HB2491 - 512R

Be it enacted by the Legislature of the State of Arizona:

Section 1. Section 36-694, Arizona Revised Statutes, is amended to read:

START_STATUTE36-694. Report of blood tests; newborn screening program; committee; fee; definitions

A. When a birth or stillbirth is reported, the attending physician or other person required to make a report of the birth shall state on the certificate whether a blood test for syphilis was made on a specimen of blood taken from the woman who bore the child or from the umbilical cord at delivery, as required by section 36‑693, and the approximate date when the specimen was taken.

B. When a birth is reported the attending physician or person who is required to make a report on the birth shall order or cause to be ordered tests for certain congenital disorders, including hearing disorders. The results of tests for these disorders must be reported to the department of health services. The department of health services shall specify in rule the disorders, the process for collecting and submitting specimens and the reporting requirements for test results.

C. When a hearing test is performed on a newborn, the initial hearing test results and any subsequent hearing test results must be reported to the department of health services as prescribed by department rules.

D. The director of the department of health services shall establish a newborn screening program within the department to ensure that the testing for congenital disorders and the reporting of hearing test results required by this section are conducted in an effective and efficient manner. The newborn screening program shall include an education program for the general public, the medical community, parents and professional groups. The director shall designate the state laboratory as the only testing facility for the program, except that the director may designate other laboratory testing facilities for conditions or tests added to the newborn screening program on or after the effective date of this amendment to this section. If the director designates another laboratory testing facility for any condition or test, the director shall require the facility to follow all of the privacy and sample destruction timeframes that are required of the state laboratory.

E. The newborn screening program shall establish and maintain a central database of newborns and infants who are tested for hearing loss and congenital disorders that includes information required in rule. Test results are confidential subject to the disclosure provisions of sections 12‑2801 and 12‑2802.

F. If tests conducted pursuant to this section indicate that a newborn or infant may have a hearing loss or a congenital disorder, the screening program shall provide follow-up services to encourage the child's family to access evaluation services, specialty care and early intervention services.

G. The director shall establish a committee to provide recommendations and advice to the department on at least an annual basis regarding tests that the committee believes should be included in the newborn screening program. Any recommendation by the committee that a test be added to the newborn screening program shall be accompanied by a cost-benefit analysis.

H. The committee shall include the following members who are appointed by the director and who serve without compensation or reimbursement of expenses at the pleasure of the director:

1. Seven physicians who are licensed pursuant to title 32, chapter 13 or 17 and who represent the medical specialties of endocrinology, pediatrics, neonatology, family practice, otology and obstetrics.

2. A neonatal nurse practitioner who is licensed and certified pursuant to title 32, chapter 15.

3. An audiologist who is licensed pursuant to chapter 17, article 4 of this title.

4. A representative of an agency that provides services under part C of the individuals with disabilities education act.

5. At least one parent of a child with a hearing loss or a congenital disorder.

6. A representative from the insurance industry familiar with health care reimbursement issues.

7. The director of the Arizona health care cost containment system administration or the director's designee.

8. A representative of the hospital or health care industry.

I. The director may establish by rule a fee that the department may collect for operation of the newborn screening program, including contracting for the testing pursuant to this section. The fee for the first specimen and hearing test shall not exceed thirty dollars.

J. For the purposes of this section:

1. "Infant" means a child who is twenty-nine days of age to two years of age.

2. "Newborn" means a child who is not more than twenty-eight days of age. END_STATUTE

Sec. 2. Department of health services; newborn screening program; rulemaking; exemption

A. On or before July 1, 2015, the department of health services shall adopt rules regarding the newborn screening program that require the physician or person who is required to make a report on the birth to order or cause to be ordered critical congenital heart defect screening using pulse oximetry on each newborn delivered before discharging the newborn and to report the results of the critical congenital heart defect screening to the department of health services as specified in rule.

B. The department of health services may adopt rules regarding adding severe combined immunodeficiency testing and krabbe disease testing to the newborn screening program established pursuant to section 36‑694, Arizona Revised Statutes, as amended by this act. The department shall perform and consider a cost benefit analysis and seek stakeholder input, including input from health care providers, in the development of these rules.

C. For the purposes of implementing this act, the department of health services is exempt from the rulemaking requirements of title 41, chapter 6, Arizona Revised Statutes, through July 1, 2015, except that the department shall provide public notice and an opportunity for public comment on proposed rules at least thirty days before a rule is adopted or amended.

Sec. 3. Department of health services; vaccine financing and availability advisory committee; report

A. The department of health services shall establish a vaccine financing and availability advisory committee to study the financing and availability of vaccines for newborns, children and adolescents.

B. The director of the department of health services shall serve as chairperson of the committee and shall appoint the following members:

1. Two members who are representatives of different health care insurers that are licensed pursuant to title 20, Arizona Revised Statutes, and that offer products in the commercial market that include coverage for newborn, childhood and adolescent vaccines.

2. Three health professionals who are licensed pursuant to title 32, Arizona Revised Statutes, whose current practice includes administering newborn or childhood and adolescent vaccines as follows:

(a) A physician who is licensed pursuant to title 32, chapter 13 or 17, Arizona Revised Statutes and who specializes in pediatrics.

(b) A physician who is licensed pursuant to title 32, chapter 13 or 17, Arizona Revised Statutes and who specializes in family medicine.

3. Two directors of local health departments one of whom shall be from a county having a population of at least three million persons.

4. One member who is a representative of an Arizona nonprofit statewide coalition whose mission is to foster a comprehensive, sustained community program for the immunization of residents of this state against vaccine-preventable diseases.

5. One member who is a representative of a vaccine manufacturer or a national association of vaccine manufacturers and who has experience in vaccine policy.

6. One member who is a representative of a statewide association of pharmacists.

7. One member who is a representative of an Arizona company that is not a health care insurer or a self-insured employer and that offers its employees a health insurance product in the commercial market that includes coverage for newborn, childhood and adolescent vaccines.

C. The directors of the Arizona health care cost containment system administration and the department of insurance, or their designees, shall serve as nonvoting members of the committee.

D. Committee members are not eligible to receive compensation or reimbursement of expenses.

E. The committee shall develop recommendations regarding the following and submit a written report of its findings on or before December 15, 2014, to the governor, the president of the senate and the speaker of the house of representatives and shall provide a copy of this report to the secretary of state:

1. The existing system of the financing, storage, distribution and availability of newborn, childhood and adolescent vaccine products and the potential impacts on the health care system, taxpayers and the community at large.

2. The costs associated with, and the adequacy of reimbursement levels for newborn, childhood and adolescent vaccines administered by private and public providers in all counties in this state.

3. The vaccine financing, storage, distribution and reimbursement models utilized in other states.

F. To the extent possible, the committee shall include and consider any estimated costs or cost savings to state and local governments associated with the committee's recommendations.

G. The committee may:

1. Request information, data and reports from any state agency, political subdivision or other persons or businesses involved in the public or private financing or administration of newborn, childhood or adolescent vaccines.

2. Hold hearings and take testimony from affected persons, including members of the public.

H. The committee shall maintain documents in a manner that preserves the confidentiality of confidential business information that may be disclosed to the committee during the course of its business.

I. This section is repealed from and after December 31, 2015.