NOTE: This bill has been prepared for the signature of the appropriate legislative officers and the Governor. To determine whether the Governor has signed the bill or taken other action on it, please consult the legislative status sheet, the legislative history, or the Session Laws. HOUSE BILL 07-1347 BY REPRESENTATIVE(S) Kerr A., Frangas, Gibbs, McGihon, Pommer, Casso, Gagliardi, Green, Labuda, Levy, Madden, Marshall, Merrifield, Roberts, Romanoff, and Todd; also SENATOR(S) Shaffer, Gordon, Morse, Sandoval, Tochtrop, Tapia, and Windels. Concerning the immunization tracking system in Colorado, and, in connection therewith, authorizing the department of public health and environment to address issues related to access to the existing immunization registry. Be it enacted by the General Assembly of the State of Colorado: SECTION 1. 25-2-122 (2) (c) (I), Colorado Revised Statutes, is amended to read: 25-2-122. Heirloom birth and marriage certificates - funds created - report - rules - definitions. (2) (c) The fee established pursuant to paragraph (a) of this subsection (2) shall be sufficient to cover the direct and indirect costs of producing and issuing the heirloom birth certificate, plus an additional ten dollars. The state registrar shall transmit moneys generated pursuant to this subsection (2), along with an explanation of the number of heirloom birth certificate sales that correspond to such moneys, to the state treasurer, who shall credit: (I) For each sale of an heirloom birth certificate, ten dollars to the infant immunization fund created in section 25-4-1708; and SECTION 2. 25-4-1004 (1) (b), Colorado Revised Statutes, is amended to read: 25-4-1004. Newborn screening. (1) (b) On or after April 1, 1989, all infants born in the state of Colorado shall be tested for the following conditions: Phenylketonuria, hypothyroidism, abnormal hemoglobins, galactosemia, cystic fibrosis, biotinidase deficiency, and such other conditions as the board of health may determine meet the criteria set forth in paragraph (c) of this subsection (1). Appropriate specimens for such testing shall be forwarded by the hospital in which the child is born to the laboratory operated or designated by the department of public health and environment for such purposes. The physician, nurse, midwife, or other health professional attending a birth outside a hospital shall be responsible for the collection and forwarding of such specimens. The results of the testing shall be forwarded directly to the physician or other primary health care provider for the provision of such information to the parent or parents of the child. The results of any testing or follow-up testing pursuant to section 25-4-1004.5 may be sent to the immunization tracking system authorized by section 25-4-2403 and accessed by the physician or other primary health care provider. The state board of health may discontinue testing for any condition listed in this paragraph (b) if, upon consideration of criteria set forth in paragraph (c) of this subsection (1), the board finds that the public health is better served by not testing infants for that condition. The department of public health and environment shall submit a report to the house and senate health, environment, welfare, and institutions committees on or before January 15, 1993, concerning the newborn screening program. Such report shall include the history of the newborn screening program and criteria used for the addition or deletion of tests utilized under this section. SECTION 3. 25-4-1705 (5) (e), (8), and (10), Colorado Revised Statutes, are amended to read: 25-4-1705. Department of public health and environment - powers and duties - rules. (5) The board of health, in consultation with the medical services board in the state department of health care policy and financing, and such other persons, agencies, or organizations that the board of health deems advisable, shall formulate, adopt, and promulgate rules governing the implementation and operation of the infant immunization program. Such rules shall address the following: (e) (I) The gathering of epidemiological information, including the establishment of a comprehensive immunization tracking system. Immunization information may be gathered for such tracking system by state and local health departments from the following sources: (A) Physicians and licensed health care practitioners; (B) Clinics; (C) Schools; (D) A parent of an infant, as defined in section 25-4-1703 (3); (E) A child or student, as defined in section 25-4-901 (1.5) and (3); (F) Managed care organizations or health insurers in which a child or student, as defined in section 25-4-901 (1.5) and (3), or an infant is enrolled as a member or insured, if such managed care organization or health insurer reimburses or otherwise financially provides coverage for immunizations; (G) Hospitals; or (H) Persons and entities that have contracted with the state pursuant to section 25-4-1705 (7). (II) Records in the immunization tracking system established pursuant to subparagraph (I) of this paragraph (e) shall be strictly confidential and shall not be released, shared with any agency or institution, or made public upon subpoena, search warrant, discovery proceedings, or otherwise, except under the following circumstances: (A) Release may be made of medical and epidemiological information in a manner such that no individual person can be identified. (B) Release may be made of immunization records and epidemiological information to the extent necessary for the treatment, control, investigation, and prevention of vaccine preventable diseases; except that every effort shall be made to limit disclosure of personal identifying information to the minimal amount necessary to accomplish the public health purpose. (C) Release may be made of immunization records and epidemiological information to the parent of an infant, the physician treating the person who is the subject of an immunization record, a school in which such person is enrolled, or any entity or person described in sub-subparagraph (E), (F), (G), or (H) of subparagraph (I) of this paragraph (e). (D) No officer or employee or agent of the state department of public health and environment or local department of health shall be examined in any judicial, executive, legislative, or other proceeding as to the existence or content of any infant's report obtained by such department without consent of the infant's parent or guardian. However, this provision shall not apply to infants who are under isolation, quarantine, or other restrictive action taken pursuant to section 25-1.5-102 (1) (c). (E) The department may release records of medicaid-eligible infants, children, and students to the department of health care policy and financing for the purposes of the medicaid program. (III) (A) Any officer, employee, agent of the department, or any other person who violates this section by releasing or making public confidential immunization records or epidemiological information in the immunization tracking system or by otherwise breaching the confidentiality requirements of subparagraph (II) of this paragraph (e) or releasing such information without authorization commits a class 1 misdemeanor and, upon conviction thereof, shall be punished as provided in section 18-1.3-501 (1), C.R.S. The unauthorized release of each record shall constitute a separate offense pursuant to this subparagraph (III). (B) Any natural person who in exchange for money or any other thing of value violates this section by wrongfully releasing or making public confidential immunization records or epidemiological information in the immunization tracking system or by otherwise breaching the confidentiality requirements of subparagraph (II) of this paragraph (e) or releasing such information without authorization commits a class 1 misdemeanor and, upon conviction thereof, shall be punished as provided in section 18-1.3-501 (1), C.R.S. (C) Any business entity who, in exchange for money or any other thing of value, violates this section by wrongfully releasing or making public confidential immunization records or epidemiological information in the immunization tracking system or by otherwise breaching the confidentiality requirements of subparagraph (II) of this paragraph (e) or releasing such information without authorization shall be assessed a civil penalty of ten thousand dollars per sale of information per subject of such information. (IV) (A) The department or the department's contractor may directly contact the parent or legal guardian for the purpose of notifying the parent or legal guardian if immunizations are due or overdue as indicated by the advisory committee on immunization practices of the United States department of health and human services or the American academy of pediatrics. The department or the department's contractor shall contact the parent or legal guardian if it is necessary to control an outbreak of or prevent the spread of a vaccine-preventable disease pursuant to section 25-1.5-102 (1) (a) or 25-4-908. (B) Any notice given pursuant to sub-subparagraph (A) of this subparagraph (IV) shall also inform the parent or legal guardian of the option to refuse an immunization on the grounds of medical, religious, or personal belief considerations pursuant to section 25-4-903, C.R.S. (C) On or before February 1, 2010, the health and human services committees of the senate and the house of representatives shall review the state's implementation of notification provisions by specified entities in relation to the implementation of the immunization tracking system pursuant to the modifications contained in Senate Bill 05-087 to determine if the utilization of the immunization tracking system has had a substantial impact on the state's immunization ranking. (V) A parent or legal guardian who consents to the immunization of an infant, child, or student pursuant to this part 17 or part 9 of this article shall have the option to exclude such information from the immunization tracking system. The parent or legal guardian shall have the option to remove such information from the immunization tracking system at any time. The physician, licensed health care practitioner, clinic, or local health department shall inform the parent or legal guardian of the option to exclude such personal information from such system and the potential benefits of inclusion in such system. In addition, the physician, licensed health care practitioner, clinic, or local health department shall inform such parent or legal guardian of the option to refuse an immunization on the grounds of medical, religious, or personal belief considerations pursuant to section 25-4-903. Neither refusing an immunization on the grounds of medical, religious, or personal belief considerations pursuant to section 25-4-903 nor opting to exclude immunization notification information from the immunization tracking system shall, by itself, constitute child abuse or neglect by a parent or legal guardian. (VI) A person licensed to practice medicine pursuant to article 36 of title 12, C.R.S., a person licensed to practice nursing pursuant to article 38 of title 12, C.R.S., providers of county nursing services, staff members of health care clinics, hospitals, and offices of private practitioners, county, district, and regional health departments, and all persons and entities listed in subparagraph (I) of this paragraph (e) are authorized to report to the immunization tracking system and to use the reminder and recall process established by the immunization tracking system. (8) Local health departments and the department shall use the birth certificate of any infant to enroll such infant in an immunization tracking system established in section 25-4-2403. Such use of the infant's birth certificate shall be considered an official duty of local health departments and the department. (10) Physicians, licensed health care practitioners, clinics, schools, licensed child care providers, hospitals, managed care organizations or health insurers in which a student, as defined in section 25-4-901 (3), or an infant is enrolled as a member or insured, persons that have contracted with the department pursuant to subsection (7) of this section, and public health officials may release any immunization records in their possession, whether or not such records are in the immunization tracking system established in section 25-4-2403, to the persons or entities specified in sub-subparagraphs (A) to (H) of subparagraph (I) of paragraph (e) of subsection (5) of this section section 25-4-2403 (1) to provide an accurate and complete immunization record for the child in order to verify compliance with state immunization law. SECTION 4. 25-4-1707, Colorado Revised Statutes, is amended to read: 25-4-1707. Moneys targeted for medical assistance for infants - reimbursement. The state department of health care policy and financing shall reimburse the department of public health and environment for the costs of vaccinating infants under the infant immunization program who are medicaid eligible pursuant to the "Colorado Medical Assistance Act", articles 4, 5, and 6 of title 25.5, C.R.S. Such moneys received from the state department of health care policy and financing shall be credited to the infant immunization fund. SECTION 5. 25-4-1708, Colorado Revised Statutes, is amended to read: 25-4-1708. Fund created. (1) There is hereby established in the state treasury a fund to be known as the infant immunization fund, which fund shall be subject to annual appropriation to the department of public health and environment by the general assembly for the purposes of purchasing vaccines, assisting users of the immunization tracking system established in section 25-4-2403 to connect to the system, utilizing the reminder and recall process of the immunization tracking system, and implementing, developing, and operating the infant immunization program programs. The fund shall be credited with such appropriations as the general assembly may make from the general fund for the infant immunization program, programs, any gifts, grants, or awards received pursuant to section sections 25-4-1705 (6) and 25-4-2403, and moneys received from the state department of health care policy and financing as reimbursement pursuant to section 25-4-1707. All income from the investment of moneys in the fund shall be credited to the fund. (2) If federal funds are not received to implement and operate the infant immunization program programs created in this part 17 and part 24 of this article, no additional general fund moneys shall be appropriated for such purposes. (3) All moneys credited to the infant immunization fund which that are not expended during the fiscal year shall be retained in the fund for its future use and shall not be credited or transferred to the general fund or any other fund. (4) Notwithstanding any provision of this section to the contrary, on July 1, 2003, the state treasurer shall deduct two hundred forty thousand dollars from the infant immunization fund and transfer such sum to the general fund. SECTION 6. Article 4 of title 25, Colorado Revised Statutes, is amended BY THE ADDITION OF A NEW PART to read: PART 24 IMMUNIZATION REGISTRY ACT 25-4-2401. Short title. This part 24 shall be known and may be cited as the "Immunization Registry Act". 25-4-2402. Legislative declaration. (1) The general assembly hereby finds and declares that: (a) Immunization is one of the most important ways to protect individuals and communities against serious infectious diseases and their consequences, and widespread immunization has virtually eliminated many serious diseases that were once responsible for millions of infections and thousands of deaths each year. (b) Although immunization rates of infants, children, adolescents, and adults in Colorado have improved over the last several years, there is a need to continue to improve the rates so that fewer individuals are put at risk from vaccine-preventable diseases. (c) Timely vaccination of children, adolescents, and adults not only protects them against common, sometimes serious, and potentially fatal diseases, but also serves the community as one of the most successful and cost-effective public health tools available for the prevention and spread of these infections, and the vaccines are safe and highly protective, particularly when administered according to recommended schedules. (d) More than twenty percent of preschool-aged children in Colorado are not fully vaccinated and are at increased risk of contracting and spreading vaccine-preventable diseases. (e) It is unnecessary for children, adolescents, and adults to be subjected to suffering or death from diseases that are immunization preventable. (f) In 2005, hospital charges for the care of children with vaccine-preventable diseases exceeded twenty-five million dollars. Additionally, tens of millions of dollars were spent on the costs of the outpatient care of affected children, in addition to the costs of the loss of productivity and absences from work for caregivers due to the absences of children from school. (g) Over the past three decades, the recommended vaccination schedules for children and adults have become increasingly more complex as vaccines have been combined, new vaccines have been added, and the delivery system has incorporated more manufacturers, distributors, and providers. Additionally, local and national vaccine shortages and distribution errors have resulted in compromised vaccination initiatives. (h) For Colorado to be consistent with the healthy people 2010 initiative and reach the goal of immunizing ninety percent of all children in the state in a timely and expeditious manner, the Colorado immunization information system must be funded and sustained. The Colorado immunization information system may also provide a secure method for authorized individuals and entities to access information collected by public agencies. (2) Therefore, the general assembly supports the expansion of the Colorado immunization registry and supports increased access to immunizations for persons in Colorado. 25-4-2403. Department of public health and environment - powers and duties - immunization tracking system. (1) In order to expand the immunization registry and increase access to immunizations, the department of public health and environment may address: (a) Mechanisms for maximizing federal funds to purchase, distribute, and deliver vaccines for individuals in Colorado, including, but not limited to, participation in a state purchasing and distribution cooperative and the mechanisms for statewide purchase, distribution, and prioritization to include, but not be limited to, the seasonal influenza vaccine; (b) Methods to reduce the administrative burden of providing immunizations to individuals in Colorado by reviewing current immunization activities and strategies and epidemiological data related to vaccine-preventable diseases and identifying opportunities to implement best practices for immunizations throughout Colorado using innovative strategies that are population-specific, culturally sensitive, and inclusive; address safety issues; and enhance current services; (c) Options for Colorado to more effectively purchase, distribute, and deliver vaccines to underinsured and uninsured individuals; (d) The pursuit of private and public partnerships for funding for the immunization registry infrastructure; (e) Options for the most effective and cost-effective use of funds that may be available to the department of public health and environment to address vaccine delivery in the state; and (f) Methods for implementing the findings addressed in paragraphs (a) to (d) of this subsection (1). (2) To enable the gathering of epidemiological information and investigation and control of communicable diseases, the department of public health and environment may establish a comprehensive immunization tracking system with immunization information gathered by state and local health officials from the following sources: (a) Practitioners; (b) Clinics; (c) Schools; (d) Parents, legal guardians, or persons authorized to consent to immunization pursuant to section 25-4-1704; (e) Individuals; (f) Managed care organizations or health insurance plans in which an individual is enrolled as a member or insured, if such managed care organization or health insurer reimburses or otherwise financially provides coverage for immunizations; (g) Hospitals; (h) The department of health care policy and financing with respect to individuals who are eligible for coverage under the "Colorado Medical Assistance Act", articles 4, 5, and 6 of title 25.5, C.R.S.; and (i) Persons and entities that have contracted with the state pursuant to paragraph (d) of subsection (9) of this section. (3) Records in the immunization tracking system shall be strictly confidential and shall not be released, shared with any agency or institution, or made public upon subpoena, search warrant, discovery proceedings, or otherwise, except under the following circumstances: (a) Medical and epidemiological information may be released in a manner such that no individual person can be identified. (b) Immunization records and epidemiological information may be released to the extent necessary for the treatment, control, investigation, and prevention of vaccine-preventable diseases; except that every effort shall be made to limit disclosure of personal identifying information to the minimum amount necessary to accomplish the public health purpose. (c) Immunization records and epidemiological information may be released to the individual who is the subject of the record, to a parent of a minor individual, to a guardian or person authorized to consent to immunization under section 25-4-1704, to the physician, clinic, hospital, or licensed health care practitioner treating the person who is the subject of an immunization record, to a school in which such person is enrolled, or any entity or person described in paragraph (f), (h), or (i) of subsection (2) of this section. (4) An officer, employee, or agent of the department of public health and environment or a local department of health shall not be examined in any judicial, executive, legislative, or other proceeding as to the existence or content of any individual's report obtained by such department without consent of the individual or the individual's parent or guardian. However, this subsection (4) shall not apply to individuals who are under isolation, quarantine, or other restrictive action taken pursuant to section 25-1.5-102 (1) (c). (5) (a) An officer, employee, or agent of the department of public health and environment or any other person who violates this section by releasing or making public confidential immunization records or epidemiological information in the immunization tracking system or by otherwise breaching the confidentiality requirements of this section or releasing such information without authorization commits a class 1 misdemeanor and, upon conviction thereof, shall be punished as provided in section 18-1.3-501 (1), C.R.S. The unauthorized release of each record shall constitute a separate offense. (b) A natural person who, in exchange for money or any other thing of value, violates this section by wrongfully releasing or making public confidential immunization records or epidemiological information in the immunization tracking system or by otherwise breaching the confidentiality requirements of this section or releasing such information without authorization commits a class 1 misdemeanor and, upon conviction thereof, shall be punished as provided in section 18-1.3-501 (1), C.R.S. (c) A business entity who, in exchange for money or any other thing of value, violates this section by wrongfully releasing or making public confidential immunization records or epidemiological information in the immunization tracking system or by otherwise breaching the confidentiality requirements of this section or releasing such information without authorization shall be assessed a civil penalty of ten thousand dollars per sale of information per subject of such information. (6) (a) The department of public health and environment or the department's contractor may directly contact the individual who is the subject of immunization records or the individual's parent or legal guardian for the purpose of notifying the individual, parent, or legal guardian if immunizations are due or overdue as indicated by the advisory committee on immunization practices of the United States department of health and human services or the American academy of pediatrics. The department or the department's contractor shall contact the individual, parent, or legal guardian if it is necessary to control an outbreak of or prevent the spread of a vaccine-preventable disease pursuant to section 25-1.5-102 (1) (a) or 25-4-908. (b) A notice given to an individual or a parent or legal guardian of an individual under eighteen years of age pursuant to this subsection (6) shall also inform the individual, parent, or legal guardian of the option to refuse an immunization on the grounds of medical, religious, or personal belief considerations pursuant to section 25-4-903. (7) An individual or a parent or legal guardian who consents to the immunization of an infant, child, or student pursuant to part 9 or 17 of this article or this part 24 may exclude immunization information from the immunization tracking system. The individual, parent, or legal guardian may remove such immunization information from the immunization tracking system at any time. The department of public health and environment shall ensure that the process to exclude immunization information from the system is readily available and not burdensome. The physician, licensed health care practitioner, clinic, hospital, or local health department shall inform the individual, parent, or legal guardian of the option to exclude such information from such system and the potential benefits of inclusion in such system. In addition, the physician, licensed health care practitioner, clinic, hospital, or local health department shall inform such parent or legal guardian of a minor individual of the option to refuse an immunization on the grounds of medical, religious, or personal belief considerations pursuant to section 25-4-903. Neither refusing an immunization on the grounds of medical, religious, or personal belief considerations pursuant to section 25-4-903 nor opting to exclude immunization notification information from the immunization tracking system shall, by itself, constitute child abuse or neglect by a parent or legal guardian. (8) A person licensed to practice medicine pursuant to article 36 of title 12, C.R.S.; a person licensed to practice nursing pursuant to article 38 of title 12, C.R.S.; any other licensed health care practitioner as defined in section 25-4-1703; providers of county nursing services; staff members of health care clinics, hospitals, and offices of private practitioners; county, district, and regional health departments; and all persons and entities listed in subsection (2) of this section are authorized to report to the immunization tracking system and to use the reminder and recall process established by the immunization tracking system. (9) The department of public health and environment may: (a) Issue immunization records to individuals, parents, or guardians authorized to consent to immunizations; (b) Assess the vaccination status of individuals; (c) Accept any gifts or grants or awards of funds from the federal government or private sources for the implementation and operation of the immunization tracking system, which shall be credited to the immunization fund created in section 25-4-1708; and (d) Enter into contracts that are necessary for the implementation and operation of the immunization tracking system. A person who enters into a contract pursuant to this paragraph (d) shall only use the information gathered from the immunization tracking system in accordance with this part 24 and shall be subject to all applicable state and federal laws regarding the confidentiality of information. (10) Local health departments and the department of public health and environment shall use the birth certificate of any person to enroll the person in an immunization tracking system. The use of the birth certificate shall be considered an official duty of local health departments and the department of public health and environment. (11) Physicians, licensed health care practitioners, clinics, schools, licensed child care providers, hospitals, managed care organizations or health insurance plans in which an individual is enrolled as a member or insured, persons that have contracted with the department of public health and environment pursuant to paragraph (d) of subsection (9) of this section, and public health officials may release any immunization records in their possession, whether or not such records are in the immunization tracking system, to the persons or entities specified in subsection (2) of this section to provide treatment for such individual or to provide an accurate and complete immunization record for the individual. (12) The department of public health and environment shall disseminate information about the immunization tracking system, including providing notification pursuant to subsection (7) of this section to birthing hospitals. The hospitals shall provide the notices to the parents of newborns. SECTION 7. 25-4-901 (1) (b), Colorado Revised Statutes, is amended to read: 25-4-901. Definitions. As used in this part 9, unless the context otherwise requires: (1) "Certificate of immunization" means one of the following forms of documentation that include the dates and types of immunizations administered to a student: (b) An electronic file or a hard copy of an electronic file provided to the school directly from the immunization tracking system, established pursuant to section 25-4-1705 (5) (e) 25-4-2403. SECTION 8. 25-4-906 (1), Colorado Revised Statutes, is amended to read: 25-4-906. Certificate of immunization - forms. (1) The department of public health and environment shall provide official certificates of immunization to the schools, private physicians, and local health departments. Upon the commencement of the gathering of epidemiological information pursuant to section 25-4-1705 (5) 25-4-2403 to implement the immunization tracking system, such form shall include a notice that informs a parent or legal guardian that he or she has the option to exclude his or her infant's, child's, or student's immunization information from the immunization tracking system created in section 25-4-1705 (5) 25-4-2403. Any immunization record provided by a licensed physician, registered nurse, or public health official may be accepted by the school official as certification of immunization if the information is transferred to the official certificate of immunization and verified by the school official. SECTION 9. 26-2-111.1, Colorado Revised Statutes, is amended to read: 26-2-111.1. Eligibility for assistance - immunization of children. As a condition of eligibility for public assistance in the form of a successor program to aid to families with dependent children funded by federal block grant moneys under the federal "Personal Responsibility and Work Opportunity Reconciliation Act of 1996", Public Law Pub. L. 104-193, a participant shall provide verification or written confirmation by a physician or nurse or pursuant to records in the immunization tracking system as set forth in section 25-4-1705 (5) (e) 25-4-2403, C.R.S., that each child in the household is being brought up-to-date with immunizations and that, no later than the first scheduled redetermination of eligibility, each child in the household has received any immunization for which the child is eligible according to the age of the child, unless exempted from this condition of eligibility based upon religious or medical reasons pursuant to rules of the state board. SECTION 10. Safety clause. The general assembly hereby finds, determines, and declares that this act is necessary for the immediate preservation of the public peace, health, and safety. ________________________________________________________ Andrew Romanoff Joan Fitz-Gerald SPEAKER OF THE HOUSE PRESIDENT OF OF REPRESENTATIVES THE SENATE ____________________________ ____________________________ Marilyn Eddins Karen Goldman CHIEF CLERK OF THE HOUSE SECRETARY OF OF REPRESENTATIVES THE SENATE APPROVED________________________________________ _________________________________________ Bill Ritter, Jr. GOVERNOR OF THE STATE OF COLORADO