate a long term savings. Equipment and service requirements needed by health care providers to access NYSIIS parallel current requirements needed by providers to order prescription pads from the Department, i.e., internet access and an HPN account. The costs associated with completing the initial entry of historical immunization information for all persons less than the age of 19 years who are administered immunizations after January 1, 2008 represent an obstacle, especially to small providers without existing data systems, and to those providers with data systems who do not have service contracts requiring the development of compliant software. While these costs represent a burden to providers, the overall system benefits are fully expected to outweigh initial burden once the implementation period is complete.
In September 2006, the American Academy of Pediatrics (AAP) Committee on Practice and Ambulatory Medicine issued a policy statement in Pediatrics strongly supporting the use of immunization information systems. The statement indicates that the savings to pediatricians of using an automated immunization information system are significant. The savings from not having to manually pull a chart for immunization records is estimated to be $14.70 per chart. AAP's Policy Statement also mentions that in 2004 there was a reported increase in cost of $0.56 per shot after implementation of an immunization registry in the private sector, with nurses spending 3.4 minutes per shot on registry activities. Again, though, this would be sufficiently offset by the savings generated of $14.70 per chart that would no longer need to be manually pulled to generate an immunization history. It is impossible to estimate with any degree of certainty the cost to practices of entering historical immunization data on patients to populate the database of the system.
Costs to the Department of Health and Local Government:
All costs to the Department of Health for implementation and maintenance of the system will be offset by funds as part of the categorical grant from CDC. There will be no costs to local governments for implementation. Local government will access and submit limited immunization data through existing HIN connections. Significant time savings will be experienced by local health department staff by accessing the data in NYSIIS for assessment and quality activities.
Cost Information:
Cost information was developed based on estimated number of positions needed to implement the system. Expenses for initial hardware and software, ongoing system maintenance, help desk services, system changes, programming needed to download existing data systems for billing and charts into the system. The cost of development in year one is approximately $3.8 million. The cost of implementation and maintenance thereafter approximately $4 million per year.
Local Government Mandates:
No mandates for any local government entities are included in these regulations, separate and apart from their responsibilities as health care providers when the local health department administers vaccines to children. However, there are provisions made for local health departments, local districts of social services, schools, day care centers, the Office of Children and Family Services, and other agencies to access this system to obtain information required in performance of their duties. Accessing immunization information system data should facilitate performance of their duties, which include verifying immunization history for specific children who fall under their administrative or clinical responsibilities.
Paperwork:
While CDC has an extensive list of variables they recommend for inclusion in a state's immunization information system, only the minimum required elements will be included in NYSIIS, plus the address, which is critical to determining regional vaccine-preventable illness patterns. Although some providers may need to defer electronic submission pending availability of internet access, ultimately submission will be electronic for all providers. This will reduce data errors through use of automated error checking and value range monitoring during data entry.
Duplication:
Every effort is being made to minimize provider burden and avoid duplication of effort. However, a uniform collection method applied to all providers is essential to ensuring that the database is complete and effective for the required purposes. Where an existing registry already exists, i.e., the Citywide Immunization Registry, no additional registry submission is being required of providers. Where existing regional registries have been supplanted by the statewide immunization system, the information will be downloaded to the statewide system, making the transition as seamless as possible for current contributors to the registries. In addition, submission of information from existing electronic billing or clinical systems is available.
Alternatives Considered:
For the past ten years, regional prototype immunization registries have been tested in two areas of the state outside of New York City. These regulations allow regional prototype immunization registries to be incorporated, to the extent feasible in the statewide system. Providers may download immunization information from existing electronic data systems. A similar registry has also been in operation in NYC. In order to minimize impact on providers, this statewide system will not change the requirement for NYC providers to report immunizations to the NYCDOHMH ("Citywide Immunization Registry") registry. There is no viable alternative to the mandate for reporting of all immunizations to a centralized database, other than attempting, as stated above, to minimize the impact by permitting NYC's registry to co-exist and by utilizing downloads from other existing regional electronic systems.
Federal Standards:
The statewide immunization system conforms to minimum data set standards for immunization registries as published by the Centers for Disease Control and Prevention in their "Recommended Core Data Set" publication (http:///www/cdc/gov/nip/registry/st_terr/tech/stds/core.htm). The New York State data set includes less than half of the CDC-recommended data elements, including only the required data elements plus one federally recommended element (patient address). The benefit of conducting regional analyses of immunization status in the event of disease outbreaks or vaccine-related incidents necessitates the inclusion of one additional (recommended but not required) data element.
Compliance Schedule:
The regulations permit deferrals for submission of electronic forms in order to minimize hardship to smaller providers who have equipment or internet access issues. Region-wide deferrals will be made available to providers who have not yet had interactive training in their areas. Also, the Department is making every effort to assist providers with existing electronic data systems to download this information into files that meet system specifications. In a further attempt to minimize provider burden and ensure accurate reporting, providers currently working on providing downloaded files will be granted deferrals, on request, providing that they document their efforts and present a realistic plan of their anticipated progress and start date.
Revised Regulatory Flexibility Analysis
Changes made to the last published rule do not necessitate revision to the previously published RFA.
Revised Rural Area Flexibility Analysis
Changes made to the last published rule do not necessitate revision to the previously published RAFA.
Revised Job Impact Statement
Changes made to the last published rule do not necessitate revision to the previously published JIS.
Assessment of Public Comment
The Department received one written comment on the proposed rule making changes to section 66-1.2 of Title 10 New York Codes, Rules and Regulations regarding implementation of Article 21, Title 6, Section 2168F of Public Health Law (PHL) during the 45-day public comment period. The written comment was submitted by the Medical Society of the State of New York (MSSNY). In their comment, MSSNY clearly reiterates their full support of PHL 2168 and the New York State Immunization Information System (NYSIIS).
"The Medical Society strongly believes that the overall goal of this legislation will greatly enhance New York State's health prevention goals. Without a doubt, childhood immunizations have led to significant reduction in preventable infectious diseases and to the elimination of diseases such as small pox. And, the Medical Society of the State of New York does agree that such a system, once successfully implemented throughout the state, will provide an invaluable resource to physicians, other health care providers and the state, in tracking infectious disease outbreaks, rates of immunizations, and in monitoring the effectiveness of immunizations."
The letter addresses two items for the Department's consideration regarding the PHL and implementation of NYSIIS.
Item 1:
"The Medical Society of the State of New York also recognizes the strong commitment of the New York State Department of Health to work with the various statewide physician organizations throughout the last year in mitigating the financial impact to the physician community. The Medical Society, however, does remain concerned about the initial financial burden that a solo or small group pediatric or family physician practice that will incur. These practices serve in many of the state's underserved areas and may be located in remote areas where access to even the internet is difficult. Over the last year, these physicians have informed the Medical Society that the inputting of data into the registry necessitates additional staff time and salary expense. Moreover, physicians indicate that there will be ongoing staff costs to continuously access and upload immunizations, as well as costs associated with updating their computer system.
One clear improvement that could be made of the statewide Immunization Registry is the requirement that information be provided by managed care or insurance plans. Children may have a variety of pediatricians throughout their life, but the one constant may very well be the insurer. The insurer has immunization data that should be readily available to the registry-thus easing the administrative costs to the physicians, other health care providers and to the state. The Medical Society strongly urges that through this regulation or by legislative means the New York State Department of Health require the input of this insurance information into the Immunization Registry. This will enable all of us to get to the goal of having all immunizations recorded in a more expeditious manner."
Response:
The Department does not plan to pursue insurance companies or managed care plans to submit immunization information. PHL 2168 does not grant the Department authority to mandate this change. As well, the Department is concerned about the potential for data inaccuracy this would create. Ultimately, only the provider of immunizations can verify the accuracy of the information reported to NYSIIS. As such, to ensure ownership and accuracy of the information, data reporting should initiate with the health care provider. PHL 2168 does allow health maintenance organizations to obtain immunization information from NYSIIS for the purpose of conducting quality assurance activities.
Item 2:
"The New York State Department of Health has worked diligently to educate physicians and other providers. The Medical Society recognizes that the regulations do permit for deferral of the deadline for submission of electronic forms for smaller providers who have equipment or internet access issues. We are also aware that the Department plans additional training to give physicians and other providers an opportunity to comply with the law in recognition that many physicians have not yet taken the educational component. The Medical Society respectfully asks for an extension of the enforcement provisions granted in the January 16, 2008 letter from Department of Health to ensure that physicians are appropriately trained and have the necessary equipment and staff to comply.
The Medical Society at its 2008 House of Delegates unanimously supported efforts for such extension to allow sufficient time to become familiar with the immunization registry and to allow physicians and their staff time to be educated, trained and to obtain the necessary equipment to the use the registry. The Medical Society also supports procedures that will ease the administrative burden to physicians such as faxing and mailing of vaccination records to the New York State Department of Health."
Response:
The Department will continue our current approach of extensive outreach and training of health care providers in New York State in order to facilitate their participation in NYSIIS. This will likely extend far beyond January 1, 2009, and will continue until the Department is confident that the majority of providers have been reached and have been afforded every opportunity to become active reporters to NYSIIS. To consider a paper-based alternative system at this early time would undermine the overall success of NYSIIS.
