In this subtitle the following words have the meanings indicated.
“Biologic” means a drug that is produced or distributed in accordance with a biologics license application approved under 42 C.F.R. § 447.502.
“Biosimilar” means a drug that is produced or distributed in accordance with a biologics license application approved under 42 U.S.C. § 262(k)(3).
“Board” means the Prescription Drug Affordability Board.
“Brand name drug” means a drug that is produced or distributed in accordance with an original new drug application approved under 21 U.S.C. § 355(c).
“Brand name drug” does not include an authorized generic as defined by 42 C.F.R. § 447.502.
“Current shortage” means a drug:
Listed as current on the federal Food and Drug Administration’s Drug Shortage Database; or
Otherwise determined by the Board to be in short supply in the State.
“Generic drug” means:
A retail drug that is marketed or distributed in accordance with an abbreviated new drug application, approved under 21 U.S.C. § 355(j);
An authorized generic as defined by 42 C.F.R. § 447.502; or
A drug that entered the market before 1962 that was not originally marketed under a new drug application.
“Manufacturer” means an entity that:
Engages in the manufacture of a prescription drug product; or
Enters into a lease with another manufacturer to market and distribute a prescription drug product under the entity’s own name; and
Sets or changes the wholesale acquisition cost of the prescription drug product it manufactures or markets.
“Prescription drug product” means a brand name drug, a generic drug, a biologic, or a biosimilar.
“Stakeholder Council” means the Prescription Drug Affordability Stakeholder Council.
There is a Prescription Drug Affordability Board.
The Board is a body politic and corporate and is an instrumentality of the State.
The Board is an independent unit of State government.
The exercise by the Board of its authority under this subtitle is an essential governmental function.
The purpose of the Board is to protect State residents, State and local governments, commercial health plans, health care providers, pharmacies licensed in the State, and other stakeholders within the health care system from the high costs of prescription drug products.
The Board consists of the following members, who must have expertise in health care economics or clinical medicine:
One member appointed by the Governor;
One member appointed by the President of the Senate;
One member appointed by the Speaker of the House of Delegates;
One member appointed by the Attorney General; and
One member appointed jointly by the President of the Senate and the Speaker of the House of Delegates, who shall serve as chair of the Board.
The Board shall have the following alternate members, who must have expertise in health care economics or clinical medicine and who shall be designated by the Board chair to participate in deliberations of the Board when a member is recused:
One alternate member appointed by the Governor;
One alternate member appointed by the President of the Senate; and
One alternate member appointed by the Speaker of the House of Delegates.
At least one member of the Board shall have expertise in:
The 340B Program under the federal Public Health Service Act;
The State’s all–payer model contract;
How the program and contract interact; and
How decisions made by the Board will affect the model and contract.
A member or an alternate member may not be an employee of, a board member of, or a consultant to a manufacturer, pharmacy benefits manager, health insurance carrier, health maintenance organization, managed care organization, or wholesale distributor or related trade association.
Any conflict of interest, including whether the individual has an association, including a financial or personal association, that has the potential to bias or has the appearance of biasing an individual’s decision in matters related to the Board or the conduct of the Board’s activities, shall be considered and disclosed when appointing members and alternate members to the Board.
To the extent practicable and consistent with federal and State law, the membership of the Board shall reflect the racial, ethnic, and gender diversity of the State.
The term of a member or an alternate member is 5 years.
The terms of the members and alternate members are staggered as required by the terms provided for members on October 1, 2019.
The chair shall hire an executive director and staff for the Board.
The chair shall develop a 5–year budget and staffing plan and submit it to the Board for approval.
Staff of the Board shall receive a salary as provided in the budget of the Board.
A member of the Board:
May receive compensation as a member of the Board in accordance with the State budget; and
Is entitled to reimbursement for expenses under the Standard State Travel Regulations, as provided in the State budget.
Subject to subparagraphs (ii) and (iv) of this paragraph, the Board shall meet in open session at least four times a year.
At the chair’s discretion, the chair may cancel or postpone a meeting.
The following actions by the Board shall be made in open session:
The study required under § 21–2C–07 of this subtitle;
Deliberations on whether to subject a prescription drug product to a cost review under § 21–2C–08(d) of this subtitle;
Any vote on whether to impose an upper payment limit on purchases and payor reimbursements of prescription drug products in the State; and
Any decision by the Board.
Notwithstanding the Open Meetings Act, the Board may meet in closed session to discuss trade secrets or confidential and proprietary data and information.
The Board shall provide public notice of each Board meeting at least 2 weeks in advance of the meeting.
Materials for each Board meeting shall be made available to the public at least 1 week in advance of the meeting.
Materials containing trade secrets or confidential and proprietary data or information that is not otherwise available to the public may not be made available to the public.
The Board shall provide an opportunity for public comment at each open meeting of the Board.
The Board shall provide the public with the opportunity to provide written comments on pending decisions of the Board.
The Board may allow expert testimony at Board meetings, including when the Board meets in closed session.
To the extent practicable, the Board shall access pricing information for prescription drug products by:
Entering into a memorandum of understanding with another state to which manufacturers already report pricing information; and
Accessing other available pricing information.
A majority of the members of the Board constitutes a quorum.
Members of the Board shall recuse themselves from decisions related to a prescription drug product if the member, or an immediate family member of the member, has received or could receive any of the following:
A direct financial benefit of any amount deriving from the result or finding of a study or determination by or for the Board; or
A financial benefit from any person that owns, manufactures, or provides prescription drug products, services, or items to be studied by the Board that in the aggregate exceeds $5,000 per year.
For the purposes of subparagraph (i) of this paragraph, a financial benefit includes honoraria, fees, stock, the value of the member’s or immediate family member’s stock holdings, and any direct financial benefit deriving from the finding of a review conducted under this subtitle.
In addition to the powers set forth elsewhere in this subtitle, the Board may:
Adopt regulations to carry out the provisions of this subtitle; and
Enter into a contract with a qualified, independent third party for any service necessary to carry out the powers and duties of the Board.
Unless permission is granted by the Board, a third party hired by the Board in accordance with subsection (f)(2) of this section may not release, publish, or otherwise use any information to which the third party has access under its contract.
Except as provided in paragraph (2) of this subsection, any procurement for services to be performed or for supplies to be delivered to the Board is not subject to Division II of the State Finance and Procurement Article.
The Board is subject to the following provisions of the State Finance and Procurement Article:
Title 3.5, Subtitle 3 (Information Processing), to the extent that the Secretary of Information Technology determines that an information technology project of the Board is a major information technology development project;
Title 12, Subtitle 4 (Policies and Procedures for Exempt Units); and
Title 14, Subtitle 3 (Minority Business Participation).
The Attorney General is the legal adviser to the Board.
The Attorney General shall designate an assistant attorney general as counsel to the Board.
As needed, the Attorney General may assign additional assistant attorneys general to the Board to give effective legal advice and counsel.
The counsel to the Board may not have a duty other than to:
Give the legal aid, advice, and counsel required by the Board;
Supervise the other assistant attorneys general assigned to the Board, if any; and
Perform for the Board the duties that the Attorney General assigns.
The counsel shall perform these duties subject to the control and supervision of the Attorney General.
After the Attorney General designates the counsel to the Board, the Attorney General may not reassign the counsel without consulting the Board.
There is a Prescription Drug Affordability Stakeholder Council.
The purpose of the Stakeholder Council is to provide stakeholder input to assist the Board in making decisions as required under this subtitle.
The Stakeholder Council consists of members appointed in accordance with this subsection.
The Speaker of the House of Delegates shall appoint:
One representative of generic drug corporations;
One representative of nonprofit insurance carriers;
One representative of a statewide health care advocacy coalition;
One representative of a statewide advocacy organization for seniors;
One representative of a statewide organization for diverse communities;
One representative of a labor union;
One representative of the rare disease community;
One health services researcher specializing in prescription drugs; and
One public member at the discretion of the Speaker of the House of Delegates.
The President of the Senate shall appoint:
One representative of brand name drug corporations;
One representative of physicians;
One representative of nurses;
One representative of hospitals;
One representative of dentists;
One representative of oncologists;
One representative of managed care organizations;
One representative of the Department of Budget and Management;
One clinical researcher; and
One public member at the discretion of the President of the Senate.
The Governor shall appoint:
One representative of brand name drug corporations;
One representative of generic drug corporations;
One representative of biotechnology companies;
One representative of for–profit health insurance carriers;
One representative of employers;
One representative of pharmacy benefits managers;
One representative of pharmacists;
One pharmacologist;
One representative of a patient advocacy organization; and
One public member at the discretion of the Governor.
Collectively, the members of the Stakeholder Council shall have knowledge of the following:
The pharmaceutical business model;
Supply chain business models;
The practice of medicine or clinical training;
Consumer or patient perspectives;
Health care costs trends and drivers;
Clinical and health services research; or
The State’s health care marketplace.
To the extent practicable and consistent with federal and State law, the membership of the Stakeholder Council shall reflect the racial, ethnic, and gender diversity of the State.
From among the membership of the Stakeholder Council, the Board chair shall appoint two members to be cochairs of the Stakeholder Council.
The term of a member is 3 years.
The initial members of the Stakeholder Council shall serve staggered terms as required by the terms provided for members on October 1, 2019.
A member of the Stakeholder Council:
May not receive compensation as a member of the Stakeholder Council; but
Is entitled to reimbursement for expenses under the Standard State Travel Regulations, as provided in the State budget.
A conflict of interest shall be disclosed:
By the Board when hiring Board staff;
By the appointing authority when appointing members and alternate members to the Board and members to the Stakeholder Council; and
By the Board, when a member of the Board is recused in any final decision resulting from a review of a prescription drug product.
A conflict of interest shall be disclosed:
In advance of the first open meeting after the conflict is identified; or
Within 5 days after the conflict is identified.
A conflict of interest disclosed under subsection (a) of this section shall be posted on the website of the Board unless the chair of the Board recuses the member from any final decision resulting from a review of a prescription drug product.
A posting under paragraph (1) of this subsection shall include the type, nature, and magnitude of the interests of the member involved.
Members and alternate members of the Board, Board staff, and third–party contractors may not accept any gift or donation of services or property that indicates a potential conflict of interest or has the appearance of biasing the work of the Board.
On or before December 31, 2021, the Board, in consultation with the Stakeholder Council, shall:
Study:
The entire pharmaceutical distribution and payment system in the State; and
Policy options being used in other states and countries to lower the list price of pharmaceuticals, including:
Setting upper payment limits;
Using a reverse auction marketplace; and
Implementing a bulk purchasing process; and
Report its findings and recommendations, including findings for each option studied under item (1)(ii) of this section and any legislation required to implement the recommendations, to the Senate Finance Committee and the House Health and Government Operations Committee in accordance with § 2–1257 of the State Government Article.
On or before December 31, 2021, the Board shall:
Collect and review publicly available information regarding prescription drug product manufacturers, health insurance carriers, health maintenance organizations, managed care organizations, wholesale distributors, and pharmacy benefits managers; and
Identify states that require reporting on the cost of prescription drug products; and
Initiate a process of entering into memoranda of understanding with the states identified under item (i) of this item to aid in the collection of transparency data for prescription drug products.
Based on the information collected under subsection (a)(1) of this section and obtained through memoranda of understanding under subsection (a)(2) of this section, the Board, in consultation with the Stakeholder Council, shall adopt regulations to:
Establish methods for collecting additional data necessary to carry out its duties under this subtitle; and
Identify circumstances under which the cost of a prescription drug product may create or has created affordability challenges for the State health care system and patients.
The Board shall use the information collected under subsection (a)(1) of this section and obtained through memoranda of understanding under subsection (a)(2) of this section to identify prescription drug products that are:
Brand name drugs or biologics that, as adjusted annually for inflation in accordance with the Consumer Price Index, have:
A launch wholesale acquisition cost of $30,000 or more per year or course of treatment; or
A wholesale acquisition cost increase of $3,000 or more in any 12–month period, or course of treatment if less than 12 months;
Biosimilar drugs that have a launch wholesale acquisition cost that is not at least 15% lower than the referenced brand biologic at the time the biosimilars are launched;
Generic drugs that, as adjusted annually for inflation in accordance with the Consumer Price Index, have a wholesale acquisition cost:
Of $100 or more for:
A 30–day supply lasting a patient for a period of 30 consecutive days based on the recommended dosage approved for labeling by the United States Food and Drug Administration;
A supply lasting a patient for fewer than 30 days based on the recommended dosage approved for labeling by the United States Food and Drug Administration; or
One unit of the drug if the labeling approved by the United States Food and Drug Administration does not recommend a finite dosage; and
That increased by 200% or more during the immediately preceding 12–month period, as determined by the difference between the resulting wholesale acquisition cost and the average of the wholesale acquisition cost reported over the immediately preceding 12 months; and
Other prescription drug products that may create affordability challenges for the State health care system and patients, in consultation with the Stakeholder Council.
After identifying prescription drug products as required by § 21–2C–08 of this subtitle, the Board shall determine whether to conduct a cost review as described in subsection (b) of this section for each identified prescription drug product by:
Seeking Stakeholder Council input about the prescription drug product; and
Considering the average cost share of the prescription drug product.
To the extent there is no publicly available information to conduct a cost review as described in subsection (b) of this section, the Board shall request the information from:
The manufacturer of the prescription drug product; and
As appropriate, a wholesale distributor, pharmacy benefits manager, health insurance carrier, health maintenance organization, or managed care organization with relevant information on setting the cost of the prescription drug product in the State.
The information to conduct a cost review may include any document and research related to the manufacturer’s selection of the introductory price or price increase of the prescription drug product, including life cycle management, net average price in the State, market competition and context, projected revenue, and the estimated value or cost–effectiveness of the prescription drug product.
Failure of a manufacturer, wholesale distributor, pharmacy benefits manager, health insurance carrier, health maintenance organization, or managed care organization to provide the Board with the information requested under this paragraph does not affect the authority of the Board to conduct a review as described in subsection (b) of this section.
If the Board conducts a review of the cost of a prescription drug product, the review shall determine whether use of the prescription drug product that is fully consistent with the labeling approved by the United States Food and Drug Administration or standard medical practice has led or will lead to affordability challenges for the State health care system or high out–of–pocket costs for patients.
To the extent practicable, in determining whether a prescription drug product identified under § 21–2C–08 of this subtitle has led or will lead to an affordability challenge, the Board shall consider the following factors:
The wholesale acquisition cost and any other relevant prescription drug cost index for the prescription drug product sold in the State;
The average monetary price concession, discount, or rebate the manufacturer provides to health plans in the State or is expected to provide to health plans in the State as reported by manufacturers and health plans, expressed as a percent of the wholesale acquisition cost for the prescription drug product under review;
The total amount of the price concession, discount, or rebate the manufacturer provides to each pharmacy benefits manager operating in the State for the prescription drug product under review, as reported by manufacturers and pharmacy benefits managers, expressed as a percent of the wholesale acquisition costs;
The price at which therapeutic alternatives have been sold in the State;
The average monetary concession, discount, or rebate the manufacturer provides or is expected to provide to health plan payors and pharmacy benefits managers in the State for therapeutic alternatives;
The costs to health plans based on patient access consistent with United States Food and Drug Administration labeled indications;
The impact on patient access resulting from the cost of the prescription drug product relative to insurance benefit design;
The current or expected dollar value of drug–specific patient access programs that are supported by the manufacturer;
The relative financial impacts to health, medical, or social services costs as can be quantified and compared to baseline effects of existing therapeutic alternatives;
The average patient copay or other cost–sharing for the prescription drug product in the State; and
Any other factors as determined by the Board in regulations adopted by the Board.
If the Board is unable to determine whether a prescription drug product will produce or has produced challenges to the affordability of the drug for the State health care system, using the factors listed in paragraph (2) of this subsection, the Board may consider the following factors:
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 in proportion to the manufacturer’s sales in the State;
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 that are multiplied by the ratio of total manufacturer in–State sales to total manufacturer sales in the United States for the product under review;
Gross and net manufacturer, pharmacy benefits manager, and wholesale distributor revenues for the prescription drug product under review for the most recent tax year;
Any additional factors proposed by the manufacturer and appropriate health insurance carriers, health maintenance organizations, managed care organizations, wholesale distributors, and pharmacy benefits managers that the Board considers relevant; and
Any additional factors as established by the Board in regulations.
On or before December 31, 2020, and each December 31 thereafter, the Board shall submit to the Senate Finance Committee and the House Health and Government Operations Committee, in accordance with § 2–1257 of the State Government Article, a report that includes:
Price trends for prescription drug products;
The number of prescription drug products that were subject to Board review and the results of the review; and
Any recommendations the Board may have on further legislation needed to make prescription drug products more affordable in the State.
If the Board sets a new upper payment limit, to the extent practicable, the Board shall include in the first report that is required under subsection (c) of this section after the upper payment limit has been in effect for 1 year information on the effects of the upper payment limit, based on available timely data, for the following:
Patient out–of–pocket costs including whether the upper payment limit was associated with increases or decreases in what patients pay for prescription drug products;
Patient health insurance premiums, including whether the upper payment limit is associated with increases or decreases in health insurance costs for patients;
Pharmacies operating in the State, including the impact on reimbursement rates and financial viability of retail and independent pharmacies;
Patient health insurance formularies, including whether the prescription drug product subject to the upper payment limit remained on formularies;
Provider–administered medications subject to the upper payment limit, including whether providers were able to acquire the prescription drug product subject to the upper payment limit at a rate to account for acquisition costs and whether there was an impact on provider reimbursement;
Patient access to the prescription drug product subject to the upper payment limit, which may include:
Whether prescription drug product shortages or other supply disruptions occurred after the upper payment limit took effect;
Whether formulary placement or plan design changes made the prescription drug product subject to the upper limit more difficult for patients to access, including if insurance plans preferred a prescription drug product without an upper payment limit over a prescription drug product subject to an upper payment limit;
Whether the distribution and delivery of specialty or rare disease medications from out–of–state pharmacies to providers, pharmacies, or patients was impacted;
Whether patients in communities of color, patients who are women, patients with a rare disease, or patients in rural areas experienced disproportionate access challenges; and
Whether cost differences as a result of the upper payment limit affected patients, pharmacies, or providers and, if the cost difference resulted in an increase in costs, who was ultimately responsible for bearing the increased cost;
Covered entity providers participating in the 340B drug discount program, including the impact of the upper payment limit on the operations of the providers and their contracted pharmacies; and
The biotechnology industry in the State, including the impact on pharmaceutical research and development, investment, and job growth.
The Board may request information necessary to complete the report required under subsections (c) and (d) of this section from an affected entity.
The entity from which information was requested under paragraph (1) of this subsection shall make a good faith effort to provide the requested information.
All information and data obtained by the Board under this subtitle, that is not otherwise publicly available:
Is considered to be a trade secret and confidential and proprietary information; and
Is not subject to disclosure under the Public Information Act.
Only Board members and staff may access trade secrets and confidential and proprietary data and information obtained under this subtitle that is not otherwise publicly available.
The provisions of Title 11, Subtitle 12 of the Commercial Law Article shall apply to any trade secrets and confidential and proprietary data and information obtained under this subtitle that is not otherwise publicly available.
In this section, “Fund” means the Prescription Drug Affordability Fund.
The Board shall assess and collect an annual fee on:
Manufacturers that sell or offer for sale prescription drug products to persons in the State;
Pharmacy benefits managers, as defined in § 15–1601 of the Insurance Article;
Carriers, as defined in § 19–132 of this article; and
Wholesale distributors, as defined in § 12–6C–01 of the Health Occupations Article, that sell or offer for sale prescription drug products to persons in the State.
The Board shall:
Assess and collect the annual fee under paragraph (1) of this subsection in accordance with criteria established in regulations adopted by the Board; and
Calculate the annual fee under paragraph (1) of this subsection in a fair and equitable manner.
On or before October 1 each year, each entity assessed a fee under this subsection shall pay the fee assessed by the Board.
The Board shall allow entities to make partial payments when paying the fee assessed under this subsection.
Any fee not paid within 30 days after the payment due date may be subject to an interest penalty to be determined and collected by the Board.
The total amount of fees that the Board collects in each calendar year under paragraph (1) of this subsection may not exceed $2,000,000.
The Board shall pay all fees collected under paragraph (1) of this subsection into the Fund.
There is a Prescription Drug Affordability Fund.
The purpose of the Fund is to provide funding for the Board and to carry out the purpose of this subtitle.
The Board shall administer the Fund.
The Fund is a special, nonlapsing fund that is not subject to § 7–302 of the State Finance and Procurement Article.
The State Treasurer shall hold the Fund separately, and the Comptroller shall account for the Fund.
The Fund consists of:
Revenue distributed to the Fund under subsection (b) of this section;
Money appropriated in the State budget to the Fund;
Interest earnings; and
Any other money from any other source accepted for the benefit of the Fund.
The Fund may be used only to provide funding for the Board and for the purposes authorized under this subtitle, including administrative expenses and any costs expended by any State agency to implement this subtitle.
The State Treasurer shall invest the money of the Fund in the same manner as other State money may be invested.
Any interest earnings of the Fund shall be credited to the Fund.
Expenditures from the Fund may be made only in accordance with the State budget.
The Fund is subject to audit by the Office of Legislative Audits as provided for under § 2–1220 of the State Government Article.
This subsection may not be construed to prohibit the Fund from receiving funds from any other source.
The Office of the Attorney General may pursue any available remedy under State law when enforcing this subtitle.
If, under § 21–2C–07 of this subtitle, the Board finds that it is in the best interest of the State to establish a process for setting upper payment limits for prescription drug products that it determines have led or will lead to an affordability challenge, the Board, in conjunction with the Stakeholder Council, shall draft a plan of action for implementing the process in accordance with the requirements of this section.
The criteria for setting upper payment limits shall include consideration of:
The cost of administering the prescription drug product;
The cost of delivering the prescription drug product to consumers;
The effect the upper payment limit will have on providers of 340B drugs;
For an upper payment limit on a drug that is designated as a drug for a rare disease or condition, the impact of the upper payment limit on patients with rare diseases; and
Other relevant administrative costs related to the prescription drug product.
If the Board previously set an upper payment limit for a drug that becomes a current shortage, the Board may reconsider the previously set upper payment limit.
The Board may not:
Apply a new upper payment limit to a drug in a current shortage;
Enforce an upper payment limit against provider or pharmacy reimbursement requirements for Medicare Part C or Part D plans; or
Count a pharmacy dispensing fee toward or subject a pharmacy dispensing fee to an upper payment limit.
If a plan of action is drafted under subsection (a) of this section, the Board shall submit the plan of action to the Legislative Policy Committee of the General Assembly, in accordance with § 2–1257 of the State Government Article, for its approval.
The Legislative Policy Committee shall have 45 days to approve the plan of action.
If the Legislative Policy Committee does not approve the plan of action, the Board shall submit the plan to the Governor and the Attorney General for approval.
The Governor and the Attorney General shall have 45 days to approve the plan of action.
The Board may not set upper payment limits unless the plan is approved, in accordance with this subsection, by:
The Legislative Policy Committee; or
The Governor; and
The Attorney General.
In accordance with the plan of action approved by the Legislative Policy Committee on October 22, 2024, the Board may set upper payment limits through regulations for prescription drug products that are:
Purchased or paid for by a unit of State or local government or an organization on behalf of a unit of State or local government, including:
State or county correctional facilities;
State hospitals; and
Health clinics at State institutions of higher education;
Paid for through a health benefit plan on behalf of a unit of State or local government, including a county, bicounty, or municipal employee health benefit plan; or
Purchased for or paid for by the Maryland State Medical Assistance Program.
A person aggrieved by an upper payment limit set by the Board may request an appeal within 30 days after the Board makes the decision to set the limit.
The Board shall hear the appeal and make a final decision within 60 days after the appeal is requested.
Any person aggrieved by a final decision of the Board issued under subsection (b) of this section may petition for judicial review as provided by the Administrative Procedure Act.
The Board, in consultation with the Stakeholder Council, shall determine whether, in addition to setting upper payment limits in accordance with § 21–2C–14 of this subtitle, it is in the best interest of the State for the Board to establish a process for setting upper payment limits for purchases and payor reimbursements of prescription drug products in the State that the Board determines have led or will lead to an affordability challenge.
When making a determination under paragraph (1) of this subsection, the Board shall consider, if applicable:
Contract and budget data provided to the Board that demonstrates savings to the State or local governments as a result of upper payment limits set in accordance with § 21–2C–14 of this subtitle;
Success of setting upper payment limits in other states; and
Expected savings from Medicare Maximum Fair Prices set by the Centers for Medicare and Medicaid Services.
If the Board makes an affirmative determination under subsection (a) of this section, the Board, in consultation with the Stakeholder Council, shall establish a process for setting upper payment limits for purchases and payor reimbursements of prescription drug products in the State that the Board determines have led or will lead to an affordability challenge.
The process established under paragraph (1) of this subsection shall:
To the extent appropriate, use the plan of action approved under § 21–2C–13(d) of this subtitle; and
Otherwise comply with the requirements for setting upper payment limits established under this subtitle.
Before establishing an upper payment limit that applies to the Maryland Medical Assistance Program, the Board shall confer with the Maryland Medical Assistance Program to approve the application of the upper payment limit by assessing whether the proposed upper payment limit will:
Conflict with the Medicaid Drug Rebates Program, the Covered Outpatient Drug Rule (CMS–2345–FC), or any other federal requirements as applicable; and
Require additional funding to be allocated to the Maryland Medical Assistance Program budget.