BEFORE THE DEPARTMENT OF PUBLIC

HEALTH AND HUMAN SERVICES OF THE

STATE OF MONTANA

 

In the matter of the amendment of ARM 37.12.401 and 37.57.301 pertaining to newborn screening

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NOTICE OF PUBLIC HEARING ON PROPOSED AMENDMENT

 

TO: All Concerned Persons

 

            1. On January 14, 2021, at 1:00 p.m., the Department of Public Health and Human Services will hold a public hearing via remote conferencing to consider the proposed amendment of the above-stated rule. Because there currently exists a state of emergency in Montana due to the public health crisis caused by the coronavirus, there will be no in-person hearing. Interested parties may access the remote conferencing platform in the following ways: 

            (a) Join Zoom Meeting at: https://mt-gov.zoom.us/j/95849495880; meeting ID:  958 4949 5880; or

            (b) Dial by telephone +1 646 558 8656; meeting ID:  958 4949 5880. Find your local number:  https://mt-gov.zoom.us/u/aeG7mJVChZ.

 

2. The Department of Public Health and Human Services will make reasonable accommodations for persons with disabilities who wish to participate in this rulemaking process or need an alternative accessible format of this notice. If you require an accommodation, contact the Department of Public Health and Human Services no later than 5:00 p.m. on January 8, 2021, to advise us of the nature of the accommodation that you need. Please contact Heidi Clark, Department of Public Health and Human Services, Office of Legal Affairs, P.O. Box 4210, Helena, Montana, 59604-4210; telephone (406) 444-4094; fax (406) 444-9744; or e-mail [email protected].

 

3. The rules as proposed to be amended provide as follows, new matter underlined, deleted matter interlined:

 

37.12.401 LABORATORY FEES FOR ANALYSES (1) remains the same.

            (2) The department will maintain a list of all tests available from the lab and the price of each test.  The department adopts and incorporates by reference the Laboratory Test Fee List effective April 1, 2018 March 1, 2021, which is available on the web site of the Department of Public Health and Human Services at http://dphhs.mt.gov/publichealth/LaboratoryServices/PublicHealthLabTesting, and by mail upon request to the lab at the Department of Public Health and Human Services, Public Health and Safety Division, P.O. Box 6489, Helena, MT 59604-6489.

            (3) and (4) remain the same.

 

AUTH: 50-1-202, MCA

IMP: 50-1-202, MCA

 

            37.57.301 DEFINITIONS As used in this subchapter, the following definitions apply:

            (1) and (2) remain the same.

            (3) "Newborn screening tests" are screening tests, procedures, or both for the following conditions:

            (a) through (i)(vi) remain the same.

            (vii) truncus arteriosus; and

            (j) Severe combined immunodeficiency disease. ; and

            (k)  Spinal muscular atrophy (SMA).

 

AUTH: 50-19-202, MCA

IMP: 50-19-203, MCA

 

            4. STATEMENT OF REASONABLE NECESSITY

 

The Department of Public Health and Human Services (department) is proposing amendments to ARM 37.57.301 and 37.12.401 regarding newborn screening. The proposed rule amendments add spinal muscular atrophy (SMA) to the list of required newborn screening panel tests.

 

ARM 37.57.301

 

The department is proposing to amend the definition of "newborn screening tests" by adding SMA to the list of required newborn screening panel tests. SMA is one of the primary conditions that the Health Resources and Services Administration (HRSA) of the U.S. Department of Health and Human Services has included in the Recommended Uniform Screening Panel (RUSP) for newborn screening. Essential requirements for inclusion in the RUSP are that the conditions are chosen based on evidence that supports the potential net benefit of screening, the ability of states to screen for the disorder, and the availability of effective treatments. Due to technological and medical advances, newborns with SMA can be screened in a highly effective manner and babies which are identified soon after birth through newborn screening can survive and lead productive lives. The proposed rule change is necessary to conform with HRSA's RUSP for all newborns and to update newborn bloodspot screening to reflect current standards of care for babies born in Montana.

 

ARM 37.12.401

 

The department is proposing to amend ARM 37.12.401 to adopt and incorporate by reference an updated Laboratory Test Fee List that takes into account the addition of SMA to the newborn screening tests. A copy of the proposed Laboratory Fee Schedule is electronically accessible at: https://dphhs.mt.gov/publichealth/LaboratoryServices/PublicHealthLabTesting.

 

The fee for newborn screening panel tests is currently $134.00. The department is proposing to revise the fee to $140.00 due to the addition of the SMA test. The proposed rule change is necessary to align with the changes being proposed to ARM 37.57.301.

 

Fiscal Impact

 

The proposed rule changes affect newborns and their families, birthing hospitals, birthing centers, and small businesses providing direct-entry midwifery services. There are approximately 12,500 babies born in Montana every year. The cost for the addition of the SMA test to the newborn screening panel is $6.00 per test. Given the modest cost of this test, the department does not anticipate these proposed rule changes will have a significant fiscal impact.

 

The department intends to adopt these rule amendments effective March 1, 2021.

 

            5. Concerned persons may submit their data, views, or arguments either orally or in writing at the hearing. Written data, views, or arguments may also be submitted to: Heidi Clark, Department of Public Health and Human Services, Office of Legal Affairs, P.O. Box 4210, Helena, Montana, 59604-4210; fax (406) 444-9744; or e-mail [email protected], and must be received no later than 5:00 p.m., January 21, 2021.

 

6. The Office of Legal Affairs, Department of Public Health and Human Services, has been designated to preside over and conduct this hearing.

 

7. The department maintains a list of interested persons who wish to receive notices of rulemaking actions proposed by this agency.  Persons who wish to have their name added to the list shall make a written request that includes the name, e-mail, and mailing address of the person to receive notices and specifies for which program the person wishes to receive notices. Notices will be sent by e-mail unless a mailing preference is noted in the request. Such written request may be mailed or delivered to the contact person in 5 above or may be made by completing a request form at any rules hearing held by the department.

 

8. The bill sponsor contact requirements of 2-4-302, MCA, do not apply.

 

9. With regard to the requirements of 2-4-111, MCA, the department has determined that the amendment of the above-referenced rules will not significantly and directly impact small businesses.

 

 

/s/ Robert Lishman                                      /s/ Erica Johnston                                       

Robert Lishman                                           Erica Johnston, Interim Director

Rule Reviewer                                              Public Health and Human Services

 

Certified to the Secretary of State December 15, 2020.