Sponsored by:
Assemblywoman NANCY J. PINKIN
District 18 (Middlesex)
SYNOPSIS
Revises access and reporting requirements for New Jersey Immunization Information System.
CURRENT VERSION OF TEXT
As introduced.
An Act concerning the New Jersey Immunization Information System, amending and supplementing P.L.2004, c.138, and amending P.L.2003, c.280.
Be It Enacted by the Senate and General Assembly of the State of New Jersey:
1. Section 3 of P.L.2004, c.138 (C.26:4-133) is amended to read as follows:
3. As used in this act:
"Authorized user" means any health care provider, child care center, school, college or university, health benefits plan, billing vendor, practice management vendor, State public health or social services program, or local health agency granted access to registry information pursuant to subsection c. of section 4 of P.L.2004, c.138 (C.26:4-134). "Authorized user" includes the designated agent of an authorized user.
"Billing vendor" means an entity that a health care provider or health care practice contracts with in order to prepare invoices, claims, or statements of services performed by the provider or practice and submit them to a third party for payment or reimbursement.
"Commissioner" means the Commissioner of Health.
"Department" means the Department of Health.
"Designated agent" means a person to whom a site administrator has delegated responsibility to submit information to, receive information from, or access or review information contained in, the registry.
"Health benefits plan" means a health benefits plan as defined in section 2 of P.L.1997, c.192 (C.26:2S-2), the State Health Benefits Program, the School Employees' Health Benefits Program, the State Medicaid program, and the NJ FamilyCare program.
"Health care provider" means a health care facility licensed pursuant to P.L.1971, c.136 (C.26:2H-1 et seq.) or a health care professional whose practice is regulated pursuant to Title 45 of the Revised Statutes.
"Practice management vendor" means a company that develops and sells information technology electronic applications or software, which primarily focuses on patient medical records.
"Registry" means the New Jersey Immunization Information System established pursuant to this act.
"Site administrator" means the person at a registry site assigned to coordinate the registry on site and accept official documents regarding the registry.
(cf: P.L.2012, c.17, s.339)
2. Section 4 of P.L.2004, c.138 (C.26:4-134) is amended to read as follows:
4. a. There is established a Statewide automated and electronic immunization registry, to be designated as the New Jersey Immunization Information System, in the Department of Health. The registry shall be designed to serve as a single repository of immunization records to aid, coordinate, and help promote effective and cost-efficient disease screening, prevention, and control efforts in the State.
b. A newborn infant in New Jersey, who is born on or after January 1, 1998, shall be enrolled in the registry immediately following birth unless the parent or legal guardian of the infant provides a written request to not participate in the registry.
A [child] person born prior to January 1, 1998 [may] who is not currently enrolled in the registry shall be enrolled in the registry [at the parent's or legal guardian's] upon receiving an immunization unless the person provides a written request not to participate in the registry.
c. [Access] (1) The commissioner shall grant access to [the] registry information [in the registry shall be limited to: health care providers, schools, colleges, licensed child care centers, and public agencies, and private organizations as determined by regulation of the commissioner] as an authorized user to any individual who is, and to any site administrator or designated agent of an entity that is, a health care provider, child care center, school, college or university, health benefits plan, billing vendor, practice management vendor, State public health or social services program, or local health agency, provided that the individual, site administrator, or designated agent has:
(a) completed either an in-person training course or the online tutorial developed by the commissioner pursuant to subsection j. of this section; and
(b) submitted a completed authorized user confidentiality agreement in a form and manner approved by the commissioner.
(2) An authorized user who accesses registry information shall certify that the information is being accessed for an authorized purpose, consistent with the scope of that user's authorization to access registry information, and consistent with the rules and regulations adopted by the commissioner pursuant to subsection i. of this section.
(3) A registrant, or the registrant's parent or legal guardian if the registrant is a minor, shall have access to the registrant's immunization and other preventive health screening information in the registry.
d. The information contained in the registry shall be used for the following purposes:
(1) to help ensure that registrants receive all recommended immunizations in a timely manner by providing access to the registrants' immunization records;
(2) to help improve immunization rates by providing notice to registrants of overdue or upcoming immunizations; and
(3) to help control communicable diseases by assisting in the identification of persons who require immediate immunization in the event of a vaccine-preventable disease outbreak.
e. The authentic immunization and other preventive health screening record of a child, which shall consist of a paper or electronic copy of the registry entry that is a true and accurate representation of the information contained therein, obtained from the registry shall be accepted as a valid immunization and preventive health screening record of the registrant for the purpose of meeting immunization and preventive health screening documentation requirements for admission to a school, college, or licensed child care center.
f. A health care provider shall not discriminate in any way against a person solely because the person elects not to participate in the registry.
g. An authorized user granted access to registry information as provided in subsection c. of this section shall only access information in the registry on a specific patient or client who is presently receiving services, is under the user's care, or is within the applicable governmental health authority's jurisdiction.
h. An agency, organization, or other entity authorized to access information in the registry shall not use any report made by a health care provider pursuant to this act in any punitive manner against the provider.
i. The commissioner, in consultation with the Public Health Council, shall adopt rules and regulations, pursuant to the "Administrative Procedure Act," P.L.1968, c.410 (C.52:14B-1 et seq.), to effectuate the purposes of this act, including, but not limited to:
(1) the establishment and maintenance of the registry;
(2) the methods for submitting, and the content of, reports of immunizations to the registry, for which purpose the commissioner shall provide, to the maximum extent practicable, for reporting options to facilitate compliance with the requirements of subsection b. of this section and section 3 of P.L. , c. (C. ) (pending before the Legislature as this bill);
(3) procedures for the birth hospital of a newborn infant or health care provider, as applicable, to inform the parent or legal guardian of a newborn infant or minor of the purpose of the registry and its potential uses by parties having authorized access to registry information, and the content of that information;
(4) procedures for a registrant, or the registrant's parent or legal guardian if the registrant is a minor, to review and correct information contained in the registry;
(5) procedures for the parent or legal guardian of a newborn infant or minor, or a person over 18 years of age, to request to not participate in the registry at any time and to remove or inactivate information from the registry;
(6) limits on, and methods of, access to the registry by those authorized pursuant to subsection c. of this section;
(7) procedures for health [insurers] benefits plans to obtain immunization information from the registry concerning only their covered persons, as well as summary statistics, which information or statistics shall not be used or disclosed for any other purpose than to:
(a) improve patient care;
(b) provide quality assurance to employers purchasing group coverage and to health care providers;
(c) improve outreach and education efforts with respect to their covered persons and health care providers; and
(d) monitor and improve quality of care standards as developed by professional organizations, accreditation agencies and government agencies in collaboration with the department; and
(8) procedures for the department to disseminate statistical information and supporting commentary.
j. The commissioner shall develop an online tutorial for the purposes of subparagraph (a) of paragraph (1) of subsection c. of this section, which shall provide information concerning:
(1) registry access requirements, including any special requirements as may apply to health care providers authorized to access registry information for the purposes of reporting immunization information for individual patients;
(2) the rights of registry enrollees;
(3) the responsibilities of authorized users accessing registry information, including any special requirements as may apply to health care providers authorized to access registry information for the purposes of reporting immunization information for individual patients; and
(4) a summary of the federal health privacy rule set forth at 45 C.F.R. Parts 160 and 164, including a hypertext link to the federal Department of Health and Human Services website for further information about the specific provisions of the federal health privacy rule.
k. The commissioner shall develop and implement measures to facilitate and streamline access to registry information for health care providers and other authorized users, which may include, but shall not be limited to, making the registry compatible with electronic health records systems. Nothing in this subsection shall be construed to authorize or require access to, or the transmission of, patient data in a form or manner that presents an increased risk that confidential patient information may be disclosed in an unlawful manner.
(cf: P.L.2012, c.17, s.340)
3. (New section) a. No later than one year after the effective date of this act, each health care provider who administers immunizations to patients shall meet the requirements, as set forth in subsection c. of section 4 of P.L.2004, c.138 (C.26:4-134), to become an authorized user with access to registry information.
b. A health care provider who administers an immunization to a patient shall report the immunization administration to the registry if the patient is enrolled in the registry. If the patient is not enrolled in the registry, the provider shall enroll the patient upon administering the immunization unless the patient provides a written request not to participate in the registry, as provided in subsection b. of section 4 of P.L.2004, c.138 (C.26:4-134).
4. Section 24 of P.L.2003, c.280 (C.45:14-63) is amended to read as follows:
24. a. No pharmacist shall administer a prescription medication directly to a patient without appropriate education or certification, as determined by the board in accordance with the requirements set forth in the rules jointly promulgated by the board and the State Board of Medical Examiners. Such medication shall only be for the treatment of a disease for which a nationally certified program is in effect, or as determined by the board, and only if utilized for the treatment of that disease for which the medication is prescribed or indicated or for which the collaborative drug therapy management permits.
b. (1) Notwithstanding any law, rule, or regulation to the contrary, a pharmacist may administer drugs to a patient 18 years of age or older, provided the pharmacist is appropriately educated and qualified, as determined by the board in accordance with the requirements set forth in the rules jointly promulgated by the board and the State Board of Medical Examiners, and provided the drugs are administered under any one of the following conditions:
(a) pursuant to a prescription by an authorized prescriber for a vaccine and related emergency medications;
(b) in immunization programs implemented pursuant to an authorized prescriber's standing order for the vaccine and related emergency medications; or
(c) in immunization programs and programs sponsored by governmental agencies that are not patient specific.
(2) A pharmacist may administer an influenza vaccine to a patient who is seven years of age or older. For a patient who is under 18 years of age, a pharmacist shall not administer a vaccine except with the permission of the patient's parent or legal guardian. For a patient who is under 12 years of age, a pharmacist shall not administer a vaccine unless pursuant to a prescription by an authorized prescriber. Nothing in this subsection shall be construed to require a patient 12 years of age or older to obtain a prescription for an influenza vaccine.
c. A pharmacy that offers vaccine administration to patients shall provide a private room for the purposes of vaccine administration and providing any patient counseling as may be necessary in association with vaccine administration.
(cf: P.L.2013, c.254, s.1)
5. This act shall take effect the first day of the fourth month next following the date of enactment, except that the Commissioner of Health may take any anticipatory administrative action in advance as may be necessary for the implementation of this act.
STATEMENT
This bill revises certain requirements for enrollment in, accessing, and reporting information to, the New Jersey Immunization Information System (NJIIS), also known as "the registry."
Currently, children born on or after January 1, 1998 are automatically enrolled in the registry at birth, and individuals born prior to that date may be enrolled by written request. The bill revises these requirements to provide that anyone born prior to January 1, 1998 who is not currently enrolled in the registry will be automatically enrolled upon receiving an immunization, unless the person submits a written request not to participate in the registry.
Additionally, the bill requires any health care provider who administers immunizations to patients to enroll as an authorized user of the registry no later than one year after the effective date of the bill; under current regulations, only health care providers who administer immunizations to patients who are younger than seven years of age are required to enroll.
The bill requires health care providers to report all immunizations administered to a patient, regardless of the patient's age, if the patient is enrolled in the registry. Currently, mandatory reporting only applies to immunizations administered to patients younger than seven years of age.
The bill additionally revises the requirements to become an authorized user of the registry. The bill defines "authorized user" to include any health care provider, child care center, school, college or university, health benefits plan, billing vendor, practice management vendor, State public health or social services program, or local health agency. "Authorized user" also includes a designated agent of an authorized user.
The commissioner is to grant access to registry information to any person or entity who: (1) is a health care provider, child care center, school, college or university, health benefits plan, billing vendor, practice management vendor, State public health or social services program, or local health agency; (2) completes either an in-person training course or an online tutorial to be developed by the commissioner; and (3) submits a completed authorized user confidentiality agreement in a form and manner approved by the commissioner. Currently, the training requirements may only be completed by attending an in-person training course. Nothing in the bill revises or limits the right of persons enrolled in the registry to access their own information.
An authorized user who accesses registry information will be required to certify that the information is being requested for an authorized purpose, consistent with the scope of that user's authorization to access registry information, and consistent with the rules and regulations adopted by the commissioner.
The bill requires the commissioner to develop an online tutorial for the purposes of granting access to the registry to authorized users that includes, at a minimum, registry access requirements, the rights of registry enrollees, the responsibilities of authorized users, and a summary of the federal health privacy rule, including a hypertext link to the federal Department of Health and Human Services website for further information about the rule. The tutorial information may include any special requirements as may apply to health care providers authorized to access registry information for the purposes of reporting immunization information for individual patients.
The commissioner will additionally be required to develop and implement measures to facilitate and streamline access to registry information for health care providers and other authorized users. The measures may include, but will not be limited to, making the registry compatible with electronic health records systems. The bill specifies that nothing in the requirement is to be construed to authorize or require access to, or the transmission of, patient data in a form or manner that presents an increased risk that confidential patient information may be disclosed in an unlawful manner.
Further, the bill requires that pharmacies that offer vaccine administrations to patients will also be required to provide a private room for the purposes of administering vaccines and providing any patient counseling as may be necessary.
The NJIIS is a Statewide information system established in 1997 to serve as the official repository of child immunization data. The NJIIS provides recommended immunization schedules for infants, children, and adults, assists State and federal agencies with population assessments in the event of preventable disease outbreaks, helps communities to assess their immunization coverage and identify pockets of need, and serves as a lifespan repository for individual immunization records.