RFR-Page 2
These new rules would establish requirements for reporting ALS to the Michigan Department of
Health and Human Services. ALS is a progressive, degenerative, neurological disease. The onset
of ALS is typically later in life, peaking between 50 and 75 years of age. The majority of patients
with ALS die within 2-5 years of diagnosis. In general, it is believed that the ALS incidence is
2/100,000, so assuming a population size in Michigan of 10 million, that is 200 new cases per
year; however, the University of Michigan ALS clinic has been seeing more cases and estimates
300 new cases per year. It is hard to determine the number of missed cases, especially given the
lack of ALS clinics in Northern Michigan. The state has the authority under the Public Health
Code to obtain, upon request, medical records to investigate, monitor, prevent, and control
diseases dangerous to public health. Many of the diseases that are currently reportable to the state
have treatments or known prevention strategies, but ALS patients and families have nothing that
makes any significant difference. All ALS patients eventually die. The cost of the care for one
ALS patient has been estimated at nearly $200,000 per year in some cases, so the prevention of
the development of ALS in one life in Michigan would have an economic impact. These rules
would establish a statewide ALS case registry based on data collection of patients with ALS,
identified by neurologists, hospitals, ALS clinics, and vital records. The ALS case registry would
provide data for public health surveillance and provide researchers with standardized and
comprehensive data aimed at identifying risk factors and prevention strategies.
8. Please cite the specific promulgation authority for the rules (i.e. department director,
commission, board, etc.).
The Department Director.
A. Please list all applicable statutory references (MCLs, Executive Orders, etc.).
By authority conferred on the department of health and human services by sections 2221, 2226,
and 2233 of the public health code, 1978 PA 368, MCL 333.2221, 333.2226, and 333.2233, and
Executive Reorganization Order No. 2015-1, MCL 400.227.
B. Are the rules mandated by any applicable constitutional or statutory provision? If so, please
explain.
The proposed rules are not mandated by any applicable constitutional or statutory provision.
9. Please describe the extent to which the rules conflict with or duplicate similar rules,
compliance requirements, or other standards adopted at the state, regional, or federal level.
The rules do not conflict with or duplicate other rules, compliance requirements, or other
standards adopted at the state, regional, or federal level.
10. Is the subject matter of the rules currently contained in any guideline, handbook, manual,
instructional bulletin, form with instructions, or operational memoranda?
The subject matter of the proposed rules is contained in guidelines, manuals, forms, and
operational memoranda.
11. Are the rules listed on the department’s annual regulatory plan as rules to be processed
for the current year?
The rules are listed on the current year annual regulatory plan.
12. Will the proposed rules be promulgated under Section 44 of the Administrative Procedures
Act, 1969 PA 306, MCL 24.244, or under the full rulemaking process?
Full Process
13. Please describe the extent to which the rules exceed similar regulations, compliance
requirements, or other standards adopted at the state, regional, or federal level.
MCL 24.239