This chapter applies to a payor that: Requires preauthorization for health care services; and Is required to report to the Maryland Health Care Commission on its attainment and plans for attainment of certain preauthorization benchmarks. This chapter does not apply to a pharmacy benefits manager that only provides services for: Workers’ compensation claims pursuant to Labor and Employment Article, Title 9, Annotated Code of Maryland; or Personal injury protection claims pursuant to Insurance Article, Title 19, Annotated Code of Maryland.. In this chapter, the following terms have the meanings indicated. Terms Defined. “Commission” means the Maryland Health Care Commission. “Executive Director” means the Executive Director of the Commission or the Executive Director’s designee. “Health Care Service” has the meaning stated in Insurance Article, §15-10A-01, Annotated Code of Maryland. “Payor” means one of the following State-regulated entities that require preauthorization for a health care service: An insurer or nonprofit health service plan that provides hospital, medical, or surgical benefits to individuals or groups on an expense-incurred basis under health insurance policies or contracts that are issued or delivered in the State; A health maintenance organization that provides hospital, medical, or surgical benefits to individuals or groups under contracts that are issued or delivered in the State; or A pharmacy benefits manager that is registered with the Maryland Insurance Commissioner, except for a pharmacy benefits manager that only provides services for: Workers’ compensation claims pursuant to Labor and Employment Article, Title 9, Annotated Code of Maryland; or Personal injury protection claims pursuant to Insurance Article, Title 19, Annotated Code of Maryland. “Preauthorization” means the process of obtaining approval from a payor by meeting certain criteria before a certain health care service can be rendered by the health care provider. “Prescriber” means a health care practitioner who has the required license and, if necessary, scope of practice or delegation agreement that permits the health care practitioner to prescribe drugs to treat medical conditions or diseases. Step therapy or fail-first protocol" is a protocol established by an insurer, a nonprofit health service plan, a health maintenance organization, or a pharmacy benefits manager that requires a certain prescription drug or sequence of prescription drugs to be used by an insured individual or an enrollee before another specific prescription drug ordered by a prescriber is covered. “Supporting medical information” means: A paid claim from a payor that requires a step therapy or fail-first protocol for an insured or an enrollee; A pharmacy record that documents that a prescription has been filled and delivered to an insured or enrollee, or to a representative of an insured or enrollee; or Other information mutually agreed to that constitutes sufficient supporting medical information by an insured's or enrollee’s prescriber and a payor that requires a step therapy or fail-first protocol. Each payor shall establish and maintain online access for a provider to the following: A list of each health care service that requires preauthorization by the payor; and Key criteria used by the payor for making a determination on a preauthorization request. Each payor shall establish and maintain an online process for: Accepting electronically a preauthorization request from a provider; and Assigning to a preauthorization request a unique electronic identification number that a provider may use to track the request during the preauthorization process, whether the request is tracked electronically, through a call center, or by fax. Each payor shall establish and maintain an online preauthorization system that meets the requirements of Health-General Article, §19-108.2(e), Annotated Code of Maryland, to: Approve in real time, electronic preauthorization requests for pharmaceutical services: For which no additional information is needed by the payor to process the preauthorization request; and That meet the payor’s criteria for approval; Render a determination within 1 business day after receiving all pertinent information on requests not approved in real time, electronic preauthorization requests for pharmaceutical services that: Are not urgent; and Do not meet the standards for real-time approval under §C(1) of this regulation; and Render a determination within 2 business days after receiving all pertinent information, electronic preauthorization requests for health care services, except pharmaceutical services, that are not urgent. Each payor that requires a step therapy or fail-first protocol shall: Establish and maintain an online process to allow a prescriber to override the step therapy or fail-first protocol if: The step therapy drug has not been approved by the United States Food and Drug Administration for the medical condition being treated; or A prescriber provides supporting medical information to the payor that a prescription drug covered by the payor: Was ordered by the prescriber for the insured or enrollee within the past 180 days; and Based on the professional judgment of the prescriber, was effective in treating the insured's or enrollee's disease or medical condition; Provide notice to prescribers regarding the availability of its online process; and Provide information to insureds or enrollees on the availability of the step therapy or fail-first protocol within its network. A payor that becomes authorized to provide benefits or services within the State of Maryland after October 1, 2012, shall meet each benchmark within this chapter within 3 months of the payor's offering of services or benefits within the State and shall thereafter maintain the processes or actions required by each benchmark. A payor that becomes authorized to provide benefits or services within the State of Maryland after October 1, 2012, shall report to the Commission in a form and manner specified by the Commission on its attainment of each benchmark in Regulation .03 of this chapter within 3 months of the payor’s offering of services or benefits within the State. If requested by the Commission, a payor shall demonstrate continued compliance with the benchmarks in Regulation .03 of this chapter. A payor that has been granted a waiver under Regulation .05 of this chapter shall notify the Executive Director if it can no longer demonstrate the extenuating circumstances for which the waiver was granted within 30 days after a payor can no longer demonstrate extenuating circumstances. A payor may request that the Commission issue or renew a waiver from the requirement to meet a benchmark in Regulation .03 of this chapter by the demonstration of the following extenuating circumstances: For an insurer or nonprofit health service plan, a premium volume that is less than $1,000,000 annually in the State; For a group model health maintenance organization, as defined in Health-General Article, §19-713.6, Annotated Code of Maryland, preauthorizations of health care services requested by providers not employed by the group model health maintenance organization; or Other circumstances determined by the Executive Director to be extenuating. Submission of Request for Waiver or Renewal of Waiver. A request for a waiver or renewal of waiver shall be in writing and shall include: An identification of each preauthorization benchmark for which a waiver is requested; and A detailed explanation of the extenuating circumstances necessitating the waiver. A request for a waiver shall be filed with the Commission in accordance with the following: For renewal of a waiver, no later than 30 days prior to its expiration; or For a payor that becomes authorized to provide benefits or services within the State of Maryland after October 1, 2012, within 3 months after the date the payor is authorized to provide benefits or services within the State. Issuance of Waiver. The Executive Director may issue a waiver from a preauthorization benchmark to a payor that demonstrates extenuating circumstances within this chapter. The Executive Director will review and provide a decision to approve or deny all waiver requests within a reasonable time frame. A waiver or renewal of a waiver shall be valid for 2 years, unless withdrawn by the Executive Director. Withdrawal of Waiver. The Executive Director may withdraw a waiver or renewal of a waiver if the Executive Director determines that the payor can no longer demonstrate extenuating circumstances. If the Executive Director withdraws a waiver or renewal of waiver, the Executive Director shall notify the payor, setting forth in writing the reasons for withdrawal. After a waiver or a renewal of a waiver is withdrawn, a payor shall submit a plan to the Executive Director within 30 days that includes a timeline for attaining each benchmark in Regulation .03 of this chapter in a format approved by the Commission. Review of Denial or Withdrawal of Waiver. If the Executive Director has denied or withdrawn a waiver, a payor may seek Commission review of the denial or withdrawal by filing a written request for review with the Commission within 20 days of receipt of the Executive Director’s notice of denial or withdrawal of a waiver, which shall: State with particularity the grounds and factual basis for a payor’s disagreement with the denial or withdrawal decision; Specify the remedy requested; and If desired, include a written request to orally address the Commission, which shall be scheduled if requested. The full Commission may review the written request for review of a denial or withdrawal of a waiver directly or, at the discretion of the Chair of the Commission, appoint a Commissioner to review the request submitted under §E(1) of this regulation, who will make a recommendation to the full Commission. If a written request was submitted under §E(1)(c) of this regulation, a payor may orally address the Commission before a determination is made by the Commission as to whether or not to issue or withdraw a waiver. After reviewing and considering a payor’s written request for review of the denial or withdrawal decision and any oral argument, if applicable, the full Commission shall issue a written decision affirming, reversing, or modifying the decision reviewed. A waiver or renewal of waiver from the requirements of this chapter may not be sold, assigned, leased, or transferred. A payor that does not meet the reporting requirements of this chapter may be assessed a fine in accordance with COMAR 10.25.12.01, et seq. Health-General Article, §§19-101 and 19-108.2, Annotated Code of Maryland Effective date: February 18, 2013 (40:3 Md. R. 218) Regulation .01 amended effective January 9, 2023 (49:27 Md. R. 1110) Regulation .02B amended effective October 12, 2015 (42:20 Md. R. 1265); January 9, 2023 (49:27 Md. R. 1110) Regulation .03 amended effective October 12, 2015 (42:20 Md. R. 1265); January 9, 2023 (49:27 Md. R. 1110) Regulation .04 amended effective October 12, 2015 (42:20 Md. R. 1265); January 9, 2023 (49:27 Md. R. 1110) Regulation .05 amended effective October 12, 2015 (42:20 Md. R. 1265); January 9, 2023 (49:27 Md. R. 1110)