In this subtitle the following words have the meanings indicated. “Adverse decision” means a utilization review determination made by a private review agent that a proposed or delivered health care service: is or was not medically necessary, appropriate, or efficient; and may result in noncoverage of the health care service. “Adverse decision” includes a utilization review determination based on a prior authorization or step therapy requirement. “Adverse decision” does not include a decision concerning a subscriber’s status as a member. “Certificate” means a certificate of registration granted by the Commissioner to a private review agent. “Employee assistance program” means a health care service plan that, in accordance with a contract with an employer or labor union: consults with employees or members of an employee’s family or both to: identify the employee’s or the employee’s family member’s mental health, alcohol, or substance abuse problems; and refer the employee or the employee’s family member to health care providers or other community resources for counseling, therapy, or treatment; and performs utilization review for the purpose of making claims or payment decisions on behalf of the employer’s or labor union’s health insurance or health benefit plan. “Employee assistance program” does not include a health care service plan operated by a hospital solely for employees, or members of an employee’s family, of that hospital. “Grievance” means a protest filed by a patient or a health care provider on behalf of a patient with a private review agent through the private review agent’s internal grievance process regarding an adverse decision concerning a patient. “Grievance” does not include a verbal request for reconsideration of a utilization review determination. “Grievance decision” means a final determination by a private review agent that arises from a grievance filed with the private review agent under its internal grievance process regarding an adverse decision concerning a patient. “Health care facility” means: a hospital as defined in § 19–301 of the Health – General Article; a related institution as defined in § 19–301 of the Health – General Article; an ambulatory surgical facility or center which is any entity or part thereof that operates primarily for the purpose of providing surgical services to patients not requiring hospitalization and seeks reimbursement from third party payors as an ambulatory surgical facility or center; a facility that is organized primarily to help in the rehabilitation of disabled individuals; a home health agency as defined in § 19–401 of the Health – General Article; a hospice as defined in § 19–901 of the Health – General Article; a facility that provides radiological or other diagnostic imagery services; a medical laboratory as defined in § 17–201 of the Health – General Article; or an alcohol abuse and drug abuse treatment program as defined in § 8–403 of the Health – General Article. “Health care provider” means: an individual who: is licensed or otherwise authorized to provide health care services in the ordinary course of business or practice of a profession; and is a treating provider of a patient; or a hospital, as defined in § 19–301 of the Health – General Article. “Health care service” means a health or medical care procedure or service rendered by a health care provider licensed or authorized to provide health care services that: provides testing, diagnosis, or treatment of a human disease or dysfunction; dispenses drugs, medical devices, medical appliances, or medical goods for the treatment of a human disease or dysfunction; or provides any other care, service, or treatment of disease or injury, the correction of defects, or the maintenance of the physical and mental well–being of human beings. “Health care service reviewer” means an individual who is licensed or otherwise authorized to provide health care services in the ordinary course of business or practice of a profession. “Private review agent” means: a nonhospital–affiliated person or entity performing utilization review that is either affiliated with, under contract with, or acting on behalf of: a Maryland business entity; or a third party that pays for, provides, or administers health care services to citizens of this State; or any person or entity including a hospital–affiliated person performing utilization review for the purpose of making claims or payment decisions for health care services on behalf of the employer’s or labor union’s health insurance plan under an employee assistance program for employees other than the employees employed by: the hospital; or a business wholly owned by the hospital. “Significant beneficial interest” means the ownership of any financial interest that is greater than the lesser of: 5 percent of the whole; or $5,000. “Utilization review” means a system for reviewing the appropriate and efficient allocation of health care resources and services given or proposed to be given to a patient or group of patients. “Utilization review plan” means a description of the standards governing utilization review activities performed by a private review agent.

The purpose of this subtitle is to: promote the delivery of quality health care in a cost effective manner that ensures timely access to health care services; foster greater coordination, communication, and transparency between payors, patients, and providers conducting utilization review activities; protect patients, business, and providers by ensuring that private review agents are qualified to perform utilization review activities and to make informed decisions on the appropriateness of medical care; and ensure that private review agents maintain the confidentiality of medical records in accordance with applicable State and federal laws.

A private review agent may not conduct utilization review in this State unless the Commissioner has granted the private review agent a certificate. The Commissioner shall issue a certificate to an applicant that has met all the requirements of this subtitle and all applicable regulations of the Commissioner. A certificate issued under this subtitle is not transferable. The Commissioner may consider an applicant as having met a particular certification requirement under this subtitle if: the applicant has obtained utilization management accreditation from an approved accrediting organization as determined by the Commissioner; the approved accrediting organization has requirements that meet or exceed the particular requirement in this subtitle; and the applicant demonstrates that the applicant meets or exceeds the particular requirement under this subtitle. The Commissioner may adopt regulations to implement the provisions of this section. The Commissioner may not issue a certificate to an applicant with utilization management accreditation by an approved accrediting organization unless the applicant meets all the requirements of this subtitle and all applicable regulations of the Commissioner. A report of an approved accrediting organization used by the Commissioner as evidence that the applicant has met a particular requirement for a private review agent certificate shall be made available by the Commissioner to the public on request. The Commissioner, after consultation with payors, including the Health Insurance Association of America, the League of Life and Health Insurers of Maryland, and the Maryland Association of Health Plans, and providers of health care, including the MHA: the Association of Maryland Hospitals and Health Systems, CareFirst BlueCross BlueShield, the Medical and Chirurgical Faculty of Maryland, and licensed or certified providers of treatment for a mental illness, emotional disorder, or a drug abuse or alcohol abuse disorder, shall adopt regulations to implement the provisions of this subtitle. Subject to the provisions of subparagraph (iii) of this paragraph, the regulations adopted by the Commissioner shall include a uniform treatment plan form for utilization review of services for the treatment of a mental illness, emotional disorder, or a substance abuse disorder. The uniform treatment plan form adopted by the Commissioner: shall adequately protect the confidentiality of the patient; and may only request the patient’s membership number, policy number, or other similar unique patient identifier and first name for patient identification. The Commissioner may waive the requirements of regulations adopted under subparagraph (i) of this paragraph for the use of a uniform treatment plan form for any entity that would be using the form solely for internal purposes.

An applicant for a certificate shall: submit an application to the Commissioner; and pay to the Commissioner the application fee established by the Commissioner through regulation. The application shall: be on a form and accompanied by any supporting documentation that the Commissioner requires; and be signed and verified by the applicant. The fees required under subsection (a)(2) of this section or § 15-10B-10(b)(2) of this subtitle shall be sufficient to pay for the administrative costs of the certificate program and any other costs associated with carrying out the provisions of this subtitle.

In conjunction with the application, the private review agent shall submit information that the Commissioner requires including: a utilization review plan that includes: the specific criteria and standards to be used in conducting utilization review of proposed or delivered health care services; those circumstances, if any, under which utilization review may be delegated to a hospital utilization review program; and if applicable, any provisions by which patients or physicians, hospitals, or other health care providers may seek reconsideration; the type and qualifications of the personnel either employed or under contract to perform the utilization review; a copy of the private review agent’s internal grievance process if a carrier delegates its internal grievance process to the private review agent in accordance with § 15–10A–02(l) of this title; the procedures and policies to ensure that a representative of the private review agent is reasonably accessible to patients and health care providers 7 days a week, 24 hours a day in this State including having a direct telephone number and monitored e–mail address as required in subsection (e) of this section; if applicable, the procedures and policies to ensure that a representative of the private review agent is accessible to health care providers to make all determinations on whether to authorize or certify an emergency inpatient admission, or an admission for residential crisis services as defined in § 15–840 of this title, for the treatment of a mental, emotional, or substance abuse disorder within 2 hours after receipt of the information necessary to make the determination; the policies and procedures to ensure that all applicable State and federal laws to protect the confidentiality of individual medical records are followed; a copy of the materials designed to inform applicable patients and providers of the requirements of the utilization review plan; a list of the third party payors for which the private review agent is performing utilization review in this State; the policies and procedures to ensure that the private review agent has a formal program for the orientation and training of the personnel either employed or under contract to perform the utilization review; a list of the persons involved in establishing the specific criteria and standards to be used in conducting utilization review, including each person’s board certification or practice specialty, licensure category, and title within the person’s organization; and certification by the private review agent that the criteria and standards to be used in conducting utilization review are generally recognized by health care providers practicing in the relevant clinical specialties and are: objective; clinically valid; reflected in published peer–reviewed scientific studies and medical literature; developed by: a nonprofit health care provider professional medical or clinical specialty society, including through the use of patient placement criteria and clinical practice guidelines; or for criteria not within the scope of a nonprofit health care provider professional medical or clinical specialty society, an organization that works directly with health care providers in the same specialty for the designated criteria who are employed or engaged within the organization or outside the organization to develop the clinical criteria, if the organization: does not receive direct payments based on the outcome of the utilization review; and demonstrates that its clinical criteria are consistent with criteria and standards generally recognized by health care providers practicing in the relevant clinical specialties; recommended by federal agencies; approved by the federal Food and Drug Administration as part of drug labeling; taking into account the needs of atypical patient populations and diagnoses, including the unique needs of children and adolescents; sufficiently flexible to allow deviations from norms when justified on a case–by–case basis, including the need to use an off–label prescription drug; ensuring quality of care of health care services; reviewed, evaluated, and updated at least annually and as necessary to reflect any changes; and in compliance with any other criteria and standards required for coverage under this title, including compliance with § 15–802(d) of this title for the treatment of substance use disorders. The private review agent shall: post on the member’s and provider’s pages of its website or the carrier’s website the specific criteria and standards to be used in conducting utilization review of proposed or delivered services and any subsequent revisions, modifications, or additions to the specific criteria and standards to be used in conducting utilization review of proposed or delivered services; and on the request of a person, including a health care facility, provide a copy of the information specified under item (1) of this subsection to the person making the request. The private review agent may charge a reasonable fee for a hard copy of the specific criteria and standards or any subsequent revisions, modifications, or additions to the specific criteria to any person or health care facility requesting a copy under subsection (b)(2) of this section. A private review agent shall advise the Commissioner, in writing, of a change in: ownership, medical director, or chief executive officer within 30 days of the date of the change; the name, address, or telephone number of the private review agent within 30 days of the date of the change; or the private review agent’s scope of responsibility under a contract. A private review agent shall: have available the following dedicated to utilization review: a direct telephone number that is not the general customer call number; and a monitored e–mail address; and except where a shorter time period is otherwise required under this title, respond to voicemails or e–mails within 2 business days after receipt of the voicemail or e–mail. The telephone number and e–mail address shall be prominently displayed on the notices required under § 15–10A–02(f) and (i) of this title.

In this section the following words have the meanings indicated. “Artificial intelligence” means an engineered or machine–based system that varies in its level of autonomy and that can, for explicit or implicit objectives, infer from the input it receives how to generate outputs that can influence physical or virtual environments. “Carrier” means: an insurer; a nonprofit health service plan; a health maintenance organization; a dental plan organization; or any other person that provides health benefit plans subject to regulation by the State. This section applies to: a carrier that: uses an artificial intelligence, algorithm, or other software tool for the purpose of utilization review; or contracts with or otherwise works through an entity that uses an artificial intelligence, algorithm, or other software tool for the purpose of utilization review; and a pharmacy benefits manager or private review agent that: contracts with a carrier to provide utilization review on behalf of the carrier; and uses an artificial intelligence, algorithm, or other software tool for the purpose of conducting utilization review on behalf of the carrier. Subject to subsection (d) of this section, an entity subject to this section shall ensure that: an artificial intelligence, algorithm, or other software tool bases its determinations on: an enrollee’s medical or other clinical history; individual clinical circumstances as presented by a requesting provider; or other relevant clinical information contained in the enrollee’s medical or other clinical record; an artificial intelligence, algorithm, or other software tool does not base its determinations solely on a group dataset; the criteria and guidelines for using an artificial intelligence, algorithm, or other software tool for making determinations comply with the requirements of this title; an artificial intelligence, algorithm, or other software tool does not replace the role of a health care provider in the determination process under § 15–10B–07 of this subtitle; the use of an artificial intelligence, algorithm, or other software tool does not result in unfair discrimination; an artificial intelligence, algorithm, or other software tool is fairly and equitably applied, including in accordance with any applicable regulations and guidance issued by the federal Department of Health and Human Services; an artificial intelligence, algorithm, or other software tool is open to inspection for audit or compliance reviews by the Commissioner; written policies and procedures are included in the utilization plan submitted under § 15–10B–05 of this subtitle, including how an artificial intelligence, algorithm, or other software tool will be used and what oversight will be provided; the performance, use, and outcomes of an artificial intelligence, algorithm, or other software tool are reviewed and revised, if necessary and at least on a quarterly basis, to maximize accuracy and reliability; patient data is not used beyond its intended and stated purpose, consistent with the federal Health Insurance Portability and Accountability Act of 1996, as applicable; and an artificial intelligence, algorithm, or other software tool does not directly or indirectly cause harm to an enrollee. An artificial intelligence, algorithm, or other software tool may not deny, delay, or modify health care services.

Except as otherwise provided in this subsection, a private review agent shall: make all initial determinations on whether to authorize or certify a nonemergency course of treatment or health care service, including pharmaceutical services not submitted electronically, for a patient within 2 working days after receipt of the information necessary to make the determination; make all determinations on whether to authorize or certify an extended stay in a health care facility or additional health care services within 1 working day after receipt of the information necessary to make the determination; make all determinations to authorize or certify a request for additional visits or days of care submitted as part of an existing course of treatment or treatment plan within 1 working day after receipt of the information necessary to make the determination; and promptly notify the health care provider of the determination. After receipt of the initial request for health care services and confirming through a complete review of information already submitted by the health care provider, if the private review agent determines that the private review agent does not have sufficient information to make a determination, the private review agent shall promptly, but not later than 3 calendar days after receipt of the initial request, inform the health care provider that additional information must be provided by specifying: the information, including any lab or diagnostic test or other medical information, that must be submitted to complete the request; and the criteria and standards to support the need for additional information. If a private review agent requires prior authorization for an emergency inpatient admission, or an admission for residential crisis services as defined in § 15–840 of this title, for the treatment of a mental, emotional, or substance abuse disorder, the private review agent shall: make all determinations on whether to authorize or certify an inpatient admission, or an admission for residential crisis services as defined in § 15–840 of this title, within 2 hours after receipt of the information necessary to make the determination; if additional information is needed, promptly request the specific information needed, including any lab or diagnostic test or other medical information; and promptly notify the health care provider of the determination. For a step therapy exception request submitted electronically in accordance with a process established under § 15–142(f) of this title or a prior authorization request submitted electronically for pharmaceutical services, a private review agent shall make a determination: in real time if: no additional information is needed by the private review agent to process the request; and the request meets the private review agent’s criteria for approval; or if a request is not approved in real time under item (i) of this paragraph, within 1 working day after the private review agent receives all of the information necessary to make the determination. If additional information is needed to make a determination after confirming through a complete review of the information already submitted by the health care provider, the private review agent shall request the information promptly, but not later than 3 calendar days after receipt of the initial request, by specifying: the information, including any lab or diagnostic test or other medical information, that must be submitted to complete the request; and the criteria and standards to support the need for the additional information. Except as provided in subsections (g) and (h) of this section, a private review agent shall make initial determinations on whether to authorize or certify an emergency course of treatment or health care service for a member within 24 hours after the initial request after receipt of the information necessary to make the determination. If the private review agent determines that additional information is needed after confirming through a complete review of the information already submitted by the health care provider, the private review agent shall: promptly request the specific information needed, including any lab or diagnostic test or other medical information; and promptly, but not later than 2 hours after receipt of the information, notify the health care provider of an authorization or certification determination when made by the private review agent. A private review agent shall initiate the expedited procedure for an emergency case if the patient or the patient’s representative requests or if the health care provider attests that the services are necessary to treat a condition or illness that, without immediate medical attention, would: seriously jeopardize the life or health of the member or the member’s ability to regain maximum functions; cause the member to be in danger to self or others; or cause the member to continue using intoxicating substances in an imminently dangerous manner. If a private review agent fails to make a determination within the time limits required under this section, the request shall be deemed approved. If an initial determination is made by a private review agent not to authorize or certify a health care service and the health care provider believes the determination warrants an immediate reconsideration, a private review agent shall provide the health care provider the opportunity to speak with the physician that rendered the determination, by telephone on an expedited basis, within a period of time not to exceed 24 hours of the health care provider seeking the reconsideration. If the physician is unable to immediately speak with the health care provider seeking the reconsideration, the physician shall provide the health care provider with the following contact information for the health care provider to use to contact the physician: a direct telephone number that is not the general customer call number; or a monitored e–mail address that is dedicated to communication related to utilization review. For emergency inpatient admissions, a private review agent may not render an adverse decision solely because the hospital did not notify the private review agent of the emergency admission within 24 hours or other prescribed period of time after that admission if the patient’s medical condition prevented the hospital from determining: the patient’s insurance status; and if applicable, the private review agent’s emergency admission notification requirements. Subject to paragraph (2) of this subsection, a private review agent may not render an adverse decision as to an admission of a patient during the first 24 hours after admission when: the admission is based on a determination that the patient is in imminent danger to self or others; the determination has been made by the patient’s physician or psychologist in conjunction with a member of the medical staff of the facility who has privileges to make the admission; and the hospital immediately notifies the private review agent of: the admission of the patient; and the reasons for the admission. A private review agent may not render an adverse decision as to an admission of a patient to a hospital for up to 72 hours, as determined to be medically necessary by the patient’s treating physician, when: the admission is an involuntary admission under §§ 10–615 and 10–617(a) of the Health – General Article; and the hospital immediately notifies the private review agent of: the admission of the patient; and the reasons for the admission. A private review agent that requires a health care provider to submit a treatment plan in order for the private review agent to conduct utilization review of proposed or delivered services for the treatment of a mental illness, emotional disorder, or a substance abuse disorder: shall accept: the uniform treatment plan form adopted by the Commissioner under § 15–10B–03(d) of this subtitle as a properly submitted treatment plan form; or if a service was provided in another state, a treatment plan form mandated by the state in which the service was provided; and may not impose any requirement to: modify the uniform treatment plan form or its content; or submit additional treatment plan forms. A uniform treatment plan form submitted under the provisions of this subsection: shall be properly completed by the health care provider; and may be submitted by electronic transfer.

Except as provided in paragraphs (2) and (3) of this subsection, all adverse decisions shall be made by a licensed physician, or a panel of other appropriate health care service reviewers with at least one physician on the panel, who is: board certified or eligible in the same specialty as the treatment under review; and knowledgeable about the requested health care service or treatment through actual clinical experience. When the health care service under review is a mental health or substance abuse service, the adverse decision shall be made by a licensed physician, or a panel of other appropriate health care service reviewers with at least one licensed physician, selected by the private review agent who: is board certified or eligible in the same specialty as the treatment under review; or is actively practicing or has demonstrated expertise in the substance abuse or mental health service or treatment under review. When the health care service under review is a dental service, the adverse decision shall be made by a licensed dentist, or a panel of other appropriate health care service reviewers with at least one licensed dentist on the panel who is knowledgeable about the requested health care service or treatment through actual clinical experience. All adverse decisions shall be made by a physician or a panel of other appropriate health care service reviewers who are not compensated by the private review agent in a manner that violates § 19–705.1 of the Health – General Article or that deters the delivery of medically appropriate care. Except as provided in subsection (d) of this section, if a course of treatment has been preauthorized or approved for a patient, a private review agent may not retrospectively render an adverse decision regarding the preauthorized or approved services delivered to that patient. A private review agent may retrospectively render an adverse decision regarding preauthorized or approved services delivered to a patient if: the information submitted to the private review agent regarding the services to be delivered to the patient was fraudulent or intentionally misrepresentative; critical information requested by the private review agent regarding services to be delivered to the patient was omitted such that the private review agent’s determination would have been different had the agent known the critical information; or the planned course of treatment for the patient that was approved by the private review agent was not substantially followed by the provider. If a course of treatment has been preauthorized or approved for a patient, a private review agent may not revise or modify the specific criteria or standards used for the utilization review to make an adverse decision regarding the services delivered to that patient.

If a carrier delegates its internal grievance process to a private review agent, the private review agent shall establish an internal grievance process for its patients and health care providers acting on behalf of a patient. A private review agent’s internal grievance process shall meet the same requirements established under §§ 15-10A-02 through 15-10A-05 of this title. A private review agent may not charge a fee to a patient or health care provider for filing a grievance.

In this section, “attending provider” means an obstetrician, pediatrician, or other physician or certified nurse midwife or pediatric nurse practitioner attending the mother or newborn child. Except as provided in subsections (c) and (d) of this section, the criteria and standards used by a private review agent or health maintenance organization in performing utilization review of hospital services related to maternity and newborn care, including length of stay, shall be in accordance with the medical criteria outlined in the most current version of the “Guidelines for Perinatal Care” prepared by the American Academy of Pediatrics and the American College of Obstetricians and Gynecologists. Subject to the provisions of subsection (d) of this section, a private review agent or health maintenance organization performing utilization review of hospital services related to maternity and newborn care shall authorize a minimum coverage of: 48 hours of inpatient hospitalization care following an uncomplicated vaginal delivery; and 96 hours of inpatient hospitalization care following an uncomplicated cesarean section. The private review agent or health maintenance organization may authorize a shorter length of stay than that provided in subsection (c) of this section if the mother, in consultation with her attending provider, decides that less time is needed for recovery. For a mother and newborn child who have a hospital stay shorter in length than that provided under subsection (c) of this section, the private review agent or health maintenance organization performing utilization review shall authorize: one home visit scheduled to occur within 24 hours after hospital discharge; and an additional home visit as may be prescribed by the attending provider. For a mother and newborn child who remain in the hospital for at least the period of time provided under subsection (c) of this section, the private review agent or health maintenance organization performing utilization review shall authorize a home visit as may be prescribed by the attending provider. A home visit under paragraph (2) or (3) of this subsection shall: be provided in accordance with generally accepted standards of nursing practice for home care of a mother and newborn child; be provided by a registered nurse with at least 1 year of experience in maternal and child health nursing or in community health nursing with an emphasis on maternal and child health; and include any services required by the attending provider. The private review agent or health maintenance organization may not require additional documentation from, require additional utilization review of, or otherwise provide financial disincentives for an attending provider who orders care for which coverage is required to be provided under this section, § 19-703 of the Health - General Article, or § 15-811 of this title. The private review agent, hospital, or health maintenance organization may not deny, limit, or otherwise impair the participation of an attending provider under a contract or any privilege granted an attending provider who advocates more than 48 hours of inpatient hospital care following a complicated vaginal delivery or more than 96 hours of inpatient hospital care following a complicated cesarean section.

A grievance decision shall be made based on the professional judgment of: a licensed physician who is board certified or eligible in the same specialty as the treatment under review and knowledgeable about the requested health care service or treatment through actual clinical experience; or a panel of other appropriate health care service reviewers with at least one licensed physician on the panel who is board certified or eligible in the same specialty as the treatment under review and knowledgeable about the requested health care service or treatment through actual clinical experience; when the grievance decision involves a dental service, a licensed dentist, or a panel of appropriate health care service reviewers with at least one dentist on the panel who is a licensed dentist, who shall consult with a dentist who is board certified or eligible in the same specialty as the service under review and knowledgeable about the requested health care service or treatment through actual clinical experience; or when the grievance decision involves a mental health or substance abuse service: a licensed physician who: is board certified or eligible in the same specialty as the treatment under review; or is actively practicing or has demonstrated expertise in the substance abuse or mental health service or treatment under review; or a panel of other appropriate health care service reviewers with at least one licensed physician, selected by the private review agent who: is board certified or eligible in the same specialty as the treatment under review; or is actively practicing or has demonstrated expertise in the substance abuse or mental health service or treatment under review.

A certificate expires on the second anniversary of its effective date unless the certificate is renewed for a 2-year term as provided in this section. Before the certificate expires, a certificate may be renewed for an additional 2-year term if the applicant: otherwise is entitled to the certificate; pays to the Commissioner the renewal fee set by the Commissioner through regulation; and submits to the Commissioner: a renewal application on the form that the Commissioner requires; and satisfactory evidence of compliance with any requirement under this subtitle for certificate renewal. If the requirements of this section are met, the Commissioner shall renew a certificate.

A private review agent may not: violate any provision of this subtitle or any rule or regulation adopted under this subtitle; fail to meet the requirements for certification under this subtitle; obtain or attempt to obtain certification based on inaccurate information; fraudulently or deceptively obtain or use a certificate; fail to make available the services of sufficient numbers of registered nurses, medical records technicians, or similarly qualified persons supported and supervised by appropriate physicians to carry out its utilization review activities; fail to meet any applicable regulations the Commissioner adopts under this subtitle relating to the qualifications of private review agents or the performance of utilization review; fail to protect the confidentiality of medical records in accordance with applicable State and federal laws; use criteria and standards to conduct utilization review unless the criteria and standards used by the private review agent are: objective; clinically valid; compatible with established principles of health care; or flexible enough to allow deviations from norms when justified on a case-by-case basis; or act as a private review agent without holding a certificate issued under this subtitle.

A person who violates any provision of § 15-10B-11 of this subtitle is guilty of a misdemeanor and on conviction is subject to a penalty not exceeding $1,000. Each day a violation is continued after the first conviction is a separate offense. In addition to the provisions of subsection (a) of this section, if any person violates any provision of § 15-10B-11 of this subtitle, the Commissioner may: deny, suspend, or revoke the certificate to do business as a private review agent; issue an order to cease and desist from acting as a private review agent without holding a certificate issued under this subtitle; require a private review agent to make restitution to a patient who has suffered actual economic damage because of the violation; and impose an administrative penalty of up to $5,000 for each violation of any provision of this subtitle.

Any person aggrieved by an order of the Commissioner under this subtitle has the right to a hearing and the right to appeal from the action of the Commissioner in accordance with §§ 2-210 through 2-215 of this article.

The Commissioner may waive the requirements of this subtitle for a private review agent that operates solely under contract with the federal government for utilization review of patients eligible for hospital services under Title XVIII of the Social Security Act.

The Commissioner shall periodically provide a list of private review agents issued certificates and the renewal date for those certificates to any person on request.

The Commissioner may establish reporting requirements to: evaluate the effectiveness of private review agents; and determine if the utilization review programs are in compliance with the provisions of this section and applicable regulations.

Except as provided in paragraph (2) of this subsection, this section does not apply to: a private review agent referring an individual to a health care provider or facility that participates in a health maintenance organization; a preferred provider organization network of participating health care providers or facilities to which the individual would otherwise be referred as part of the individual’s membership or insurance contract; or an employee assistance program referring an individual to a network of participating health care providers or facilities in accordance with a contract with the individual’s employer or labor union to provide comprehensive mental health and substance abuse services. A private review agent or any other individual who is either affiliated with, under contract with, or acting on behalf of a private review agent may not approve or fail to approve a course of treatment based on whether the treatment is delivered by a provider who is a participating or nonparticipating provider in the preferred provider organization or employee assistance program network. A private review agent or any individual who is either affiliated with, under contract with, or acting on behalf of a private review agent may not: refer a patient who has undergone utilization review by the private review agent to: a health care facility in which the private review agent owns a significant beneficial interest; or the private review agent’s own health care practice; pay or agree to pay any sum to, or accept or agree to accept any sum from, any person for bringing or referring a patient to the private review agent; or provide for different insurance coverage or benefits based on receiving the service from a health care facility or health care provider in which the private review agent owns a significant beneficial interest. A private review agent or any individual who is either affiliated with, under contract with, or acting on behalf of a private review agent may refer a patient who has undergone utilization review by the private review agent to another health care provider regulated under the Health Occupations Article if: the patient or provider requests the private review agent to provide the patient with the name of a health care provider appropriate to meet the health care needs of the patient; or the patient has no attending physician; and the private review agent provides the patient with the names of at least two health care providers appropriate to meet the health care needs of the patient.

A private review agent shall advise the Commissioner, in writing, of its intention to withdraw its certificate within 60 days of intention to cease operations as a private review agent. A private review agent shall submit its certificate to the administration within 30 days after the date that the private review agent ceased operations.

Whenever the Commissioner considers it advisable, the Commissioner shall examine the affairs, transactions, accounts, records, and assets of each private review agent at least once every 5 years. The Commissioner shall examine the affairs, transactions, accounts, records, and assets of each private review agent that applies for a certificate of registration under § 15-10B-03 of this subtitle. The examination shall be conducted in accordance with § 2-207 of this article. The expense of the examination shall be paid in accordance with § 2-208 of this article. The reports of the examination and investigation shall be issued in accordance with § 2-209 of this article.

In addition to the requirements under § 15-10B-19 of this subtitle, the Commissioner shall conduct an examination of any pharmacy benefit manager registered as a private review agent to determine whether the pharmacy benefit manager is acting in compliance with this subtitle. The examination shall be conducted: in accordance with § 2-207 of this article; and at least once every 3 years. The expense of the examination shall be paid in accordance with § 2-208 of this article. The reports of the examination shall be issued in accordance with § 2-209 of this article. Within 30 days after the completion of a final report of an examination under this section, the Commissioner shall submit a copy of the report to the Senate Finance Committee and the House Health and Government Operations Committee in accordance with § 2–1257 of the State Government Article.

The Commissioner may conduct an examination of a carrier that has issued a pattern of adverse decisions or grievance decisions for a claim or authorization request for services in, or related to services in, an emergency department. A carrier examined under subsection (a) of this section shall produce all documents related to an adverse decision or grievance decision described under subsection (a) of this section, including documents or electronic documents in the possession of a private review agent acting on behalf of the carrier. The Commissioner may have an adverse decision or grievance decision described under subsection (a) of this section reviewed by an independent review organization. The costs of a review conducted under paragraph (1) of this subsection shall be paid by the carrier.