Routine Technical Rule Proposal: The Department proposes to establish an expanded list of congenital, genetic and metabolic conditions for 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, Mucopolysaccharidosis Type 1 (MPS-1), X-linked Adrenoleukpdystrophy (X-ALD), and Spinal Muscular Atrophy (SMA). This change is consistent with rule changes implemented by emergency rule adoption March 11, 2021 and due to expire within 90 days. Major Substantive Rule Proposal: In this same rulemaking, pursuant to 5 MRS 8072, the Department is also proposing a major substantive rule change to increase the filter paper fee from $110 to $220, which is required for NBS specimen collection. (22-A MRS 210).

On March 11, 2021, the Department adopted an Emergency Routine Technical/Major Substantive Rule with these proposed changes. The purpose of this rulemaking is to make permanent the changes made in the Emergency routine technical rule, and to provisionally adopt this Major Substantive rule. The emergency routine technical rule will be effective for up to 90 days after the effective date, in accordance with 5 M.R.S. 8054(3) However, in accordance with 5 M.R.S. 8073, the emergency Major Substantive rule changes (increasing the filter paper fee) may be in effect for up to twelve months, or until the Maine Legislature has completed its review.

This notice corrects information about the public hearing and comment period. The Notice of Rulemaking provides additional details regarding this rulemaking, including public hearing information. During the comment period, comments may be submitted to the agency contact person identified in the Notice of Agency Rulemaking.

Pursuant to 5 MRS 8072, this major substantive rule is proposed to permanently establish reporting requirements for emergency medical service (EMS) organizations and emergency medical dispatch (EMD) centers during extreme public health emergencies. Although an emergency rule became effective on April 22, 2020, to address potential shortages during the current extreme public health emergency caused by COVID-19, an emergency major substantive rule only remains effective for one year or until the Legislature approves a provisionally-adopted major substantive rule. Information collected under this rule is specific to EMS personnel who are temporarily absent from duty during an extreme public health emergency due to reasons related to exposure or potential exposure to a notifiable condition or disease. EMS personnel include, but are not limited to, licensed EMS responders, medical transportation services and dispatch. Electronic reports must be completed within 24 hours of the removal of the EMS personnel and the individual must be monitored for changes in status that must be reported within 24 hours of the change (e.g., dates of hospitalization, completion of quarantine, return to work, etc.). Information collected will be used for public health purposes and will inform system capacity in the event of a declared extreme public health emergency. The Notice of Rulemaking provides additional details regarding this rulemaking, including public hearing information. During the comment period, comments may be submitted to the agency contact person identified in the Notice of Agency Rulemaking.

The Department is proposing routine technical rule changes to amend 10-144 CMR ch. 264, Immunization for Healthcare Workers, to update exemption requirements following recent law changes; update the definition section to add public health threat and extreme public health emergency and revise Intermediate Care Facility for the Mentally Retarded (ICF/MR) to reflect Intermediate Care Facility for Individuals with Intellectual Disabilities (ICF/IID), aligning with CMS language; remove H1N1 2009-10 immunization requirements; and add seasonal influenza to the list of vaccine preventable diseases for which designated healthcare facility employees must show proof of immunization or documented immunity, or provide appropriate exemption documentation. Rule changes are proposed to clarify the Departments authority to impose control measures due to a public health emergency or an extreme public health emergency, including, but not limited to, requiring vaccinations and exclusions from the workplace to protect public health and minimize the impact from the specific notifiable communicable disease by reducing the potential disease spread by healthcare workers.
................................................................................................................................................ UPDATE: Second Publication - In accordance with 5 MRS sec. 8052 sub-sec 1, a public hearing is scheduled for this rule initially proposed September 30, 2020.

This routine technical rulemaking proposes to permanently establish the changes implemented on a temporary basis by emergency rule requiring designated health care facilities to report information related to emergency preparedness and responsiveness (i.e. the number and type of available beds, medical supply inventory, etc.) and clarifying the Department's authority to directly access provider records through the state health information exchange described at 22 MRS 1711-C(18). Further amendments to this rule propose to: 1) add five additional disease conditions; 2) modify the existing notification for two disease conditions; 3) retire one disease condition from the list; 4) update the human immunodeficiency virus (HIV) testing terminology; 5) clarify laboratories electronic reporting requirements; 6) clarify temporary reporting requirements when the disease or condition can cause serious morbidity or mortality and the report of the disease or condition is necessary to monitor, prevent, or control the disease or condition to protect public health; and 7) clarify the Departments authority to take enforcement action for noncompliance, including referral to the Office of the Attorney General to seek injunctive relief and assess civil fines. Proposed changes also revise the definition section and rule construction; correct grammatical errors; and include other minor technical changes to improve readability and consistency with agency standards. (Hearings requested during the State of Emergency will be conducted in accordance with 1 MRS,403-A (PL 2020 c. 617).

The Maine CDC is proposing an increase of its licensing fees for eating places (excluding municipal licenses, schools, electrologists and senior citizen meal sites), lodging places, campgrounds, combination licenses, youth camps, public pools/spas, tattooist and body piercers. The increases that are proposed in this rule are within the statutory caps or have otherwise been designated routine technical by statute. The Maine CDC has determined that these fee increases are necessary to keep the program solvent, ensuring that inspections continue for the health and safety of people served at facilities licensed through HIP.

The DHHS Maine CDC proposes this new rule to comply with 2019 P.L. Ch. 158, An Act to Strengthen Testing for Lead in School Drinking Water, codified at 22 MRS 2604-B. The Act directs the Department to provisionally adopt a major substantive rule by January 10, 2020 and establish the following: drinking water testing protocols for lead in schools, a standard of lead in school drinking water, abatement and mitigation methods, as well as public notification and reporting protocols.

This rule was enacted to ensure that all State contracts for family planning services included assurances that State contractors were in compliance with federal Title X Program Guidelines for Project Grants for Family Planning Services. Recent changes to the federal Title X Program Guidelines would prevent Maine health care providers who receive Title X funding from informing patients of all available health care options and from making referrals for abortion services. The Department's proposed repeal of this rule will ensure continued access to reproductive health care services by allowing the State to set its own requirements for program standards through contract negotiations with providers. The Rules for Family Planning Funding do not contain enforcement mechanisms; nor does the rule cite any statutory authority for requiring recipients of state family planning funding to comply with federal Title X Program Guidelines.

The Department is proposing to repeal this rule. The Rules for the SSI Children's Program of Services were originally adopted on May 19, 1980. The intent of the rule was to provide medical and health services to children receiving SSI when referred to the program by the Social Security Administration. The rule provides information on eligibility, services provided and reimbursed through the program, provider reimbursement, confidentiality, and rights of appeal. The Maine CDC is proposing to repeal this rule, because these services have long been provided through the DHHS, Office of Child and Family Services and MaineCare. No services are provided pursuant to this rule. Therefore, the Department is proposing to repeal the rule, because it is no longer necessary.

The Rules Establishing Blind Seroprevalence Surveys for Occurrence of HIV in Newborns, 10-144 CMR Ch. 259, was originally adopted to establish procedures for a seroprevalence survey to target public health efforts to control HIV and to ensure the anonymity of all test subjects. This was a study involving newborn bloodspot specimens that occurred between 1988 and 1993. The statute that authorized the Department to adopt this rule was repealed in 1989. P.L. 1989, ch. 487, 12. Accordingly, the Department has determined that the rule needs to be repealed.

The Maine CDC is proposing to repeal this rule. The Prenatal Care Program rule was originally adopted to define and describe the program standards necessary, that encouraged pregnant adolescent women to obtain prenatal care, including those who lacked healthcare insurance or the financial resources necessary to obtain prenatal care. Pregnant women 18 years or younger can become eligible for prenatal services under similar eligibility criteria through 10-144 CMR Chapter 332, MaineCare Eligibility Manual and through the Maine Center for Disease Control and Prevention, Special Supplemental Nutrition Program for Women, Infants, and Children (WIC) program. No services are provided pursuant to this rule. Therefore, the Department has determined that this rule is no longer necessary and is proposing its repeal.