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Montana Administrative Register Notice 37-971 No. 15   08/05/2022    
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BEFORE THE DEPARTMENT OF PUBLIC

HEALTH AND HUMAN SERVICES OF THE

STATE OF MONTANA

 

In the matter of the amendment of ARM 37.114.101, 37.114.105, 37.114.201, 37.114.203, 37.114.204, 37.114.314, 37.114.315, 37.114.501, 37.114.512, 37.114.515, 37.114.530, 37.114.531, 37.114.552, and 37.114.583 and the repeal of 37.114.586 pertaining to communicable disease control

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NOTICE OF PUBLIC HEARING ON PROPOSED AMENDMENT AND REPEAL

 

TO: All Concerned Persons

 

            1. On August 25, 2022, at 10:00 a.m., the Department of Public Health and Human Services will hold a public hearing via remote conferencing to consider the proposed amendment and repeal of the above-stated rules. Interested parties may access the remote conferencing platform in the following ways:

            (a) Join Zoom Meeting at: https://mt-gov.zoom.us/j/84077716165?pwd=L0dKOERXcHJvK2xKb21IdlJjSXloQT09, Meeting ID: 840 7771 6165, and Password: 705919; or

            (b) Dial by telephone: +1 646 558 8656, Meeting ID: 840 7771 6165, and Password: 705919.

Find your local number: https://mt-gov.zoom.us/u/kvVCivfTe.

 

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 August 11, 2022, to advise us of the nature of the accommodation that you need. Please contact Kassie Thompson, 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:

 

37.114.101 DEFINITIONS In addition to the definitions contained in 50-1-101, MCA, Unless unless otherwise indicated, the following definitions apply throughout this chapter:

(1) remains the same.

            (2) "Communicable disease" means an illness due or suspected to be due to a specific infectious agent or its toxic products, which results from transmission of that agent or its products to a susceptible host, directly or indirectly.

(3) and (4) remain the same but are renumbered (2) and (3).

(5)(4) "Control of Communicable Diseases Manual" means the "Control of Communicable Diseases Manual, An Official Report of the American Public Health Association," 20th edition, 2015 publication adopted and incorporated by reference in ARM 37.114.105(1)(a).

(5)  "Day care facility" has the meaning provided for under 52-2-703, MCA.

(6) "Department" means the Department of Public Health and Human Services.

(7)(6)  "Directly observed therapy (DOT)" means the method whereby a trained health-care health care worker or another trained designated person watches a patient swallow each dose of antituberculosis medication and documents it. DOT can include electronic directly observed therapy (eDOT) utilizing a video conferencing application only with express permission from the state TB program.

(8) "2007 Guideline for Isolation Precautions: Preventing Transmission of Infectious Agents in Healthcare Settings" means the guideline published by the Centers for Disease Control and Prevention in association with the Healthcare Infection Control Practices Advisory Committee publication adopted and incorporated by reference in ARM 37.114.105(1)(b).

(9) remains the same, but is renumbered (7).

(10) through (16) remain the same, but are renumbered (9) through (15).

(17)(16) "Infection control precautions" means those measures necessary to prevent the transmission of disease from an infected person to another person, taking into consideration the specific suspected or confirmed communicable disease and the specific circumstances of the case. The infection control precautions required for a case admitted to a hospital or other health care facility are those measures identified as isolation precautions applicable to the specific disease in the "2007 Guideline for Isolation Precautions: Preventing Transmission of Infectious Agents in Healthcare Settings" adopted and incorporated by reference in ARM 37.114.105(1)(b).  The infection control precautions required for a case not admitted to a hospital or other health care facility are those measures identified as methods of control applicable to the specific disease in the "Control of Communicable Diseases Manual", An Official Report of the American Public Health Association", 20th edition, 2015, adopted and incorporated by reference in ARM 37.114.105(1)(a).  Infection control precautions are required, as stated in this rule, whether or not the person is subject to isolation.

(18) through (20) remain the same, but are renumbered (17) through (19).

(21) "Isolation" means separation during the period of communicability of an infected or probably infected person from other persons, in places and under conditions approved by the department or local health officer and with observance of all applicable infection control precautions.

(22) and (23) remain the same, but are renumbered (20) and (21).

(24) "Local health officer" means a county, city, city-county, or district health officer appointed by a local board of health. As used in these rules, the term will include the authorized representative of a local health officer.

(25) and (26) remain the same, but are renumbered (22) and (23).

(27) "Physician" means a person licensed to practice medicine in any jurisdiction in the United States or Canada.

(28) remains the same, but is renumbered (24).

(29) "Quarantine" means those measures required by a local health officer or the department to prevent transmission of disease to or by those individuals who have been or are otherwise likely to be in contact with an individual with a communicable disease.

(30) and (31) remain the same, but are renumbered (25) and (26).

(32)(27) "Sexually transmitted disease infection" means human immunodeficiency virus (HIV) infection, syphilis, gonorrhea, chancroid, lymphogranuloma venereum, granuloma inguinale, or all chlamydia trachomatis infections including chlamydial genital infections.

(33)(28) "Sexually Transmitted Diseases Infections Treatment Guidelines, 2015" means the guidelines published by the U.S. Centers for Disease Control and Prevention adopted and incorporated by reference in ARM 37.114.105(1)(c).

(34) through (36) remain the same, but are renumbered (29) through (31).

(32) "Youth camp" has the meaning provided for under 50-52-101, MCA.

 

AUTH: 50-1-202, 50-2-116, 50-17-103, MCA

IMP: 50-1-202, 50-17-103, 50-18-101, MCA

 

37.114.105 INCORPORATION BY REFERENCE (1) The department adopts and incorporates by reference the following publications:

(a) The "Control of Communicable Diseases Manual, An Official Report of the American Public Health Association", 20th 21st edition, 2015 2022, which lists and specifies control measures for communicable diseases.

(b) The "2007 Guideline for Isolation Precautions: Preventing Transmission of Infectious Agents in Healthcare Settings," published by the U.S. Centers for Disease Control and Prevention, which specifies precautions that should be taken to prevent transmission of communicable diseases for cases admitted to a hospital or other health care facility.

(c) The "Sexually Transmitted Diseases Infections Treatment Guidelines, 2015 2021," are published by the U.S. Centers for Disease Control and Prevention in the June 5, 2015 July 23, 2021, Morbidity and Mortality Weekly Report, volume 64 70, hereafter referred to as "Sexually Transmitted Diseases Infections Treatment Guidelines, 2015 2021," and specify the most currently accepted effective treatments for sexually transmitted diseases infections.

(d) The "Food Code, 2013, Recommendations of the United States Public Health Service, Food and Drug Administration," published by the National Technical Information Service.

(e) through (g) remain the same.

(2) To obtain, or for information on how to obtain, any document or publication incorporated by reference, contact the Department of Public Health and Human Services, Public Health and Safety Division, Communicable Disease Control and Prevention Bureau Epidemiology and Scientific Support, 1400 Broadway, P.O. Box 202951, Helena, MT 59620-2951, phone: (406) 444-0919 0273, or by visiting its our website at: https://dphhs.mt.gov/publichealth/cdepi/reporting.

 

AUTH: 50-1-202, MCA

IMP: 50-1-202, MCA

 

37.114.201 REPORTERS (1) With the exceptions noted in (3), (4), and (5), any person, including a physician, dentist, nurse, medical examiner, other health care practitioner, administrator of a health care facility or laboratory, public or private school administrator, day care facility or youth camp personnel, or laboratory professional, who knows or has reason to believe that a case exists of a reportable disease or condition defined in ARM 37.114.203 must immediately report to the local health officer the information specified in ARM 37.114.205(1) and (2).

(2) through (5) remain the same.

 

AUTH: 50-1-202, 50-17-103, 50-18-105, MCA

IMP: 50-1-202, 50-2-118, 50-17-103, 50-18-102, 50-18-106, MCA

 

37.114.203 REPORTABLE DISEASES AND OTHER CONDITIONS OF PUBLIC HEALTH IMPORTANCE (1) The following communicable diseases and conditions and other conditions of public health importance are reportable:

(a) through (p) remain the same.

(q) Coronavirus Disease 2019 (COVID-19);

(q) through (ah) remain the same, but are renumbered (r) through (ai).

(ai)(ak) Lead poisoning (≥ five micrograms per deciliter µg/dL total blood lead levels) Lead levels in a venous blood specimen at any level;

(aj) Lead levels in a capillary blood specimen of ≥ 3.5 micrograms per deciliter(µg/dL) in a person less than 16 years of age;

(aj) through (ap) remain the same, but are renumbered (al) through (ar).

(as) Melioidosis;

(aq) remains the same, but is renumbered (at).

(ar)(au) Mercury poisoning (≥ 200 ten µg/L total mercury in urine; or ≥ 20 ten µg elemental mercury/g creatinine in urine; or ≥ 10 ten µg/L elemental, organic, and inorganic blood mercury levels);

(av) Monkeypox;

(as) through (az) remain the same, but are renumbered (aw) through (bd).

(be) Salmonella Paratyphi infection;

(bf) Salmonella Typhi infection;

(ba)(bg) Salmonellosis (including Salmonella Typhi and Paratyphi);

(bb) through (bs) remain the same, but are renumbered (bh) through (by).

(2) Also reportable is an outbreak of any communicable disease listed in the "Control of Communicable Diseases Manual", an Official Report of the American Public Health Association" (20th edition, 2015) that occurs in an institutional or congregate setting and any unusual incident of unexplained illness or death in a human or animal with potential human health implications.

 

AUTH: 50-1-202, 50-17-103, 50-18-105, 50-18-106, MCA

IMP: 50-1-202, 50-2-118, 50-17-103, 50-18-102, 50-18-106, MCA

 

37.114.204 REPORTS AND REPORT DEADLINES (1) A local health officer must immediately report (within four hours) to the department by telephone the information cited in ARM 37.114.205(1) through (2) whenever a case of one of the following diseases or other condition of public health importance is suspected or confirmed:

(a) through (h) remain the same.

(2) A local health officer must transmit by telephone or secure electronic means to the department the information required by ARM 37.114.205(1) and (2) for each suspected or confirmed case of one of the following diseases, within the time limit noted for each:

(a) through (a)(vii) remain the same.

(viii) Melioidosis;

(ix) Monkeypox;

(viii) through (xi) remain the same, but are renumbered (x) through (xiii).

(b) through (b)(xiii) remain the same.

(xiv) Coronavirus Disease 2019 (COVID-19);

(xiv) through (xxv) remain the same, but are renumbered (xv) through (xxvi).

(xxvi)(xxviii) Lead poisoning Lead levels in a venous blood specimen at any level (≥ five micrograms per deciliter, µg/dL total blood lead levels);

(xxvii) Lead levels in a capillary blood specimen of ≥ 3.5 micrograms per deciliter(µg/dL) in a person less than 16 years of age;

(xxvii) through (xxxii) remain the same, but are renumbered (xxix) through (xxxiv).

(xxxiii)(xxxv) Mercury poisoning (≥ 200 ten µg/L total mercury in urine; or ≥ 20 ten µg elemental mercury/g in creatinine in urine; or ≥ 10 ten µg/L elemental, organic, and inorganic blood mercury levels);

(xxxiv) through (xxxvii) remain the same, but are renumbered (xxxvi) through (xxxix).

(xl) Salmonella Paratyphi infection;

(xli) Salmonella Typhi infection;

(xxxviii)(xlii) Salmonellosis (including Salmonella Typhi and Paratyphi);

(xxxix) through (lii) remain the same, but are renumbered (xliii) through (lvi).

(3) through (5) remain the same.

 

AUTH: 50-1-202, 50-17-103, 50-18-105, MCA

IMP: 50-1-202, 50-17-103, 50-18-102, 50-18-106, MCA

 

37.114.314 INVESTIGATION OF A CASE (1) remains the same.

            (2) If the local health officer finds that the nature of the disease and the circumstances of the case or outbreak warrant such action, the local health officer must:

            (a) and (b) remain the same.

            (c) take appropriate steps, as outlined in the "Control of Communicable Diseases Manual", An Official Report of the American Public Health Association" (20th edition, 2015), to prevent or control the transmission of disease; and; and

            (d) remains the same.

            (3) Whenever the identified source of a reportable disease or a person infected with or exposed to a reportable disease who should be isolated, quarantined, interviewed, or placed under surveillance is located outside of the jurisdiction of the local health officer, the local health officer must coordinate with the department to notify the health officer of the relevant jurisdiction.

 

AUTH: 50-1-202, 50-2-118, 50-17-103, 50-18-105, MCA

IMP: 50-1-202, 50-2-118, 50-17-103, 50-17-105, 50-18-102, 50-18-107, 50-18-108, MCA

 

37.114.315 POTENTIAL OUTBREAKS (1) Whenever a communicable disease listed in ARM 37.114.203, or the "Control of Communicable Diseases Manual", An Official Report of the American Public Health Association" (20th edition, 2015), or other communicable disease that constitutes a threat to the health of the public, becomes so prevalent as to endanger an area outside of the jurisdiction where it first occurred, the local health officer of the jurisdictional area in which the disease occurs must notify and cooperate with the department to control the transmission of the disease in question.

 

AUTH: 50-1-202, MCA

IMP: 50-1-202, 50-2-118, MCA

 

37.114.501 MINIMAL CONTROL MEASURES (1) The department, except as otherwise provided in this subchapter, adopts and incorporates by reference the control measures in the ″Control of Communicable Diseases Manual, An Official Report of the American Public Health Association″ (20th edition, 2015) The control measures described in the "Control of Communicable Diseases Manual" must be employed, unless otherwise provided in this subchapter.  Unless a particular control measure specifies who is responsible, the local health officer or the authorized representative of a local health officer must:

(a) and (b) remain the same.

 

AUTH: 50-1-202, 50-2-116, 50-2-118, MCA

IMP: 50-1-202, 50-2-116, 50-2-118, MCA

 

            37.114.512 CHANCROID (1) The local health officer or the department must either employ or ensure that control measures as outlined in the Centers for Disease Control and Prevention "Sexually Transmitted Diseases Infections Treatment Guidelines, 2015" are followed.

 

AUTH: 50-1-202, 50-2-118, 50-18-105, MCA

IMP: 50-1-202, 50-2-118, 50-18-102, MCA

 

37.114.515 CHLAMYDIA INFECTION (1) The local health officer or the department must either employ or ensure that control measures as outlined in the Centers for Disease Control and Prevention "Sexually Transmitted Diseases Infections Treatment Guidelines, 2015" are followed.

(2) An individual who contracts the infection must be interviewed by the local health officer to determine the person's sexual contacts, and those contacts must be provided with appropriate medical treatment The local health officer must interview an individual who contracts the infection in order to determine the person's sexual contacts, and must ensure that those contacts are examined and receive the medical treatment indicated by clinical or laboratory findings.

 

AUTH: 50-1-202, 50-2-118, 50-18-105, MCA

IMP: 50-1-202, 50-2-118, 50-18-102, 50-18-107, MCA

 

37.114.530 GONORRHEA (1) The local health officer or the department must either employ or ensure that control measures as outlined in the Centers for Disease Control and Prevention "Sexually Transmitted Diseases Infections Treatment Guidelines, 2015" are followed.

(2) remains the same.

 

AUTH: 50-1-202, 50-2-118, 50-18-105, MCA

IMP: 50-1-202, 50-2-118, 50-18-102, 50-18-107, MCA

 

37.114.531 GRANULOMA INGUINALE (1) The local health officer or the department must either employ or ensure that control measures as outlined in the Centers for Disease Control and Prevention "Sexually Transmitted Diseases Infections Treatment Guidelines, 2015" are followed.

 

AUTH: 50-1-202, 50-2-118, 50-18-105, MCA

IMP: 50-1-202, 50-2-118, 50-18-102, MCA

 

37.114.552 LYMPHOGRANULOMA VENEREUM (1) The local health officer or the department must either employ or ensure that control measures as outlined in the Centers for Disease Control and Prevention "Sexually Transmitted Diseases Infections Treatment Guidelines, 2015" are followed.

 

AUTH: 50-1-202, 50-2-118, 50-18-105, MCA

IMP: 50-1-202, 50-2-118, 50-18-102, MCA

 

37.114.583 SYPHILIS (1) The local health officer or the department must either employ or ensure that control measures as outlined in the Centers for Disease Control and Prevention "Sexually Transmitted Diseases Infections Treatment Guidelines, 2015" are followed.

 

AUTH: 50-1-202, 50-2-118, 50-18-105, MCA

IMP: 50-1-202, 50-2-118, 50-18-102, 50-18-107, MCA

 

4. The department proposes to repeal the following rule:

 

ARM 37.114.586 TUBERCULOSIS

 

AUTH: 50-1-202, 50-2-118, MCA

IMP: 50-1-202, 50-2-118, MCA

 

            5. STATEMENT OF REASONABLE NECESSITY

 

The Department of Public Health and Human Services (department) is proposing to amend and repeal the above-stated rules pertaining to communicable disease control.

 

The proposed amendments are necessary to keep Montana's communicable disease control rules current with national disease surveillance, investigation, and control recommendations.  The proposed amendments reflect changing knowledge of improved disease specific control measures.  The department is also proposing amendments to simplify and clarify references to publications adopted and incorporated by reference with the rules.

 

ARM 37.114.101

The department is proposing to amend this rule to remove references to the titles of publications adopted and incorporated by reference because the titles for these publications are identified under ARM 37.114.105. The department is also proposing to revise the rule to remove definitions for terms that are already defined in statute.

 

ARM 37.114.105

The department is proposing to amend this rule to update the guidelines for the control of communicable disease and treatment of sexually transmitted infections to reference the most current version of these guidelines. These updated guidelines reflect changing knowledge of improved disease specific control measures and are necessary to keep Montana's communicable disease control rules current with the best available practices.

 

ARM 37.114.201

The department is proposing to amend this rule to clarify that day care facilities and youth camps are entities required to report a reportable disease or condition to the local health officer. In practice, many day care facilities and youth camps already report reportable diseases or conditions because ARM 37.114.203 requires reporting of an outbreak of communicable disease in an institutional or congregate setting. Day care facilities and youth camps are congregate settings. The proposed amendment clarifies reporting requirements for these types of establishments for prevention and control of outbreaks to protect the health of infants, children, and staff.

 

ARM 37.114.203

The department is proposing to update this rule to align it with the nationally notifiable disease listing terminology and to better define reportable diseases and outbreaks. The department is proposing to amend the definition of blood lead levels and mercury poisoning and to clarify the Salmonella-related diseases to report to align them with best available surveillance practices.  The department is also proposing to revise the rule to refer to ARM 37.114.105, which incorporates by reference the communicable disease control manual to identify reportable outbreaks in institutional and congregate settings. The department is proposing to add coronavirus disease 2019 (COVID-19), melioidosis, and monkeypox diseases to the list of notifiable diseases and conditions.

 

Coronavirus disease 2019 (COVID-19) is a highly contagious respiratory disease that was first identified in March 2020. Presently, this disease presents high morbidity and mortality among the Montana population. The department has received reports of COVID-19 as required by the Coronavirus Aid, Relief, and Economic Security Act (CARES Act) through the duration of the federal public health emergency. The department is proposing to add COVID-19 to the reportable diseases and conditions list to continue surveillance of COVID-19 incidence (cases), following the best available surveillance practice, to measure the burden of disease, monitor community transmission levels, detect emerging variants of concern, inform public health response, and monitor the effectiveness of COVID-19 vaccinations and therapeutics. The addition of COVID-19 to the list of reportable communicable disease is consistent with the current listing of other infectious respiratory diseases on this list such as pertussis, as well as the listing of another coronavirus, severe acute respiratory syndrome-associated coronavirus (SARS-CoV) disease.

 

Melioidosis is a rare but potentially severe and fatal disease caused by the bacterium Burkholderia pseudomallei, which is designated a Tier 1 Select Agent by the National Select Agent Program because it presents a risk for bioterrorism use. The organism is endemic in some parts of the world. Identification of a single person with melioidosis without appropriate travel history indicates either an accidental or intentional introduction of this organism. The department is proposing to add melioidosis to the list of reportable diseases and conditions to allow for prompt public health notification to facilitate rapid response to protect the public's health.

 

Monkeypox is a rare zoonotic disease that is caused by infection with monkeypox virus. Recently, an unprecedented and rapid increase in detection of this disease among a wide geographic area and among people without traditional risk factors indicate that this is an emerging public health concern that requires prompt public health notification to facilitate rapid response to control this communicable disease.

 

Salmonellosis, Salmonella Typhi infection, and Salmonella Paratyphi infection are distinct diseases which require unique public health control measures.  The proposed change clarifies the distinct Salmonella-related diseases to report to align with the best available surveillance practices.

 

ARM 37.114.204

The department is proposing to revise this rule to update certain reportable conditions and the associated timeline for reporting those conditions.  The department is proposing to amend the reporting requirements to align with the generally accepted surveillance definition of blood lead levels, coronavirus disease 2019 (COVID-19), melioidosis, mercury poisoning, and monkeypox.  The department is also proposing to revise the rule to align with the proposed revisions to definitions under ARM 37.114.101.

 

ARM 37.114.314, 37.114.315, 37.114.501, 37.114.512, 37.114.515, 37.114.530, 37.114.531, 37.114.552, and 37.114.583

The department is proposing non-substantive revisions to these rules to align with the revisions being made to definitions under ARM 37.114.101.

 

ARM 37.114.586

The department is proposing to repeal this rule because the control of Tuberculosis is addressed under ARM Title 37, chapter 114, subchapter 10, and it is unnecessary to cross-reference these rules.

 

Fiscal Impact

 

The department anticipates no fiscal impact regarding the proposed rulemaking.

 

6. The proposed rule changes are intended to be effective upon the day after the date of publication of the adoption notice.

 

7. 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: Kassie Thompson, 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., September 2, 2022.

 

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

 

9. 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 7 above or may be made by completing a request form at any rules hearing held by the department.

 

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 and repeal of the above-referenced rules will not significantly and directly impact small businesses.

 

 

 

/s/ ROBERT LISHMAN                               /s/ CHARLES T. BRERETON                   

Robert Lishman                                           Charles T. Brereton, Director

Rule Reviewer                                             Department of Public Health and Human Services

 

 

Certified to the Secretary of State July 26, 2022.


 
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