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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