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COMMITTEE ON HEALTH, HOSPITALS AND HUMAN SERVICES 03/20/2024-AMENDED AND REPORTED OUT TO THE FLOOR 03/19/2024-AMENDED AND REPORTED OUT TO THE COMMITTEE ON RULES AND JUDICIARY 02/07/2024-REPORTED OUT TO THE COMMITTEE ON BUDGET, APPROPRIATIONS AND FINANCE BILL NO. 35-0207 Thirty-Fifth Legislature of the Virgin Islands December 11, 2023 An Act amending title 19 Virgin Islands Code, part I adding chapter 6a to create the Territorial Chronic Kidney Disease, Stroke and Diabetes Registry PROPOSED BY: Senators Ray Fonseca and Dwayne M. DeGraff Co-sponsor: Marise C. James Be it enacted by the Legislature of the Virgin Islands: 1 SECTION 1. Title 19 Virgin Islands Code, part I is amended by adding a chapter 6a that 2 reads as follows: 3 “Chapter 6a. Territorial Chronic Kidney Disease, Stroke and Diabetes Registry 4 § 121. Definitions 5 As used in this chapter: 6 (a) “Health care facility” means hospitals; health care clinics; health centers; skilled 7 nursing facilities; mental health facilities; kidney disease treatment centers, including 8 freestanding hemodialysis units; intermediate care facilities; ambulatory surgical facilities; 9 rehabilitation facilities; health maintenance organizations; and hospice care facilities. 10 2 (b) “Health care provider” means a person, corporation, facility or institution licensed 1 in the Territory to provide health care or professional, medical services including a medical, 2 osteopathic, chiropractic or naturopathic physician; hospital; dentist; registered nurse, 3 including an advanced practice registered nurse; optometrist; podiatrist; physical therapist; 4 psychologist; pharmacist and laboratory technician. 5 (c) “Individually identifiable health information” means information that is a subset of 6 health information, including demographic information collected from an individual, and: 7 (1) is created or received by a health care provider, health plan, employer, or 8 health care clearinghouse; 9 (2) relates to the past, present, or future physical or mental health or condition 10 of an individual; the provision of health care to an individual; or the past, present or future 11 payment for the provision of health care to an individual; and 12 (3) identifies the individual: 13 (A) by such common identifiers as name, address, birth date, social 14 security number and other common identifies, or 15 (B) with respect to which there is a reasonable basis to believe the 16 information can be used to identify the individual. 17 (d) “Registry” means the Territorial Chronic Kidney Disease, Stroke and Diabetes 18 Registry. 19 (e) “Reporting entity” means a healthcare facility that provides services to individuals 20 who are diabetic and/or have chronic kidney disease and those receiving dialysis treatments. 21 (f) “Territory” means the Virgin Islands of the United States. 22 § 122. Establishment of the Territorial Chronic Kidney Disease, Stroke and Diabetes 23 Registry 24 3 (a) There is established within the Department of Health, the Territorial Chronic 1 Kidney Disease, Stroke and Diabetes Registry. The Registry serves as the territorial 2 surveillance system and repository of data regarding patients who have been diagnosed with 3 chronic kidney disease, patients who are receiving dialysis, patients diagnosed with a stroke 4 and patients diagnosed with diabetes in the Territory. 5 (b) The data concerning each case of diabetes is to be collected and used to conduct 6 epidemiological surveys of diabetes cases in this Territory. The data collected must include: 7 (1) an individual's date of diagnosis; 8 (2) age at time of diagnosis; 9 (3) the type of diabetes that was diagnosed; 10 (4) whether the individual has a known history of any type of diabetes in the 11 individual's family; 12 (5) the individual's height and weight, and 13 (6) the individual's sex, race, ethnicity, and residential address. 14 (c) The data concerning each person with chronic kidney disease is to be collected and 15 used to conduct epidemiological surveys of chronic kidney disease cases in this territory. The 16 data collected must include: 17 (1) the patient's height, weight, medical history, diet, and lifestyle; 18 (2) the patient's sex, race, ethnicity, and residential address; 19 (3) kidney disease stage (1-early, 2-mild, 3-moderate, 4-severe, 5-end stage), and 20 information about related comorbidities such as heart disease, hypertension, and diabetes; 21 (4) the total number of patients on dialysis, per each island, and whether the 22 patient is receiving hemodialysis or peritoneal dialysis; 23 (5) laboratory values for diagnostic tests, and medications; 24 4 (6) insurance coverage details of chronic kidney disease patients including 1 whether the patient is uninsured, or utilizing private insurance, Medicaid, or Medicare; 2 (7) kidney transplant patients being treated; 3 (8) kidney transplant candidates; and 4 (9) the location of healthcare facilities and healthcare providers that offer dialysis 5 services. 6 (d) The data concerning each diagnosis of a stroke must be collected and used to 7 conduct epidemiological surveys of stoke cases in the Virgin Islands. The data collected must 8 include: 9 (1) each individual’s date of diagnosis; 10 (2) age at the time of diagnosis; 11 (3) the type of stroke that was diagnosed; 12 (4) the individual’s family history regarding risk factors for stroke; 13 (5) the individual’s height and weight; 14 (6) the individual’s sex, race, ethnicity and residential addresses; and 15 (7) the individual’s health insurance/medical coverage or lack thereof. 16 (e) The Registry shall train and certify personnel designated by the reporting entities 17 as persons responsible for reporting information to the Registry. 18 (f) The Commissioner of Health shall promulgate administrative guidelines as may 19 be amended from time to time to ensure that the Registry performs its mandate. 20 § 123. Participation in the program 21 (a) Within 60 days of the enactment of this act, the Registry shall create a standardized 22 form for each healthcare provider and health care facility to use to submit all reportable data. 23 Each healthcare provider and health care facility shall report in an electronic format, or any 24 5 other format requested by the Registry each new case of diabetes, stroke and chronic kidney 1 disease to the Registry not later than 180 days after the date of diagnosis or date of first contact 2 with the already diagnosed patient. 3 § 124. Confidentiality 4 (a) All chronic kidney disease, stroke and diabetes data provided to the Registry must 5 be kept confidential. No information reported to the Registry which identifies or could lead to 6 the identification of an individual patient may be disclosed to any person or entity; except that 7 the identifying information may be disclosed to another state chronic kidney disease, stroke 8 and diabetes registry and territorial health officers. 9 (b) State chronic kidney disease, stroke and diabetes registries, chronic kidney 10 disease, stroke and diabetes researchers or federal chronic kidney disease, stroke and diabetes 11 control agencies that receive chronic kidney disease, stroke and diabetes case data from the 12 Registry shall enter into an agreement with the Registry to keep the information confidential. 13 (c) All Registry employees and researchers shall sign a confidentiality agreement. 14 These agreements remain effective after the employee or researcher no longer has a relationship 15 with the Registry and will expire after two years. 16 § 125. Disclosure 17 (a) Chronic kidney disease, stroke and diabetes case data may be shared with chronic 18 kidney disease, stroke and diabetes researchers or Federal chronic kidney disease, stroke and 19 diabetes control agencies for the purposes of chronic kidney disease, stroke and diabetes 20 prevention, control, and research upon the submittal of documentation to the Registry providing 21 that research in chronic kidney disease, stroke and diabetes prevention or control is ongoing or 22 approval for such research has been granted. If applicable, the Registry shall also request 23 6 evidence of compliance with the requirements of 45 CFR Part 46: Protection of Human 1 Subjects. 2 (b) The Registry may share statistical compilations of the chronic kidney disease, 3 stroke and diabetes case data with state chronic kidney disease, stroke and diabetes registries 4 and Federal chronic kidney disease, stroke and diabetes control agencies for the following 5 reasons: 6 (1) to perform studies on the sources and causes of chronic kidney disease, 7 stroke and diabetes; 8 (2) to track the changing patterns of chronic kidney disease, stroke and diabetes 9 incidences; 10 (3) to provide patient education and support, individualized to patients’ stage of 11 disease and related health conditions; 12 (4) to create a robust database of patient outcomes, perceptions, priorities and 13 activities that will facilitate research, clinical care and policy decisions to improve 14 patients’ experience and outcomes; and 15 (5) for any other clinical, epidemiological, or other chronic kidney disease, stroke 16 and diabetes research. 17 § 126. Liability 18 (a) No person, who in good faith, discloses privileged or confidential information or 19 provides chronic kidney disease, stroke and diabetes case reports to the Registry or allows the 20 Registry access to a chronic kidney disease, stroke and diabetes case report is liable in any civil 21 action. 22 7 (b) The license of a health care provider or a health care facility may not be 1 suspended or revoked for the disclosure of information provided to the Registry pursuant to 2 this chapter. 3 (c) The protection from liability provided in subsection (a) and (b) does not apply to 4 the unauthorized disclosure of confidential or privileged information when the disclosure is due 5 to gross negligence or willful misconduct. 6 § 127. Penalties 7 Any person who violates a reporting provision of this chapter or regulations or orders 8 pertaining to the reporting of information to the Registry is subject to a civil fine of not less 9 than $1,000 per case but not more than $5,000 per case. Before assessing the fine, the 10 Commissioner of Health, or the Commissioner’s designee, shall conduct a hearing with the 11 person or entity to ascertain the reason for noncompliance and determine if an adjustment in 12 the fine is warranted. Funds collected pursuant to this subsection must be deposited in an 13 account established by the Department of Health within the Department of Finance. The 14 monies in this account must be used exclusively to assist in the funding of the chronic kidney 15 disease, stroke and diabetes Registry as prescribed by law. 16 § 128. Annual Report 17 The Registry shall publish an annual statistical compilation that does not include 18 identifying information showing the incidence of chronic kidney disease, stroke and diabetes 19 in the Territory.” 20 SECTION 2. The sum of $50,000 is appropriated in the fiscal year ending September 21 30, 2024, from the General Fund of the Government of the Virgin Islands to the Department of 22 Health to create the Chronic Kidney Disease, Stroke and Diabetes Registry and is available 23 until December 30, 2024. In the fiscal years ending September 30, 2025, 2026, 2027, and 2028, 24 8 the sum of $75,000 is appropriated from the General Fund of the Treasury of the Government 1 of the Virgin Islands to the Department of Health for the completion of the Chronic Kidney 2 Disease, Stroke and Diabetes Registry. 3 BILL SUMMARY 4 Section 1 creates title 19, chapter 6a. The new chapter is divided into eight sections. 5 Section 121 defines the terms used in the chapter; section 122 establishes the Registry; section 6 123 describes how and what entities must participate; section 124 discusses confidentiality; 7 section 125 addresses what disclosures are allowed; section 126 addresses liability; section 127 8 sets out penalties for violations of the mandates; and section 128 sets out the annual reporting 9 requirements. Section 2 appropriates funds to create the Registry. 10 BR23-0762/November 6, 2023/HLF 11 ..\..\..\..\AMENDS\35th Legislature\FONSECA, RAY\Amendment 35-730\35-730- 12 DRAFTED ON YELLOW.docx 13 ..\..\..\..\AMENDS\35th Legislature\FRANCIS, JR., NOVELLE E\Amendment 35- 14 665\35-665 - DRAFTED ON YELLOW.docx 15