Maine's Newborn Bloodspot Screening Rule (10-144 CMR Ch. 283) is a routine technical rule, except for Section 14 - Fees, which is a major substantive rule provision, pursuant to 5 MRS 8071(3)(B).

On March 11, 2021, the Department implemented Routine Technical and Major Substantive rule changes by emergency rulemaking. The subsequent adoption of Routine Technical rule changes effective June 1, 2021 permanently added four conditions to Maines newborn bloodspot screening panel. Major Substantive rule changes increasing the filter paper fee from $110 to $220 per infant tested were provisionally adopted May 24, 2021. The final adoption of this rule permanently implements the increase to the filter paper fee from $110 to $220 per infant tested, the major substantive portion of the rule. (5 MRS 8073.) The current emergency major substantive rule provision remains in effect up to 60 days after the legislative review and will expire when this final major substantive rule change becomes legally effective. (5 MRS 8072(8).)

The Department is adopting routine technical rule changes amending 10-144 CMR chapter 264, Immunization Requirements for Healthcare Workers. The Department is adding COVID-19 to the list of vaccine preventable diseases for which Designated Healthcare Facility employees must show proof of immunization or provide appropriate exemption documentation pursuant to 22 M.R.S. 802(4-B) or as otherwise required by law. The adopted rule reflects changes made following the public comment period for the proposed rule and these include the removal of EMS organizations and dental practices. The Department clarified the definition of "employee" to include independent contractors but to exclude persons who provide ad hoc, non-healthcare services for a Designated Healthcare Facility and have no potential for direct contact with staff, patients, or visitors. Amendments also clarify exclusion and reporting requirements, update the required dosage for Hepatitis B, clarify that no Proof of Immunization is available for Influenza or COVID-19, and specify the manner in which annual survey data must be reported and the manner in which it may be used by the Department.

The DHHS Maine CDC is adopting updates to align with statutory changes and clarifying requirements for the Dental Care Access Credit Program Rule. These changes include specifying the application-submission deadline, establishing when the applications process ends, outlining the competitive order of receipt process for initial applicants, and extending the certification period for eligible dentists, following the deadline for applications. The Department is also adopting updated responsibilities for certificate holders, further clarifying the Department's notification process of certificate award recipients and updating formatting to align with Maine CDC rulemaking convention.

The Department of Health and Human Services, Maine CDC is adopting changes to the Primary Care Tax Credit Certification Rule, to clarify application requirements and eliminate any reference to specific tax years. These amendments reflect current processes and standards in a clearer way.

The Department of Health and Human Services - Maine Center for Disease Control and Prevention (DHHS) and the Maine Department of Education (DOE) are jointly proposing these routine technical rule changes to implement PL 2019 ch. 154, An Act to Protect Maine Children and Students from Preventable Disease by Repealing Certain Exemptions from the Laws Governing Immunization Requirements (the "Act"). The Act prohibits the rule from including any provision governing medical exemptions and repeals the exemption from required immunization for school students who object, based solely on a sincere religious belief or philosophical reason, effective September 1, 2021, with exemptions for certain students. Those students who may have declined immunizations based on religious or philosophical objection and are otherwise not eligible for exemptions permitted under Maine's immunization laws, including those attending elementary or secondary schools for pre-kindergarten instruction, will be subject to current immunization requirements for the certain specified diseases. This rule proposes to require schools to include in their annual report any stricter immunization requirements that may be adopted by ordinance or policy, in addition to the immunization status of all students, including immune students, exempt and non-immunized excluded students. Additionally, these proposed rule changes include new and revised definitions; add a vaccine schedule for pre-kindergarten students; clarify existing authority and responsibility to dismiss or exclude a child from school when there is a public health threat (20-A MRS 6301; 22 MRS ch. 250); and clarify superintendent and school authority and responsibility related to recordkeeping and attendance tracking for those students exempt from immunization requirements. Finally, changes are proposed to the format of the rule for conformity with Maine CDC rulemaking standards. The Notice of Rulemaking provides additional details regarding this rulemaking, including public hearing information. Comments may also be submitted directly to Bridget.Bagley@maine.gov

The Department is adopting amendments to 10-144 CMR ch. 262, to implement changes required by PL 2019 ch. 154, An Act to Protect Maine Children and Students from Preventable Disease by Repealing Certain Exemptions from the Laws Governing Immunization Requirements (the "Act"), enacted by the 129th Maine Legislature and effective June 16, 2020. The Act prohibits the Department from including any provision governing medical exemptions in this rule. (PL 2019 ch. 154 7.) The Act repeals the exemption from required immunization for post-secondary school students who state a sincere religious belief or philosophical reasons for opposing immunization, effective September 1, 2021. (PL 2019 ch. 154 6.) The adopted rule clarifies the documentation required for students' health records for all students, including immune students, exempt and non-immunized students, and the minimum content for the schools annual report of students immunization status. These rule changes further clarify that this information may be accessed by the Department to ensure compliance with the law and inform measures for controlling the spread of certain diseases. Additionally, this rule amendment clarifies that remote students who do not enter onto school premises are exempt from immunization requirements. In alignment with 20-A MRS 6359(6), nothing in this rule may be construed to preclude the governing board of a public or private post-secondary school from adopting immunization requirements that are more stringent than the provisions set forth in this rule. The final rule adoption also includes proposed minor changes to the rule format and revised title, for consistency with agency standards.

On March 11, 2021 the Department adopted and filed with the Secretary of State's office an emergency Routine Technical/Major Substantive Ch. 283 (Newborn Bloodspot Screening Rule) rule. The emergency major substantive rule changes will be in effect for up to 12 months or until the Legislature has completed its review, as provided by 5 M.R.S. 8072. In this rulemaking, the Department permanently adopts the emergency routine technical rule changes, as shown below, which add four conditions for newborn screening. In addition, the Department provisionally adopts the emergency major substantive rule changes that increase the filter paper fee to $220. The Department will proceed to submit the provisionally adopted major substantive rule changes to the Legislature for its review and approval.

Routine Technical Adopted Rule Changes: The Department expanded the conditions on Maines newborn bloodspot screening panel to include the following conditions to APPENDIX A, Core Conditions, in this rule. These conditions were added on March 11, 2021 by emergency rule for 90 days, pursuant to 5 MRS 8072: Mucopolysaccharidosis Type 1 (MPS-1) Pompe Spinal Muscular Atrophy (SMA) X-linked Adrenoleukpdysrophy (X-ALD)

Early detection and timely diagnosis of certain congenital genetic disorders impact health outcomes for newborns, reducing the mortality and morbidity from certain heritable disorders. Beginning July 1, 2001, Maine began mandatory newborn testing to include nine disorders and, because of the importance of screening, early detection and treatment, and coordination of services for long-term care, the Maine CDC NBSP, with the support of Maines Joint Advisory Committee for Maine Newborn Screening (JAC), has since continued to expand the panel of disorders and revise requirements for screenings for certain conditions to be consistent with the U.S. DHHS Recommended Universal Screening Panel (RUSP). Disorders on the RUSP are chosen based on evidence that supports the potential net benefit of screening, the ability to screen for the disorder, and the availability of effective treatments.

These four conditions were added to the RUSP in the following years: Pompe (2013) MPS-1 (2015) X-ALD (2015) SMA (2018)

The Maine Joint Advisory Committee for Newborn Bloodspot Screening recommended that the Department add Pompe, MPS-1 and X-ALD to the Core Conditions for screening, in October 2018, and in May 2019, the Committee recommended adding SMA.

The Department adopted the four additional conditions to this rule to reduce mortality and morbidity from certain heritable conditions.

Major Substantive Rule Changes Provisionally Adopted: The filter paper fee increase is necessary to off-set anticipated costs corresponding to the added conditions (i.e. genetic clinic contracts, resource material, follow- up services and other related program operations). The emergency adoption of the major substantive rule changes became effective on March 11, 2021. 5 M.R.S. 8002(3-A).

Routine technical rule changes to 10-144 CMR chapter 283, Newborn Bloodspot Screening Rule, have been adopted and are effective June 1, 2021. Major substantive rule change was provisionally adopted on May 19, 2021.

The Department is adopting routine technical rule changes to amend 10-144 CMR ch. 264, Immunization for Healthcare Workers rule, which include (1) Adding and updating references to the statutory authority for the rule; (2) Clarifying, in the Summary, that the rule is purposed to reduce the risk for exposure to and transmission of vaccine-preventable diseases; (3) Updating the definition of Designated Healthcare Facility to clarify the term applies to facilities subject to licensure by the Department; (4) Updating the term Intermediate Care Facility for the Mentally Retarded (ICF/MR) to Intermediate Care Facility for Individuals with Intellectual Disabilities (ICF/IID); (5) Adding definitions for Public Health Emergency, Public Health Threat, and Extreme Public Health Emergency; (6) Removing outdated H1N1 2009-10 reporting language; (7) Adding influenza to the list of vaccine-preventable diseases for which healthcare facilities must require all employees to provide proof of immunization, or immunity, or documentation of an authorized exemption; (8) Adding a description of the Department's authority during a declared Extreme Public Health Emergency, to impose additional disease prevention control measures, including mandatory and mass vaccinations and recommended dosages therefor; and (9) Clarifying that records of Designated Healthcare Facility employee vaccinations must be maintained by the facility for six years following termination.

This routine technical rule amends the Control of Notifiable Diseases and Conditions Rule to: 1) add the following five additional disease conditions: Acute flaccid myelitis, Candida auris, Borrelia miyamotoi, vaping-associated pulmonary illness, and Zika; 2) modify the two listings of multi drug-resistant organisms; 3) remove Staphylococcus aureus (MRSA) from the list; 4) update the human immunodeficiency virus (HIV) testing terminology; 5) clarify authority to access health information, including healthcare information from other entities not specified (e.g. MaineCare), through the state health information exchange; 6) clarify laboratories' electronic reporting requirements (e.g. designated use of HL7 messaging); 7) clarify that when a potentially emerging disease or condition that can cause serious morbidity or mortality and for which the reporting is necessary to monitor, prevent, or control the disease or condition to protect public health, the Department can, through public notice, require immediate reporting for a limited time; and 8) clarify enforcement actions, including referrals to licensing boards and/or the Office of the Attorney General to seek injunctive relief for noncompliance with reporting Category I conditions, specifically, and fine imposition for noncompliance and false reporting. Additionally, the adopted rule includes a change in the proposed frequency for bed occupancy reporting outside of a declared health emergency to allow for weekly reporting and includes additional and revised definitions for epidemic and outbreak. Provisions of this rule ensure that the Department is consistent with national disease reporting recommendations for conditions impacting public health and safety, to ensure timely and accessible information, as diseases and conditions emerge and data needs evolve. Amendments also require designated health care facilities to report information related to emergency preparedness and responsiveness.

The DHHS, Maine CDC is adopting an update to the schedule of charges for testing and services provided by the Maine Health and Environmental Testing Laboratory (HETL), including, but not limited to the following: chemical and microbiological testing and examination of surface water sources, food products, public and private drinking water well samples, and environmental and forensic samples; the examination of cases and suspected cases of infectious and communicable diseases; and other public health services required by the recently revised 22 M.R.S. Chapter 601. This rule repeals and replaces 10-144 C.M.R. Chapter 257 and repeals 10-144 C.M.R. Chapter 233. This rule establishes a fee schedule for testing and services performed by HETL based on the average cost of providing the service and serves to: 1) Update the charges for analytical testing, including chemical, microbiology, water quality, environmental, radiation, lead, and forensic testing, and other public services performed by HETL according to a rate setting methodology to determine the average cost of the service; 2) Set the additional charge of $2 that may be applied to the cost for residential private drinking water well test orders; 3) Establish administrative charges for licensing, manual data entry for all clinical submissions not sent electronically, and collection of overdue payment; 4) Amend the list of testing services available (i.e., add new tests and services and remove certain tests and services no longer available through HETL); 5) Specify the Department's uniform recommendations for periodic testing of residential private drinking water wells in written outreach material; 6) Require labs to submit electronic orders to HETL and use HL7 messaging, as of January 2022; 7) Clarify the types of services deemed essential to public health; and 8) Clarify considerations for granting fee waivers.

Pursuant to 22 M.R.S. 820(1)(C), this is a major substantive rule. Pursuant to Resolve 2021, ch. 51, the Department of Health and Human Services (Department) finally adopts this new major substantive rule, 10-144 C.M.R. chapter 124, Emergency Medical Services Personnel Reporting Rule.

On April 22, 2020, the Department adopted an emergency major substantive rule, which, per 5 M.R.S. 8073, was effective one year, through April 21, 2021. The Department then proposed a major substantive rule. After the comment period, the rule was provisionally adopted and submitted to the Legislature for its review pursuant to 5 M.R.S. 8072. Resolve ch. 51 authorized final adoption of this rule and directed that immediate enactment of the Resolve was necessary, and therefore directed that the Resolve took effect when approved. The Resolve was approved by the Governor on June 11, 2021. In accordance with 5 M.R.S. 8072(8), the Department has finally adopted this rule within 60 days of the effective date of the legislation approving this rule.

Through its authority in 22 M.R.S. 820(1)(C), the Department is establishing a uniform system of reporting requirements, to enable statewide surveillance of the response capacity of the State of Maine's healthcare workforce, specifically emergency medical service (EMS) personnel, during a declared Extreme Public Health Emergency (22 M.R.S. 802(2-A)). This rule ensures the Departments continued coordination and integration of activities and resources related to emergency medical services, to inform the overall planning, evaluation, coordination, facilitation and operations of an effective comprehensive statewide emergency medical services system.

This rule requires EMS organizations and emergency medical dispatch (EMD) centers to report information about EMS personnel who, during a declared Extreme Public Health Emergency, have been removed from the workforce temporarily because they have been exposed to a Notifiable Disease or Condition, or because they have developed symptoms of a Notifiable Disease, in accordance with the guidance issued by the Department, in partnership with the Department of Public Safety Maine EMS. Under this rule, EMS organizations and EMD centers are responsible for compliance with electronic reporting. Reporting must be completed within 24 hours of when the EMS personnel is removed from service. Reporting of certain subsequent events must also be completed within 24 hours. Information collected specific to EMS personnel, which includes licensed emergency medical service responders, emergency medical transportation services and dispatch, will be used for public health surveillance purposes and will inform decisions regarding healthcare workforce capacity as a key element of a comprehensive and effective emergency medical services system. Accurate and reliable statewide data is essential for coordinating with municipal localities, other State offices, federal emergency management agencies and healthcare systems across the State, in order to prepare for and respond to public health emergency needs.

This emergency amendment allows Department-certified Syringe Services Programs to implement a needs-based distribution model instead of requiring syringes to only be exchanged on a one-to-one basis. Pursuant to 5 MRS 8054, and as further set forth in the Basis Statement, the Department finds that the emergency adoption of 10-144 CMR Ch. 252 is necessary to avoid an immediate threat to public health, safety or general welfare and to comply with PL 2021 ch. 545, An Act to Amend Syringe Services Programs, which became effective on August 8, 2022. This adopted emergency rule is effective September 1, 2022.

In accordance with 5 MRS 8054, the Department is amending 10-144 CMR chapter 264, Immunization Requirements For Healthcare Workers on an emergency basis to immediately add COVID-19 to the list of vaccine-preventable diseases for which employees of a licensed nursing facility, residential care facility, Intermediate Care Facility for Individuals with Intellectual Disabilities (ICF/IID), multi-level healthcare facility, hospital, or home health agency subject to licensure by the State of Maine, Department of Health and Human Services Division of Licensing and Certification must be immunized. In addition, the Department is also requiring Emergency Medical Services Organizations and Dental Health Practices to require all employees to provide proof of immunization against COVID-19. Employees who do not provide proof of immunization must be excluded from the workplace for the duration of the Department's declared public health emergency, currently in effect, which started July 1, 2021. Requiring these healthcare workers to be immunized against COVID-19 is necessary to avoid or mitigate the spread of COVID-19, including, in particular, the Delta variant, which is significantly more contagious than past versions of the virus and poses an immediate threat to public health, safety, and general welfare. Specifically, this requirement will slow the spread of COVID-19, protecting both healthcare workers and the public from infection, serious illness, hospitalization, and/or death. Additionally, this requirement will help to prevent strain on the healthcare system both by limiting the number of hospitalizations as a result of COVID-19 and by protecting individual members of the workforce. The emergency routine technical rule remains in effect for up to ninety (90) days pursuant to 5 MRS 8054(3). To avoid any lapse in this new immunization requirement, the Department is planning to engage in the standard rulemaking process, which will, in addition to other non-emergency changes, propose these changes to become permanent.

This rule is a routine technical rule, except for Section 14 (Fees), which is a major substantive rule, pursuant to 5 M.R.S. 8071(3)(B).

The emergency routine technical rule change expands the list of congenital, genetic and metabolic conditions on Maine's newborn bloodspot screening (NBS) panel to include the following four conditions recently added to the U.S. DHHS Recommended Universal Screening Panel and recommended by the Maine Joint Advisory Committee for Newborn Bloodspot Screening: Pompe (2013) MPS-1 (2105) X-ALD (2015) SMA (2018)

The emergency major substantive rule increases the filter paper fee from $110/per infant tested, to $220/per infant tested. This fee increase is necessary to off-set anticipated costs corresponding to the added conditions (i.e. genetic clinic contracts, resource material, follow- up services and other related program operations).

The Department has determined that adding these four conditions for newborn screening immediately is necessary to avoid an immediate threat to public health, safety or general welfare, as it will reduce mortality and morbidity from certain heritable conditions. The fee increase is necessary to offset anticipated costs corresponding to the added conditions.

EFFECTIVE DATE: March 11, 2021