ARC 6432C

ARC 6432C

PUBLIC HEALTH DEPARTMENT[641]

Notice of Intended Action

Proposing rule making related to the center for congenital and inherited disorders

and providing an opportunity for public comment

The Public Health Department hereby proposes to amend Chapter 4, "Center for Congenital and Inherited Disorders," Iowa Administrative Code.

Legal Authority for Rule Making

This rule making is proposed under the authority provided in Iowa Code section 136A.8 and 2022 Iowa Acts, Senate File 2345.

State or Federal Law Implemented

This rule making implements, in whole or in part, Iowa Code chapter 136A and 2022 Iowa Acts, Senate File 2345.

Purpose and Summary

The proposed amendments will accomplish the following:

●Add definitions of "Iowa newborn screening panel," "Iowa newborn screening program," and "federal recommended uniform screening panel" (pursuant to 2022 Iowa Acts, Senate File 2345).

●Rescind language requiring State Board of Health approval to add disorders to or remove disorders from the newborn screening panel.

●Provide a fax number for the submission of refusal forms.

●Remove language establishing the newborn screening fee and describe the authority given to the State Hygienic Laboratory (SHL) to establish the newborn screening fee, pursuant to Senate File 2345.

●Describe the authority given through Senate File 2345 to the Congenital and Inherited Disorders Advisory Committee (CIDAC) to review newborn screening conditions on the federal recommended uniform screening panel (U.S. Department of Health and Human Services Recommended Uniform Screening Panel (RUSP)) to determine whether to add them to Iowa's newborn screening panel.

●Establish timelines for CIDAC's review and consideration of RUSP conditions (within 12 months of the addition of the condition to the RUSP) and for the Department to add the condition(s) to the state newborn screening panel (within 18 months of CIDAC's recommendation).

●Add a description of CIDAC membership pursuant to Senate File 2345.

Fiscal Impact

This rule making may have a fiscal impact to the State of Iowa. There will be additional expenses for laboratory equipment and infrastructure to support the testing, including test supplies, education materials, and training provided to expecting parents and providers. 2022 Iowa Acts, Senate File 2345, gives authority to the SHL to establish a newborn screening fee schedule in a manner sufficient to support the newborn screening system of care.

The costs of the additional jobs, equipment, supplies, trainings, and educational materials are dependent on the type of disorders added to the newborn screening panel; each disorder comes with specific testing methodology and expertise requirements, so costs are unknown until such time as the capacity of the current system and the administration, laboratory, clinical, and follow-up needs for expansion of the panel for the specific disorder(s) can be assessed.

Jobs Impact

The addition of disorders to the newborn screening panel as required by 2022 Iowa Acts, Senate File 2345, may create additional jobs for those with expertise in the disorder(s) added, such as laboratory scientists, bioinformaticians, medical geneticists, genetic counselors, and follow-up nurses.

Waivers

Any person who believes that the application of the discretionary provisions of this rule making would result in hardship or injustice to that person may petition the Department for a waiver of the discretionary provisions, if any, pursuant to the Department's waiver provisions contained in 641—Chapter 178.

Public Comment

Any interested person may submit written comments concerning this proposed rule making. Written comments in response to this rule making must be received by the Department no later than 4:30 p.m. on August 16, 2022. Comments should be directed to:

Public Hearing

No public hearing is scheduled at this time. As provided in Iowa Code section 17A.4(1)"b," an oral presentation regarding this rule making may be demanded by 25 interested persons, a governmental subdivision, the Administrative Rules Review Committee, an agency, or an association having 25 or more members.

Review by Administrative Rules Review Committee

The Administrative Rules Review Committee, a bipartisan legislative committee which oversees rule making by executive branch agencies, may, on its own motion or on written request by any individual or group, review this rule making at its regular monthly meeting or at a special meeting. The Committee's meetings are open to the public, and interested persons may be heard as provided in Iowa Code section 17A.8(6).

The following rule-making actions are proposed:

Item 1. Amend subrule 4.1(1) as follows:

4.1(1) Advisory committee. The center for congenital and inherited disorders advisory committee represents the interests of the people of Iowa and assists in the development of programs that ensure the availability of and access to quality genetic and genomic health care services by all residents. The advisory committee advises the director of the department of public health regarding issues related to genetics and hereditary and congenital disorders and makes recommendations about the design and implementation of the center's programs.

Item 2. Adopt the following new definitions of "Federal recommended uniform screening panel," "Iowa newborn screening panel" and "Iowa newborn screening program" in rule 641—4.2(136A):

"Federal recommended uniform screening panel" means the list of disorders for which the U.S. Department of Health and Human Services recommends states screen as part of their state newborn screening panels.

"Iowa newborn screening panel" or "newborn screening panel" means the list of disorders for which the department screens Iowa newborns.

"Iowa newborn screening program" or "INSP" means a program that provides screening of live-born Iowa newborns for the disorders listed on the Iowa newborn screening panel.

Item 3. Amend rule 641—4.2(136A), definitions of "Committee" and "Specialty genetics provider," as follows:

"Committee Advisory committee" means the congenital and inherited disorders advisory committee (CIDAC).

"Specialty genetics provider" means a medical geneticist, genetic nurse, or genetic counselor.

Item 4. Amend paragraphs 4.3(1)"a" and "b" as follows:

a. All newborns and infants born in the state of Iowa shall be screened for all congenital and inherited disorders on the Iowa newborn screening panel as specified by the center and approved by the state board of health.

b. As new disorders are recognized and new technologies and tests become available, the center shall follow protocols developed by the department in regard to the addition of disorders to or the deletion of disorders from the screening panel. The state board of health shall provide final approval for the addition of disorders to or the deletion of disorders from the screening panel.

Item 5. Amend paragraph 4.3(2)"b" as follows:

b. Refusal of screening. Should a parent or guardian refuse the screening, said refusal shall be documented in the infant's medical record, and the parent or guardian shall sign the refusal of screening form. The birthing facility or attending health care provider shall submit the signed refusal of screening form to the central laboratory within six days of the refusal. The birthing facility or attending health care provider may submit refusal forms via the courier service established for the transportation of newborn screening specimen collection forms or via secure facsimile to (319)384–5116.

Item 6. Amend subparagraph 4.3(9)"a"(2) as follows:

(2)Refusal. Should a parent or guardian refuse the screening, said refusal shall be documented in the infant's medical record, and the parent or guardian shall sign the refusal of screening form. The birthing facility or attending health care provider shall submit the signed refusal form to the central laboratory within six days of the refusal. The birthing facility or attending health care provider may submit refusal forms via the courier service established for the transportation of newborn screening specimen collection forms or via secure facsimile to (319)384–5116.

Item 7. Amend subrule 4.3(10) as follows:

4.3(10) INSP and IMPSP fees.

a. The department shall annually review and determine the fee to be charged for all activities associated with the INSP and the IMPSP. The review and fee determination shall be completed at least one month prior to the beginning of the fiscal year. The newborn screening fee is $122. In consultation with the department, the SHL shall establish the newborn screening fee schedule in a manner sufficient to support the newborn screening system of care including, but not limited to, laboratory screening costs, short-term and long-term follow-up program costs, the newborn screening developmental fund, and the cost of the department's newborn screening data system.

b. The department SHL shall include as part of the INSP fee an amount determined by the committee and department to fund the provision of special medical formula and foods for eligible individuals with inherited diseases of amino acids and organic acids who are identified through the programs.

c. Funds collected through newborn screening fees shall be used for newborn screening program activities only.

d. Funds collected through maternal prenatal screening fees shall be used for maternal prenatal screening activities only.

e. In order to support newborn and maternal prenatal screening activities, the department shall authorize the expenditure and exchange of newborn screening and maternal prenatal screening developmental funds between the SHL (as designated fiscal agent) and the department.

f. Upon department approval of proposed budgets, a A portion of INSP and IMPSP fees shall be distributed to the department to support activities of the INSP and the IMPSP at the center for congenital and inherited disorders (CCID).

Item 8. Amend rules 641—4.11(136A) to 641—4.13(136A) as follows:

641—4.11(136A) Purpose. CIDAC represents the interests of the people of Iowa and assists in the development of programs that ensure the availability of and access to quality genetic and genomic health care services by all residents. The committee advises the director regarding issues related to genetics and hereditary and congenital disorders. A congenital and inherited disorders advisory committee (CIDAC or advisory committee) is established to assist the center for congenital and inherited disorders and the department in the development of programs that ensure the availability of and access to quality genetic and genomic health care services for all Iowans.

641—4.12(136A) Duties of the advisory committee. CIDAC shall perform the following duties:

4.12(1) Make recommendations about the design and implementation of the center's programs, including but not limited to:

a. The Iowa newborn screening program;, including management of the Iowa newborn screening panel.

(1)The advisory committee shall assist the center for congenital and inherited disorders and the department in designating the conditions to be included in the newborn screening and in regularly evaluating the effectiveness and appropriateness of the newborn screening.

(2)Beginning July 1, 2022, the advisory committee shall ensure that all conditions included in the federal recommended uniform screening panel as of January 1, 2022, are included in the newborn screening.

(3)Within 12 months of the addition of a new condition to the federal recommended uniform screening panel, the advisory committee shall consider and make a recommendation to the department regarding inclusion of the new condition in the newborn screening panel, including the current newborn screening capacity to screen for the new condition and the resources necessary to screen for the new condition going forward.

(4)If the advisory committee recommends inclusion of a new condition, the department shall include the new condition in the newborn screening panel within 18 months of receipt of the recommendation;

b. The regional genetics consultation service;

c. The maternal prenatal screening program;

d. The neuromuscular and related genetic disorders program; and

e. The Iowa registry for congenital and inherited disorders.

4.12(2) Support the development of special projects and conferences regarding genetic and genomic health care services and issues.

4.12(3) Advocate for quality genetic and genomic health care services for all residents in the state of Iowa.

641—4.13(136A) Membership. The members of the advisory committee shall be appointed by the director and shall include persons with relevant expertise and interest including parent representatives. Membership will be comprised of representatives of professional groups, agencies, legislators, parents, consumers, and professional health care providers.

4.13(1) CIDAC shall be comprised of regular, ex officio, and honorary members membership.

a. to e. No change.

4.13(2) No change.

4.13(3) The director will appoint regular and honorary advisory committee members for three fiscal years. Reappointment of regular and honorary members shall be at the discretion of the director.

Item 9. Amend subrule 4.14(1) as follows:

4.14(1) Meetings of the advisory committee will be held as necessary and at the call of the director or the chairperson. There shall be a minimum of four meetings per year.

Item 10. Amend subparagraph 4.14(6)"b"(1) as follows:

(1)A designee of similar standing must be able to reasonably fulfill the member's role on the advisory committee in discussions.