§ 21-2C-16
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/md/health-general/21-2c-16A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
§21–2C–16. ** CONTINGENCY – IN EFFECT – CHAPTERS 610 AND 611 OF 2025 **
(1)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.
(2)When making a determination under paragraph
(1)of this subsection, the Board shall consider, if applicable:
(i)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;
(ii)Success of setting upper payment limits in other states; and
(iii)Expected savings from Medicare Maximum Fair Prices set by the Centers for Medicare and Medicaid Services.
(1)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.
(2)The process established under paragraph
(1)of this subsection shall:
(i)To the extent appropriate, use the plan of action approved under § 21–2C–13(d) of this subtitle; and
(ii)Otherwise comply with the requirements for setting upper payment limits established under this subtitle.
(3)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:
(i)Conflict with the Medicaid Drug Rebates Program, the Covered Outpatient Drug Rule (CMS–2345–FC), or any other federal requirements as applicable; and
(ii)Require additional funding to be allocated to the Maryland Medical Assistance Program budget.
§21–2C–16. ** CONTINGENCY – NOT IN EFFECT – CHAPTERS 610 AND 611 OF 2025 **
(1)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.
(2)When making a determination under paragraph
(1)of this subsection, the Board shall consider, if applicable:
(i)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;
(ii)Success of setting upper payment limits in other states; and
(iii)Expected savings from Medicare Maximum Fair Prices set by the Centers for Medicare and Medicaid Services.
(1)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.
(2)The process established under paragraph
(1)of this subsection shall:
(i)To the extent appropriate, use the plan of action approved under § 21–2C–13(d) of this subtitle; and
(ii)Otherwise comply with the requirements for setting upper payment limits established under this subtitle.
(3)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:
(i)Conflict with the Medicaid Drug Rebates Program, the Covered Outpatient Drug Rule (CMS–2345–FC), or any other federal requirements as applicable; and
(ii)Require additional funding to be allocated to the Maryland Medical Assistance Program budget.
(1)Subject to paragraph
(2)of this subsection, if the Board establishes a process under subsection
(b)of this section, the Board shall set upper payment limits for purchases and payor reimbursements of prescription drug products in the State in accordance with the process.
(2)This subsection does not apply with respect to:
(i)Payor reimbursements under Medicare Part C and D Plans;
(ii)Purchases under the federal 340B Drug Pricing Program; and
(iii)Purchases and payor reimbursements by federal agencies or federal programs that the State is preempted from regulating by federal law.