Title 22, Title 22

A hospice provider who provides services to a client in the home of the client or the family of the client or another person shall provide a written policy to the client or family as part of developing the care plan. The written policy must include, but is not limited to, the fol…

A volunteer hospice program must comply with this section and with all provisions of subchapter I that are relevant to a volunteer hospice program. [PL 1993, c. 692, §1 (NEW).] 1. Direct services. At a minimum, a direct service volunteer must: A. Submit a written application; [PL…

It is the intent of the Legislature that uniform systems of reporting health care information be established; that all providers and payors who are required to file reports do so in a manner consistent with these systems; and that, using the least restrictive means practicable fo…

As used in this chapter, unless the context otherwise indicates, the following terms have the following meanings. [PL 1995, c. 653, Pt. A, §2 (NEW); PL 1995, c. 653, Pt. A, §7 (AFF).] 1. Board. "Board" means the Board of Directors of the Maine Health Data Organization established…

The Maine Health Data Organization is established as an independent executive agency. [PL 1995, c. 653, Pt. A, §2 (NEW); PL 1995, c. 653, Pt. A, §7 (AFF).] 1. Objective. The purposes of the organization are to create and maintain a useful, objective, reliable and comprehensive he…

The board has the following powers and duties. [PL 1995, c. 653, Pt. A, §2 (NEW); PL 1995, c. 653, Pt. A, §7 (AFF).] 1. Uniform reporting systems. The board shall establish uniform reporting systems. A. The board shall develop and implement policies and procedures for the collect…

(TEXT EFFECTIVE UNTIL CONTINGENCY: See PL 2013, c. 528, §12) The board shall adopt rules to ensure that payors, providers, prescription drug manufacturers, wholesale drug distributors and pharmacy benefits managers file data as required by section 8704, subsection 1; that users t…

1. Transition funding. 2. Permanent funding. Permanent funding for the organization is provided from reasonable costs, user fees and assessments according to this subsection and as provided by rules adopted by the board. A. Fees may be charged for the reasonable costs of duplicat…

The board shall adopt rules to provide for public access to data and to implement the requirements of this section. [PL 1995, c. 653, Pt. A, §2 (NEW); PL 1995, c. 653, Pt. A, §7 (AFF).] 1. Public access; confidentiality. The board shall adopt rules making available to any person,…

Clinical data must be filed, stored and managed as follows. [PL 1995, c. 653, Pt. A, §2 (NEW); PL 1995, c. 653, Pt. A, §7 (AFF).] 1. Information required. Pursuant to rules adopted by the board for form, medium, content and time for filing, each health care facility shall file wi…

The board shall adopt rules regarding the collection of quality data. The board shall work with the Maine Quality Forum and the Maine Quality Forum Advisory Council established in Title 24‑A, chapter 87, subchapter 2 to develop the rules. The rules must be based on the quality me…

Financial data and scope of service data must be filed, stored and managed as follows. [PL 1999, c. 353, §15 (AMD).] 1. Financial data. Each health care facility shall file with the organization, in a form specified by rule pursuant to section 8704, financial information includin…

Restructuring data must be filed, stored and managed as follows. [PL 1995, c. 653, Pt. A, §2 (NEW); PL 1995, c. 653, Pt. A, §7 (AFF).] 1. Major structural changes. The board may require providers and payors to report the occurrence of major structural changes relevant to the rest…

1. Development of health care information systems. In addition to its authority to obtain information to carry out the specific provisions of this chapter, the organization may require providers and payors to furnish information with respect to the nature and quantity of services…

The organization shall produce clearly labeled and easy-to-understand reports as follows. Unless otherwise specified, the organization shall distribute the reports on a publicly accessible site on the Internet or via mail or e-mail, through the creation of a list of interested pa…

The board shall adopt rules to provide for public access to data allowed under this chapter and to implement the requirements of this section. [PL 2013, c. 528, §10 (NEW); PL 2013, c. 528, §12 (AFF).] 1. Confidentiality. All data collected by the organization that contain protect…

1. Permitted use and disclosure to public health authorities. The organization may disclose protected health information, without an individual's authorization, to a public health authority for public health purposes mandated by state or federal law. 2. Use by public health autho…

1. Reporting; joint rule-making authority. The organization and the Department of Health and Human Services may adopt a joint rule to require the reporting to the organization of data from the cancer-incidence registry established pursuant to section 1404 and data related to the …

The board may approve the disclosure of protected health information to persons conducting health care improvement studies, subject to the following conditions. [PL 2013, c. 528, §10 (NEW); PL 2013, c. 528, §12 (AFF).] 1. Disclosure to study entities. For health care improvement …

1. Permitted uses and disclosures; definitions. The organization may disclose protected health information without authorization by the subject of the information for the treatment activities of any health care provider, the payment activities of a covered entity and of any healt…

The Maine Health Data Organization Health Information Advisory Committee, referred to in this section as "the advisory committee," is established in accordance with this section to make recommendations to the organization regarding public reporting of health care trends developed…

1. Provider database. The organization shall develop and maintain a multipayor provider database that must be used by the department to provide information for a service locator available on a publicly accessible website for use by the public, by providers and by state agencies i…

As used in this subchapter, unless the context otherwise indicates, the following terms have the following meanings. [PL 2019, c. 470, §8 (NEW).] 1. Brand-name drug. "Brand-name drug" means a prescription drug marketed under a proprietary name or registered trademark name, includ…

1. Notifications by manufacturers. 1-A. Public notice of substantial drug price change or introduction. No later than January 30, 2022 and annually thereafter, the organization shall produce and post on its publicly accessible website a list of prescription drugs for which the ma…

Information provided to the organization as required by this subchapter by a manufacturer, wholesale drug distributor or pharmacy benefits manager is confidential and not a public record under Title 1, chapter 13, except that the organization may share information: [PL 2019, c. 4…

Beginning January 1, 2020, manufacturers, wholesale drug distributors and pharmacy benefits managers subject to this subchapter shall register annually with the organization in a manner prescribed by the organization.

1. Certification of accuracy. A manufacturer, wholesale drug distributor or pharmacy benefits manager that submits a notification or report to the organization pursuant to this subchapter shall submit with the notification or report a signed written certification of the notificat…

Beginning November 1, 2020 and annually thereafter, the organization shall produce and post on its publicly accessible website an annual report, including information developed from the disclosures received pursuant to this subchapter on trends in the cost of prescription drugs, …

The organization may adopt rules to implement this subchapter. Rules adopted pursuant to this section are major substantive rules as defined in Title 5, chapter 375, subchapter 2‑A.

1. Definitions. As used in this section, unless the context otherwise indicates, the following terms have the following meanings. A. "Manufacturer" has the same meaning as in section 8731, subsection 3. [PL 2021, c. 606, §1 (NEW).] B. "Prescription drug" has the same meaning as i…

There is established under this chapter a system for reporting sentinel events for the purpose of improving the quality of health care and increasing patient safety.

As used in this chapter, unless the context otherwise indicates, the following terms have the following meanings. [PL 2001, c. 678, §1 (NEW); PL 2001, c. 678, §3 (AFF).] 1. Division. "Division" means the department's division of licensing and certification. 2. Health care facilit…

A health care facility shall notify the division whenever a sentinel event has occurred, as provided in this chapter. [PL 2009, c. 358, §2 (AMD).] 1. Notification. Using the sentinel event notification process under this chapter, a health care facility shall notify the division o…

A health care facility shall have a written standardized procedure for the identification of sentinel events. The division shall develop the standardized reporting and notification procedures by adoption of routine technical rules under Title 5, chapter 375, subchapter 2-A.

The division has the following duties under this chapter. [PL 2001, c. 678, §1 (NEW); PL 2001, c. 678, §3 (AFF).] 1. Initial review; other action. Upon receipt of a notification or report of a suspected sentinel event the division shall determine whether the event constitutes a s…

1. Oversight. The division shall place primary emphasis on ensuring effective corrective action by the facility. The division may conduct on-site visits to health care facilities to determine compliance with this chapter. 2. Penalties. When the division determines that a health c…

The department shall adopt rules to implement this chapter. Rules adopted pursuant to this section are routine technical rules as defined in Title 5, chapter 375, subchapter II‑A.

All hospitals licensed under chapter 405 shall: [PL 2011, c. 316, §1 (RPR).] 1. Enrollment. No later than October 1, 2011, enroll and shall maintain enrollment after that date in the National Healthcare Safety Network within the United States Department of Health and Human Servic…

There is established within the department the Newborn Hearing Program, referred to in this chapter as the "program," to enable children and their families and caregivers to obtain information regarding hearing screening and evaluation and to learn about treatment and interventio…

1. Definitions. As used in this chapter, unless the context indicates otherwise, the following terms have the following meanings. A. "Birth admission" means the time after birth that the newborn remains in the hospital nursery prior to discharge. [PL 1999, c. 647, §2 (NEW).] B. "…

The Newborn Hearing Screening Advisory Board, as established in Title 5, section 12004-G, subsection 14-C, is created to provide oversight and advice on the program. The department shall provide administrative support services required by the board. [PL 1999, c. 647, §2 (NEW).] 1…

The department is authorized to implement a tracking system that provides the information necessary to effectively plan, establish and evaluate a comprehensive system of developmentally appropriate services for newborn infants and children up to 3 years of age who are deaf or har…

The department shall adopt rules as required to implement this chapter. Rules adopted pursuant to this section are routine technical rules as defined by Title 5, chapter 375, subchapter II‑A.

There is established, within the Bureau of Health, the Birth Defects Program, referred to in this chapter as the "program," to identify and investigate birth defects in children. The program shall identify and research birth defects in children and maintain a central registry of …

The department may conduct investigations and inspections, including medical, demographic, environmental, epidemiological and toxicological investigations, of current or past cases of suspected birth defects in order to determine the nature and extent of disease or known or suspe…

The department shall establish and maintain a central registry for cases of birth defects to accomplish the purposes of this chapter and facilitate research on birth defects. The submission of information to and distribution of information from the central registry are subject to…