A3693

An Act concerning Parkinson’s disease and supplementing Title 26 of the Revised Statutes.

Be It Enacted by the Senate and General Assembly of the State of New Jersey:

1. As used in this act:

“Advisory committee” means the Parkinson’s disease registry advisory committee established pursuant to section 3 of this act.

“Commissioner” means the Commissioner of Health.

“Department” means the Department of Health.

“Health care provider” means a health care facility licensed pursuant to P.L.1971, c.163 (C.26:2H-1 et seq.) or an individual licensed or certified to practice a health care profession pursuant to Title 45 of the Revised Statutes.

“Parkinson’s disease” means a chronic and progressive neurologic disorder resulting from deficiency of the neurotransmitter dopamine as the consequence of specific degenerative changes in the area of the brain called the basal ganglia. Parkinsonisms are related movement abnormalities and conditions that may overlap with or evolve from Parkinson’s disease.

“Registry” means the Parkinson’s disease registry established pursuant to section 2 of this act.

2. a. The department shall establish a Statewide population-based Parkinson's disease registry.

b. The department shall collect data on the incidence of Parkinson's disease within the State. The registry, data collection, and dissemination of information shall be under the direction of the commissioner, who may enter into contracts, grants, or other agreements as are necessary for the conduct of the registry.

c. (1) In consultation with the advisory committee, the department shall establish a system for the collection and dissemination of information concerning the incidence and prevalence of Parkinson's disease and Parkinsonisms. The system shall be designed in a way that prevents the inclusion of duplicate registry records for a single individual.

(2) Subject to the provisions of subsection e. of this section, all cases of Parkinson’s disease that are diagnosed or treated in the State, including cases of Parkinson’s disease that were diagnosed prior to the effective date of this act, shall be reported to the department in a form and manner as the department requires.

(3) The department shall establish, review, and revise as needed a list of mandatory and advisory data points for the purposes of reporting Parkinson's disease and Parkinsonisms under this section. Such list shall include, but not be limited to, necessary triggering diagnostic conditions, consistent with the latest International Statistical Classification of Diseases and Related Health Problems, and resulting case data including, but not limited to, diagnosis, treatment, and survival; and may include appropriate patient

demographic information concerning the individual’s age, gender, race, and ethnicity, to the extent the individual chooses to disclose such demographic information.

d. Subject to the provisions of subsection e. of this section, a health care provider that diagnoses an individual with Parkinson’s disease or Parkinsonisms or that is the primary treatment provider for an individual diagnosed with Parkinson's disease or Parkinsonisms shall report each unique case of Parkinson's disease or Parkinsonisms to the registry. The department may enter into data sharing contracts with data reporting entities and associated electronic medical record systems vendors to securely and confidentially receive information related to Parkinson's disease testing, diagnosis, and treatment.

e. An individual may opt out of the registry at any time by providing a written opt-out form to the health care provider seeking to enroll the individual in the registry, or by submitting a request to the department to be removed from, or not to be included in, the registry. The department shall develop a written opt-out request form for use by health care providers for the purposes of this paragraph, and shall establish a written or online opt-out request form for requests submitted directly to the department. If an individual chooses not to participate in the registry, the only required information to be collected shall be the incidence of Parkinson's disease or Parkinsonisms, and no further data shall be reported to the registry for that individual. At such time as a health care provider seeks to enroll an individual in the registry, the health care provider shall provide the individual with written notice, in a form and manner developed by the department, of the individual’s right to opt-out of participation in the registry.

f. The Department shall provide notification of the mandatory reporting of Parkinson’s disease and Parkinsonism on its website and may also provide that information to professional associations representing physicians, nurse practitioners, and hospitals at least 90 days prior to requiring information be reported. 

g. All registry information collected pursuant to this section shall be confidential. To protect against disclosure of personal identifying information and confidential health information, the department shall establish a coding system that removes any identifying information about individuals included in the registry.

h. The department may enter into agreements to furnish data collected in the registry to other states' Parkinson's disease registries, federal Parkinson's disease control agencies, local health officers, or health researchers for the study of Parkinson's disease. In addition to the requirements of subsection h. of this section, before registry information is disclosed to an agency, officer, researcher, or out-of- State registry, the requesting entity shall agree in writing to maintain the confidentiality of the information, and in the case of a researcher, shall:

(1) obtain approval from the researcher’s Committee for the Protection of Human Subjects (CPHS) established in accordance with 45 CFR Part 46; and

(2) provide documentation to the department that demonstrates, to the department’s satisfaction, that the researcher has established procedures, and has the ability, to maintain the confidentiality of the information.

i. (1) Notwithstanding any other provision of law to the contrary, registry information provided to a requester pursuant to subsection g. of this section shall include only the information necessary for the stated purpose outlined in the request, and shall not be used by the requester for any purpose other than the purpose outlined in the request. Unless approved by the department in writing, an entity that is provided registry information pursuant to subsection g. of this section shall not furnish the registry information to any other entity for any purpose.

(2) Notwithstanding any other provision of law to the contrary, registry information shall not be subject to subpoena or otherwise subject to disclosure, discovery, or compelled production in any civil, criminal, administrative, or other proceeding. Registry information shall not be deemed admissible as evidence in any civil, criminal, administrative, or other tribunal or court for any reason.

(3) The department shall maintain an accurate record of all persons who are provided registry information pursuant to subsection

g. of this section. The record shall include: the name of the person authorizing access; the name, title, address, and organizational affiliation of the requester; the date the registry information was provided to the requester; and the specific purpose for which the registry information is provided. Records of access maintained pursuant to this paragraph shall be open to public inspection during normal operating hours of the department.

(4) Nothing in this subsection shall be construed to prohibit the department from publishing reports and statistical compilations that do not in any way identify individual cases or individual sources of information included in the registry.

(5) An individual whose information is included in the registry shall have access to the individual’s own registry information.

j. Commencing 18 months after the effective date of this act, and annually thereafter, the department shall prepare and submit a report to the Governor and, pursuant to section 2 of P.L.1991, c.164 (C.52:14-19.1), to the Legislature, which shall provide information and statistics concerning: (1) the incidence and prevalence of Parkinson's disease and Parkinsonisms in the State, by county; (2) the overall number of cases of Parkinson’s disease and Parkinsonisms included in the registry and the number of new enrollments in the registry during the reporting period; and (3) demographic information for individuals enrolled in the registry, to the extent such demographic information is disclosed by individuals enrolled in the registry, which demographic information may include, but shall not be limited to, age, gender, race, and ethnicity.

k. The department shall create and maintain on its internet website a publicly-accessible webpage dedicated to the State Parkinson's disease registry, which shall include information related to the registry, a yearly program summary, copies of the annual reports prepared pursuant to subsection j. of this section, and any other relevant or helpful information related to the registry as the department, in consultation with the advisory council, deems necessary and appropriate.

3. a. The department shall establish a Parkinson’s disease registry advisory council, which advisory council shall assist in the development and administration of the registry, including determining what data is collected and maintained in the registry and generally advising the department concerning the implementation of this act.

b. Members of the advisory council shall be appointed by, and shall serve at the pleasure of, the commissioner. at a minimum, the membership of the advisory council shall include:

(1) a neurologist;

(2) a movement disorder specialist;

(3) a primary care provider;

(4) a physician informaticist;

(5) a patient living with Parkinson’s disease;

(6) a public health professional;

(7) a population health researcher familiar with registries;

(8) a Parkinson’s disease researcher; and

(9) any other members as the commissioner deems necessary.

c. Members of the advisory council shall serve without compensation but may be reimbursed for reasonable expenses incurred in the performance of their official duties, subject to the availability of funds made available to the advisory council for this purpose.

d. The commissioner shall appoint a chair and a vice-chair of the advisory council. The chair may appoint a secretary, who need not be a member of the advisory council.

e. The advisory council shall meet at least quarterly at such times and places as are determined by the chair. The advisory council shall additionally meet at the call of the commissioner or of the chair.

4. The Commissioner of Health may adopt rules and regulations, in accordance with the “Administrative Procedure Act,” P.L.1968, c.410 (C.52:14B-1 et seq.), if necessary to effectuate the provisions of this act.

5. This act shall take effect immediately.

STATEMENT

This bill requires the Department of Health (DOH) to establish a State Parkinson’s disease registry. Parkinson’s disease is a chronic and progressive neurologic disorder resulting from deficiency of the neurotransmitter dopamine as the consequence of specific degenerative changes in the area of the brain called the basal ganglia. Parkinson’s disease is characterized by tremor at rest, slow movements, muscle rigidity, stooped posture, and unsteady or shuffling gait. Parkinsonisms are related movement abnormalities and conditions that may overlap with or evolve from Parkinson’s disease.

Under this bill, the DOH is to oversee the creation and management of a Statewide Parkinson’s disease registry. The registry will collect data on the incidence of Parkinson's disease and Parkinsonisms within the State. Health care providers, including hospitals and other health care facilities and health care practitioners, such as physicians, physician assistants, and advanced practice nurses, that diagnose or treat people diagnosed with Parkinson's disease or Parkinsonisms will be required to report each unique case of Parkinson's disease or Parkinsonisms to the registry. The DOH will determine the specific mandatory and permissive data points to be collected in the registry.

Registry information will generally be deemed confidential, but may be made available to various entities, including other Parkinson’s disease registries, public health entities, and researchers, under certain circumstances. Patients will have the opportunity to opt out of inclusion in the registry, in which case only the incidence of a Parkinson’s diagnosis will be reported.

The DOH will be required to prepare an annual report concerning registry information and will be required to maintain a publicly- accessible webpage providing information about the registry and links to the DOH’s annual reports.

The DOH will additionally be required to establish a Parkinson’s disease registry advisory council to assist in the development of the registry, determine what data will be collected, and advise the DOH as to the implementation of the bill.

Public health agencies have long recognized that population-based data registries are required to estimate the incidence and prevalence of non-communicable chronic diseases. Registries have been developed throughout the world for the purpose of surveillance of these diseases to inform public health agencies and the public on the extent of the disease and to identify trends amidst population centers to support the development of public health interventions.

States that have adopted statewide Parkinson’s disease registries include California, Nebraska, Utah, and Washington. A population- based registry is necessary to generate the basic data that will help researchers, treatment providers, and legislators determine the causes of the disease, evaluate the efficacy of treatment, uncover inequities in Parkinson’s disease healthcare, and make decisions about the allocation of resources for prevention and treatment. It is the sponsor’s belief that a State Parkinson’s disease registry will enable the State to better understand the full, diverse, and heterogeneous nature of Parkinson’s disease among New Jerseyans and ensure that the regional nuances and trends are captured in effort to minimize over or underrepresentation.