Text: HF02176 Text: HF02178 Text: HF02100 - HF02199 Text: HF Index Bills and Amendments: General Index Bill History: General Index
PAG LIN 1 1 Section 1. NEW SECTION. 249A.20A PREFERRED DRUG 1 2 FORMULARY SPENDING CONTROL PROGRAM. 1 3 1. The department shall establish and implement a 1 4 preferred drug formulary spending control program applicable 1 5 to the provision of medical assistance in accordance with this 1 6 section. 1 7 2. a. A medical assistance pharmaceutical and 1 8 therapeutics committee is created within the department for 1 9 the purpose of developing a preferred drug formulary pursuant 1 10 to 42 U.S.C. } 1396r-8. 1 11 b. The committee shall be comprised as specified in 42 1 12 U.S.C. } 1396r-8 and shall consist of eleven members appointed 1 13 by the governor. Four members shall be physicians, licensed 1 14 pursuant to chapter 148 or 150A, five members shall be 1 15 pharmacists licensed pursuant to chapter 155A, one member 1 16 shall be a consumer representative, and one member shall 1 17 represent the interests of pharmaceutical manufacturers. A 1 18 portion of the appointees shall include representatives of 1 19 medical assistance program participating physicians and 1 20 pharmacists who have experience in either developing or 1 21 practicing under a preferred drug formulary. 1 22 c. The members shall be appointed to terms of two years. 1 23 Members may be appointed to more than one term. The 1 24 department shall provide staff for the committee. 1 25 d. Committee members shall select a chairperson and a vice 1 26 chairperson annually from the committee membership. 1 27 e. The committee shall meet at least quarterly and may 1 28 meet at other times at the discretion of the chairperson. 1 29 3. a. The committee shall recommend a preferred drug 1 30 formulary to the department established in accordance with 42 1 31 U.S.C. } 1396r-8. The committee shall develop the preferred 1 32 drug formulary recommendations by considering the drug's 1 33 clinically meaningful therapeutic advantage in terms of 1 34 safety, effectiveness, or clinical outcome. 1 35 b. The department shall adopt by rule a preferred drug 2 1 formulary applicable to the provision of medical assistance 2 2 based upon the recommendations of the committee. 2 3 c. To the extent possible, the committee shall review all 2 4 drug classes included in the formulary at least every twelve 2 5 months, and may recommend additions to and deletions from the 2 6 formulary, so that the formulary provides for medically 2 7 appropriate drug therapies for medical assistance recipients 2 8 and achieves cost savings to the medical assistance program. 2 9 4. a. The department may negotiate supplemental rebates 2 10 from manufacturers that are in addition to those required by 2 11 Title XIX of the federal Social Security Act and at no less 2 12 than ten percent of the average manufacturer price as defined 2 13 in 42 U.S.C. } 1396r-8(k)(1) on the last day of a quarter, 2 14 unless the federal or supplemental rebate, or both, equals or 2 15 exceeds twenty-five percent. An upper limit on the 2 16 supplemental rebates the department may negotiate shall not be 2 17 established. 2 18 b. The department may determine that specific products, 2 19 brand-name or generic, are competitive at lower rebate 2 20 percentages. Agreement to pay the minimum supplemental rebate 2 21 percentage shall guarantee a manufacturer that the committee 2 22 will consider a product for inclusion on the preferred drug 2 23 formulary. However, a pharmaceutical manufacturer is not 2 24 guaranteed placement on the formulary simply by paying the 2 25 minimum supplemental rebate. 2 26 c. The department may contract with an outside entity or 2 27 contractor to conduct negotiations for supplemental rebates. 2 28 d. For the purposes of this subsection, the term 2 29 "supplemental rebates" may include, at the department's 2 30 discretion, cash rebates and other program benefits that 2 31 offset a medical assistance expenditure. The program benefits 2 32 may include, but are not limited to, disease management 2 33 programs, drug product donation programs, drug utilization 2 34 control programs, prescriber and beneficiary counseling and 2 35 education, fraud and abuse initiatives, and other services or 3 1 administrative investments with guaranteed savings to the 3 2 medical assistance program. 3 3 5. With the exception of mental health-related drugs, 3 4 antiretroviral drugs, and drugs for health care facility 3 5 residents, reimbursement of drugs not included in the 3 6 formulary is subject to prior authorization. 3 7 6. The department shall publish and disseminate the 3 8 preferred drug formulary to all medical assistance providers 3 9 in the state. 3 10 7. The committee shall ensure that pharmaceutical 3 11 manufacturers agreeing to provide a supplemental rebate as 3 12 provided in this section have an opportunity to present 3 13 evidence supporting inclusion of a product on the preferred 3 14 drug formulary. Upon timely notice, the department shall 3 15 ensure that any drug that has been approved or had any of its 3 16 particular uses approved by the United States food and drug 3 17 administration under a priority review classification will be 3 18 reviewed by the committee at the next regularly scheduled 3 19 meeting. To the extent possible, upon notice by a 3 20 manufacturer, the department shall also schedule a product 3 21 review for any new product at the next regularly scheduled 3 22 meeting. 3 23 8. The committee may also make recommendations to the 3 24 department regarding the prior authorization of any prescribed 3 25 drug covered under the medical assistance program. 3 26 9. The department shall seek any federal waivers necessary 3 27 to implement this program. 3 28 EXPLANATION 3 29 This bill directs the department of human services to 3 30 establish and implement a preferred drug formulary spending 3 31 control program applicable to the provision of medical 3 32 assistance. The bill creates the medical assistance 3 33 pharmaceutical and therapeutics committee, within the 3 34 department, to develop a preferred drug formulary in 3 35 accordance with federal law. The committee is comprised of 11 4 1 members appointed by the governor. Four members are to be 4 2 physicians, five members are to be pharmacists, one member is 4 3 to be a consumer representative, and one member is to be a 4 4 representative of the interests of pharmaceutical 4 5 manufacturers. A portion of the appointees is to include 4 6 representatives of medical assistance program participating 4 7 physicians and pharmacists. The bill provides procedural 4 8 requirements for the committee. 4 9 The committee is directed to recommend a preferred drug 4 10 formulary to the department in accordance with federal law. 4 11 The recommendations are to be developed by the committee 4 12 considering the drug's clinically meaningful therapeutic 4 13 advantage in terms of safety, effectiveness, or clinical 4 14 outcome. The bill directs the department to adopt by rule a 4 15 preferred drug formulary applicable to the provision of 4 16 medical assistance based upon the recommendations of the 4 17 committee. The bill directs the committee, to the extent 4 18 possible, to review all drug classes included in the formulary 4 19 at least every 12 months, and to recommend additions to and 4 20 deletions from the formulary. 4 21 The bill authorizes the department to negotiate 4 22 supplemental rebates from manufacturers that are in addition 4 23 to those required by Title XIX of the federal Social Security 4 24 Act based upon a rebate percentage. Under the bill, an 4 25 agreement to pay the minimum supplemental rebate percentage 4 26 guarantees a manufacturer that the committee will consider a 4 27 product for inclusion on the preferred drug formulary, but a 4 28 manufacturer is not guaranteed placement on the formulary 4 29 solely by paying the minimum supplemental rebate. 4 30 "Supplemental rebate" may include cash rebates and other 4 31 program benefits such as disease management programs, drug 4 32 product donation programs, drug utilization control programs, 4 33 prescriber and beneficiary counseling and education, fraud and 4 34 abuse initiatives, and other services or administrative 4 35 investments with guaranteed savings to the medical assistance 5 1 program. The bill authorizes the department to contract with 5 2 an outside entity or contractor to conduct negotiations for 5 3 supplemental rebates. The bill provides that with few 5 4 exceptions, reimbursement of drugs not included in the 5 5 formulary is subject to prior authorization. 5 6 The bill directs the department to seek any federal waivers 5 7 necessary to implement the program, and provides that the 5 8 committee may also make recommendations to the department 5 9 regarding the prior authorization of any prescribed drug 5 10 covered under the medical assistance program. 5 11 LSB 5636YH 79 5 12 pf/cf/24
Text: HF02176 Text: HF02178 Text: HF02100 - HF02199 Text: HF Index Bills and Amendments: General Index Bill History: General Index
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