Illinois Administrative Code › Title 89 - SOCIAL SERVICES › Part 140 - MEDICAL PAYMENT › Subpart D - PAYMENT FOR NON-INSTITUTIONAL SERVICES › Section 140.442 - Drug Product Prior Approval and the Preferred Drug List

Current through Register Vol. 48, No. 28, July 12, 2024
a) The Department may require prior approval
				for the reimbursement of any drug product, except as provided in this Section.
				Determinations of whether a drug product is listed as preferred on the
				Preferred Drug List (PDL) and when prior approval for any drug product is
				required shall be made in the following manner:
1) The Department shall consult with the Drug
				and Therapeutics Advisory Board (the Board), comprised of individuals that
				possess appropriate expertise in the areas of pharmacology and medicine, when
				determining which drug products to list as preferred on the PDL, as well as
				which drug products outside of the PDL require prior approval.
2) Board Members. The Board shall be
				compromised of voting members appointed by the Governor in accordance with
				Section 5-30.11 of the Public Aid Code.
3) Board Advisors. The Department will select
				nonvoting clinicians to advise the Board in accordance with Section
				5-30.11.
4) Board members shall
				serve 3 year terms without compensation. Board advisors are appointed by the
				Department to serve 3 years terms without compensation.
5) Board members and advisors shall disclose
				conflicts of interest and shall not participate in matters in which they have a
				potential conflict of interest.
6)
				The Board shall meet not less than one time per calendar quarter. The
				recommendations of the Board shall be non-binding upon the Department and can
				in no way bind or otherwise limit the Department's right to determine, in its
				sole discretion, those drugs that shall be available with or without prior
				approval, or as preferred or non-preferred products.
7) Upon U.S. Food and Drug Administration
				approval of a new drug product, the new drug product shall require prior
				approval until the Department determines otherwise. When a newly approved drug
				product enters the market, or when post-marketing information becomes available
				for existing drug products requiring prior approval, the drug manufacturer
				shall be responsible for submitting materials to the Department that the
				Department and the Board will consider in determining whether reimbursement for
				the drug product will require prior approval.
8) New dosage strengths and new dosage forms
				of drug products already available without prior approval (see Section
				140.440(e)
				) shall be available without prior approval upon the request of the
				manufacturer, unless otherwise designated by the Director. In such a case, the
				Director shall submit the new dosage strength, or new form, to the prior
				approval procedures described in this Section.
9) To ensure all Board members and the
				Department have the same information regarding drug products, drug
				manufacturers shall provide, in writing, all relevant drug product information
				to the Department and the Board in its entirety. The Board shall only consider
				information given to both the entire Board and the Department when reviewing a
				drug product.
10) The Board shall
				evaluate drug products in an impartial manner, and base recommendations on
				clinical and cost effectiveness factors.
11) Board members shall make motions and take
				votes during the meeting, and the Department shall record the results in the
				meeting minutes.
12) The Department
				shall make a final determination on the status of drug products reviewed by the
				Board. Final determinations will be made using complete clinical and financial
				information received by the Department. The Department shall notify the Board
				and the affected manufacturers of all final determinations within 30 business
				days after receipt of a recommendation from the Board.
13) Drug manufacturers shall be afforded an
				opportunity to request reconsideration of products recommended for prior
				approval or non-preferred status. The drug manufacturers may submit any
				information they deem appropriate to support their request for reconsideration
				of the drug product. All reconsideration requests must be submitted in writing
				to the Department for inclusion on the agenda at a subsequent
				meeting.
14) The Department shall
				require that contraceptive drugs and products are available without prior
				approval.