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 laboratory fees for analysis and newborn screening for severe combined immunodeficiency disease (SCID)

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NOTICE OF PUBLIC HEARING ON PROPOSED AMENDMENT

 

TO: All Concerned Persons

 

          1. On June 3, 2015, at 9:00 a.m., the Department of Public Health and Human Services will hold a public hearing in the auditorium of the Department of Public Health and Human Services Building, 111 North Sanders, Helena, Montana, to consider the proposed amendment of the above-stated rules.

 

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 May 27, 2015, to advise us of the nature of the accommodation that you need. Please contact Kenneth Mordan, 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 dphhslegal@mt.gov.

 

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) Fees for clinical and environmental analyses performed by the laboratory of the Department of Public Health and Human Services department are set to reflect the actual costs of the tests and services provided.

          (2) The Department of Public Health and Human Services 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 January 1, 2014 July 1, 2015, which is available on the web site of the Department of Public Health and Human Services at www.dphhs.mt.gov/publichealth/lab/labfees.shtml http://www.dphhs.mt.gov/portals/85/publichealth/documents/lab/publichealthlabtesting/phlfees2014_1.pdf, 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) The fee for a specific lab test will be lowered by the Department of Public Health and Human Services department to a level not exceeding the cost to the department of the test in question whenever a change of analysis method warrants lower fees.

          (4) remains 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)(v) remain the same.

          (vi) tricuspid atresia; and

          (vii) truncus arteriosus.; and

          (j) Severe combined immunodeficiency disease.

 

AUTH: 50-19-202, MCA

IMP: 50-19-203, MCA

 

          4. STATEMENT OF REASONABLE NECESSITY

 

The Department of Public Health and Human Services (the department) is proposing an amendment to ARM 37.12.401 in order to increase the laboratory fee for newborn screening and to ARM 37.57.301 regarding the required conditions that are screened or tested for in the newborn screening panel. The proposed fee change in ARM 37.12.401 is related to the proposed change in ARM 37.57.301(3), which would add Severe Combined Immunodeficiency Disease (SCID) to the required conditions that are screened or tested for in the newborn screening panel.

 

SCID 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 SCID can be screened in a highly effective manner and babies with confirmed SCID can mature and live normal lives.

 

The department is also proposing to amend the link to the department's web site containing the fees for lab tests. The department recently updated its web site and this change is necessary to ensure the public has access to the most current web site.

 

ARM 37.12.401

 

The proposed change to this rule is necessary in order to cover the additional cost of performing the SCID screening test. It is estimated that this will result in an increase of $6.00 to the laboratory fee for screening each baby or cumulative fees of $72,000 annually for the estimated 12,000 babies that are screened each year in the state of Montana.

 

ARM 37.57.301

 

The proposed change to this rule is necessary to conform to HRSA's Recommended Uniform Screening Panel for all newborns and to update newborn bloodspot screening to reflect current standards of care for babies born in Montana.

 

Fiscal Impact

 

The adoption of the proposed amendment to the administrative rule listed above could have a fiscal impact on the following groups in Montana: newborns and their families, birthing hospitals, birthing centers, and direct entry midwifery services.

 

There are currently 28 birthing hospitals in Montana. Estimated costs that may be incurred due to adding SCID to the required conditions screened in newborn bloodspot testing include the following:

 

An additional charge of approximately $6.00 per newborn screen will be added to the cost of the screening panel.  In some circumstances, providers may incur this cost.

 

Other Considerations

 

The department will provide family education materials.

 

Impact to babies born in Montana

 

There are approximately 12,000 babies born in Montana every year.  It is possible that hospitals and other providers may in some circumstances bill families for the additional cost associated with performing this screening.

 

          5. The department intends to adopt these rule amendments effective July 1, 2015.

 

          6. 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: Kenneth Mordan, 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 dphhslegal@mt.gov, and must be received no later than 5:00 p.m., June 11, 2015.

 

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

 

8. 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 6 above or may be made by completing a request form at any rules hearing held by the department.

 

9. An electronic copy of this proposal notice is available through the Secretary of State's web site at http://sos.mt.gov/ARM/Register.  The Secretary of State strives to make the electronic copy of the notice conform to the official version of the notice, as printed in the Montana Administrative Register, but advises all concerned persons that in the event of a discrepancy between the official printed text of the notice and the electronic version of the notice, only the official printed text will be considered.  In addition, although the Secretary of State works to keep its web site accessible at all times, concerned persons should be aware that the web site may be unavailable during some periods, due to system maintenance or technical problems.

 

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

 

11. 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/ Nicholas Domitrovich                        /s/ Richard H. Opper                            

Nicholas Domitrovich, Esq.                    Richard H. Opper, Director

Rule Reviewer                                       Public Health and Human Services

 

 

Certified to the Secretary of State May 4, 2015.