PURSUANT TO THE PROVISIONS OF THE State Administrative Procedure Act, NOTICE is hereby given of the following proposed rule:
Proposed Action:
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 proposed rule (Full text is posted at the following State website:www.health.state.ny.us):
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 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.
Text of proposed 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
Data, views or arguments may be submitted to:
Same as above.
Public comment will be received until:
45 days after publication of this notice.
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 law specifies a 1/1/08 implementation date for reporting. It is expected that a significant proportion of providers will come into compliance after training occurs in each region according to the established regional implementation plan through July 2008. 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.
Regulatory Flexibility Analysis
Effect of Rule:
The mandated statewide immunization system will affect only small businesses and local governments in New York State outside of NYC (hereinafter referred to as rest of state, or ROS), since the regulations allow for the continued operation of the City of New York's mandatory immunization registry that has been operating for the past decade. The primary type of business impacted by this new rule will be health care providers who deliver primary care to children from shortly after birth to the age of 18 years. The exact number of health care providers in the ROS who vaccinate children is unknown, but is estimated to be in excess of 2,000. While other types of providers are affected in that they will be able to access registry information if they so choose, such as schools, day care centers, local health departments, local districts of social services, etc., access will be voluntary and should decrease existing workload by ensuring a single point of access to immunization history information.
Compliance Requirements:
Health care providers will be required to submit information into the system. Such data entry will likely be less cumbersome than manually updating immunization histories for documents needed by parents or guardians. Providers will be able to download and print copies of immunization histories to give to parents, saving substantial time, and will be able to automatically generate reminder and recall notices, to notify parents when their child is due for an immunization or is being recalled to the office for immunization follow-up. This is expected to result in an overall reduction in time required. Another significant benefit of the system will be the ability to generate a report regarding vaccine accountability for the Vaccines for Children program. Two thousand, two hundred of the health care providers participate in this program.
While some of the system's data fields to be entered may not be currently recorded by providers, e.g. vaccine lot number, manufacturer, and mother's maiden name, these critical pieces of information should be maintained in a patient's record to ensure appropriate care to the particular patient.
Providers are required to submit information online. A minority of providers may find this difficult. However, Health Provider Network (HPN) accounts are used by a significant number of providers in order to obtain prescription pads. Deferrals for such providers are possible, although paper records will need to be submitted in a timely fashion while the change to electronic reporting occurs.
The major compliance requirement that might generate initial workload burden for providers is the need to enter immunization histories into the system for all children administered immunizations after the system implementation date of 1/1/08. For providers in many areas, this can be accomplished by migrating regional registry information into the statewide system. For providers not already participating in a regional registry, accommodations to allow use of existing electronic data sets for downloading information will be attempted wherever feasible, given adequate provider resources to generate compatible files.
Professional Services:
If providers have existing electronic data systems and access to the internet, no additional professional services will likely be needed for those providers entering records directly online. However, for providers who have existing electronic data systems and wish to submit historical immunization data directly from those systems rather than entering such information at the time the first immunization is given to each child after 1/1/08, the services of a programmer may be required to generate electronic downloads in the format prescribed by the system. The cost of such one-time programming might vary according to the number of providers using a given data system. For providers with unique electronic record keeping systems, such costs could exceed several thousand dollars. The Department of Health will assist providers, wherever possible. For small providers with no electronic systems, a computer professional may be needed to set up a new computer system.
Compliance Costs:
No detailed cost data is available based on the implementation of regional systems. However, it is expected that ongoing compliance costs for the new statewide system will be negligible for other than some small providers who may need to purchase a computer and obtain internet access. Providers will have the option of downloading historical immunization records from existing electronic systems, in a format compliant with the system. Providers pursuing this option will incur programming costs which will vary according to the extent to which the electronic data system is shared by other providers. However, a net savings will accrue once initial implementation is completed and backlogged data are entered. Retrieval of information will be more streamlined, saving support staff time. Data entry costs were reported in the journal Pediatrics to be $0.56 additional per record in 2004. The savings per each patient record generated electronically has estimated to be over $14 as opposed to manual efforts to pull the chart when immunization records were needed.
Economic and Technological Feasibility:
The feasibility of a registry has been tested using a regional approach. No economic or technological barriers emerged, aside from routine system download issues requiring programming time. However, since DOH contractors have addressed most downloading issues, the provider burden has been minimized.
Minimizing Adverse Impact:
In addition to the measures already mentioned, e.g., utilizing existing regional data systems for downloading backlogs of information and attempting to work with existing electronic systems to develop downloads, two other measures were taken to minimize adverse impact. In the regulations, providers are permitted to request an extension of the deadlines for submission of information, with adequate justification. This will allow providers with compliance issues additional time to come into compliance. Program staff will approve all reasonable requests. The deferral of the start date for immunization information data entry (of all immunizations occurring since 1/1/08) until interactive training has been made available to providers regionally, whether face-to-face or via webinars also minimizes adverse impact. Providers will be offered the option of deferring their implementation date until the first of the month following the last training session made available in their region, whether they have attended or not. This training-related deferral, in addition to the electronic download deferral and the internet access availability deferrals, should accommodate most of the providers wishing for an extension on the deadline for data entry.
Small Business and Local Government Participation:
A series of meetings have been held at various locations around the state to ensure that many affected individuals and entities have the opportunity to share their concerns with the Department. These concerns have been incorporated into the development of the regulations. In addition, the regulations have been drafted to reflect the maximum degree of flexibility and responsiveness to the regulated community, e.g., incorporating downloads of historical information from existing registries, using existing data systems that already gather information as vehicles for downloading of information into the system and incorporating extensions of the implementation deadline for various reasons.
Rural Area Flexibility Analysis
Types and Estimated Numbers of Rural Areas:
This rule will apply to health care providers throughout the state, including all 44 counties delineated in SAPA Section 102(10) as rural counties (Allegany, Cattaraugus, Cayuga, Chautauqua, Chemung, Chenango, Clinton, Columbia, Cortland, Delaware, Essex, Franklin, Fulton, Genesee, Greene, Hamilton, Herkimer, Jefferson, Lewis, Livingston, Madison, Montgomery, Ontario, Orleans, Oswego, Otsego, Putnam, Rensselaer, St. Lawrence, Saratoga, Schenectady, Schoharie, Schuyler, Seneca, Steuben, Sullivan, Tioga, Tompkins, Ulster, Warren, Washington, Wayne, Wyoming, and Yates); and nine counties with a population density outside of townships of less than 150 persons per square mile (i.e., Albany, Broome, Dutchess, Erie, Monroe, Niagara, Oneida, Onondaga and Orange).
Reporting, Recordkeeping and other Compliance Requirements; and Professional Services:
The system will require that all immunizations be reported to the statewide immunization system, outside of those performed in NYC (which must be reported to the citywide registry, in operation for almost a decade, and thus not a new requirement). The information reported to the registry, though, is equivalent to the information currently recorded by providers in the charts and, in some cases, via electronic billing systems. The ability to call up a patient's immunization record from the system and print the immunization history will save providers significant time and costs, more than exceeding costs required for reporting. Physicians and other health care providers are routinely asked to provide written immunization records for school entry, camp enrollment, sports physicals, etc. Printing out this information from the system will require far less staff time than copying the immunization history onto whatever form is required. The system is being designed to be used by nonprofessionals, with only minimal acquaintance with computers and the internet. No on-going professional expertise or services should be required. The system will maintain a help desk to answer questions from providers, so that no rural professional should be negatively affected by this regulation. For small rural providers without existing computers, allowances will be made for delays in compliance as computer equipment and internet access are obtained. Every effort will be made to ensure that training is provided on a regional basis to provide an acceptable comfort level to all providers. Training will encompass a range of options, such as regional face-to-face sessions in every region, self-paced online training, webinars, online manuals, help buttons for use during data entry, range-checking to ensure valid information is entered online, and programmers to answer questions regarding downloading from existing data systems, such as billing and electronic chart systems. Informational materials will be available through the DOH website, as well as manuals, newsletters, and frequently asked questions to assist providers with implementing the system.
Costs:
For most health care providers, who already have computers and internet access, there will be no additional cost, unless they must engage the services of a programmer in order to execute downloads of historical immunization information from existing electronic data systems. For the few providers who need to obtain the equipment and engage an internet provider, start up costs will be approximately $800 for equipment, and the going rate for internet service in the region on an annual basis.
Minimizing Adverse Impact:
As mentioned, the ability to postpone electronic submission will be available to providers who can demonstrate a hardship with compliance, i.e., lack of a computer or internet access. DOH will allow providers to defer implementation based on regional readiness, judged by interactive training made available in each area, transition issues with regard to existing regional immunization registries, or lack of DOH resources to implement NYSIIS in a timely fashion. Where existing regional immunization registries exist, the ability of providers to authorize downloading of previously nonconsented historical immunization information, rather than having to input this information anew after 1/1/08, will be offered to minimize provider burden. Where such information has already been submitted to regional registries, there will be no need to re-enter this information.
Rural Area Participation:
All areas of the state have had the opportunity to provide input in this process. To date, regional meetings have been held with concerned stakeholders. A statewide meeting of stakeholders was held on July 16, 2007, and provider organizations were invited to attend this meeting to discuss implementation of the new system and all their concerns. To date, the major concerns expressed by providers have been the burden involved in entering historical immunization records into the system for clients receiving immunizations after 1/1/08, and the lack of a provision to opt out of the system. The statute requires that all providers participate in the system. However, the regulations permit deferral of participation in the system for providers experiencing hardship in complying with electronic transmission of records or who choose to wait until interactive training has been made available in their region. In addition, deferred participation is available for providers who are actively engaged in arranging for electronic downloads from existing systems. Further, deferrals of compliance deadlines will be granted to providers who have no access to the internet available in their region.
Job Impact Statement
Nature of Impact:
It is not expected that implementation of the statewide immunization system will have any impact on jobs, other than the creation of the system's basic infrastructure within the Department of Health. New York City has a preexisting immunization registry and the regulations will not impact the manner in which New York City administers their registry.
In the region outside of New York City, physicians and others currently providing immunizations within the scope of their duties and respective practice acts will be required to report immunizations to NYSIIS. However, the system will be pre-populated by birth certificates from 2004 on, which will reduce burden on health care providers by removing the necessity of filling in identifying information for the vast majority of children immunized, and requiring only a look-up function to locate individuals. Health care providers currently fill out immunization histories for patients multiple times, e.g., for parents' take home records, for schools when parents cannot locate records, for camps, for physicals required by schools, etc. The ability to print out a copy of a child's immunization history for the parents or caregivers, rather than manually copying the information, should more than compensate over time for the initial burden of entering a new child into the system.
Health care providers will also have the ability to delegate responsibility for immunization system entries to their staff members. All health care providers and their designees will be required to apply for access to the system, and sign a confidentiality statement. However, these activities will be streamlined to minimize provider burden. Some providers with existing electronic data systems will be afforded the opportunity to download immunization information directly from their current data systems, as appropriate, virtually eliminating time required for reporting to the system.
Categories and Numbers Affected:
None. For some small providers, who elect not to use the electronic download from existing data systems option, initial entry of immunization histories for children receiving immunizations after 1/1/08 will require additional hours of staff time. This time is offset by savings at a later time in printing immunization records from the system.
Regions of Adverse Impact:
None.
Minimizing Adverse Impact:
No adverse impact expected. The program has gone to significant lengths to ensure that no additional manpower would be required in physician's offices, where system start-up would be most labor intensive, requiring that immunization histories of patients immunized after 1/1/08 were entered into the system. The program is encouraging download of data from the two existing regional immunization registries in lieu of entry of old records, and is going to extend the opportunity for downloading immunization information from existing electronic systems in providers' offices, e.g., billing systems, wherever possible. In addition, the regulations provide the providers with an opportunity to request an extension on full electronic submission, if needed.
