In this subtitle, the following terms have the meanings indicated. Terms Defined. “Abbreviated new drug application (ANDA)” means a submission to the FDA for the review and potential approval for marketing of a generic drug product, including bioequivalence data, as defined in 21 CFR §314.3 and described under 21 CFR §314.50. “Accelerated approval” means the FDA drug approval process defined in 21 U.S.C. §356(c)(1)(A). “Active ingredient” means a component of a drug that is intended to provide pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the body, as defined in 21 CFR §314.3. “Active moiety” means the molecule or ion responsible for the physiological or pharmacological action of the drug substance, excluding those appended portions of the molecule that cause the drug to be an ester, salt, or other noncovalent derivative of the molecule, as defined in 21 CFR §314.3. “Average cost share” means the sum of the cost share of a prescription drug product for each patient, divided by the number of patients. “Average payor cost per patient” means the sum of the total dollars paid by all payors over the most recent calendar year, divided by the number of patients. “Average sales price (ASP)” has the meaning stated in 42 U.S.C §1395w-3a(c)(1). “Average total out-of-pocket cost” means the sum of all patient total out-of-pocket costs, divided by the number of patients. “Average wholesale price (AWP)” means the average suggested price paid by a retailer to buy a drug from a wholesaler, excluding price concessions, discounts, and rebates. “Biologic” means a biological product, as defined in 42 U.S.C. §262(i)(1). “Biologics license application (BLA)” means a request to the FDA to introduce, or deliver for introduction, a biological product, as defined in 21 CFR §600.3(h), into interstate commerce, as regulated under 21 CFR §600-680. “Biosimilar” means a biological product, as defined in 42 U.S.C. §262(i)(2), that is produced or distributed in accordance with a biologics license application approved under 42 U.S.C. §262(k)(3). “Board” has the meaning stated in Health-General Article, §21-2C-01, Annotated Code of Maryland. “Board staff” means an employee of the Board or a qualified independent third party that has contracted with the Board and is subject to a nondisclosure or confidentiality agreement. “Brand name drug” has the meaning stated in Health-General Article, §21-2C-01, Annotated Code of Maryland. “Carrier” has the meaning stated in Health-General Article, §19-132, Annotated Code of Maryland. “Chair” means the chair of the Board, as provided in Health-General Article, §21-2C-03, Annotated Code of Maryland. “Coinsurance” means the percentage of costs paid by the patient after meeting the deductible. “Consumer Price Index for All Urban Consumers (CPI-U)” means the measure of the average change over time in the prices paid by urban consumers for a defined market basket of consumer goods and services. “Copayment” means the set dollar amount that a patient pays for prescriptions or services covered by the patient’s health insurance, separate from the deductible. “Cost share” means the patient total out-of-pocket costs divided by gross spending. “Deductible” means the set amount a patient pays for health and medical services and products each calendar year before a health insurance plan begins to provide coverage, usually expressed in dollars. “Discount” means a monetary adjustment that reduces the price paid or dollar amount received by an entity engaging in a prescription drug transaction that occurs during the prescription drug transaction as reflected on the invoice. “Disease burden” means the impact of a health condition measured by financial cost, mortality, morbidity, severity, and epidemiological indicators. “Drug class” means the grouping of medications based on a common active ingredient, or ingredients, or by pharmacologic or therapeutic class. “Drug-specific patient access program” means a program designed to provide a patient with assistance in affording a prescription drug or paying for a prescription drug, including but not limited to the provision of a drug to a patient, coupons supplied by the manufacturer, donations to a nonprofit or foundation associated with the manufacturer, and donations to an independent nonprofit that are earmarked expressly for the manufacturer’s drugs. “Federal Supply Schedule (FSS)” means the drug pricing program under the collection of multiple award contracts used by federal agencies, U.S. territories, Indian tribes, and other specified entities to purchase supplies and services from outside vendors. “Food and Drug Administration (FDA)” means the federal agency of the U.S. Department of Health and Human Services tasked with protecting and promoting public health through the control and supervision of food safety, tobacco products, dietary supplements, prescription and over-the-counter pharmaceutical drugs, vaccines, biopharmaceuticals, medical devices, and certain other consumer products. “Formulary” has the meaning stated in Insurance Article, §15-1601, Annotated Code of Maryland. “Fund” means the Prescription Drug Affordability Fund, as provided for in Health-General Article, §21-2C-11, Annotated Code of Maryland. “Generic drug” has the meaning stated in Health-General Article, §21-2C-01, Annotated Code of Maryland. “Gross spending” means the sum of all monies paid for a prescription drug product for an individual patient in a calendar year. “Health economics and outcomes research” means the form of economic analysis that compares the relative costs and outcomes of different treatments, such as cost effectiveness analysis, comparative effectiveness research, health economic information analysis, and health technology assessments. “Health maintenance organization (HMO)” has the meaning stated in Health-General Article, §19-701, Annotated Code of Maryland. “Indication” means labeling that discusses the disease or condition the drug product is intended to diagnose, treat, prevent, cure, or mitigate, including a description of the patient population. “Insurance benefit design” means the rules that determine the services covered by the plan and any other cost-sharing measures. “Managed care organization (MCO)” has the meaning stated in Health-General Article, §15-102.4, Annotated Code of Maryland. “Manufacturer” has the meaning stated in Health-General Article, §21-2C-01, Annotated Code of Maryland. “Maryland Medical Care Database (MCDB)” means the database established and maintained by the Maryland Health Care Commission pursuant to Health-General Article, §19-133, Annotated Code of Maryland. “Medicaid” means the public health program jointly administered by the federal government and states that primarily serves low-income people (children, parents, and, in certain states, other adults) and some medically needy patients. “Medicare” means the health insurance program administered by the federal government for people 65 years old or older or with certain disabilities. “National average drug acquisition cost (NADAC)” means the pricing benchmark calculated from the Centers for Medicare & Medicaid Services’ (CMS) monthly surveys of retail pharmacies that reflects the average price pharmacies pay to acquire a drug from a wholesaler or manufacturer, excluding subsequent discounts or rebates from manufacturers to wholesalers or pharmacies. “National Drug Code (NDC)” means the unique three-segment number used for identification and reporting as set forth in 21 CFR §207.33. “Net cost” means the per-unit cost paid by payors and purchasers of a drug after accounting for all price concessions, discounts, and rebates. “Net price” means the per-unit amount received by manufacturers of a drug after accounting for price concessions, discounts, and rebates. “New drug application (NDA)” means a submission to the FDA for the review and potential approval for marketing of a drug product, which includes chemical, pharmacological, medical, biopharmaceutical, and statistical data, as defined in 21 CFR §314.3 and described under 21 CFR §314.50. “Other cost-sharing” means a program, benefit design, or other mechanism that determines a patient’s responsibility for a prescription drug product, such as a copayment, coinsurance, deductible, formulary, or other management tool. “Out-of-pocket costs” means the expenses for medical care, including prescription drug therapy, that are not reimbursed by insurance and are paid by a patient, including copayments, coinsurance, and deductibles for covered services, and the costs for all non-covered services. “Patient total out-of-pocket costs” means the sum of a patient’s out-of-pocket costs, including items such as copayments, coinsurance, and deductibles, in a calendar year. “Payor” means the entity other than the patient that is responsible for paying for health care costs, including health insurance carriers, health plan sponsors, PBMs, Medicare, Medicaid, MCOs, and HMOs. “Person” means an individual, limited liability company, partnership, corporation, association, county, and public or private organization of any character other than an agency. “Pharmacy benefit manager (PBM)” means a third-party administrator of prescription drug programs as stated in Insurance Article, §15-1601, Annotated Code of Maryland. “Prescription drug product” has the meaning stated in Health-General Article, §21-2C-01, Annotated Code of Maryland. “Price concession” means a mechanism other than a rebate or discount that reduces the price paid by a payor. “Proprietary” means something that is used, produced, or marketed under the exclusive legal right of the inventor, maker, or owner. “Purchaser” means an entity that purchases prescription drug products that is not a payor or patient. “Rebate” means a monetary adjustment that reduces the price paid or dollar amount received by an entity engaging in a prescription drug transaction that occurs after the prescription drug transaction. “Regulatory exclusivity” means any exclusive marketing rights or data exclusivity rights conferred by the FDA with respect to a pharmaceutical product other than patents, including but not limited to 180-day exclusivity, orphan drug exclusivity, new chemical entity exclusivity, data exclusivity, and pediatric exclusivity. “Stakeholder Council” means the Prescription Drug Affordability Stakeholder Council, as provided for in Health-General Article, §21-2C-04, Annotated Code of Maryland. “Standard medical practice” means the customary treatment by medical professionals: Based on credible scientific evidence published in peer reviewed medical literature generally recognized by the relevant medical community; Consistent with physician specialty society recommendations; or Consistent with the views of physicians practicing in the relevant clinical areas. “State actual acquisition cost (SAAC)” has the meaning stated in COMAR 10.09.03.01B(42). “System net cost” means the sum of the net cost as defined above and the per unit patient out-of-pocket cost. “Therapeutic alternative” means a drug product that has one or more of the same or similar indications for use as a particular drug but is not a therapeutic equivalent to that drug. “Therapeutic class” means a group of drugs containing active moieties that share scientifically documented properties and are defined on the basis of any combination of three attributes: mechanism of action, physiologic effect, and chemical structure. “Therapeutic equivalent” has the meaning stated in 21 CFR §314.3. “Total gross spending” means the sum of all monies paid for a prescription drug product in a calendar year. “Total patient out-of-pocket cost” means the sum of all patient out-of-pocket costs in a calendar year, including items such as copayments, coinsurance, and deductibles. “Trade secret” has the meaning stated in Commercial Law Article, §11-1201, Annotated Code of Maryland. “Wholesale acquisition cost (WAC)” means the manufacturer’s list price for a prescription drug product to wholesalers or direct purchasers in the United States, not including prompt pay or other discounts, rebates, or reductions in price, as reported in a wholesale price guide or other publication of prescription drug product pricing data. “Wholesale distributor” has the meaning stated in Health Occupations Article, §12-6C-01, Annotated Code of Maryland. “Utilization” means information about the use of a drug including the number of units, the number of patients and number of prescriptions or claims. Singular and Plural. In interpreting and applying this subtitle, the singular includes the plural. Computation of Time. In computing a period of time prescribed by this subtitle or an applicable statute, after a day, act, or event occurs, the following rules apply: The day of the act, event, or default after which the designated period of time begins to run is not included; If the period of time allowed is more than 7 days, intermediate Saturdays, Sundays, and legal holidays are counted; If the period of time allowed is 7 days or less, intermediate Saturdays, Sundays, and legal holidays are not counted; and The last day of the computed period is included unless it is a Saturday, Sunday, or legal holiday, in which event the period runs until the end of the next day that is a work day. In computing a period of time prescribed by this subtitle or an applicable statute, before a day, act, or event occurs, the following rules apply: In determining the latest day for performing an act that is required to be performed a prescribed number of days before a certain day, act, or event, all days preceding that day, including intervening Saturdays, Sundays, and legal holidays, are counted in the number of days so prescribed; and The latest day is included in the determination unless it is a Saturday, Sunday, or legal holiday, in which event the latest day is the first preceding day that is a work day. Public Attendance. The general public is invited to attend and observe an open session of the Board. A member of the public attending an open session may not participate in the session, except when: The Board expressly invites public testimony, questions, comments, or other forms of public participation; or Public participation is otherwise authorized by law or regulation. The Chair, or the Chair’s designee, may extend or waive any time requirement in this regulation. Public Comments. A member of the public may provide oral public comment and written public comment in accordance with Regulation .05 of this chapter. Disruptive Conduct. An individual attending an open session of the Board may not engage in any conduct, including visual demonstrations such as waving of placards, signs, or banners, that disrupts the session or that interferes with the right of members of the public to attend and observe the session. Restoring Order. The presiding officer or Chair may: Order an individual who persists in conduct prohibited by §C(1) of this regulation, or who has violated any other regulation concerning the conduct of the open session, to be removed or disconnected from the session, and may request police assistance to restore order; and Recess the session while order is restored. Collection of Records and Information. Identification. A person submitting information, including data and records, for the Board’s consideration under this subtitle and Health-General Article, Title 21, Subtitle 2C, Annotated Code of Maryland, shall: Clearly designate the specific information the person considers to be confidential, trade-secret, or proprietary; and Submit a form certifying that the information so designated is not otherwise publicly available and has been handled and maintained to preserve its confidential, trade-secret, or proprietary nature. The Board may also determine that information it has received is confidential, trade-secret, or proprietary. The Board may seek additional information regarding whether the information is confidential, trade-secret, proprietary, or not otherwise publicly available from: The person submitting the information; or To the extent the Board is able to determine who created the document or information, the person who created the document or information. Designation. The information and data obtained by the Board under this subtitle and Health-General Article, Title 21, Subtitle 2C, Annotated Code of Maryland, that is not otherwise publicly available, is: Considered to be a trade secret and confidential and proprietary information; and Is not subject to inspection or disclosure under the Public Information Act. Management of Information Received by the Board. Access to Information. Confidential, trade-secret, or proprietary information obtained by the Board under this subtitle and Health-General Article, Title 21, Subtitle 2C, Annotated Code of Maryland, may be accessed only by: Board members; and Board staff including a qualified independent third party that has contracted with the Board and is subject to a nondisclosure agreement prohibiting disclosure of such information. A person with access to confidential, trade-secret, or proprietary information shall maintain the confidentiality of the information in accordance with State Government Article, §10-617, and Health-General Article, §21-2C-10, Annotated Code of Maryland. Consideration by Board. The Board may discuss confidential, trade-secret, and proprietary information in a closed session. The Board may not disclose confidential, trade-secret, or proprietary information in an open meeting, its public meeting materials, or its summary report of a cost review study. Public Oral Comments for a Board Meeting. A member of the public may register to provide oral comments at a Board meeting by: Submitting a written notice that: Contains the individual’s name and email address or phone number; Identifies whether the individual is affiliated with or commenting on behalf of an organization, agency, employer, or other entity; and Identifies the agenda item the individual wishes to address; and Submitting the written notice to the Board at least 2 work days before the scheduled meeting. Oral comments shall be made to the Board in open session. Public Written Comment Procedures. General Procedures. Unless expressly exempted, these provisions apply to all written public comments. Except as provided in §B(5) of this regulation, a member of the public may submit written comments to the Board by email, courier, or postal service. An individual submitting comments on behalf of an organization, agency, employer, or other entity shall: Submit the comments on the letterhead of the organization, agency, employer, or other entity; or Disclose in writing the organization, agency, employer, or other entity with which the individual is affiliated; Written comments received by the date prescribed by regulation or set by the Board will be: Shared with the Board; Where applicable, made part of the record on the issue or matter before the Board where applicable; and Posted on the Board’s website. Board staff shall redact sociological information prior to posting the written comments on the Board website. Public Written Comments for a Board Meeting. A member of the public may submit written comments concerning any agenda item of the Board or any decision pending before the Board in accordance with the procedures in §B(1) and (5) of this regulation. Written comments received more than 2 work days before the scheduled Board meeting will be shared with the Board prior to the Board meeting. Written comments received less than 2 work days before the scheduled Board meeting will be shared with the Board and posted on the Board’s website after the scheduled meeting. Written comments received less than 2 work days before the scheduled Board meeting may be considered at the next Board meeting if the issue, matter, or decision is still pending. Public Written Comments Authorized by Regulation. If a regulation expressly provides for public written comment, a member of the public may submit written comments to the Board within the time period prescribed by regulation in accordance with the procedures in §B(1) and (5) of this regulation. Public Written Comments Requested by the Board. If the Board requests public comment by posting notice of the request and a due date on its website, a member of the public may submit written comments to the Board within the time period prescribed by the notice in accordance with the procedures in §B(1) and (5) this regulation. Public Written Comments Containing Confidential, Trade-Secret, and Proprietary Information. A member of the public that wishes to submit written comments or attachments to written comments that contain confidential, trade-secret, and proprietary information shall: Redact the specific information the person considers to be confidential, trade-secret, or proprietary from the written comments and attachments; Submit a form certifying that the redacted information is not otherwise publicly available and has been handled and maintained to preserve its confidential, trade-secret, or proprietary nature; Submit the redacted comments and attachments to the Board by email, courier, or postal service; and Submit the unredacted comments and attachments to the Board in paper form using a tracked common carrier, courier, or postal service, or electronically using secure file transfer. The Board and Board staff shall use, protect, and manage written comments and attachments containing confidential, trade-secret, and proprietary information in compliance with Regulation .04 of this chapter and Health-General Article, §§21-2C-03 and 21-2C-10, Annotated Code of Maryland. Scope. This regulation applies to hearings held: To gather information from the general public before making recommendations or taking action with respect to a policy; or For the purpose of receiving technical input, technical information or expert testimony before making recommendations or taking action with respect to a policy. This regulation does not apply to contested case hearings, any part of an appeal process or a hearing where the purpose is other than to gather information from: The public; A person with a specific interest in the issue including a stakeholder; or A person with specific knowledge, skills, expertise or technical information or input. General Hearing Provisions. Notice of Hearing. The Board shall publish a notice of the hearing on the Board’s website. The Board shall include in the notice of the hearing: The date and time of the hearing; The physical location of the hearing, or link or registration information if the hearing is held remotely or live streamed; The purpose of the hearing; A statement that the Board will make reasonable accommodation for individuals with disabilities if these individuals advise the Board of their special needs by giving the Board reasonable advance notice; and Any other applicable information. Conducting a Quasi-Legislative Hearing. A hearing held under this regulation is quasi-legislative and may be conducted or presided over by: The Board Chair; or Designee. The Chair or designee shall determine the conduct of the hearing, including: The order of presentation; and Time limits for questions and testimony. The Chair or designee may: Order a person who engages in disruptive behavior that interferes with the orderly conduct of the hearing to be removed from the hearing; Request police assistance to assure or restore order; and Recess a disorderly hearing. For hearings held under this regulation the following does not apply: The right of cross-examination; and The rules of evidence. If an exhibit is offered and is relevant to the hearing, the Chair or designee shall receive and mark the exhibit offered in testimony. Unless the Chair or designee believes that an oath provides some assurance of veracity, formality, or decorum to the hearing, the Chair or designee may dispense with the formality of an oath. The Chair or designee has discretion to: Postpone or continue the hearing; and Accept additional materials beyond the date of the hearing. Informational Hearings. Convening an Informational Hearing. The Board may, through Board staff, convene informational hearings to receive input, information, and opinions from the public and stakeholders to inform the consideration and development of a recommendation, policy, regulation or action. The Board shall provide public notice of the hearing in accordance with §B of this regulation. In advance of the scheduled hearing, the Board may identify and publish questions, topics or matters about which the Board would like to receive information. Conducting an Informational Hearing. A person who wishes to provide input, information and opinions by testifying shall: Register to speak in advance of the hearing as directed by staff; and Provide the information requested by staff. The Chair or designee shall give all persons who register to speak an opportunity to do so but may limit repetitious testimony. The Chair or designee may: Allow questions from the audience; Take questions from the audience and redirect the questions to others present at the hearing; Ask questions of anyone present at the hearing; and Refer questions to Board staff who may respond after the hearing. Following an informational hearing, Board staff may provide the Board with summaries of the information received and staff’s recommendations. Technical Hearings. Convening a Technical Hearing. The Board may convene a hearing for the purpose of receiving technical input, technical information or expert testimony from persons with specific knowledge, skills or expertise. The Board shall provide public notice of the hearing in accordance with §B of this regulation. The Board shall identify and invite a person to testify at a technical hearing to provide technical input, technical information or expert testimony on an issue the Board wishes to explore. The Board may request that a person invited to testify submit a written statement to the Board two business days before the scheduled hearing. Conducting a Technical Hearing. The Chair may: Ask questions of any person present at the hearing; Allow each Board member to ask questions of any person present at the hearing; and Refer questions to Board staff who may respond after the hearing. Following a technical hearing, Board staff may provide the Board with summaries of the information received and staff’s recommendations. Recordings of Quasi-Legislative Hearings. At the Board’s discretion, the Board or court reporter service may record the hearing. If a court reporter service records the hearing: The Board shall arrange for the court reporter service to retain the recording for 1 year following the final decision or action; and A person who desires a copy of the transcript may purchase a copy from the court reporter service. If Board staff records the hearing: The Board shall keep the recording with the original of the record; and A person who desires a copy of the transcript may purchase a copy from the Board for a reasonable cost in accordance with COMAR 14.01.03, if a transcript has been prepared. Hearing Record. The Chair or designee controls the record. The Chair or designee shall assemble a record that may include the following: Exhibits and documents entered into the record; Documents concerning the hearing such as a proposed regulation, the purpose of the hearing and public notice of the hearing; Relevant supporting and opposing documentation obtained before, during, and subsequent to the hearing; The register of persons who attended the hearing including name, address, and any affiliation relevant to the hearing; In accordance with §E of this regulation, any: Full or partial transcript of the hearing made or purchased by the Board, and A recording or stenographic notes of the hearing made by the Board; and Board staff’s summaries of the information received and staff’s recommendations, if any. The record of a policy action may include the hearing records of multiple hearings, public written comments, comments at Board meetings, Stakeholder Council input, any input, data, or information received and considered by the Board and any final action or decision. Health-General Article, §21-2C-03(f), Annotated Code of Maryland Effective date: September 6, 2021 (48:18 Md. R. 692) Regulation .01B amended effective December 25, 2023 (50:25 Md. R. 1089) Regulation .01B amended effective December 25, 2023 (50:25 Md. R. 1089); April 28, 2025 (52:8 Md. R. 359) Regulation .02 adopted effective December 25, 2023 (50:25 Md. R. 1089) Regulation .03 adopted effective December 25, 2023 (50:25 Md. R. 1089) Regulation .04 adopted effective December 25, 2023 (50:25 Md. R. 1089) Regulation .05 adopted effective December 25, 2023 (50:25 Md. R. 1089) Regulation .06 adopted effective April 28, 2025 (52:8 Md. R. 359) The Prescription Drug Affordability Fund is a special, non-lapsing fund that is not subject to State Procurement Article, §7–302, Annotated Code of Maryland. The Prescription Drug Affordability Fund consists of: The assessment provided for by Regulation .02 of this chapter; Money appropriated by the State budget; Interest earnings; and Any other money from any other source accepted for the benefit of the Fund. Annual Assessment. In each State fiscal year, the Board shall issue a fee assessment to each entity identified in Health-General Article, §21-2C-11, Annotated Code of Maryland, and Regulation .03 of this chapter and collect the assessment. Unless the entity requests and is granted an exemption from the assessment, the entity shall pay the assessment by October 1. An entity may pay the assessment by ACH transfer, wire transfer, or check. Exemption from Assessment. An entity may request an exemption from the annual assessment by submitting a completed exemption form to the Board within 30 days of the Board transmitting the fee assessment. The exemption form shall be executed under oath and attest that: The entity is not a qualifying entity as defined in COMAR 14.01.01 and Health-General Article, §21-2C-11(b)(1), Annotated Code of Maryland; The entity no longer does business in Maryland; or The entity is not subject to assessment for another reason with an explanation of that reason. The entity bears the burden of demonstrating it qualifies for the claimed exemption and shall submit documentation in support of the exemption request, as follows: The entity shall provide an executed certificate of business record (available on the Board’s website) authenticating any business record the entity submits in support of the request for exemption. For carriers, supporting documentation may include but is not limited to NAIC “Annual Statement” including the cover page (signature page/jurat), Maryland State page, and Schedule T, acknowledgment from Maryland Insurance Administration of merger/change in subsidiary status, and SEC 10-K (any applicable exhibits). For manufacturers, distributors, and PBMs, supporting documentation may include but is not limited to discharge in bankruptcy, documentation of merger/change in corporate structure/subsidiary status (for example, SEC 10-K and any applicable exhibits), acknowledgment from Board of Pharmacy of expiration of license/registration, expired license/registration, documentation that manufacturer/distributor provides only non-covered products (for example, provides gases only, product or inventory lists), and documentation that the entity does not do business in Maryland. If the entity is unable to provide any documentation supporting the claimed exemption, the entity shall provide an affidavit (form on Board’s website) from the chief operating officer, chief financial officer, or other authorized official attesting to the factual basis of the claimed exemption. While the exemption request is pending, payment of the assessment is deferred. The Board shall determine all requests for exemption promptly. Reconsideration. Within 15 days of the notice denying the exemption, an entity may file for reconsideration of the denial of a request for exemption by submitting: A request for reconsideration on the form provided; and Additional information or documentation in support of the claimed exemption. A request for reconsideration that does not include additional information or additional documentation will be denied. If the request for exemption is denied after reconsideration, the entity shall pay the assessment within 30 days of the issuance of the notice of denial. Collection and Penalties. Any fee assessment not paid within 30 days of the payment due date may be subject to an interest penalty to be determined and collected by the Board. In addition to any penalties the Board may impose on an entity that fails to pay the fee assessed by the Board in a timely manner, the Board may also refer an entity’s delinquent account to the Department of Budget and Management’s Central Collection Unit, pursuant to the procedures in State Finance and Procurement Article, Title 3, Subtitle 3, Annotated Code of Maryland, and COMAR 17.01.01. Maintenance of Assessment List. The Board shall maintain a list of entities that are subject to assessment as identified in Health-General Article, §21-2C-11, Annotated Code of Maryland. At any time, Board staff may: Review the list, but staff shall review the list on at least an annual basis; Add additional entities reported by or obtained from other agencies or identified by staff; and Remove entities if the entity: Is no longer a going concern; or Has been determined to be exempt from assessment. Entities identified in Health-General Article, §212C11, Annotated Code of Maryland, shall be subject to the following fee schedule: Manufacturers engaged in wholesale distribution, as defined in Health Occupations Article, §126C01, Annotated Code of Maryland, shall pay an assessment of $1,000; Wholesale distributors, as defined in Health Occupations Article, §126C01, Annotated Code of Maryland, that distribute prescription drugs shall pay an assessment of $1,000; Pharmacy benefits managers, as defined in Insurance Article, §151601, Annotated Code of Maryland, shall pay an assessment of $1,000; and Carriers that provide health benefit plans, as defined in Health-General Article, §19-132(e), Annotated Code of Maryland, shall pay an assessment of $1,000. An entity may request to pay the annual assessment in installments by submitting a letter to the Board demonstrating significant financial hardship in paying the assessment in a single payment. The Fund may only be used to finance the operation of the Board, as permitted in Health-General Article, §21–2C–11(c)(6), Annotated Code of Maryland. Interest earned from the monies collected through the assessment in Regulation .02 of this chapter shall be retained to the credit of the Fund. If the amount of assessed funds collected in a calendar year exceeds the cap identified in Health-General Article, §21–2C–11(B)(4), the Board shall: Issue a notice of such surplus; and Remit the surplus funds in a fair and equitable manner across all qualifying entities that have paid the assessment. Health-General Article, §§21-2C-03(f) and 21-2C-11, Annotated Code of Maryland Effective date: September 6, 2021 (48:18 Md. R. 692) Regulation .02 amended as an emergency provision effective November 16, 2021 (48:26 Md. R. 1107); emergency provision expired May 6, 2022 Regulation .02 amended effective August 22, 2022 (49:17 Md. R. 791); October 2, 2023 (50:19 Md. R 854) Regulation .03 amended effective August 19, 2024 (51:16 Md. R. 743) Regulation .03A amended effective October 2, 2023 (50:19 Md. R 854) Regulation .03B amended as an emergency provision effective November 16, 2021 (48:26 Md. R. 1107); emergency provision expired May 6, 2022 Regulation .03B amended effective August 22, 2022 (49:17 Md. R. 791) This chapter sets out procedures under the Public Information Act for filing and processing requests for the public records of the Prescription Drug Affordability Board. It is the policy of the Board to facilitate access to the public records of the Board, if access is allowed by law, by minimizing costs and time delays to applicants. In this chapter, the following terms have the meanings indicated. Terms Defined. “Act” means the Public Information Act, General Provisions Article, §§4-101—4-601, Annotated Code of Maryland. “Applicant” has the meaning stated in General Provisions Article, §4-101(b), Annotated Code of Maryland. “Copy” means any form of reproduction using a photocopying machine or other reproduction technology, including a paper copy, an electronic copy, a printout, or an image. “Custodian” has the meaning stated in General Provisions Article, §4-101(d), Annotated Code of Maryland. “Executive Director” means the Executive Director of the Board as provided in Health-General Article, §21-2C-03, Annotated Code of Maryland. “Indigent” has the meaning stated in General Provisions Article, §4-206(a)(2), Annotated Code of Maryland. “Metadata” has the meaning stated in General Provisions Article, §4-205(a), Annotated Code of Maryland. “Official custodian” has the meaning stated in General Provisions Article, §4-101(f), Annotated Code of Maryland. “PIA coordinator” means the Board employee who is responsible for accepting requests for public records. “Public Access Ombudsman” means the official appointed under General Provisions Article, Title 4, Subtitle 1B, Annotated Code of Maryland, to resolve disputes under the Act. “Public record” has the meaning stated in General Provisions Article, §4-101(j), Annotated Code of Maryland. “Reasonable fee” has the meaning stated in General Provisions Article, §4-206(a)(3), Annotated Code of Maryland. “Sociological information” means personal phone number, personal email address, and personal home address. Unless otherwise provided by law, the Executive Director is the official custodian of the public records of the Board. Any person may request to inspect or copy the public records of the Board. Inspection. Except as otherwise provided in this chapter, the custodian shall make public records of the Board available for inspection by an applicant without demanding a written request. The custodian shall require a written request if the custodian reasonably believes that: The Act or any other law may prevent the disclosure of the public record to the applicant; or A written request will materially assist the Board in responding. Copies. If the applicant requests one or more copies of any public record of the Board, the custodian may require a written request. A written request shall: Contain the applicant’s contact information; and Reasonably identify, by brief description, the public record sought. Written requests from the same requestor may be consolidated A request to inspect or copy a public record of the Board shall be addressed to the custodian of the record or to the Board’s PIA coordinator as designated under General Provisions Article, §4-503, Annotated Code of Maryland. If the custodian is unknown, the request may be addressed to “Executive Director” or “PIA Coordinator”. Grant of Request. If the custodian decides to grant a request for inspection, the custodian shall produce the public record for inspection: Immediately; or Within a reasonable time period, not to exceed 30 days after the date of the request, if that period is needed to retrieve the public record and conduct any necessary review. If the custodian reasonably believes that it will take more than 10 working days to produce the public record, the custodian shall indicate in writing or by electronic mail within 10 working days after receipt of the request: The amount of time that the custodian anticipates it will take to produce the public record; An estimate of the range of fees that may be charged to comply with the request for public records; and The reason why it will take more than 10 working days to produce the records. Denial of Request. If the custodian decides to deny a request for inspection, the custodian shall: Deny the request within 30 days after the request; and Notify the applicant of the denial. If a request is denied, the custodian shall provide the applicant, at the time of the denial or within 10 working days, a written statement that includes: The reasons for the denial, including, for records denied under General Provisions Article, §4-343, Annotated Code of Maryland, a brief explanation of: Why the denial is necessary, that is, why disclosure of the public record would be contrary to the public interest; and An explanation of why redacting information would not address the reasons for the denial; The legal authority for the denial; Without disclosing the protected information, a brief description of the undisclosed record or records that will enable the applicant to assess the applicability of the legal authority for the denial; and Notice of the remedies available for review of the denial. If a requested public record is not in the custody or control of the person to whom application is made, that person shall, within 10 working days after receipt of the request: Notify the applicant that the person does not have custody or control of the requested public record; and If the person knows, include: The name of the custodian of the public record; and The location or possible location of the public record. Any time limit imposed by §§A—C of this regulation may be extended, with the consent of the applicant, for an additional period of up to 30 days. Unless prohibited by law, the custodian may provide notice of a request for inspection or copying of any public record of the Board to any person who, in the judgment of the custodian, could be adversely affected by disclosure of that public record. The custodian may consider the views of the potentially affected person before deciding whether to disclose the public record to an applicant. Except as provided in §§C and D of this regulation, the custodian shall provide an applicant with a copy of the public record in a searchable and analyzable electronic format if: The public record is in a searchable and analyzable electronic format; The applicant requests a copy of the public record in a searchable and analyzable electronic format; and The custodian is able to provide a copy of the public record, in whole or in part, in a searchable and analyzable electronic format that does not disclose information that is protected from disclosure under the Act. The custodian shall provide a portion of the public record in a searchable and analyzable electronic format if: Requested by the applicant; and The custodian is able to do so by using the existing functions of the database or software program that contains the searchable and analyzable data. The custodian is not required to: Create or reconstruct a public record in an electronic format if the public record is not available in an electronic format; Release an electronic record in a format that would jeopardize or compromise the security or integrity of the original record or of any proprietary software in which the record is maintained; or Create, compile, or program a new public record. The custodian may remove metadata from an electronic document before providing the electronic record to an applicant by: Using a software program or function; or Converting the electronic record into a different searchable and analyzable format. If the person to whom application is made knows that a requested public record of the Board has been destroyed or lost, that person shall promptly: Notify the applicant that the public record is not available; and Explain the reasons why the public record cannot be produced. If the custodian denies a request to inspect or copy a public record of the Board, the applicant may file an action for judicial enforcement under General Provisions Article, §4-362, Annotated Code of Maryland, without pursuing the remedies set forth in General Provisions Article, Subtitles 1A and 1B, Annotated Code of Maryland. Denial Pending Court Order. If, in the opinion of the Executive Director, disclosure of a public record of the Board otherwise subject to disclosure under the Act would do substantial injury to the public interest, the Executive Director may temporarily deny the request to obtain a court order allowing nondisclosure. The temporary denial shall be in writing. Circuit Court Review. Within 10 working days after the denial, the Executive Director shall apply to the appropriate circuit court for an order permitting continued denial or restriction of access. Notice of the Executive Director’s complaint shall be served on the applicant in the manner provided for service of process by the Maryland Rules of Procedure Except as provided in §§B and C of this regulation, the fee schedule for copying and certifying copies of public records of the Board is as follows: For each copy made by a standard printer or a photocopying machine within the Board, the fee is 25 cents per page; For each copy made other than by a standard printer or a photocopying machine within the Board, the fee shall be based on the actual cost of reproduction; and For a public record certified as a true copy, an additional fee of $1 per page (or, if appropriate, per item) shall be charged. Minimum Fee. A charge may not be made if the total fee is $1 or less. If the fee for copies or certified copies of any public record of the Board is specifically set by a law other than the Act or this regulation, the custodian shall charge the prescribed fee. If the custodian cannot copy a public record within the Board, the custodian shall make arrangements for the prompt reproduction of the record at public or private facilities outside the Board. The custodian shall: Collect from the applicant a fee to cover the actual cost of reproduction; or Direct the applicant to pay the cost of reproduction directly to the facility making the copy. Before copying a public record of the Board, the custodian shall estimate both the cost of reproduction and the search and preparation fee under §F of this regulation and either: Obtain the agreement of the applicant to pay the cost; or Demand prepayment of all or a portion of the cost. Search and Preparation Fee. Except as provided in §G of this regulation, the custodian may charge a reasonable fee for time that an official or employee of the Board spends to: Search for requested public records; Review requested public records for potential disclosure; and Prepare public records for inspection and copying. The custodian shall determine the fee under §F(1) of this regulation by multiplying the employee’s salary, prorated to an hourly basis, by the actual time attributable to the search for, review of, and preparation of public records for inspection and copying. The custodian may not charge a search or preparation fee under §F of this regulation for the first 2 hours needed to search for and prepare a public record for inspection. Waiver or Reduction of Fee. The official custodian may waive or reduce any fee set under this regulation if: The applicant requests a waiver; and Either: The custodian determines that the waiver or reduction is in the public interest; or The applicant is indigent and files an affidavit verifying the facts that support a claim of indigency. In determining whether a fee waiver is in the public interest, the custodian shall consider, among other relevant factors, the ability of the applicant to pay the fee. If the applicant requests that copies of a public record be mailed or delivered to the applicant or to a third party, the custodian may charge the applicant for the cost of postage or delivery. An applicant may inspect any public record of the Board that the applicant is entitled to inspect during the normal working hours of the Board. The inspection shall occur where the public record is located unless the custodian, after taking into account the applicant's expressed wish, determines that another place is more suitable and convenient. Except for use in carrying out the custodian’s governmental functions or if disclosure is otherwise required by law, and in compliance with General Provisions Article, §4-330, Annotated Code of Maryland, a custodian may not disclose under the Act, and shall deny a request for inspection or copying of, the part of a public record that contains sociological information relating to an individual. General Provisions Article §§4-101—4-601; Health-General Article, §21-2C-03(f)(1), Annotated Code of Maryland Effective date: October 2, 2023 (50:19 Md. R. 854) Individual members of the public may report their personal experience with a drug or drugs that have caused or are causing an affordability issue for the individual. Individuals may report a drug: By completing the form available on the Board’s website electronically; or By downloading or obtaining the form from the Board, completing the form, and submitting it to the Board. Blank forms may be requested by contacting the Board by email or phone. The Board shall apply the metrics specified in Health-General Article, §21-2C-08(c), Annotated Code of Maryland, and this regulation to the following data sets to identify drugs eligible for selection for a cost review study: The claims data in the MCDB; Available subsets of claims data in the MCDB, such as the commercial market, Medicaid, and Medicare; and The data obtained from governmental and commercial databases, other databases, and other data sets as available. The Board may identify the prescription drug products that meet these statutory metrics and regulatory criteria on at least an annual basis. Data Management. For any metric requiring adjustment for inflation, the adjustment for inflation shall be based on the Consumer Price Index for All Urban Consumers (CPI-U) as reported by the U.S. Bureau of Labor Statistics. For any data-based metric, the Board may account for data errors and outliers. To the extent practicable, and in addition to the statutory metrics set forth in Health-General Article, §21-2C-08(c), Annotated Code of Maryland, the Board may consider the following additional metrics and criteria to identify prescription drug products eligible for selection for a cost review study: Aggregated Spending and Pricing Data: The 100 prescription drug products with the highest total gross spending in the most recent available calendar year; The 100 prescription drug products with the highest total gross spending per patient in the most recent available calendar year; The 100 prescription drug products with the highest percent change increase in WAC over the most recent available calendar year; The 100 prescription drug products with the highest percent change increase in WAC over the most recent available 5-year period; The 100 prescription drug products with the highest dollar increase in WAC per year or course of treatment over the most recent available calendar year; The 100 prescription drug products with the highest dollar increase in WAC over the most recent available 5-year period; and The 100 prescription drug products with the highest percent change increase in total gross spending; Patient Out-of-Pocket Costs: The 100 prescription drug products with the highest total patient out-of-pocket costs in the most recent available calendar year; The 100 prescription drug products with the highest average patient total out-of-pocket costs in the most recent available calendar year; The 100 prescription drug products ranked at the 50th percentile for patient total out-of-pocket costs in the most recent available calendar year; and The 100 prescription drug products ranked at the 90th percentile for patient total out-of-pocket costs; and Any prescription drug product added by the Board to the list of prescription drug products eligible for cost review under this regulation. At an open meeting, a Board member may propose one or more additional prescription drug products for inclusion on the list of drugs eligible for cost review by: Moving that the prescription drug product or products be added to the eligible list; and Identifying how the prescription drug product or products may create affordability challenges for the State health care system or patients. After discussion at an open meeting, the Board may vote to add one or more prescription drug products to the list of drugs eligible for selection for a cost review study. Board staff may provide the Board with a dashboard containing the prescription drug products identified under the statutory metrics and regulatory criteria in Regulation .02 of this chapter. To the extent practicable, Board staff may provide the following information for each prescription drug product in the dashboard: FDA Approval: The date the FDA first approved the prescription drug product; If applicable, the date the last patent expired or will expire; Whether the prescription drug product was approved through an FDA accelerated approval pathway; and Whether the prescription drug product is designated by the Secretary of the FDA, under 21 U.S.C. §360bb, as a drug for a rare disease or condition; Therapeutic Class: The class of the prescription drug product as identified in a recognized classification system; Whether the prescription drug product is the only prescription drug product in its class; Any therapeutic equivalent prescription drug product identified by examination of the FDA Orange Book, FDA Purple Book, or other therapeutic equivalence databases; and The availability and number of therapeutic equivalents for sale in the State; Utilization, Spending and Price Data: The patient count for the prescription drug product in the most recent available calendar year; The total gross spending for the prescription drug product in the most recent available calendar year; The total gross spending per patient for the prescription drug product in the most recent available calendar year; The WAC on January 1 of the current calendar year, on January 1 of the previous calendar year, and at launch of the product; The percent increase in WAC of the prescription drug product over the most recent available calendar year; The percent increase in WAC of the prescription drug product over the most recent available 5-year period; The dollar increase in WAC over the most recent available calendar year; The dollar increase in WAC over the most recent available 5-year period; The dollar increase in WAC per year or course of treatment over the most recent available calendar year; The percent increase in overall total gross spending for the prescription drug product in the most recent available calendar year; The estimated percentage of manufacturer national net sales to gross sales of a prescription drug product for the most recently reported year; The average payor cost per patient for the prescription drug product in the most recent available calendar year; and The average cost share for the prescription drug product; Patient Out-of-Pocket: The total patient out-of-pocket cost for the prescription drug product in the most recent available calendar year; The average total out-of-pocket costs in the most recent available calendar year; Patient total out-of-pocket costs ranked at the 50th percentile in the most recent available calendar year; and Patient total out-of-pocket costs ranked at the 90th percentile in the most recent available calendar year; Whether the prescription drug product is currently in active shortage status; and Whether the prescription drug product is currently subject to or has been subject to the Medicare Drug Price Negotiation Program, under the Inflation Reduction Act (IRA) (Public Law 117-169). Selecting Drugs for Referral to Stakeholder Council. The Board may select one or more prescription drug products identified in Regulation .02 of this chapter as eligible for cost review to refer to the Stakeholder Council. Prior to a Board meeting, a Board member may request that a prescription drug product or products be placed on the Board’s meeting agenda for consideration for referral to the Stakeholder Council by submitting the proprietary drug name or nonproprietary name, as applicable, and NDC to the Board Chair in writing. The Board Chair may include the prescription drug product name and dose on the Board’s agenda. The public may provide oral and written comments concerning the drugs proposed for referral to the Stakeholder Council and identified on the meeting agenda in accordance with the procedures and timelines in COMAR 14.01.01.05A and B(2). Notwithstanding the pre-meeting identification of drugs for consideration, the Board may consider any drug identified in Regulation .02 of this chapter for referral to the Stakeholder Council. At an open meeting, the Board may: Consider the prescription drug products identified on the Board’s agenda and any eligible drug proposed for consideration by a Board member at the meeting; and Select one or more prescription drug products by NDC to refer to the Stakeholder Council to receive input from the Stakeholder Council on the selection of prescription drug products for cost review. In selecting one or more prescription drug products to refer to the Stakeholder Council, the Board may consider: The prescription drug products identified under the statutory metrics and regulatory criteria in Regulation .02 of this chapter; The information provided under §B this regulation; The average cost share of the prescription drug product, the average patient total out-of-pocket cost, and the average total payor cost; and Any written or oral public comment. The Board shall post notice of the prescription drug products referred to the Stakeholder Council on its website. The public may provide written comments concerning the list of prescription drug products referred to the Stakeholder Council by: Complying with the procedures in COMAR 14.01.01.05B(3); and Submitting the written comments to the Board within 30 calendar days of the date the list is posted on the Board’s website. Stakeholder Council Input. To the extent practicable, the Board may provide the Stakeholder Council with: The information set forth in §B of this regulation; Whether the prescription drug product was reported by an individual member of the public; and Whether the prescription drug product was added by the Board for consideration under Regulation .02 of this chapter. To the extent practicable, the Stakeholder Council shall: Review the information provided for each referred prescription drug product; and Discuss the referred prescription drug products at an open meeting. Board staff may present the Stakeholder Council input discussed at the open meeting to the Board. Therapeutic Alternatives. Board staff may develop a list of therapeutic alternatives for each prescription drug product referred to the Stakeholder Council. Board staff shall post a list of therapeutic alternatives developed by staff on the Board’s website for comment. The public may provide written comments concerning the list of therapeutic alternatives by: Complying with the procedures in COMAR 14.01.01.05B(3); and Submitting the written comments to the Board within 30 calendar days of the date the list is posted on the Board’s website. Board staff may modify the list of therapeutic alternatives for consideration by the Board. The Board shall determine the therapeutic alternatives for each prescription drug product selected for a cost review study. Board Selection of Drugs for Cost Review. At an open meeting, the Board may select one or more prescription drug products for a cost review study. The public may provide oral and written comments concerning the selection of a prescription drug product for cost review in accordance with the procedures and timelines in COMAR 14.01.01.05A and B(2). In selecting a prescription drug product for cost review, the Board shall consider: The prescription drug products referred to the Stakeholder Council from the prescription drug products identified under the statutory metrics and regulatory criteria in Regulation .02 of this chapter and the information provided under §B of this regulation; The average cost share of the prescription drug product, the average patient total out-of-pocket cost, the average total payor cost, and publicly available data on direct-to-consumer advertising spending for the prescription drug product; Input from the Stakeholder Council provided under §G of this regulation; and Input from the public provided under COMAR 14.01.01.05. During an open meeting, the Board may select one or more prescription drug products for cost review under Regulation .05 of this chapter and provide notice of the selection on its website within 3 work days of the meeting. The prescription drug product shall be identified by: NDC; ANDA, NDA, or BLA, as applicable; and Active moiety or active ingredient. If the Board selects a prescription drug product for cost review, the Board may identify and approve all NDCs marketed under the same ANDA, NDA, or BLA to be included in the cost review. If the Board selects a prescription drug product for cost review that is an unapproved generic within the meaning of Health-General Article, §21-2C-01(f), Annotated Code of Maryland, the Board may identify and approve all NDCs with the same active moiety and manufacturer to be included in the cost review study. If the Board selects a prescription drug product for cost review, the Board shall approve the therapeutic alternatives to be used in conducting the cost review study. Request for Information. The Board shall post notice of the prescription drug product or products selected for cost review through the process outlined in Regulation .03I of this chapter on the Board’s website. To the extent there is no publicly available information to conduct an aspect of the statutory cost review, the Board may request information to conduct a cost review study under Health-General Article, §21-2C-09(a)(2), Annotated Code of Maryland, and this regulation. The Board may request information by sending an email or postal mail to the manufacturer, PBMs, health insurance carriers, wholesale distributors, HMOs, and MCOs. The Board shall post notice of the request for information on its website. An entity that has not received a request for information from the Board may submit relevant information in accordance with this regulation. Within 30 days of the date the request for information is posted to the website or transmitted to the entity, an entity may submit the information requested by the Board, and any other relevant information, in accordance with §C of this regulation. An entity may request one 30-day extension of time to submit information under §A(6) of this regulation. An entity shall submit the request for a 30-day extension to the Board in writing on or before the expiration of the initial submission period. For each prescription drug product under review, the Board may request the following information from: Manufacturer: Documents and research explaining the relationship between the pricing of the prescription drug product and the cost of development, the relationship between the pricing of the prescription drug product and the therapeutic benefit, and information that is otherwise pertinent to the manufacturer’s pricing decision such as: Life cycle management; Net average price in the State; and The estimated value or cost-effectiveness of the prescription drug product; The total amount of the price concessions, discounts, and rebates provided to each payor type operating in the State; The total amount of the price concessions, discounts, and rebates the manufacturer is expected to provide to each payor type; The net price received by manufacturers for the drug product in the State accounting for all price concessions, discounts, and rebates; The units of the prescription drug product sold in the State; The units of the prescription drug product sold nationally; The total dollar amount of sales of the prescription drug product into the State; The total dollar amount of sales of the prescription drug product nationally; The invoice price per unit for the prescription drug product charged to purchasers in the United Kingdom, Germany, France, and Canada, reported in U.S. dollars; Prices charged to purchasers in the State, including but not limited to pharmacies, pharmacy chains, pharmacy wholesalers, and other direct purchasers; The average profit margin of the prescription drug product over the prior 5-year period and the projected profit margin anticipated for the current year for the prescription drug product; Maryland and national gross and net manufacturer revenues for the prescription drug product under review for the most recent tax year; Information concerning all authorized generics as defined by 42 CFR §447.502 for the prescription drug product; Information concerning all other ANDAs, BLAs, and NDAs that pertain to the same active moiety and the same manufacturer; The manufacturer’s research and development costs, as indicated on the manufacturer’s federal tax filing or information filed with the Federal Securities and Exchange Commission for the most recent tax year; The portion of direct-to-consumer marketing costs eligible for favorable federal tax treatment in the most recent tax year that are specific to the prescription drug product under review; and Any additional factors or information the manufacturer proposes that the Board consider. Health Insurance Carrier, HMO, and MCO: The total amount of the price concessions, discounts, and rebates the manufacturer provides to each health plan operating in the State, expressed as a percent of the WAC; The average price concession, discount, and rebate provided in the State for therapeutic alternatives; Placement in each formulary offered or administered in the State and the number of covered lives for each formulary; Benefit design around the prescription drug product, including copayment and coinsurance amounts in the State; The net cost incurred by the insurance carrier for the prescription drug product in the State; and Any additional factors or information the health insurance carrier, HMO, or MCO proposes that the Board consider. Pharmacy Benefits Managers: The therapeutic alternatives for the prescription drug product(s) under review identified by each formulary administered by the PBM; The total amount of the price concessions, discounts, and rebates the manufacturer provides to each PBM operating in the State, expressed as a percent of the WAC; The average price concession, discount, and rebate provided in the State for therapeutic alternatives; Placement in each formulary offered or administered in the State and the number of covered lives for each formulary; Benefit design around the prescription drug product, including copayment and coinsurance amounts; Maryland and national gross and net PBM revenues for the prescription drug product under review for the most recent tax year; and Any additional factors or information the PBM proposes that the Board consider. Wholesale Distributors: Prices charged to purchasers in the State, including but not limited to pharmacies, pharmacy chains, pharmacy wholesalers, and other direct purchasers; The total amount of price concessions and discounts provided by the wholesale distributor to purchasers in the State, including but not limited to pharmacies, pharmacy chains, pharmacy wholesalers, and other direct purchasers; Units of the prescription drug product sold in the State; and Any additional factors or information the wholesale distributor proposes that the Board consider. Submission of Information. An entity may submit the information requested in §A of this regulation by: Completing the data form developed by the Board; and Providing supporting documentation. A person submitting information, including data and records, for the Board’s consideration shall comply with the procedures for designating confidential, trade-secret, and proprietary information set forth in COMAR 14.01.01.04. Information may be submitted to the Board: In paper form using a tracked common carrier, courier, or postal service; or Electronically using secure file transfer. The Board may determine: Whether use of the prescription drug product has led or will lead to: Affordability challenges to the State health care system; or High out-of-pocket costs for patients; Whether the use that has led to affordability challenges or high out-of-pocket costs is consistent with: The labeling approved by the FDA; or Standard medical practice; and The circumstances under which the prescription drug product has or will lead to an affordability challenge to the State health care system or high out-of-pocket costs to patients under §A(1) of this regulation. Analyses and Data Compilation. To the extent practicable, Board staff may assemble the data and analyses specified by Health-General Article §21-2C-09(b), Annotated Code of Maryland, and this regulation for consideration by the Board, including the data elements and information provided to the Board under Regulation .03A and B of this chapter. These data and analyses may be: Derived from published peer-reviewed literature; Derived from published public sources such as the FDA Orange Book, the FDA Purple Book, and other sources; Reported by or derived from manufacturers, health insurance plans, HMOs, MCOs, PBMs, and wholesale distributors; Produced by Board staff through analysis; Derived from external analyses and modeling studies; Derived from the MCDB, any claims set of the MCDB, and any other databases containing relevant information; Derived from reports generated by U.S. governmental entities, State governmental entities, foreign governmental and quasi-governmental agencies, and U.S. and foreign non-profit organizations; or Derived from quantitative and qualitative data collected by Board staff. Factors Considered in Cost Review Study. To the extent practicable, the Board may consider the following data, information, and analyses in conducting a cost review study: Drug Pricing for Drug Product Under Review: The WAC, AWP, NADAC, SAAC, ASP, and FSS; and Information estimating manufacturer net price and net sales amounts of the prescription drug product under review; Price Concessions, Discounts, and Rebates: The average price concession, discount, and rebate provided by the manufacturer or expected to be provided to each payor class in the State for the drug under review, expressed as a number and as a percent of the WAC; and The average price concession, discount, and rebate the manufacturer provided or is expected to provide for the prescription drug product under review to each PBM operating in the State, expressed as a number and as a percent of the WAC; Therapeutic Alternatives: The average price concession, discount, or rebate the manufacturer provides or is expected to provide to health plans in the State for therapeutic alternatives; The WAC, AWP, NADAC, SAAC, ASP, and FSS at which each therapeutic alternative has been sold in the State; and The utilization, costs, and out-of-pocket costs for therapeutic alternatives; Patient Access: The costs to health plans based on patient access consistent with FDA-labeled indications or standard medical practice; The estimated impact on patient access resulting from the cost of the prescription drug product relative to insurance benefit design; and The current or expected dollar value of drug-specific patient access programs that are supported by the manufacturer for the drug product under review and the policies surrounding and implementing such programs; Cost and Comparative Effectiveness Analyses: The incremental costs associated with a prescription drug product, including financial impacts to health, medical, or social services as can be quantified and compared to baseline effects of existing therapeutic alternatives; and Information derived from health economics and outcomes research that may address the effectiveness of the prescription drug product in treating the conditions for which it is prescribed or in improving a patient’s health, quality of life, or overall health outcomes, and the effectiveness of the prescription drug product compared with therapeutic alternatives or no treatment. Cost Sharing: The average patient copay and other cost-sharing data for the prescription drug in the State; and The average cost share; and Additional Board Factors: Clinical information, including FDA indications and doses and information concerning standard medical practice; The disease burden of the condition that is treated by the prescription drug product; In the case of generic prescription drug products, the number of pharmaceutical manufacturers that produce the prescription drug product; The total gross spending in the State for the prescription drug product under review, the total number of patients in the State using the prescription drug product, and the percentage of overall total prescription drug product spending that the product’s spending represents; The change in total gross spending and utilization for a prescription drug product in the State between the two most recent available calendar years and the percent change in total gross spending for a prescription drug product in the State between the two most recent available calendar years; The mean, median, and 90th percentile out-of-pocket costs per patient compared to State incomes; An assessment of the impact of the prescription drug product’s cost to access by priority populations and the impact on equity; Information supplied by the manufacturer, if any, explaining the relationship between the pricing of the prescription drug product and (a) the cost of development and (b) the therapeutic benefit of the prescription drug product, or information that is otherwise pertinent to the manufacturer’s pricing decision; Analysis of the prescription drug product’s approval process; Analysis of the prescription drug product’s shortage status; Analysis of the market context of the prescription drug product including the prescription drug product’s lifecycle management, patent management, regulatory exclusivities, and product hopping; The utilization and pricing of therapeutically equivalent drug products; Analysis of the impact of state and federal regulatory and compliance issues related to the prescription drug product; Input from state and local governmental entities and the entities’ contractors such as health plans and plan administrators; Impact of the utilization and spending for the prescription drug product on public budgets and comparison of the spending on the prescription drug product to relevant benchmarks; Analyses and research including literature review by Board staff in response to information submitted by an entity under Regulation .04 of this chapter, or through any public comment or public input procedure Input from the public; and Information and analyses submitted by an entity under Regulation .04 of this chapter. The public may provide written comments concerning the prescription drug product: Within 60 days of the date the drug’s selection for cost review study is posted on the Board’s website; and In accordance with the procedures in COMAR 14.01.01.05B(3). At an open meeting, the Board may: Hear oral public comments concerning the prescription drug product in accordance with the procedures in COMAR 14.01.01.05A; To the extent permitted by Health-General Article, §§21-2C-03 and 21-2C-10, Annotated Code of Maryland, consider written comments submitted in accordance with the procedures in COMAR 14.01.01.05; To the extent practicable, and in compliance with Health-General Article, §21-2C-03(e)(1)(iv), Annotated Code of Maryland, consider the data and analyses specified by §C of this regulation, including the data elements and information provided to the Board under Regulation .03 of this chapter; Close the session to discuss confidential, trade-secret, and proprietary information; and Preliminarily determine whether: Use of the prescription drug product, identified by NDC, has led or will lead to: Affordability challenges to the State health care system; or High out-of-pocket costs for patients; and Whether the use that has led to affordability challenges or high out-of-pocket costs is consistent with: The labeling approved by the FDA; or Standard medical practice. If the Board is unable to determine whether a prescription drug product will produce or has produced challenges to the affordability of the prescription drug product for the State health care system, the Board may consider: The additional factors identified in Health-General Article, §21-2C-09(b)(3)(i)—(iv), Annotated Code of Maryland; and The following additional factors: Federal support for the research and development of the prescription drug product; and Pricing data from other countries for the prescription drug product. Preliminary Determination. In accordance with §C of this regulation, the Board may make a preliminary determination of whether use of the prescription drug product has led or will lead to affordability challenges for the State health care system or high out-of-pocket costs for patients. A preliminary determination is non-final and subject to revision and modification. Preliminary Determination of Affordability Challenge. Board staff shall prepare a draft of the preliminary determination cost review report that summarizes the information considered by the Board in conducting the cost review study, the Board’s deliberations, the circumstances or indicia reflecting the affordability challenge, and the Board’s preliminary determination. The public may comment on the draft of the preliminary determination cost review report. Final Determination Concerning Affordability Challenge and Final Cost Review Study Report. The Board may vote to finalize the preliminary determination and approve the draft cost review report as final. The Board’s determination of whether a prescription drug has or will lead to an affordability challenge is not final until the final cost review report is adopted by the Board. The Board shall create and adopt a final report of the cost review study that, to the extent permitted by Health-General Article, §§21-2C-03 and 21-2C-10, Annotated Code of Maryland, summarizes the information considered by the Board in conducting the cost review study, the Board’s deliberations, and the Board’s determination. Health-General Article, §§21-2C-03(f)(1), 21-2C-08(b), and 21-2C-09, Annotated Code of Maryland Effective date: December 25, 2023 (50:25 Md. R. 1089) Regulation .05 amended as an emergency provision effective November 14, 2024 (51:25 Md. R. 1140); adopted permanently effective March 3, 2025 (52:4 Md. R. 220) In this chapter, the following terms have the meanings indicated. Terms Defined. “Driver” means a factor that causes a particular phenomenon to happen or develop. “Eligible governmental entity” means a unit of State or local government, an organization on behalf of a unit of State or local government, or the Maryland State Medical Assistance Program, as identified in Health-General Article, §21-2C-14(a), Annotated Code of Maryland, that pays for or purchases prescription drug products. “Eligible governmental entities upper payment limit” or “GovUPL” means upper payment limit established by the Board minus applicable patient out-of-pocket costs. “FDA prescription drug shortage list” means the U.S. Food and Drug Administration’s Drug Shortage Database. “Medicaid Best Price” has the meaning stated in 42 CFR §447.505. “Medicare Maximum Fair Price” has the meaning stated in 42 USC §1320f(c)(3). “System net ingredient cost” means the final system cost attributable to or related to the prescription drug product after accounting for all discounts and price concessions, excluding dispensing, administration and direct and indirect remuneration to pharmacies, including patient out-of-pocket costs. “Upper payment limit” or “UPL” means the amount established by the Board and represents the system net ingredient cost. For the purpose of this chapter, “affordability challenge” refers to either (a) high out-of-pocket costs for patients or (b) an affordability challenge for the State health care system. When determining whether to set an upper payment limit and when setting an upper payment limit amount, the Board shall apply the criteria set forth in this regulation. The Board shall: Consider the cost of administering the drug and delivering the drug to consumers, as well as other relevant administrative costs; Determine whether an upper payment limit is an appropriate tool to address the drivers of the affordability challenge identified for the prescription drug product; Set an upper payment limit in a way to minimize adverse outcomes and minimize the risk of unintended consequences; and Prioritize drugs that have a high proportion of out-of-pocket costs compared to the system net cost of the drug. The Board shall not set an upper payment limit if: Spending on the prescription drug product by the eligible governmental entities is less than the administrative cost to implement an upper payment limit; or The prescription drug product is a generic and there are nine or more marketed therapeutic equivalents for the product. The Board shall not set an upper payment limit at an amount that: Impacts statutory or regulatory amounts, such as Medicaid Best Price; or Is lower than the Medicare Maximum Fair Price. If the Board makes a preliminary determination that use of the prescription drug product has led or will lead to an affordability challenge, the Board shall commence the policy review process. The purpose of the policy review process is to: Based on the best available information, confirm the drivers and market conditions causing the affordability challenge phenomena; and Identify the policies that may address those drivers and redress the affordability challenges. The policy review process includes: Information gathering: Informational hearings; Stakeholder Council input; Expert testimony hearings; Board staff research and analysis; and Eligible governmental entities’ information; Preliminary policy recommendations: Policy actions other than UPLs; and Policy action in the form of a UPL and the process for setting upper payment limits; and Final actions: Adoption of the final cost review report; Adoption of non-UPL policy recommendations; and Adoption of proposed regulations setting a UPL amount. In studying the drivers, market conditions and policy options, the Board and staff may consider the information collected through the cost review study process pursuant to Health-General Article, §21-2C-09, Annotated Code of Maryland and COMAR 14.01.04.05, including all information, analyses, and public input collected and considered during the selection of drug for the cost review study and the cost review study process. If additional information is needed, the Board and staff may gather additional information through the tools outlined in §D of this regulation. If additional information is needed, the Board may utilize the information-gathering tools outlined in §D of this regulation at any point in the policy review process, including the consideration and setting of a UPL. Information Gathering Tools. Public Informational Hearings. The Board may, through Board staff, convene a hearing to receive input, information, and opinions from the public and stakeholders to inform the consideration and development of policy options including upper payment limits to redress an affordability challenge. The public informational hearing shall be conducted in accordance with COMAR 14.01.01.06. Stakeholder Council Input. The Board may request input from the Stakeholder Council. This input can be a request for general input and ideas on policies or more specific requests for specific information. Board staff may provide the Board with summaries of input from the Stakeholder Council. Technical Hearings. The Board may convene a hearing for the purpose of receiving technical input, technical information or expert testimony. The technical hearing shall be conducted in accordance with COMAR 14.01.01.06. Board Staff Research and Analysis. Board staff may provide the Board with policy research and analyses related to the drivers of the potential affordability and potential options. Research may include a literature review of available literature and original quantitative or qualitative research conducted by staff. Eligible Governmental Entities’ Information. Board staff may collect information concerning the prescription drug product and therapeutic alternatives from eligible governmental entities. The information collected may include utilization, spending, costs, benefit design, formulary placement, rebates, discounts, price concessions and other relevant information. When developing preliminary policy recommendations for the Board, Board staff may use information gathered or obtained through the: Cost review study process under COMAR 14.01.04; and Information gathering process under Regulation .04 of this chapter. Policy Action Other than UPL. Board staff may recommend policy options to redress the affordability challenge. When recommending policy options, Board staff may analyze the: Drivers of the affordability challenge; How the policy addresses a driver; Strengths and weaknesses of the policy; Possible implementation of the policy through legislation, regulation, or enforcement; and Potential impacts of the policy. The Board may: Adopt none of the non-UPL policy recommendations; Adopt one or more policy recommendations; or Adopt and modify one or more policy recommendations. The Board may adopt a final policy recommendation only after the Board has: Made a final affordability challenge determination; and Adopted the final cost review study report under COMAR 14.01.04.05G. The public may provide oral and written comments concerning any agenda item of the Board or any decision pending before the Board in accordance with the procedures and timelines in COMAR 14.01.01.05A and B(2). Policy Action in the Form of an Upper Payment Limit. Board staff may recommend a UPL as a policy option to redress an affordability challenge. When recommending a UPL as a policy option, Board staff may analyze the: The drivers and market conditions causing the affordability challenge phenomena; Ability of a UPL to address these issues; Strengths and weaknesses of the UPL policy; Potential impacts of the UPL policy; Possible implementation of the policy through legislation, regulation or enforcement; Relevant regulatory criteria under Regulation .02 of this chapter; and Use of the drug by eligible governmental entities. Board staff may provide recommendations related to establishing a UPL including: An assessment of the drivers of the affordability challenge; and The extent to which a UPL may address the drivers. The Board may pursue development of a UPL as a policy option and direct Board staff to provide recommendations concerning the frameworks and contextual information that may be used to set a UPL in accordance with the UPL process set forth in Regulation .06 of this chapter. The public may provide oral and written comments concerning any agenda item of the Board or any decision pending before the Board in accordance with the procedures and timelines in COMAR 14.01.01.05A and B(2). Staff Recommends Frameworks and Contextual Information. Board staff shall recommend at least one framework, identified in §B of this regulation, for use in developing a UPL for the subject prescription drug product. Board staff may recommend certain contextual information identified in §C of this regulation for use in developing a UPL for the subject prescription drug product. Board staff shall: Post staff’s recommendations on the Board’s website in advance of the Board meeting; and Request public comment. The public may submit written comments by the date specified in the posting in accordance with COMAR 14.01.01.05B(4). Board staff shall present the recommendations to the Board. Frameworks. Cost Effectiveness Analysis. Under this framework, a maximum UPL value may be set by: Using a cost-effectiveness analysis to model how much additional health outcome is gained per dollar of additional spending when using a drug product compared to an alternative; Comparing this number to a threshold to determine if a product is “cost-effective”; and Then, if the product is not already cost-effective, given the specified threshold in §B(1)(a)(ii) of this regulation and the model in §B(1)(a)(i) of this regulation, calculating the maximum UPL for which it would be “cost-effective.” When providing a UPL amount developed using this framework, Board staff shall identify the health outcome, threshold, and relevant underlying assumptions used in the analysis. Therapeutic Class Reference Upper Payment Limit. Under this framework, a UPL value may be set using the lowest net price or net cost among competitor products in the same therapeutic class. The Board may limit the prescription drug products used for analysis to a subset of drugs in the same therapeutic class. When determining whether to use a product in the same therapeutic class as a reference product, the Board may consider: A difference in indication including a difference in the patient population and disease severity; and Comparative effectiveness research. Launch Price-Based Upper Payment Limit. Under this framework, a UPL value may be set based on the initial price at which the drug was first marketed (launch price) adjusted for inflation. The Board shall adjust the launch price using the CPI-U. Same Molecule Reference Upper Payment Limit. Under the same molecule reference UPL framework, a UPL value may be set by comparing prices of certain reference drugs: A generic drug product that is therapeutically equivalent to the product under the review; An authorized generic of the product under review; A drug product licensed under a BLA that has the same active ingredient and is approved for one or more of the same or similar indications as the product under review; A biosimilar for the product under review; The reference product for the product under review; and A drug product approved under an NDA or ANDA that has the same active ingredient and is approved for one or more of the same or similar indications as the product under review. When using this framework Board staff may consider: Any differences between the product under review and the same molecule reference products; and The utilization of the same molecule reference products. Domestic Reference Upper Payment Limit. Under the domestic reference UPL framework, a UPL value may be set using the estimated net cost of a prescription drug product to other purchasers and payors for the same prescription drug product within the United States or the net price received by the manufacturer. Under this framework, the UPL may be set using the cost of the lowest estimated net-cost purchaser or payor, excluding Medicaid. The Board may consider information for all other payors, including information on the Medicare Maximum Fair Price. International Reference Upper Payment Limit. Under the international reference UPL framework, a UPL value may be set by comparing drug prices in other countries. Under this framework, the Board may consider the lowest price received by manufacturers for sales in the United Kingdom, Germany, France, and Canada, converted to U.S. dollars. Budget Impact-Based Upper Payment Limits. Under the budget impact-based UPL framework, a UPL value may be set so that spending on the drug does not exceed a certain percentage of a budget as specified by the Board or have a disproportionate impact on that budget. The Board may consider current spending, projected spending, and potential offsets in developing a UPL value. When setting the percentage, the Board may consider the number of patients impacted, the disease burden, the current and projected future spending on other treatments and management of the disease. Blend of Multiple Frameworks. Under this framework, Board staff may recommend potential UPL values derived from: A blend of frameworks; and A variation in implementing a framework. When providing a blended UPL amount developed using this framework, Board staff shall identify how the potential blended UPL value was generated. Contextual Information for the Prescription Drug Product: Information gathered during the cost review study process or the policy review process; Net costs for: State health plan; County, bicounty, and municipal health plans; Direct government purchases; and Medicaid; Total out-of-pocket costs in: State health plan; County, bicounty, and municipal health plans; and Medicaid; Current coverage status of the drug in: State health plan; County, bicounty, and municipal health plans; and Medicaid; Utilization in the following program by patients and prescriptions: State health plan; County, bicounty, and municipal health plans; and Medicaid; Amount of direct government purchases by units and patients served; For the Maryland State Medical Assistance Program: Number of prescriptions paid; Number of patients who received the prescription drug product; and Total amount paid for the prescription drug product; Budget impact analysis; Comparisons of health system costs to research and development costs; Life cycle revenue analysis; and Information that can be derived from the aggregation, calculation, and comparison of available information. UPL Values. The Board may: Select one or more of the frameworks and contextual information identified in §§B and C of this regulation; Identify another framework; Prioritize the selected and identified frameworks and contextual information; and Direct staff to use the selected and identified frameworks and contextual information to perform analyses and calculations to obtain UPL values. Based on guidance from the Board and the regulatory criteria under Regulation .02 of this chapter, Board staff shall perform calculations and analyses to develop a collection of potential UPL values. These calculations and analyses may include appropriate adjustments to ensure that the UPL value: Reflects all discounts, rebates and price concessions; Excludes dispensing and administration fees and direct and indirect renumeration to pharmacies; and Includes patient out-of-pocket costs other than costs attributable to dispensing fees under §D(3)(b) of this regulation. Board staff shall post a public version of: The UPL values developed through analysis; Staff’s recommendation for a proposed UPL amount with a description of the calculation and analyses and relevant underlying assumptions used in the analysis such as health outcome or threshold; and A request for public written comment on the Board’s website. Board staff may also request public written comment addressing specific questions or proposing alternative analyses. The public may submit written comments by the date specified in the posting in accordance with COMAR 14.01.01.05B(4). Technical Hearing. The Board may convene a hearing for the purpose of receiving technical input, technical information or expert testimony. The technical hearing shall be conducted in accordance with COMAR 14.01.01.06. Amendment of Recommendations and UPL Values. Board staff may modify or amend the public version of the developed UPL values, and staff’s recommendations for a proposed UPL amount. If Board staff modifies or amends the developed UPL values and staff’s recommendations, staff shall post the amendments to the Board’s website, and request public written comment by a specified date. The public may submit written comments by the date specified in the posting in accordance with COMAR 14.01.01.05B(4). Final Determination Concerning Affordability Challenge. Prior to taking an action with respect to policy, the Board shall: Make a final determination of whether the prescription drug has or will create an affordability challenge; and Adopt as final a cost review study report under COMAR 14.01.04.05G. The Board’s determination of whether a prescription drug has or will create an affordability challenge is not final until the final cost review study report is adopted by the Board. The public may provide oral and written comments concerning any agenda item of the Board or any decision pending before the Board in accordance with the procedures and timelines in COMAR 14.01.01.05A and B(2). Final Policy Action: Policy Recommendations and Proposed Regulations. If the Board makes a final determination that the prescription drug has or will create an affordability challenge, the Board may adopt: Non-UPL policy recommendations in accordance with Regulation .05 of this chapter; Proposed regulations setting the UPL at the specified amount in accordance with Regulation .08 of this chapter; or Both. The public may provide oral and written comments concerning any agenda item of the Board or any decision pending before the Board in accordance with the procedures and timelines in COMAR 14.01.01.05A and B(2). Where applicable, the adoption of the final cost review study report, non-UPL policy recommendations, and proposed regulations setting a UPL amount: Shall be performed sequentially; and May be taken at the same Board meeting. Adopting a Proposed Regulation Setting a UPL. The proposed regulation shall set a specified UPL amount for specified eligible governmental entities. The Board and staff shall work with eligible governmental entities to develop the best method for implementing the UPL for the entity and a prospective effective date that provides sufficient time for implementation. The per unit final net cost paid by the eligible governmental entity shall not exceed the GovUPL. The Board shall provide for the automatic suspension of the UPL for the time that the prescription drug product is on the federal Food and Drug Administration prescription drug shortage list by regulation. Monitoring a UPL. The Board shall develop a program for monitoring the availability of any prescription drug product for which it sets a UPL. If monitoring discloses a shortage of the prescription drug product in the State, the Board may suspend or modify the UPL. Authority to Reconsider UPL. The Board may reconsider a UPL for any reason. If the Board becomes aware of a shortage of a prescription drug product in the State, for a drug that is subject to a UPL, the Board shall reconsider the UPL. The Board may suspend a UPL at any time and may suspend the UPL for the duration of the reconsideration process by proposing an amended regulation. Following completion of the reconsideration process the Board may: Take no action and allow the UPL to stand; Modify the UPL amount and propose amendment of the UPL regulation setting the new modified UPL amount; Suspend the UPL for a specified period and propose amendment of the regulation to proscribe the suspension; and Repeal the UPL and propose repealing the regulation setting the UPL amount. Reconsideration Process. General Procedures. Board staff shall post notice of the reconsideration of the UPL on the Board’s website. The Board may solicit patient and stakeholder feedback through written comments submitted in accordance with COMAR 14.01.01.05B(4) and informational hearings held under COMAR 14.01.01.06C. The Board may use the information gathering process under Regulation .04 of this chapter to obtain information for the reconsideration process. Board staff shall present to the Board: The basis for reconsideration; A summary of the feedback obtained through written comments, informational hearings and the information gathering process, as applicable; A summary of the information generated through the UPL monitoring program, as applicable; Estimated impact of the UPL to date such as savings estimates, and estimated impact on access to the drug; and Staff recommendations for Board action. The Board may take any action specified under §A(4) of this regulation. Modifying a UPL. If Board staff recommends further study to support modification of the UPL, the Board shall use the procedures in Regulations .06D-F and .07B(1)(b) of this chapter to develop a new UPL amount and receive public comment. The Board may modify the UPL amount and propose amendment of the UPL regulation setting the modified UPL amount under § A(4)(b) of this regulation. Action on Drug where UPL was Repealed. For any prescription drug product previously subject to a UPL that was later repealed, the Board may: Select the prescription drug product for cost review study if the drug product meets the eligibility requirements set forth in COMAR 14.01.04.02; Conduct a cost review study in accordance with COMAR 14.01.04.05; and Make a preliminary determination in accordance with COMAR 14.01.04.05. If the Board makes a preliminary determination that the prescription drug product has or will create an affordability challenge the Board may: Consider any element or analysis from the original cost review study report; If available, consider information from the UPL monitoring program; Consider information obtained through the reconsideration process under §B of this regulation; and Set a UPL or make other policy recommendations in accordance with Regulations .07—.08 of this chapter. Effective date: April 28, 2025 (52:8 Md. R. 359)