Missouri Code of State Regulations › Title 13 - DEPARTMENT OF SOCIAL SERVICES › Division 70 - MO HealthNet Division › Chapter 20 - Pharmacy Program › Section 13 CSR 70-20.250 - Prior Authorization of New Drug Entities or New Drug Dosage Form

Current through Register Vol. 49, No. 14, July 15, 2024
PURPOSE: The purpose of this amendment is to shift
				  these responsibilities to the MO HealthNet Drug Utilization Review Board. This
				  will streamline the New Drug and Prior Authorization process. The Drug Prior
				  Authorization Committee was established by a state regulation.
(1) New drug entities, and new drug product
				dosage forms of existing drug entities, that have been approved by the Food and
				Drug Administration and are available on the market, shall comply with prior
				authorization requirements imposed by the division, in compliance with federal
				law.
(2) Prior authorization
				restrictions shall continue on new drug entities and new drug product dosage
				forms of existing drugs until reviewed by the division and the division
				eliminates the restriction or makes a final determination to require
				restriction. The division shall consider known cost and use data, medical and
				clinical criteria, and prudent utilization of state funds in the review.
				Interested parties may present clinical data to the division.
(3) The review referenced in section (2)
				shall occur within thirty (30) business days after the division receives notice
				through pricing updates of the availability of the drug entity on the market.
				Upon completion of the review, the division shall make the drug available for
				use by all MO HealthNet participants or refer the new drug or new drug dosage
				form to the MO HealthNet Drug Utilization Review (DUR) Board with a
				recommendation for continued prior authorization. Staff recommendations
				regarding continued prior authorization of a new drug or new drug dosage form
				shall be made in writing to the DUR Board. A copy shall be available to the
				public prior to the DUR Board meeting in which the continued prior
				authorization is to be discussed.
(4) The DUR Board shall consider any
				recommendations related to continued prior authorization of a new drug or new
				drug dosage form at the next scheduled DUR Board meeting. The division and the
				DUR Board may actively seek comments about the proposed restrictions. The DUR
				Board shall include five (5) minutes for any interested parties who have
				notified the division in advance of the scheduled meeting to comment about such
				proposed restrictions.
(5) If the
				DUR Board finds that use and cost data, pharmacoeconomic information, along
				with medical and clinical implications of restriction, are documented and
				restriction is warranted, the DUR Board shall hold a public hearing regarding
				the continued restriction and make a recommendation to the division. Such
				recommendation shall be provided to the division, in writing, prior to the
				division making a final determination. The division shall provide notice of the
				final determination through the Department of Social Services, MO HealthNet
				Division website at dss.state.mo.gov/mhd, provider bulletins, and updates to
				the provider manual.
(6) If, after
				the hearing referenced in section (5) above, prior authorization of the new
				drug or new drug dosage form is required, the prior authorization requirement
				shall be reviewed at least once every twelve (12) months by the DUR
				Board.
*Original authority: 208.153, RSMo 1967, amended 1967,
					 1973, 1989, 1990, 1991, 2007, 2012 and 208.201, RSMo 1987, amended
					 2007.