SECTION 354.1923. Review and Evaluation

(a) The Health and Human Services Commission (Commission) reviews Certifications of Information to determine the need for a drug to be added to the Texas Drug Code Index and to determine the need for restrictions, when appropriate. In determining need, the Commission considers the following:

(1) expansion of the prescriber's armamentarium by a new drug entity or an additional multiple source drug;

(2) the predominant use of the drug in an outpatient setting;

(3) the cost of the drug to pharmacies compared to:

(A) relevant costs as published in price reporting compendia;

(B) the drug company's prices for the drug in other packaging sizes;

(C) the Average Manufacturer Price (AMP) as defined by 42 U.S.C. 1396r-8(k), as amended; and

(D) other generically equivalent drug products; and

(4) whether the drug is part of a category that is subject to inclusion in a preferred drug list (PDL) under §354.1924 of this division (relating to Preferred Drug List). If a drug is subject to inclusion in the PDL, the manufacturer or labeler's provision of supplemental rebates will be considered when determining whether the product is subject to prior authorization.

(b) The Commission may return a Certification of Information for any of the following reasons:

(1) discovery of false, erroneous, or incomplete information or documentation in the Certification of Information;

(2) failure of the drug company to provide the Commission with documentation of the:

(A) approved New Drug Application or Abbreviated New Drug Application, if applicable; or

(B) Food and Drug Administration (FDA) approval for marketing;

(3) failure of the drug company to provide the Commission with the National Drug Code, as defined by and filed with the FDA, for the drug product as shown on the drug product container sold to the pharmacy; or

(4) failure of the drug company to provide the Commission with current prices for the pricing points on the Certification of Information.

(c) The Commission may deny a request if it determines that the drug is included in one or more of the following classes:

(1) amphetamines, when used for weight loss, and obesity control drugs;

(2) appliances;

(3) cosmetics;

(4) DESI-ineffective products;

(5) diagnostic aids;

(6) durable medical equipment (rental or purchase);

(7) elastic stockings;

(8) experimental drugs;

(9) fertility drugs;

(10) first aid supplies;

(11) immunizing agents;

(12) irrigating sets;

(13) IV sets;

(14) medical devices;

(15) medical supplies;

(16) oxygen;

(17) products unsuitable for use outside of physician offices or health care facilities;

(18) shampoos, unless medicated for parasite control;

(19) skin lotions and creams (nonlegend cosmetic types);

(20) soaps and soap substitutes;

(21) supports and suspensories;

(22) syringes and needles;

(23) unit-dose or convenience packaging;

(24) vitamin and antianemia combinations;

(25) medical foods; and/or

(26) nutritional supplements.

Source Note: The provisions of this §354.1923 adopted to be effective November 16, 1987, 12 TexReg 3553; amended to be effective October 28, 1988, 13 TexReg 5207; amended to be effective January 1, 1991, 16 TexReg 4630; transferred effective September 1, 1993, as published in the Texas Register September 7, 1993, 18 TexReg 5978; transferred effective September 1, 2001, as published in the Texas Register May 24, 2002, 27 TexReg 4562; amended to be effective June 19, 2003, 28 TexReg 4541; amended to be effective November 16, 2003, 28 TexReg 9802; amended to be effective January 14, 2013, 37 TexReg 8462;amended to be effective May 15, 2016, 41 TexReg 3291