By Uresti H.B. No. 2999 77R3345 MCK-D A BILL TO BE ENTITLED 1-1 AN ACT 1-2 relating to creating a prescription drug purchasing program. 1-3 BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF TEXAS: 1-4 SECTION 1. Subtitle B, Title 2, Health and Safety Code, is 1-5 amended by adding Chapter 48 to read as follows: 1-6 CHAPTER 48. PRESCRIPTION DRUG PROGRAM 1-7 SUBCHAPTER A. GENERAL PROVISIONS 1-8 Sec. 48.001. DEFINITIONS. In this chapter: 1-9 (1) "Labeler" means an entity that: 1-10 (A) receives prescription drugs from a 1-11 manufacturer or wholesaler and repackages those drugs for later 1-12 retail sale; and 1-13 (B) has a labeler code from the federal Food and 1-14 Drug Administration under 21 C.F.R. Section 207.20. 1-15 (2) "Manufacturer" means a manufacturer of 1-16 prescription drugs, including a subsidiary or affiliate of a 1-17 manufacturer. 1-18 (3) "Participating retail pharmacy" means a retail 1-19 pharmacy or other business licensed to dispense prescription drugs 1-20 in this state that participates in the state Medicaid program or 1-21 voluntarily agrees to participate in the prescription drug program. 1-22 (Sections 48.002-48.050 reserved for expansion 1-23 SUBCHAPTER B. PRESCRIPTION DRUG PROGRAM 1-24 Sec. 48.051. PRESCRIPTION DRUG PROGRAM. The prescription 2-1 drug program is a program within the department designed to lower 2-2 prescription drug prices for uninsured and underinsured residents 2-3 of the state. 2-4 Sec. 48.052. REBATE AGREEMENT. A manufacturer or labeler 2-5 that sells prescription drugs in this state may voluntarily elect 2-6 to enter into a rebate agreement with the department. 2-7 Sec. 48.053. REBATE AMOUNT. The commissioner shall 2-8 negotiate the terms of the rebate from a manufacturer or labeler, 2-9 taking into consideration: 2-10 (1) the rebate calculated under the Medicaid Rebate 2-11 Program under 42 U.S.C. Section 1396r-8; 2-12 (2) the average wholesale price of prescription drugs; 2-13 and 2-14 (3) any other available information on prescription 2-15 drug prices and price discounts. 2-16 Sec. 48.054. FAILURE TO AGREE. (a) If the commissioner and 2-17 a manufacturer or labeler fail to reach an agreement on the terms 2-18 of a rebate, the commissioner shall determine whether to place the 2-19 manufacturer's or labeler's products on the prior authorization 2-20 list for the state Medicaid program or any other state-funded 2-21 prescription drug program. 2-22 (b) The commission by rule shall implement this section. 2-23 The names of manufacturers and labelers that do not enter into 2-24 rebate agreements are public information, and the department shall 2-25 publish the information on the department's Internet site. 2-26 (c) The department shall distribute to doctors, pharmacists, 2-27 and other health professionals information about the relative cost 3-1 of drugs produced by manufacturers and labelers that enter into 3-2 rebate agreements compared to manufacturers and labelers that do 3-3 not enter into rebate agreements. 3-4 Sec. 48.055. DISCOUNTED PRICES FOR PRESCRIPTION DRUG PROGRAM 3-5 PARTICIPANTS. (a) A participating retail pharmacy shall discount 3-6 the price of prescription drugs sold to prescription drug program 3-7 participants. 3-8 (b) The department shall establish discounted prices for 3-9 drugs covered by a rebate agreement and shall promote the use of 3-10 effective and reduced-cost drugs, taking into consideration reduced 3-11 prices for state and federally capped drug programs, differential 3-12 dispensing fees, administrative overhead, and incentive payments. 3-13 (c) A participating retail pharmacy shall offer prescription 3-14 drugs at or below the average wholesale price, minus six percent, 3-15 plus a dispensing fee designated by the department. The initial 3-16 price levels shall be calculated by the department, and the 3-17 dispensing fee may not be less than that provided under the state 3-18 Medicaid program. The average wholesale price is the wholesale 3-19 price charged on a specific commodity that is assigned by the drug 3-20 manufacturer and is listed in a nationally recognized drug pricing 3-21 file. 3-22 (d) A participating retail pharmacy shall offer prescription 3-23 drugs at or below the initial price levels specified under 3-24 Subsection (b) minus the amount of any rebate paid by the state to 3-25 the retail pharmacy. The discounted price levels shall be 3-26 calculated by the department. In determining the discounted price 3-27 levels, the department shall consider an average of all rebates 4-1 weighted by sales of drugs subject to the rebates over the most 4-2 recent 12-month period for which the information is available. 4-3 Sec. 48.056. ELIGIBILITY OF INDIVIDUALS TO PARTICIPATE IN 4-4 PRESCRIPTION DRUG PROGRAM. All residents of the state are eligible 4-5 to participate in the prescription drug program. The department 4-6 shall establish simplified procedures for issuing prescription drug 4-7 program enrollment cards to eligible residents. The department 4-8 shall undertake outreach efforts to build public awareness of the 4-9 prescription drug program and maximize enrollment by eligible 4-10 residents. 4-11 Sec. 48.057. OPERATION OF PRESCRIPTION DRUG PROGRAM. (a) 4-12 The Texas State Board of Pharmacy shall adopt rules requiring 4-13 participating retail pharmacies to disclose to prescription drug 4-14 program participants the amount of savings provided as a result of 4-15 the prescription drug program. The rules must protect information 4-16 that is proprietary in nature. 4-17 (b) The department may not impose transaction charges on 4-18 participating retail pharmacies that submit claims or receive 4-19 payments under the prescription drug program. 4-20 (c) A participating retail pharmacy shall submit claims to 4-21 the department to verify the amount charged to prescription drug 4-22 program participants. On a weekly or biweekly basis, the 4-23 department shall reimburse a retail pharmacy for discounted prices 4-24 provided to prescription drug program participants and dispensing 4-25 fees set by the department. 4-26 (d) The department shall collect from the participating 4-27 retail pharmacies utilization data necessary to calculate the 5-1 amount of the rebate from the manufacturer or labeler. The 5-2 department shall protect the confidentiality of all information 5-3 subject to confidentiality protection under state or federal law, 5-4 rule, or regulation. 5-5 Sec. 48.058. DISCREPANCIES IN REBATE AMOUNTS. (a) 5-6 Discrepancies in rebate amounts must be resolved using the process 5-7 established in this section. 5-8 (b) If there is a discrepancy in the manufacturer's or 5-9 labeler's favor between the amount claimed by a participating 5-10 retail pharmacy and the amount rebated by the manufacturer or 5-11 labeler, the department, at the department's expense, may hire a 5-12 mutually agreed-on independent auditor. If a discrepancy still 5-13 exists following the audit, the manufacturer or labeler shall 5-14 justify the reason for the discrepancy or make payment to the 5-15 department for any additional amount due. 5-16 (c) If there is a discrepancy against the interest of the 5-17 manufacturer or labeler in the information provided by the 5-18 department to the manufacturer or labeler regarding the 5-19 manufacturer's or labeler's rebate, the manufacturer or labeler, at 5-20 the manufacturer's or labeler's expense, may hire a mutually 5-21 agreed-on independent auditor to verify the accuracy of the data 5-22 supplied to the department. If a discrepancy still exists 5-23 following the audit, the department shall justify the reason for 5-24 the discrepancy or refund to the manufacturer any excess payment 5-25 made by the manufacturer or labeler. 5-26 (d) After the results of an audit are received, the 5-27 department or the manufacturer or labeler may request a hearing by 6-1 filing a statement with the department requesting a hearing and 6-2 providing supporting documentation. 6-3 Sec. 48.059. DEDICATED ACCOUNT. (a) The prescription drug 6-4 program account is a dedicated account in the general revenue fund. 6-5 The account consists of money received from manufacturers and 6-6 labelers that pay rebates and any appropriations or allocations 6-7 designated for the fund. 6-8 (b) The legislature may appropriate money deposited to the 6-9 credit of the prescription drug program account only to the 6-10 department to reimburse: 6-11 (1) participating retail pharmacies for discounted 6-12 prices provided to prescription drug program participants; and 6-13 (2) the department for the costs of administering the 6-14 program, including costs of contracted services, computer costs, 6-15 professional fees paid to participating retail pharmacies, and 6-16 other reasonable program costs. 6-17 (c) Interest earned from the investment of the prescription 6-18 drug program account shall be deposited to the credit of the 6-19 account. 6-20 Sec. 48.060. ANNUAL REPORT. Not later than January 1 of 6-21 each year, the department shall report to the legislature the 6-22 enrollment and financial status of the prescription drug program. 6-23 Sec. 48.061. COORDINATION WITH OTHER PROGRAMS. If the 6-24 department determines that it is beneficial, the department may 6-25 combine drug pricing negotiations for the prescription drug program 6-26 and other state programs, including the Medicaid program, to 6-27 maximize drug rebates. 7-1 Sec. 48.062. RULES. The board may adopt rules necessary to 7-2 administer this chapter. 7-3 SECTION 2. If before implementing this Act a state agency 7-4 determines that a waiver or authorization from a federal agency is 7-5 necessary to implement a provision of this Act, the state agency 7-6 shall request the waiver or authorization and may delay 7-7 implementing the provision until the waiver or authorization is 7-8 granted. 7-9 SECTION 3. This Act takes effect September 1, 2001.